옵션 체인은 다양한 행사가격과 만기일에 대한 Roche Holding의 주식 옵션 주요 데이터를 보여줍니다. 트레이더들은 이 정보를 사용하여 잠재적 거래를 분석하고 Roche Holding에 대한 시장 심리를 평가합니다..

Roche Holding (OTC:RHHBY) 주식, 옵션 체인

Roche Holding

ROCHE HLDG LTD SPONS

Roche is a Swiss biopharmaceutical and diagnostic company. The firm's bestselling pharmaceutical products include a variety of oncology therapies from acquired partner Genentech, and its diagnostics group was bolstered by the acquisition of Ventana in 2008. Oncology products account for 50% of pharmaceutical sales, and centralized and point-of-care diagnostics for more than half of diagnostic-related sales.

Medical,Billing,Document,And,Dollar,Banknote,,Calculator,,Stathoscope.,Medical,Treatment

Health Care

Markets

AMGN

REGN

RHHBY

일요일(11일) 도널드 트럼프 대통령은 트루스 소셜을 통해 처방약 가격 인하를 목표로 하는 미국 역사상 &#34;가장 중대한 행정명령&#34;에 서명할 계획이라고 발표했다.무슨 일 있었나: 트럼프 대통령은 월요일(12일) 오전 9시에 서명할 예정인 행정명령은 제약사가 미국 소비자에게 다른 국가에서 동일한 의약품에 대해 제공하는 최저 가격 이상을 청구하지 않도록 요구하는 &#34;최혜국대우&#34; 정책을 시행할 것이라고 했다.

트럼프의 처방약 가격 인하 행정명령으로 제약주 흔들···노보 노디스크, 화이자 및 존슨앤드존슨 프리마켓 하락세

Stethoscope,Laying,On,Medicine,White,Pills,Money,With,Rx,Prescription

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UCBJY

도널드 트럼프 대통령은 화요일(8일) 외국 의약품에 대한 &#34;주요 관세&#34; 계획을 공개했다.트럼프 대통령은 전국공화당의회위원회(NRCC) 만찬에서 이렇게 말했다. &#34;우리는 곧 의약품에 대한 주요 관세를 발표할 것이다...관세 소식을 들으면 회사들은 중국을 떠날 것이다...대부분 제품이 미국에서 판매되기 때문이다.&#34;

트럼프의 의약품 관세 계획...뱅크오브아메리카에서 제시한 타임라인은?

weight loss ai

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Global

BHVN

GPCR

스트럭처 테라퓨틱스(NASDAQ:GPCR)의 주식은 비만 치료제 시장에서 잠재적인 승자로 지목되었다. JP모건은 주식에 상당한 상승 잠재력을 부여했다. What Happened: JP모은 생명공학 회사인 스트럭처 테라퓨틱스에 대해 &#34;비중확대(Overweight)&#34; 등급과 목표 주가를 65달러로 이 주식의 커버리지를 시작했다. 이는 현재 수준보다 80%의 잠재적 상승여력을 나타낸다. 비지니스 인사이더(Business Insider)에 따르면 은행은 빠르게 성장하는 GLP-1 체중 감량 약물 시장에서 스트럭처 테라퓨틱스를 주요 업체로 확인했다.

스트럭처 테라퓨틱스 주식은 비만 치료제 시장의 돌파구로 80% 상승 예상: JP모건

ROCHE HOLDING LTD S/ADR by Roche Holding Ltd

Roche Holding AG

On Monday, HC Wainwright initiated coverage on Septerna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEPN#NASDAQ">SEPN</a>), citing a next-generation drug design platform aimed at <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">hitherto-undruggable targets</a>.
Septerna is working on G protein-coupled receptor (GPCR) drug discovery powered by its proprietary Native Complex Platform. Its industrial-scale platform aims to unlock the full <a href="https://www.benzinga.com/pressreleases/25/05/g45450781/septerna-highlights-business-progress-and-reports-first-quarter-2025-financial-results" target="_blank" rel="noreferrer noopener">potential of GPCR therapies</a>.
It has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs" target="_blank" rel="noreferrer noopener">Novo Nordisk Inks $2.2 Billion Deal With Septerna To Develop Oral Weight Loss And Diabetes Drugs</a>
Analyst Raghuram Selvaraju, in his report, highlighted several compelling factors for investors.
He pointed out that &#8220;Septerna trades at a discount to its most recently reported cash position and upfront cash from a recently-inked partnership.&#8221; 
This, he argues, makes Septerna &#8220;a risk-mitigated opportunity with multiple shots on goal and catalysts constituting key value inflection points slated to accrue over the next six to 12 months.&#8221;
HC Wainwright has initiated coverage on the biotechnology firm with a Buy rating and a <a href="https://www.benzinga.com/quote/SEPN/analyst-ratings">price forecast of $26</a>.
The company&#8217;s most advanced drug candidate, SEP-631, is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) in development for mast cell diseases, including chronic spontaneous urticaria (CSU).
Wainwright believes SEP-631 could offer a distinct treatment option for CSU patients. This is due to its selective inhibition of mast cells, convenient oral administration, and potential for combination therapy. 
Selvaraju further noted that if SEP-631 can replicate the efficacy of Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>)/Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Xolair (omalizumab) – an anti-IgE monoclonal antibody that generated nearly $3.9 billion in sales in 2023, it &#8220;could readily achieve blockbuster status based on an enhanced convenience profile.
Further solidifying its position, Septerna recently announced an exclusive global collaboration and license agreement with Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) in May. 
This <a href="https://www.benzinga.com/general/biotech/25/05/45407486/novo-nordisk-inks-22-billion-deal-with-septerna-to-develop-oral-weight-loss-and-diabetes-drugs">significant pact</a> covers the discovery, development, and commercialization of oral small-molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases, with<a href="https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916006"> four development programs</a> initially commencing. 
HC Wainwright underscored the financial implications of this partnership, stating, &#8220;given the size of the upfront and near-term milestone payments, we feel that Septerna&#8217;s implied enterprise value is either negligible or actually negative, further mitigating risk and underscoring the extent to which the company appears undervalued.&#8221;
Price Action: SEPN stock is trading higher by 0.38% to $10.51 at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/news/management/25/05/45466201/ozempic-maker-novo-nordisk-looks-for-new-chief-jorgensen-steps-down" target="_blank" rel="noreferrer noopener">Ozempic Maker Novo Nordisk Looks For New Chief, Jørgensen Steps Down From CEO Role</a></li>
</ul>
Photo via Shutterstock

Price Target

Initiation

SEPN

Analyst Flags Septerna As Undervalued Biotech Play With Significant Upside

On Sunday, Exelixis, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXEL#NASDAQ">EXEL</a>) revealed topline results from the STELLAR-303 phase 3 pivotal trial of zanzalintinib (100 mg) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46044198/exelixis-announces-zanzalintinib-in-combination-with-an-immune-checkpoint-inhibitor-improved-overa" rel="noreferrer noopener">combined with atezolizumab</a>.
The study includes patients with previously treated non-microsatellite instability (MSI)-high <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">metastatic colorectal cancer (CRC)</a>.
Zanzalintinib in combination with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) Stivarga (regorafenib).
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45418036/exelixis-stock-soars-as-analysts-applaud-raised-2025-guidance-q1-earnings-beat" target="_blank" rel="noreferrer noopener">Exelixis Stock Soars As Analysts Applaud Raised 2025 Guidance, Q1 Earnings Beat</a>
These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial.
The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).
The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.
Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.
Following this positive news, analysts at William Blair said that the announcement &#8220;represents the first pivotal success from the zanzalintinib program, and we are encouraged that the STELLAR-303 study met one of the dual primary endpoints of overall survival among the intent-to-treat population, representing the largest commercial opportunity (risk-adjusted U.S. peak sales of $875 million, according to our estimates).&#8221;
Management had earlier projected that zanzalintinib could reach $5 billion in U.S. net product sales by 2033, with 45% expected from genitourinary cancers, another 45% from gastrointestinal cancers, and the remaining 10% from head-and-neck cancers. Analyst Andy Hsieh asserted that the early positive results from the STELLAR-303 trial mark the first step toward reaching that target.
He added, &#8220;From a stock perspective, given its substantial and likely durable cash flow generation into early 2030, we continue to believe Exelixis provides investors with a highly defensive investment profile. We also believe that the strategic positioning outlined by Exelixis should drive moderate growth into the next decade.&#8221;
Adding to Exelixis&#8217; recent positive developments, its partner Ipsen also recently achieved a regulatory milestone.
On Friday, Exelixis&#8217; partner Ipsen received a positive opinion from the European Medicine Agency&#8217;s Committee for Medicinal Products for Human Use for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" rel="noreferrer noopener">other than somatostatin analogs</a>.
A regulatory decision by the European Medicines Agency is anticipated in 2025. In March 2025, the U.S. Food and Drug Administration approved <a href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" target="_blank" rel="noreferrer noopener">Cabometyx in this setting</a>.
Price Action: EXEL stock is trading higher by 11.1% to $44.85 at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/biotech/25/05/45703024/pfizer-reports-survival-gains-in-colorectal-cancer-study-combo-therapy-cuts-death-risk-by-over-50" target="_blank" rel="noreferrer noopener">Pfizer Reports Survival Gains In Colorectal Cancer Study, Combo Therapy Cuts Death Risk By Over 50%</a></li>
</ul>
Photo via Shutterstock

BAYRY

EXEL

Exelixis' Zanzalintinib Combo Boosts Survival In Colorectal Cancer, Stock Soars

<figure class="wp-block-image aligncenter size-full"><img loading="lazy" decoding="async" width="896" height="504" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes.jpg" alt="" class="wp-image-14732" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes.jpg 896w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes-300x169.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23064915/Syringes-768x432.jpg 768w" sizes="(max-width: 896px) 100vw, 896px" /></figure>
Two Biotechs Poised For Big Moves On Monday (Sana Biotechnology &#x7C; Lineage Cell Therapeutics)
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">1&#xFE0F;&#x20E3; Sana Biotechnology</h3>
Sana Biotechnology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SANA#NASDAQ">SANA</a>)
Catalyst: Invited six-month clinical update — ADA Scientific Sessions, Monday @ 10:30 a.m. CT <a href="https://ir.sana.com/news-releases/news-release-details/sana-biotechnology-announces-invited-oral-presentation-85th?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">ir.sana.com</a><a href="https://www.globenewswire.com/news-release/2025/06/09/3096183/0/en/Sana-Biotechnology-Announces-Invited-Oral-Presentation-at-the-85th-Annual-American-Diabetes-Association-Scientific-Sessions.html?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">globenewswire.com</a>
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>What we'll hear</th>
<th>Why it matters</th>
</tr>
</thead>
<tbody>
<tr>
<td>First-in-human data on UP421, a hypoimmune‐modified islet-cell therapy for Type 1 diabetes</td>
<td>• One treated patient is six months insulin- &amp; immunosuppression-free. • If replicated, UP421 could leapfrog donor-islet transplants, the current gold standard that still requires lifelong immunosuppression.</td>
</tr>
<tr>
<td>Safety &amp; durability profile through 180 days</td>
<td>• The ADA crowd is data‐driven: low adverse events and durable C-peptide levels would de-risk the platform.</td>
</tr>
<tr>
<td>Expansion path (multi-patient cohort)</td>
<td>• Positive signals open the door to "breakthrough" or RMAT dialogue with FDA, accelerating timelines.</td>
</tr>
</tbody>
</table>
</figure>
Why the stock could pop Monday
<ul class="wp-block-list">
<li>Audience effect: the ADA meeting pulls in ~11-12 k registrants; roughly 3–4 k are adult endocrinologists who influence treatment paradigms and often trade or recommend names they've just seen. <a href="https://www.breakthrought1d.org/news-and-updates/adas-85th-scientific-sessions/?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">breakthrought1d.org</a></li>
<li>Scarcity value: no other public company has shown insulin independence without immunosuppression.</li>
<li>Float dynamics: SANA's free float is only ~24 % of shares outstanding; a modest uptick in buy-interest can move the tape quickly.</li>
</ul>
Watch-for: If the single-patient success extends to the next two patients in cohort B, look for sell-side upgrades and chatter about a pivotal trial design in H2-25.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">2&#xFE0F;&#x20E3; Lineage Cell Therapeutics</h3>
Lineage Cell Therapeutics, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LCTX#NYSE">LCTX</a>)
Catalyst window: Genentech PR "within weeks" + 36-month OpRegen&#xAE; read-out at CTS-2025 (June 27) <a href="https://www.businesswire.com/news/home/20250512395886/en/RG6501-OpRegen-Phase-12a-Clinical-Study-36-Month-Results-to-Be-Featured-at-Clinical-Trials-at-the-Summit-2025?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">businesswire.com</a><a href="https://www.businesswire.com/news/home/20250605204221/en/Lineage-Cell-Therapeutics-Announces-Updates-to-the-3rd-Annual-Spinal-Cord-Injury-Investor-Symposium?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">businesswire.com</a><a href="https://www.modernretina.com/view/lineage-to-announce-data-from-phase-1-2a-study-on-use-of-rg6501?utm_source=chatgpt.com" target="_blank" rel="noreferrer noopener">modernretina.com</a>
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>What could hit</th>
<th>Price-sensitive angle</th>
</tr>
</thead>
<tbody>
<tr>
<td>Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) subsidiary Genentech/LCTX services-agreement milestones or data-share PR</td>
<td>• Prior Genentech press releases on OpRegen have triggered double-digit one-day moves in LCTX.</td>
</tr>
<tr>
<td>36-month functional vision data (phase 2a, GA secondary to AMD)</td>
<td>• If BCVA gains remain ≥7 letters and lesion growth stays slowed, analysts will start modelling blockbuster-size royalties.</td>
</tr>
<tr>
<td>Potential partner opt-in for spinal cord (SCIIS meeting)</td>
<td>• Separately, Lineage tees-up a June 27 investor symposium on spinal cord injury – any strategic partner news adds another risk-on spark.</td>
</tr>
</tbody>
</table>
</figure>
Why Monday could be the start of a new leg
<ul class="wp-block-list">
<li>Pattern set-up: the stock has been basing in the $1.60–1.80 zone; traders remember the May 2024 Genentech PR that drove a 40 % gap.</li>
<li>Valuation gap: LCTX trades at &lt; 3× 2026e OpRegen royalty sales versus cell-therapy peers at 8–10×.</li>
<li>Short-term IV low: front-month at-the-money calls imply a ±12 % move by July — well under the 20–30 % jumps we saw on the last three data bursts.</li>
</ul>
Watch-for: A Monday-morning 8-K or Genentech newsroom post; if nothing drops, option premiums may leak until later in the week — keep a trading tranche nimble.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">Tactical takeaways</h3>
<ol class="wp-block-list">
<li>SANA: momentum play into the ADA deck. Small float + novel cure angle = potential volatility.</li>
<li>LCTX: event-driven swing; even a "PR-then-data" one-two punch could squeeze shorts.</li>
<li>Risk management: both names are clinical-stage — size positions modestly, use stops, and consider call-spreads to bound downside.</li>
</ol>
<hr class="wp-block-separator has-alpha-channel-opacity" />
Bottom line: Monday's calendar lines up two asymmetric biotech shots: If Sana's six-month data look anything like the first patient's, endocrinologists will be talking — and buying — before lunch. If Lineage's big-pharma partner steps back into the headlines, we could see the May-style pop all over again.
<hr class="wp-block-separator has-alpha-channel-opacity" />
<h3 class="wp-block-heading">Our positions in both stocks</h3>
Portfolio Armor Substack subscribers and I are long SANA and LCTX via options. I wrote about SANA <a href="https://www.benzinga.com/general/biotech/25/05/45498697/the-end-of-the-diabetes-industry-this-small-cap-could-upend-the-business-models-of-pharma-giants">here</a>.
<figure class="wp-block-image size-full"><a href="https://portfolioarmor.substack.com/p/the-end-of-the-diabetes-industry"><img loading="lazy" decoding="async" width="828" height="812" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA.jpg" alt="" class="wp-image-14724" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA.jpg 828w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA-300x294.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050427/SANA-768x753.jpg 768w" sizes="(max-width: 828px) 100vw, 828px" /></a></figure>
And I first wrote about LCTX <a href="https://portfolioarmor.substack.com/p/trade-alert-biotech-lotto-ticket">last Friday</a>. 
<figure class="wp-block-image size-full"><a href="https://portfolioarmor.substack.com/p/trade-alert-biotech-lotto-ticket"><img loading="lazy" decoding="async" width="833" height="733" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX.jpg" alt="" class="wp-image-14725" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX.jpg 833w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX-300x264.jpg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050717/LCTX-768x676.jpg 768w" sizes="(max-width: 833px) 100vw, 833px" /></a></figure>
We plan on selling half of our positions into a strong upward move to lock in profits. 
If you would like a heads up when we place our next trade, feel free to subscribe to the Portfolio Armor Substack below. 
<figure class="wp-block-image aligncenter size-full"><a href="https://portfolioarmor.substack.com/"><img loading="lazy" decoding="async" width="581" height="372" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1.jpg" alt="" class="wp-image-14726" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1.jpg 581w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23050929/Widget-2-1-300x192.jpg 300w" sizes="(max-width: 581px) 100vw, 581px" /></a></figure>
And if you want to limit your downside risk, in light of the conflict in the Mideast, consider <a href="https://apps.apple.com/us/app/portfolio-armor/id394951144">the Portfolio Armor iPhone app</a> or <a href="https://apps.apple.com/us/app/portfolio-armor/id394951144">website</a>. Both will help you scan for the optimal hedge given your risk tolerance and time frame. 
<figure class="wp-block-image aligncenter size-large"><a href="https://apps.apple.com/us/app/portfolio-armor/id394951144"><img loading="lazy" decoding="async" width="1024" height="683" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-1024x683.jpeg" alt="" class="wp-image-14727" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-1024x683.jpeg 1024w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-300x200.jpeg 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2-768x512.jpeg 768w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/06/23051320/PA-JPEG-1-2.jpeg 1200w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>

Long Ideas

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Two Biotech Stocks Poised For Big Moves On Monday

<ul>
<li>Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1</li>
<li>The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3
<ul>
<li>Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261</li>
</ul>
</li>
</ul>

RHHBF

RHHVF

Roche's NXT007 Shows No Treated Bleeds In Highest Dose Groups, Advancing Toward Phase III Trials For Haemophilia A

Sarepta Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) stock experienced a steep decline of approximately 40% in premarket trading on Monday following a sobering safety update for its <a href="https://www.benzinga.com/general/health-care">Duchenne muscular dystrophy (DMD)</a> gene therapy, Elevidys.
<h2 class="wp-block-heading">What Happened</h2>
On Sunday, Sarepta provided a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the company is taking to strengthen the safety profile in non-ambulatory patients.
These steps follow a second reported case of acute liver failure (ALF), <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b45940036/sarepta-provides-safety-update-for-elevidys-and-initiates-steps-to-strengthen-safety-in-non-ambula" rel="noreferrer noopener">resulting in death</a>.
In March,&nbsp;Sarepta Therapeutics reported a patient death following treatment with Elevidys, having suffered <a target="_blank" href="https://www.benzinga.com/25/03/44376919/sarepta-therapeutics-reports-patient-death-post-elevidys-gene-therapy-treatment-stock-plunges" rel="noreferrer noopener">acute liver failure</a>.
The cases of ALF to date have both occurred in non-ambulatory (patients who cannot walk independently) individuals with Duchenne.
Sarepta and Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) temporarily halted several <a target="_blank" href="https://www.benzinga.com/25/04/44634689/sareptaroche-suspend-elevidys-gene-therapy-trials-in-europe-after-patient-death" rel="noreferrer noopener">clinical studies in April</a>.
During its first-quarter earnings release, Sarepta revised its 2025 total net product revenues guidance to $2.3-$2.6 billion <a target="_blank" href="https://www.benzinga.com/25/05/45261806/sarepta-therapeutics-stock-sinks-on-gloomy-forecast-analysts-cut-price-forecasts" rel="noreferrer noopener">from $2.9-$3.1 billion</a>.
William Blair writes that the revised guidance primarily concerns delayed Elevidys turnaround times.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" target="_blank" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a>
<h2 class="wp-block-heading">Key Safety Initiatives</h2>
As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients.
A panel will evaluate data and assess the company&#8217;s proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events.
Sarepta will share the panel&#8217;s recommendations with the U.S. Food &amp; Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance.
In the meantime, Sarepta is temporarily suspending shipments of Elevidys for non-ambulatory patients.
For ambulatory patients, no treatment <a target="_blank" href="https://www.roche.com/investors/updates/inv-update-2025-06-15" rel="noreferrer noopener">changes</a> are being proposed and the current practice of administering corticosteroids before and after Elevidys infusion and post-treatment monitoring remains the same.
Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303).
ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating Elevidys in older ambulatory and non-ambulatory Duchenne muscular dystrophy patients.
In the U.S., it serves as the confirmatory trial required under the FDA&#8217;s accelerated approval pathway for non-ambulatory patients.
Price Action: SRPT stock is trading lower by 42.0% to $21.00 during the premarket session at last check Monday.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/markets/biotech/25/06/45797348/early-wins-regenxbios-gene-therapy-helps-duchenne-patients-walk-stronger-longer" target="_blank" rel="noreferrer noopener">Early Wins: RegenXBio&#8217;s Gene Therapy Helps Duchenne Patients Walk Stronger, Longer</a></li>
</ul>
Photo via Shutterstock

SRPT

Sarepta Therapeutics Stock Plummets Over 40% On Second Fatal Case Linked To Its Gene Therapy

<ul>
<li>Results from Phase IIb PADOVA and longer term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson's disease&nbsp;</li>
<li>Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson's disease progression</li>
<li>Parkinson's disease affects over 10 million people globally and significant unmet need remainS</li>
</ul>

Roche's Genentech Advances Prasinezumab To Phase III After PADOVA And PASADENA Data Suggest Long-Term Benefit In Early Parkinson's Disease

Chugai Pharmaceutical Co. Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CHGCY#OTC">CHGCY</a>) believes its anti-muscle-wasting drug could be used alongside Eli Lilly And Co.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">oral obesity pill</a>, orforglipron.
Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) is a major shareholder of Chugai, a Japanese pharmaceutical company. The company&#8217;s optimism stems from growing evidence that modern weight-loss drugs can lead to significant muscle loss, an issue Chugai thinks it can help address.
Hitoshi Iikura, a senior executive at Chugai, <a target="_blank" href="https://www.ft.com/content/4fd1fd94-0b70-48fb-861b-3bad6286ebae" rel="noreferrer noopener">told</a> the Financial Times the company has &#8220;high expectations&#8221; for combining GYM329, initially developed for spinal muscular atrophy (SMA), with orforglipron or similar therapies.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45769020/mounjaro-maker-eli-lilly-taps-swedish-firm-camurus-to-target-long-acting-obesity-market-in-870-million-deal" rel="noreferrer noopener">Mounjaro Maker Eli Lilly Taps Swedish Firm Camurus To Target Long-Acting Obesity Market In $870-Million Deal</a>
Orforglipron, which Lilly licensed from Chugai, showed strong late-stage trial results, matching the safety and efficacy of popular injectables like Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) Wegovy and Ozempic and Lilly&#8217;s Zepbound and Mounjaro.
The drug significantly <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44934811/eli-lilly-positioned-to-dominate-obesity-market-with-oral-option-analyst-initiates-with-confidence" rel="noreferrer noopener">reduced weight and blood sugar levels</a> and is expected to hit the market next year.
Chugai began developing orforglipron in 2003 as part of an effort to enhance diabetes treatments, aiming to make them longer-acting and tablet-based. Although obesity wasn&#8217;t an initial target, the company saw broader potential as research evolved. &#8220;We didn&#8217;t anticipate it but it&#8217;s ballooning,&#8221; Iikura said, referring to the unexpectedly large obesity market.
Studies suggest that 25% to 39% of weight loss from obesity drugs may be due to lean mass reduction, which includes muscle. Chugai argues that maintaining muscle mass is vital, especially for aging populations, and its GYM329 drug could be a key component in preventing this loss during weight-loss treatment.
Despite Chugai&#8217;s success, Roche had previously passed on orforglipron due to setbacks with an earlier weight-loss drug. At the time, much of the pharmaceutical industry was hesitant to enter the obesity space, except companies like Lilly and Novo Nordisk with strong metabolic disease portfolios.
However, with market interest and scientific breakthroughs accelerating, Roche reversed course in 2023 and <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422774/roche-misses-out-on-weight-loss-blockbuster-drug-now-playing-catch-up-in-booming-market" rel="noreferrer noopener">reentered the field</a>.
Meanwhile, Bloomberg <a target="_blank" href="https://www.bloomberg.com/news/articles/2025-06-07/lilly-s-obesity-drug-sales-rise-60-in-india-amid-rising-demand" rel="noreferrer noopener">reported</a> that Eli Lilly saw a 60% jump in sales of its weight-loss and diabetes drug Mounjaro in India in May compared to April, marking its second full month on the Indian market.
India has the third-largest obese population in the world.
According to market research firm Pharmarack Technologies, the U.S. drugmaker made 126 million rupees ($1.5 million) from Mounjaro injections last month.
Sales of the 5 mg dose more than doubled to 75 million rupees, while the 2.5 mg version brought in 51 million rupees.
According to the Indian Council of Medical Research (ICMR), there are 101 million people with diabetes in India. Of these, at least 40 million are on medication.
Vishal Manchanda, SVP of institutional research at Systematix Group,&nbsp;told&nbsp;Livemint that even if 0.5% of 40 million use Mounjaro, it would fetch Eli Lilly sales of <a target="_blank" href="https://www.benzinga.com/25/04/44824190/eli-lillys-mounjaro-launch-triggers-weight-loss-craze-in-india-novo-nordisk-seeks-to-move-up-wegovy-launch" rel="noreferrer noopener">$1.5 billion annually</a>.
Novo Nordisk&nbsp;is also trying to move up the launch of Wegovy in India to better compete with Lilly.
Price Action: LLY stock closed up 0.55% at $769.88 on Friday.
Read Next:
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<li><a href="https://www.benzinga.com/markets/large-cap/25/06/45814068/novo-nordisks-wegovy-tied-to-increased-risk-of-rare-vision-loss-disorder-european-regulators-say" target="_blank" rel="noreferrer noopener">Novo Nordisk&#8217;s Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say</a></li>
</ul>
Photo via Shutterstock

CHGCY

Eli Lilly's Obesity Drug Success Spurs Japanese Biotech's Anti-Muscle-Wasting Combo Therapy

Jazz Pharmaceuticals plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JAZZ#NASDAQ">JAZZ</a>) on Monday revealed results from the Phase 3 IMforte study of Zepzelca (lurbinectedin) in combination with Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Tecentriq (atezolizumab) as a first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">etoposide and atezolizumab</a>.
The study met both primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to atezolizumab alone, <a href="https://www.benzinga.com/pressreleases/25/06/n45733928/jazz-pharmaceuticals-announces-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-signi">according to a press release</a>. 
IMforte is the first global Phase 3 trial to demonstrate clinically meaningful PFS and OS benefits in the first-line maintenance setting for ES-SCLC. It supports maintenance therapy with&nbsp;Zepzelca plus atezolizumab as a new standard of care for patients.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44140310/jazz-pharma-to-buy-chimerix-for-935-million-strengthening-rare-cancer-pipeline" rel="noreferrer noopener">Jazz Pharma To Buy Chimerix For $935 Million, Strengthening Rare Cancer Pipeline</a>
The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting.
Following induction therapy with carboplatin, etoposide and atezolizumab, patients who did not have disease progression were randomized to receive&nbsp;Zepzelca&nbsp;plus atezolizumab or atezolizumab alone.
Four hundred and eighty-three patients were randomized after completion of four cycles of induction therapy with atezolizumab plus carboplatin and etoposide.
From the point of randomization, the median PFS was 5.4 months for the&nbsp;Zepzelca&nbsp;plus atezolizumab combination versus 2.1 months for atezolizumab alone, and the median OS was 13.2 months versus 10.6 months.
Compared to atezolizumab alone, the combination reduced the risk of disease progression or death by 46% and the risk of death by 27%. The&nbsp;Zepzelca&nbsp;plus atezolizumab combination had no new or unexpected safety signals.
The&nbsp;Zepzelca&nbsp;plus atezolizumab&nbsp;combination as maintenance therapy was generally well tolerated, and no new safety signals were identified.
In the&nbsp;Zepzelca&nbsp;plus atezolizumab&nbsp;and atezolizumab arms, respectively, treatment-related adverse events (TRAEs) occurred in 83.5% versus 40.0% of patients, with Grade 3-4 TRAEs in 25.6% versus 5.8% and Grade 5 TRAEs in 0.8% (two patients with sepsis and febrile neutropenia) versus 0.4% (one patient with sepsis).
AEs led to treatment discontinuation in 6.2% of patients in the Zepzecla plus atezolizumab&nbsp;arm and 3.3% in the atezolizumab arm.
JAZZ Price Action: JAZZ stock is up 2.07% at $110.53 at publication on Tuesday.
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Photo: Shutterstock

JAZZ

Jazz Pharma's Zepzelca Combo Shows Survival Edge In Lung Cancer Study

<ul>
<li>The Itovebi (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone –</li>
<li>The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis –</li>
<li>New data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine</li>
</ul>

Reported Saturday, Genentech's Itovebi-Based Regimen Cuts Risk Of Death By Over 30% In PIK3CA-Mutated HR-Positive, HER2-Negative Advanced Breast Cancer, Phase III INAVO120 Data Show

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Friday announced new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low disease activity levels for up to two years.
The latest <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-05-30" rel="noreferrer noopener">results</a> for this investigational Bruton&#8217;s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.
Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 weeks.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45393806/ten-year-data-from-roches-breast-cancer-trial-shows-perjeta-based-regimen-cuts-death-risk-by-17" rel="noreferrer noopener">Ten-Year Data From Roche&#8217;s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%</a>
During the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS).
MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected.
In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12-week double-blind period to 0.34 by 96 weeks.
The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks.
During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation.
Three Phase 3 trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies are expected at the end of 2025.
In April, Roche announced it would invest $50 billion in the U.S. over&nbsp;the <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" rel="noreferrer noopener">next five years</a>.
These investments further strengthen Roche&#8217;s already significant U.S. footprint, which includes 13 manufacturing and 15 R&amp;D sites across the Pharmaceutical and Diagnostics Divisions.
The investment is expected to&nbsp;<a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-04-22?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">create</a> over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities.
Price Action: RHHBY stock is trading higher by 1.83% to $40.25 at last check Friday.
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<li><a href="https://www.benzinga.com/trading-ideas/movers/25/05/45692578/regeneron-sanofi-stock-falls-after-uneven-smokers-lung-drug-data" target="_blank" rel="noreferrer noopener">Regeneron, Sanofi Stock Falls After Uneven Smoker&#8217;s Lung Drug Data</a></li>
</ul>
Photo by OleksSH via Shutterstock

Roche's Multiple Sclerosis Drug Shows Low Disease Activity Over Two Years

<ul>
<li>- Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment -</li>
<li>- Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end -</li>
</ul>

Roche's Genentech Reports Long-Term Data Showing Fenebrutinib Prevents Active Brain Lesions And MS Disability Progression Over 2 Years

<ul>
<li>Updated data from the pivotal Phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant</li>
<li>89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment</li>
<li>Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease&nbsp;</li>
<li>Results demonstrate potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option&nbsp;</li>
</ul>

Roche's Genentech Highlights Two-Year STARGLO Data: Columvi Plus Chemotherapy Delivers 40% Overall Survival Benefit In Transplant-Ineligible Relapsed Or Refractory DLBCL Patients

Contracts

Watching Roche; Reuters Reports Statement From Co Stating It Plans To Invest Up To 4 Billion Pesos In Clinical Investigation In Mexico In Next 5-Years

<a href="https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease">https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease</a>.

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ANVS

BIIB

DNLI

PRTA

SAVA

'FDA Clears First Blood Test Used In Diagnosing Alzheimer's Disease; New Test Provides Less Invasive Option, Reduces Reliance On Pet Scans And Increases Diagnosis Accessibility' - FDA

Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) on Thursday said the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and in all comers</a>.
The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45418609/fda-approves-mercks-kidney-cancer-drug-for-rare-type-of-neuroendocrine-tumors" rel="noreferrer noopener">FDA Approves Merck&#8217;s Kidney Cancer Drug For Rare Type Of Neuroendocrine Tumors</a>
The study is evaluating Keytruda&nbsp;(pembrolizumab), Merck&#8217;s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Avastin (bevacizumab) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/b45431872/merck-announces-phase-3-keynote-b96-trial-met-primary-endpoint-of-progression-free-survival-pfs-in" rel="noreferrer noopener">for these patients</a>.
The trial continues, and OS for the full study population will be evaluated at a future analysis.
The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.
The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) compared to placebo plus chemotherapy with or without bevacizumab.
&#8220;This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,&#8221; said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
Keytruda is not approved for ovarian cancer.
Lynparza (olaparib), jointly developed by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Merck, has three approved ovarian <a href="https://www.benzinga.com/24/12/42393128/merck-reveals-mixed-data-from-keytrudalynparza-regime-in-ovarian-cancer" target="_blank" rel="noreferrer noopener">cancer indications in the U.S</a>.
In October, Merck&nbsp;announced that the Phase 3 KEYNOTE-689 trial of Keytruda, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma, met its primary endpoint of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/health-care/24/10/41230591/merck-touts-phase-3-success-for-20b-cancer-drug-keytruda-in-untreated-head-and-neck-cancer-pa" rel="noreferrer noopener">event-free survival (EFS)</a>.
Price Action: MRK stock is
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Image: Shutterstock

Merck Data Shows Positive Outcomes For Ovarian Cancer Patients Treated With Keytruda

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced on Wednesday that it will invest at least $20 billion in the <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">U.S. through 2030</a>.
Research and development, plus U.S. manufacturing, will receive the bulk of the spending.
The company also expects higher job creation within the communities where Sanofi and its partners are located, which will help <a href="https://www.benzinga.com/pressreleases/25/05/n45414947/sanofi-to-invest-at-least-20-billion-in-the-us-through-2030-growing-investments-in-science-and-exp" target="_blank" rel="noreferrer noopener">enhance the U.S. supply chain</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44981281/french-drugmaker-sanofi-clocks-20-q1-profit-growth-forecasts-strong-rebound-in-annual-profit" rel="noreferrer noopener">French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit</a>
Sanofi has 13,000 US-based employees, according to CEO Paul Hudson.
&#8220;Our expected investments in the US will be substantial and will help ensure the production of key medicines in the U.S.,&#8221; he added.
Sanofi also expects to partner with other domestic manufacturers to help ensure the production of medicines in the U.S.  
Earlier in May, U.S. President&nbsp;Donald Trump's&nbsp;signed an executive order to promote prescription drug manufacturing in the U.S., streamlining the path for companies to build new production sites as potential tariffs on&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">imported medicines loom</a>.
The White House wants facilities to come on board at a faster rate. It <a href="https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">estimates</a> that it can currently take five to 10 years to build new pharmaceutical manufacturing capacity, which it calls "unacceptable from a national-security standpoint.&#8221;
It&#8217;s not just Sanofi. <a href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufacturing-oversight" target="_blank" rel="noreferrer noopener">Amid tariff uncertainty</a>, many drug companies are investing to boost production within the U.S.:
<ul class="wp-block-list">
<li>Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) doubled&nbsp;<a href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" target="_blank" rel="noreferrer noopener">domestic medicine production</a>.</li>
<li>Thermo Fisher Scientific Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) announced it would invest an additional $2 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/general/health-care/25/04/44995428/thermo-fisher-doubles-down-on-us-manufacturing-in-2b-expansion-plan" target="_blank" rel="noreferrer noopener">the next four years</a>.</li>
<li>Medtech firm&nbsp;Becton, Dickinson, and Company&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) also announced its intention to invest&nbsp;$2.5 billion&nbsp;in U.S. manufacturing capacity&nbsp;<a href="https://www.benzinga.com/general/health-care/25/05/45140102/potential-tariff-bites-into-becton-dickinson-2025-profit-outlook-company-will-invest-2-5-billion-to-boost-us-manufacturing" target="_blank" rel="noreferrer noopener">over the next 5 years</a>.</li>
<li>Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)  seeks to nearly double its manufacturing capacity through a new agreement with <a href="https://www.benzinga.com/general/biotech/25/04/44931246/regeneron-partners-with-japan-based-fujifilm-to-bolster-us-manufacturing-capacity-via-3-billion-deal" target="_blank" rel="noreferrer noopener">FUJIFILM Diosynth Biotechnologies</a>.</li>
<li>Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) unveiled a $23 billion investment plan to expand in the U.S. <a href="https://www.benzinga.com/general/biotech/25/04/44761201/novartis-commits-23-billion-to-expand-us-manufacturing-over-five-years-despite-tariffs-uncertaint" target="_blank" rel="noreferrer noopener">over the next five years</a>.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) plans to invest more than <a href="https://www.benzinga.com/markets/equities/25/03/44433978/johnson-johnson-to-invest-55-billion-in-us-to-boost-manufacturing-drug-discovery" target="_blank" rel="noreferrer noopener">$55 billion in the U.S. over the next four years</a>.</li>
<li>Roche Holdings AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)&nbsp;announced that it will invest $50 billion in the U.S. over&nbsp;<a href="https://www.benzinga.com/topic/pharmaceuticals" target="_blank" rel="noreferrer noopener">the next five years.</a></li>
<li>Bristol-Myers Squibb &amp; Co.'s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Christopher Boerner, chair and chief executive officer,&nbsp;<a href="https://www.statnews.com/2025/05/05/bristol-myers-squibb-pharmaceutical-policy-us-trump-administration-innovation-tariffs/?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" target="_blank" rel="noreferrer noopener">shared</a>&nbsp;plans to invest $40 billion in U.S. R&amp;D, technology, and manufacturing over the next five years in an op-ed published by Statnews.</li>
</ul>
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is one pharma company that did not highlight investments in new manufacturing plants. The company noted that they already have significant capacity and flexibility to manufacture <a href="https://www.benzinga.com/general/biotech/25/04/45118145/pfizer-ceo-albert-bourla-emphasizes-national-security-in-us-drug-manufacturing" target="_blank" rel="noreferrer noopener">products in the U.S</a>.
Price Action: Sanofi stock is down 1.53% at $49.20 at the last check on Wednesday.
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Image: Shutterstock

Sanofi To Navigate Tariff Impact With $20 Billion In Spending Through 2030

The U.S. Food and Drug Administration (FDA) granted accelerated approval to AbbVie&nbsp;Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) Emrelis&nbsp;(telisotuzumab vedotin-tllv) for adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">received a prior systemic therapy</a>.
High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45415840/u-s-fda-approves-emrelis-telisotuzumab-vedotin-tllv-for-adults-with-previously-treated-advanced-no" rel="noreferrer noopener">by an FDA-approved test</a>.
This indication is approved based on overall response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), the company said in a statement on Wednesday.
Also Read: <a target="_blank" href="https://www.benzinga.com//node/45079377" rel="noreferrer noopener">AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis</a>
Emrelis is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population.&nbsp;
ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent &#8216;payload&#8217; directly to the biomarker-expressing cell.
Data from the Phase 2 LUMINOSITY study, designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations, support the FDA&#8217;s accelerated approval.
Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months.
In&nbsp;December 2021, the FDA granted EMRELIS&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=2952437730&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4264002-1%26h%3D3470428670%26u%3Dhttps%253A%252F%252Fnews.abbvie.com%252F2022-01-04-AbbVie-Announces-U-S-FDA-Granted-Breakthrough-Therapy-Designation-BTD-to-Telisotuzumab-Vedotin-Teliso-V-for-Previously-Treated-Non-Small-Cell-Lung-Cancer%26a%3DBreakthrough%2BTherapy%2BDesignation%2Bby%2Bthe%2BFDA&amp;a=Breakthrough+Therapy+Designation" rel="noreferrer noopener">Breakthrough Therapy Designation</a> (BTD) based on Phase 2 LUMINOSITY study data.
Emrelis is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4408820-1&amp;h=741691694&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04928846&amp;a=TeliMET+NSCLC-01" rel="noreferrer noopener">TeliMET NSCLC-01</a>.
Enrollment in the study is underway and continues across global clinical trial sites.
The FDA has also approved Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) VENTANA&nbsp;MET (SP44) RxDx Assay, the only IHC companion diagnostic identifying patients eligible for Emrelis treatment.
On Wednesday, AbbVie&nbsp;and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45405186/abbvie-and-adarx-pharmaceuticals-announce-collaboration-and-license-option-agreement-to-develop-ne" rel="noreferrer noopener">immunology, and oncology</a>.
siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates gene expression. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.
ADARx will receive a&nbsp;$335 million&nbsp;upfront payment and is eligible to receive several billion dollars in additional contingent payments, including option-related fees, milestone payments, and royalties.
Price Action: ABBV stock is down 5.32% at $177.96&nbsp;at the last check on Wednesday.
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Photo via Shutterstock

ABBV

FDA Fast-Tracks AbbVie's New Lung Cancer Therapy Emrelis For Tough Lung Cancer Cases

<a href="https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans" title="https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans">https://www.bloomberg.com/news/articles/2025-05-14/roche-warns-us-investments-at-risk-from-trump-drug-price-plans</a>

'Roche Warns US Investments at Risk From Trump Drug Price Plans' - Bloomberg News

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) on Tuesday released statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">early-stage breast cancer</a>.
After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab), and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" target="_blank" rel="noreferrer noopener">Roche Plans $50 Billion US Investment Over 5 Years With 12,000 New Jobs</a>
After ten years, <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2025-05-13" rel="noreferrer noopener">results</a> show:
<ul class="wp-block-list">
<li>91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, p-value=0.044).</li>
<li>A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79).</li>
<li>The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79), strengthening results from earlier APHINITY analyses. No benefit was seen in the node-negative subgroup.</li>
<li>The safety profile, including cardiac safety, was consistent with previous studies, and no new or unexpected safety signals were identified.</li>
</ul>
Full results will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress.
In April, Sarepta Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) and&nbsp;Roche temporarily&nbsp;halted&nbsp;several clinical studies for Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with <a target="_blank" href="https://www.benzinga.com/25/04/44634689/sareptaroche-suspend-elevidys-gene-therapy-trials-in-europe-after-patient-death" rel="noreferrer noopener">Duchenne muscular dystrophy</a>.
The company reported a patient death following treatment with Elevidys, having suffered&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44376919/sarepta-therapeutics-reports-patient-death-post-elevidys-gene-therapy-treatment-stock-plunges" rel="noreferrer noopener">acute liver failure</a>.
In April, Roche&#8217;s MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous infusion for relapsing multiple sclerosis did not meet its primary endpoint in showing additional benefit in slowing disability progression compared with the currently approved <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613949/why-is-pharma-giant-roche-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Ocrevus IV 600 mg dose</a>.
Price Action: RHHBY stock is trading at $38.34 at the last check on Tuesday.
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Photo by OleksSH via Shutterstock

Ten-Year Data From Roche's Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%

<ul>
<li>An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution.</li>
<li>Expansion will create hundreds of jobs while also enhancing U.S. production capabilities.</li>
<li>Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally.</li>
</ul>
INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today it plans to invest up to $550 million in its Diagnostics site in Indianapolis by 2030. The site will become a major hub for the manufacturing of&nbsp;Roche's continuous glucose monitoring (CGM) systems – marking a new milestone in Roche's long history of revolutionizing healthcare across the globe.

Roche Plans To Invest Up To $550M In Its Diagnostics Site In Indianapolis By 2030

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