에 대한 최신 뉴스 Roche Holding (OTC:RHHBY) 주식

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.

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RHHBY

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

Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva&#xAE; (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard therapy alone.The FDA is expected to make a decision on approval by October 2025.

Government

Regulations

Genentech's Gazyva Moves Closer to FDA Approval for Lupus Nephritis After Positive Phase III Trial

– TNKase&#xAE; (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years –
– Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care –
– Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase&#xAE; (alteplase)–
Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:<a href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase&#xAE; (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech's second approval for stroke, reinforcing the company's long-standing dedication to advancing stroke care as the developer of the only two FDA-approved medicines for AIS, TNKase and Activase&#xAE; (alteplase).
TNKase is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care, Activase, which is administered as an IV bolus followed by a 60-minute infusion. Genentech will also be introducing a new 25 mg vial configuration in the coming months to support the approval of TNKase for AIS.

General

FDA Approves Genentech's TNKase In Acute Ischemic Stroke In Adults

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) released data Sunday on its Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH study for Xolair (omalizumab) for one or more food allergies.
Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.
<ul>
<li>In the first head-to-head trial comparing Xolair to OIT, the <a href="https://www.roche.com/media/releases/med-cor-2025-03-02" target="_blank" rel="noreferrer noopener">study</a> met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group.</li>
<li>These findings were largely driven by the high rates of adverse events (AEs) in the OIT group.</li>
<li>Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%), and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient&#8217;s diet after stopping Xolair.
Stage 3 is ongoing, and study investigators continue to analyze data from additional patients who completed Stage 2 and then entered Stage 3.
In the US, Genentech, a member of the Roche Group, and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) are co-developing and co-promoting Xolair.
Last February, the FDA approved Xolair for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older <a target="_blank" href="https://www.benzinga.com/pressreleases/24/02/b37182116/fda-approves-xolair-as-first-and-only-medicine-for-children-and-adults-with-one-or-more-food-aller" rel="noreferrer noopener">with IgE-mediated food allergy</a>.
Price Action: RHHBY stock closed at $41.74 on Friday.
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</ul>
Image: Shutterstock

Large Cap

Roche Touts Food Allergy Drug As Superior Than Oral Immunotherapy

– First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) –
– Results were featured as late-breakers at the 2025 AAAAI Annual Meeting –
– Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies –

RHHBF

RHHVF

Reported Sunday, Roche's Genentech Phase III Study Finds Xolair More Effective And Safer Than Oral Immunotherapy For Food Allergies

AMGN

DRIO

Hims & Hers Health, Inc. Class A Common Stock

HIMS

LFVN

TERN

VANI

VKTX

FDA Says Novo Nordisk's Ozempic Injection .68 mg/1 ml, Injection 1.34 mg/1 ml, Injection 2.68 Mg/1 ml Available As Of Feb 21; Novo Nordisk's Wegovy, Injection, 1.7 mg/.75 ml , Wegovy, Injection, 2.4 mg/.75 ml Now Available; FDA Says Semaglutide Injection Shortage Is Resolved As Of Feb 21

Roche Group Announced Detailed Analysis Of Its Phase III Regency Trial Of Gazyva (Obinutuzumab) In People With Active Lupus Nephritis - Company Says Trial Demonstrated Statistically Significant Improvement In Primary Endpoint Of Complete Renal Response

<ul>
<li>As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be eligible for a targeted treatment, which could significantly improve their outcomes.</li>
<li>The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022,&nbsp; is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.</li>
<li>HER2 interpretation in breast cancer is evolving. With the introduction of HER2-low and now HER2-ultralow classifications, Roche continues to lead in HER2 diagnostics, helping to expand patient access to personalised treatment.</li>
</ul>
Basel, 31 January 2025 - Roche ((SIX: RO, ROG, OTCQX:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTCQX">RHHBY</a>) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY&#xAE; anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody&#x2A; to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU&#xAE;. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
Until the introduction of HER2-low status in 2022, HER2 status was categorised as either "positive" or "negative" based on the level of HER2 expression. The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as "HER2-ultralow." HER2-ultralow refers to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category.

Roche Receives FDA Approval For The First Companion Diagnostic To Identify Patients With Her2-Ultralow Metastatic Breast Cancer Eligible For ENHERTU

For 2025, the company expects mid-single-digit sales growth and high-single-digit core EPS growth, with a further increase in dividends in Swiss francs.

Earnings

Guidance

Roche For 2025 Expects Mid-Single-Digit Sales Growth And High-Single-Digit Core EPS Growth

Roche's Q4 Adj. EPS CHF18.80 Up From CHF18.57 YoY, Sales CHF60.49B Up From CHF58.72B YoY

Piper Sandler analyst David Amsellem reiterated the Overweight rating on Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) <a href="https://www.benzinga.com/quote/TEVA/analyst-ratings">with a price forecast of $30.</a>
Amsellem writes that he hosted a call with a top gastroenterologist who treats many ulcerative colitis and Crohn&#8217;s disease patients. The doctor specializes in managing treatment-experienced and refractory cases at a major referral center.
From the call, the analyst notes that feedback on Teva's/Sanofi's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) anti-TL1A antagonist duvakitug, along with the broader anti-TL1A class, suggests these agents could play a significant role in treating both ulcerative colitis and Crohn&#8217;s disease, which is supported by competitive data.
Amsellem highlights that according to the featured expert, biomarkers are crucial, and they are particularly interested in studies/data stratified by biomarkers.
The analyst will closely follow what Teva shares on this at the upcoming ECCO meeting.
Both Merck &amp; Company, Inc. and Roche Holding Ltd are also stratifying their anti-TL1A studies by biomarkers.
The expert considers that biomarkers could greatly benefit the broader inflammatory bowel disease (IBD) field if they are easy to assess and help predict clinical response.
While Teva/Sanofi&#8217;s all-comers Phase III program for duvakitug is commercially reasonable, the goal is to address a wide ulcerative colitis and Crohn&#8217;s disease patient audience.
Price Action: TEVA shares are trading lower by 1.47% to $21.46 at last check Tuesday.
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</ul>
Photo by Ralf Liebhold via Shutterstock.

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Reiteration

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TEVA

Teva's Duvakitug Set To Shake Up IBD Treatment, Analyst Highlights Competitive Data

– Updated overall survival (OS) results – a key secondary endpoint – reinforce the significant benefit of the ItovebiTM (inavolisib)-based regimen for patients with advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer in the first-line setting –
– Primary analysis showed the Itovebi-based regimen reached statistical significance, more than doubling progression-free survival in this patient population –
– Full OS results from the Phase III INAVO120 study will be presented at an upcoming medical meeting –

Roche's Genentech Reports Significant Survival Benefit With Itovebi In Advanced HR-Positive Breast Cancer Patients

On Monday, Sarepta Therapeutics Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) released topline results from Part 2 of EMBARK (Study SRP-9001-301) Phase 3 clinical study of Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with <a target="_blank" href="https://www.benzinga.com/quote/SRPT" rel="noreferrer noopener">Duchenne muscular dystrophy</a>.
Crossover-treated patients who received a placebo in Part 1, crossed over at 52 weeks and were treated with Elevidys in Part 2 improved 2.34 points from baseline compared to matched external controls on the North Star Ambulatory Assessment (NSAA) 52 weeks after treatment. NSAA measures functional motor abilities in <a href="https://www.benzinga.com/pressreleases/25/01/b43220537/sarepta-therapeutics-announces-results-from-part-2-of-the-embark-study-demonstrating-sustained-ben" target="_blank" rel="noreferrer noopener">children with Duchenne</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42883730/solid-biosciences-outpaces-competitors-in-duchenne-gene-therapy-development" rel="noreferrer noopener">Solid Biosciences Outpaces Competitors In Duchenne Gene Therapy Development</a>
Despite being one year older (average age 7.18 years) than those treated in Part 1 (average age 5.98 years), crossover-treated patients showed clinically meaningful and statistically significant functional benefit for NSAA, Time to Rise (TTR) and 10-meter walk/run (10MWR) function tests compared with a pre-specified, propensity-weighted external control group (EC).
Individuals treated in part one of EMBARK (n=63) showed clinically meaningful and statistically significant improvements on the NSAA sustained two years after treatment with Elevidys. Functional motor improvements include:
<ul>
<li>+2.88 points (improvement) on NSAA.</li>
<li>-2.06 seconds (improvement) on Time to Rise.</li>
<li>-1.36 seconds (improvement) on 10MWR.</li>
</ul>
Muscle biopsies from a subset of patients taken 64 weeks after dosing in part one showed consistent and sustained expression of micro-dystrophin. Muscle pathology on MRI continues to show minimal progression in underlying muscle pathology and remains highly consistent with the functional benefits shown.
No new safety signals were observed.
As part of a collaboration agreement signed in 2019, Sarepta is working with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>). Sarepta is responsible for regulatory approval and commercializing Elevidys in the U.S. and manufacturing.
Roche is responsible for regulatory approvals and bringing Elevidys to patients across the rest of the world.
Price Action: SRPT stock closed at $116.46 on Friday.
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</ul>

SRPT

Sarepta Therapeutics' Duchenne Gene Therapy Shows Sustained Benefits And Disease Stabilization At Two Years

In states where both medical and recreational marijuana are legal, patients are filling fewer prescriptions for medications commonly used <a href="https://www.benzinga.com/topic/anxiety">to treat anxiety</a>, according to a recent study published in JAMA Network Open.
The findings consistently showed that increased access to marijuana correlates with reductions in benzodiazepine prescription fills, which refer to the number of prescriptions picked up by patients, not the number written by doctors. 
Lead <a href="https://spp.gatech.edu/people/person/ashley-bradford">author</a> Ashley Bradford, PhD, of the Georgia Institute of Technology, <a href="https://www.painnewsnetwork.org/stories/2025/1/19/prescriptions-for-anti-anxiety-meds-decline-in-states-where-marijuana-is-legal#google_vignette">noted</a> that the research is particularly relevant given that nearly 23% of U.S. adults reported having a diagnosable mental health disorder in 2021, but only 65% of them received treatment.
Expanding cannabis access offers an alternative treatment avenue, especially as many <a href="https://www.benzinga.com/cannabis/laws">state medical marijuana laws</a> allow patients with mental health conditions like post-traumatic stress disorder (PTSD) to use medical cannabis. The Food and Drug Administration <a href="https://www.benzinga.com/24/11/42100354/fda-approves-cannabis-trial-for-veterans-with-ptsd-after-years-of-delays">approved a clinical trial in November 2024</a> to assess the efficacy of smoked medical marijuana in treating PTSD among military veterans.
The <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2823248?resultClick=3">findings</a> have significant implications for insurance providers, prescribers, patients and pharmaceutical companies that produce benzodiazepines, which, like opioids, carry risks. In 2020, benzodiazepines contributed to 14% of total opioid overdose deaths, said Bradford, who added that the substitution of marijuana for medications with high misuse potential could also have far-reaching public health benefits.
<h2 class="wp-block-heading">Could Cannabis For Anxiety Cut Into Big Pharma's Bottom Line?</h2>
Bradford&#8217;s research focused on medications like Valium, Xanax and Ativan, which are brand names for diazepam, alprazolam and lorazepam, respectively. Xanax and Lorazepam are produced by Pfizer, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Wyeth Pharmaceuticals, which <a href="https://www.investopedia.com/companies-owned-by-pfizer-5211303">Pfizer acquired in 2009</a>.
The most common drug, Valium, produced by the Hoffmann-La Roche pharmaceutical company – now <a href="https://www.benzinga.com/24/12/42721437/roche-ceo-reassures-no-job-cuts-despite-drug-development-challenges-reports">Roche Holdings</a> (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) &nbsp;&#8211; was introduced in 1963 and gained popularity as a sedative almost immediately. Between 1969 and 1982, "Mother's Little Helper" as the Rolling Stones called it in their 1966 hit song, Valium was the <a href="https://drugabuse.com/benzodiazepines/valium/history-and-statistics/">most prescribed drug in the US</a>. Sales peaked in 1978 with more than 2.3 billion pills sold that year. 
Roche, with a market value of $244.27 billion, is among the <a href="https://www.visualcapitalist.com/cp/worlds-50-largest-pharmaceutical-companies/">largest pharmaceutical companies</a> in the world.
According to <a href="https://my.clevelandclinic.org/health/treatments/24570-benzodiazepines-benzos">the</a> Cleveland Clinic, benzodiazepines are still among the most commonly prescribed medications and are notably &#8220;habit-forming.&#8221; 
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</ul>
Photo: Shutterstock

Cannabis

Legal Marijuana Linked To Drop In Anxiety Medications: What It Means For Pharma Giants

On Thursday, Outlook Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g43023003/outlook-therapeutics-announces-complete-twelve-week-efficacy-and-safety-results-of-norse-eight-cli" rel="noreferrer noopener">degeneration (wet AMD) patients</a>.
ONS-5010 demonstrated non-inferiority to 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>) Lucentis (ranibizumab) at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.
The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37893076/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-higher-on-friday" rel="noreferrer noopener">Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?</a>
BCVA measures how well a person can see after wearing corrective lenses, such as glasses or contact lenses.
In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. <a target="_blank" href="https://www.benzinga.com/24/11/42214804/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Food and Drug Administration (FDA)</a>.
However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.
Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab.
ONS-5010/LYTENAVA (bevacizumab gamma) has been approved in the European Union and the United Kingdom. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.
The company also entered into agreements for warrant inducement transactions expected to result in up to $20.4 million in gross proceeds.
The company will use the proceeds to fund its ONS-5010 clinical development programs, the European commercial launch of LYTENAVA, and working capital and general corporate purposes.
Price Action: OTLK stock is down 9.78% at $2.06 at last check Thursday.
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</ul>

Financing

Offerings

OTLK

Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug

<ul>
<li>The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2</li>
<li>The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients.</li>
<li>B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.3</li>
</ul>

Roche's VENTANA ISH Test Secures FDA Clearance For Accurate B-Cell Lymphoma Diagnosis

<ul>
<li>The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. &nbsp;</li>
<li>This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab. &nbsp;</li>
<li>Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.</li>
</ul>

Roche's Digital Pathology Dx System Expands With FDA Approval Of High-Capacity VENTANA DP 600 Scanner

Under the agreement, Innovent has granted Roche exclusive global rights to develop, manufacture and commercialize IBI3009. The two parties will jointly focus on the early-stage development of this ADC candidate, after which Roche will take over full development. Innovent will receive an upfront payment of US$80 million and is eligible to receive up to US$1 billion in development and commercial milestone payments, along with tiered royalties on net sales.

IVBIY

Reported Wednesday, Roche And Innovent Forge Exclusive Global License Deal To Develop DLL3-Targeting ADC For Advanced Lung Cancer

On Monday, Sangamo Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMO#NASDAQ">SGMO</a>) regained the development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for moderately severe to severe hemophilia A that it has co-developed with and licensed to Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
Pfizer decided to terminate the global collaboration and license agreement <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42733065/sangamo-therapeutics-to-regain-full-rights-to-hemophilia-a-gene-therapy-program-following-pfizers-" rel="noreferrer noopener">between the parties</a>. Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41310468/fda-approves-pfizers-second-hemophilia-drug-with-six-months" rel="noreferrer noopener">FDA Approves Pfizer&#8217;s Second Hemophilia Drug With Six Months</a>
In July 2024, Pfizer announced topline results from the Phase 3 AFFINE trial of giroctocogene fitelparvovec, which demonstrated that the trial met the primary and key secondary objectives of superiority <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39937203/sangamo-stock-spikes-as-pfizer-partnership-meets-goal-in-late-stage-study" rel="noreferrer noopener">compared to prophylaxis</a>.
&#8220;&#8230;we believe it is well positioned for regulatory submissions and potential commercialization,&#8221; said Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics. &#8220;While we were surprised and extremely disappointed by Pfizer&#8217;s decision to end our collaboration so close to the anticipated BLA and MAA submissions&#8230;&#8221;
The collaboration and license agreement with Pfizer will terminate effective April 21, 2025. All trial participants will continue to be monitored as planned during the transition period.
Sangamo believes that its recently announced partnerships with Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Genentech and Astellas Pharma Inc (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMF#OTC">ALPMF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMY#OTC">ALPMY</a>) and advanced business development discussions for its Fabry gene therapy program will allow it to chart a path forward for its neurology genomic medicine pipeline.
The company prepares to initiate the expected enrollment of patients in the Phase 1/2 study of ST-503 for idiopathic small fiber neuropathy in mid-2025 and file an anticipated Clinical Trial Authorisation submission for the prion disease program in Q4 2025, each subject to securing additional funding.
Price Action: SGMO stock is down 54.70% at $1.106 during the premarket session at last check Tuesday.
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Contracts

ALPMF

ALPMY

SGMO

Sangamo Therapeutics Stock Plunges As Pfizer Terminates Hemophilia Gene Therapy Pact

Swiss pharmaceutical giant Roche Holding AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) reportedly has no plans for job cuts despite facing recent challenges in its drug development pipeline.
CEO Thomas Schinecker, in an interview with NZZ am Sonntag, reassured that worker numbers are constant to slightly increasing, reported Reuters.
He also emphasized healthy business and not having a growth problem either. Meanwhile, the report noted Schinecker&nbsp;saying that the company&#8217;s research and development budget remains stable without expansion.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Schinecker also provided insights into Roche&#8217;s pipeline, estimating that the company&#8217;s anti-obesity drug could hit the market by 2029 or earlier, per the report.
Addressing the broader economic landscape, Schinecker acknowledged challenges in Europe and China, contrasting them with moderate growth in the U.S.
Price Action: RHHBY shares closed at $35.07 on Friday.

Media

Roche CEO Reassures No Job Cuts Despite Challenges: Report

On Thursday, Prothena Corporation plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTA#NASDAQ">PRTA</a>) released results from the Phase 2b PADOVA study of prasinezumab in early-<a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42568873/roches-phase-iib-study-of-prasinezumab-missed-primary-endpoint-but-suggests-possible-clinical-bene" rel="noreferrer noopener">stage Parkinson&#8217;s disease</a>.
Partner Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) conducted the 586-subject study investigating prasinezumab in early-stage Parkinson&#8217;s disease patients who had been treated for a minimum of 18 months while on stable symptomatic treatment.
Prasinezumab <a target="_blank" href="https://www.roche.com/media/releases/med-cor-2024-12-19" rel="noreferrer noopener">showed</a> a potential clinical effect in the primary endpoint of time to confirmed motor progression with an HR=0.84 and p=0.0657, missing statistical significance.
The companies said the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa (75% of participants), HR=0.79 and nominal p=0.0431.
Pre-specified supplementary covariate-adjusted analyses of these endpoints demonstrated nominally significant effects on the primary endpoint (HR=0.81; nominal p=0.0334) and in the levodopa subgroup (HR=0.76; nominal p=0.0175).
Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Prasinezumab continues to be well tolerated, and no new safety signals were observed in the study.
The Phase 2 PASADENA and Phase 2b PADOVA open-label extension studies will continue to explore the observed effects in both studies.
Roche will continue to evaluate the data and work together with health authorities to determine the next steps.
Full results from the PADOVA study will be presented at an upcoming medical meeting.
Price Action: PRTA stock is up 32.40% at $15.83 at the last check on Thursday.
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PRTA

Roche-Prothena Partnered Mid-Stage Parkinson's Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits

Small Cap

Press Releases

Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma

Dyno Therapeutics Announces Exercise of Option by Roche for Next-Generation AAV Vector for Neurological Gene Therapy

Genentech's Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer

FDA Approves Genentech's Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness

New England Journal of Medicine Publishes New Data for Genentech's Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis

FDA Approves Genentech's Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)

Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies

FDA Approves Genentech's TNKase® in Acute Ischemic Stroke in Adults

FDA Accepts Supplemental Biologics License Application for Genentech's Gazyva for the Treatment of Lupus Nephritis

TD Cowen

Cowen & Co.

스트럭처 테라퓨틱스(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GPCR#NASDAQ">GPCR</a>)의 주식은 비만 치료제 시장에서 잠재적인 승자로 지목되었다. JP모건은 주식에 상당한 상승 잠재력을 부여했다.
What Happened: JP모은 생명공학 회사인 스트럭처 테라퓨틱스에 대해 &#8220;비중확대(Overweight)&#8221; 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 테라퓨틱스는 GLP-1 체중 감량 시장을 겨냥해 고안된 경구용 알약인 &#8216;1290&#8217;이라는 약물 후보를 개발하고 있다. 이 약물은 잠재적으로 경쟁사보다 1~2년 앞서 시장에 출시될 수 있는 소분자 제제를 기반으로 한다.
이 약은 다른 경구용 체중 감량 약물 후보와 차별화되어 안전성에 큰 우려가 없는 환자에게 상당한 체중 감량 효과를 제공할 것으로 기대된다.
"우리는 전례 없이 큰 시장에서 구강 시장에서 GPCR의 시장 점유율이 시간이 지남에 따라 5%에 접근할 수 있다고 생각한다. 전체적으로 우리는 1290/스트럭처가 T2D/비만 시장에 참여하려는 대규모 바이오제약 회사들에게 매력적인 파트너십 기회가 될 수 있다고 생각한다"라고 JP모건이 말했다.
JP모건은 스트럭처 테라퓨틱스의 경구용 GLP-1 체중 감량 약물 후보가 2035년까지 10억 달러 이상의 최고 매출을 올릴 수 있을 것으로 믿고 있다. 이 회사는 2023년 2월에 상장되었다.
참조: <a href="https://www.benzinga.com/markets/cryptocurrency/24/05/38910906/bitcoin-dogecoin-ethereum-retrace-on-profit-taking-by-retail-investors-analyst-predicts-pa?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">비트코인, 도지코인, 이더리움은 소매 투자자들의 이익 실현에 하락</a>
Why It Matters: 비만 치료제 시장은 중요한 발전을 보이고 있다. 최근 로슈(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>)은 이중 GLP-1/GIP 수용체 작용제 CT-388의 1b상 시험에서 유망한 결과를 발표하여 비만 치료 시장에서 <a href="https://www.benzinga.com/general/biotech/24/05/38878582/roche-to-ride-booming-obesity-treatment-market-with-newly-acquired-drug-candidate">상당한 잠재력</a>을 나타냈다.
또한 일라이 릴리(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>)는 중국에서 당뇨병 치료제 티르제파티드(tirzepatide)에 대한 승인을 확보하여 중요한 아시아 시장에서 노보 노디스크 A/S(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>)와의 <a href="https://www.benzinga.com/general/biotech/24/05/38941485/eli-lilly-secures-china-nod-for-popular-weight-lossdiabetes-drug-tirzepatide">경쟁</a>이 치열해질 수 있는 발판을 마련했다.
앞서 바이오헤븐(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BHVN#NYSE">BHVN</a>)은 체중 감량을 돕는 동시에 근육 손실을 예방할 수 있는 실험 약물인 탈데프그로벱 알파(taldefgrobep alfa)(BHVN-2000)를 통해 비만 치료제 시장에 대한 <a href="https://www.benzinga.com/general/biotech/24/03/37942782/obesity-drug-landscape-has-a-contender-from-biohaven-ceo-highlights-different-approach-amid-stiff">다른</a> 접근 방식을 강조했다.
다음 읽기: <a href="https://www.benzinga.com/tech/24/05/38919616/apples-groundbreaking-iphone-16-could-spark-another-stock-surge-building-on-an-800-growth-over-the-l?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">애플, 6월 WWDC에서 아이폰 13 시리즈 공개 예고</a>
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Benzinga Neuro의 기술, <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a> 편집
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GPT-4 기반의 Benzinga Neuro 콘텐츠 생성 시스템은 광벤짜 생태계의 네이티브 데이터, API 등을 활용하여 포괄적이고 시의적절한 이야기를 제공합니다. <a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">더 알아보기</a>.
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수요일, 5월 22, 2024

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