옵션 체인은 다양한 행사가격과 만기일에 대한 Dyne Therapeutics의 주식 옵션 주요 데이터를 보여줍니다. 트레이더들은 이 정보를 사용하여 잠재적 거래를 분석하고 Dyne Therapeutics에 대한 시장 심리를 평가합니다..

Dyne Therapeutics (NASDAQ:DYN) 주식, 옵션 체인

DYNE THERAPEUTICS INC

Dyne Therapeutics

Dyne Therapeutics Inc is a clinical-stage neuromuscular disease company focused on discovering and advancing life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Its FORCE platform develops targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system, or CNS. Its FORCE platform therapeutics consist of a payload that is rationally designed to target the genetic basis of the disease are seeking to treat, a linker, and an antigen-binding fragment, that attaches to the payload using the linker. Its Pipeline includes DYNE-101, DYNE-251, DYNE-302, and DYNE-401.

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다음은 지난주 큰 폭의 상승세를 보인 11개의 중형주 주식이다. 이 주식들은 여러분의 포트폴리오에 있나요? 퀀텀스케이프(NYSE:QS)의 주가는 회사가 폭스바겐(Volkswagen)의 배터리 회사인 파워코(PowerCo)와 전고체 배터리 산업화 계약을 체결했다고 발표한 후 64.34% 급등했다.

샤오펑 및 퀀텀스케이프는 지난주 최고 성과를 보여준 11개 중형주 중 일부(7월 7일-7월 13일)

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Guggenheim analyst Debjit Chattopadhyay reiterates Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Buy and maintains $50 price target.

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Reiteration

Analyst Ratings

Guggenheim Reiterates Buy on Dyne Therapeutics, Maintains $50 Price Target

Baird analyst Brian Skorney maintains Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Outperform and lowers the price target from $46 to $32.

Baird Maintains Outperform on Dyne Therapeutics, Lowers Price Target to $32

<h3>Gainers</h3>
<ul>
<li>Acurx Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACXP#NASDAQ">ACXP</a>) shares rose 117.3% to $0.67 during Tuesday's regular session. The market value of their outstanding shares is at $15.6 million. </li>
<li>Verve Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERV#NASDAQ">VERV</a>) stock rose 78.95% to $11.22. The market value of their outstanding shares is at $1.0 billion. </li>
<li>Eyenovia (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EYEN#NASDAQ">EYEN</a>) shares rose 67.34% to $4.97. The company's market cap stands at $14.3 million. </li>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) shares moved upwards by 58.35% to $0.99. The company's market cap stands at $2.1 million. </li>
<li>Galectin Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GALT#NASDAQ">GALT</a>) stock increased by 55.03% to $2.31. The market value of their outstanding shares is at $146.2 million. </li>
<li>Beyond Air (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XAIR#NASDAQ">XAIR</a>) shares moved upwards by 26.67% to $0.23. The company's market cap stands at $20.0 million. As per the press release, Q4 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Adial Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADIL#NASDAQ">ADIL</a>) stock declined by 27.6% to $0.24 during Tuesday's regular session. The company's market cap stands at $2.0 million. </li>
<li>Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) shares declined by 21.55% to $10.84. The market value of their outstanding shares is at $1.2 billion. </li>
<li>Biodexa Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDRX#NASDAQ">BDRX</a>) shares decreased by 19.24% to $0.84. The company's market cap stands at $2.4 million. </li>
<li>Basel Medical Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMGL#NASDAQ">BMGL</a>) shares declined by 17.1% to $2.57. The company's market cap stands at $48.2 million. </li>
<li>Helius Medical Tech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>) stock decreased by 15.53% to $0.32. The company's market cap stands at $1.0 million. </li>
<li>Healthcare Triangle (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCTI#NASDAQ">HCTI</a>) stock decreased by 14.97% to $0.02. The market value of their outstanding shares is at $9.1 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Tuesday's Intraday Session

Dyne Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) stock is trading lower after the company announced on Tuesday that it had revised the ongoing Registrational Expansion Cohort in the Phase 1/2 ACHIEVE trial for DYNE-101 for <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">myotonic dystrophy type 1 (DM1)</a>.
The primary endpoint is a change from baseline in middle finger myotonia as measured by vHOT at 6 months, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g45968516/dyne-therapeutics-announces-fda-breakthrough-therapy-designation-for-dyne-101-and-updated-plan-for" rel="noreferrer noopener">compared to placebo</a>.
<ul class="wp-block-list">
<li>Video hand opening time (vHOT) measures hand function and myotonia (delayed relaxation of skeletal muscles after voluntary contraction).</li>
</ul>
Secondary endpoints include change from baseline in splicing as measured by the composite alternative splicing index (CASI-22), muscle strength as assessed by Quantitative Muscle Testing (QMT), performance on both the 10-Meter Walk/Run Test (10MWR) and 5 Times Sit to Stand Test (5xSTS), and the Myotonic Dystrophy Health Index (MDHI) patient-reported outcome measure, all at 6 months compared to placebo.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44441276/jpmorgan-seeks-clarity-on-dyne-therapeutics-dyne-101-expansion-regulatory-path" target="_blank" rel="noreferrer noopener">JPMorgan Seeks Clarity On Dyne Therapeutics&#8217; DYNE-101 Expansion, Regulatory Path</a>
The cohort is expected to enroll 60 participants, randomized 3:1 to receive DYNE-101 6.8 mg/kg Q8W or placebo. Dyne plans to complete enrollment in the Registrational Expansion Cohort in the fourth quarter of 2025.
Dyne intends to use data from the Registrational Expansion Cohort and the already enrolled patients in the multiple ascending dose (MAD) and ongoing long-term extension portions of the ACHIEVE trial to support a potential submission for Accelerated Approval in the U.S.
Data from the cohort are planned for mid-2026 to support a potential U.S. Accelerated Approval submission in late 2026.
It seems that the company&#8217;s stock plunged as earlier Dyne expected to submit an Accelerated Approval Biologics License Application (BLA) in <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45281892/dyne-therapeutics-reports-first-quarter-2025-financial-results-and-recent-business-highlights" rel="noreferrer noopener">the first half of 2026</a>.
Dyne plans to initiate a confirmatory Phase 3 clinical trial in Q1 2026.
Dyne also reported new long-term data from adult DM1 patients enrolled in the randomized, placebo-controlled MAD portion of the DYNE-101 ACHIEVE trial, including data from the 6.8 mg/kg Q8W cohort (n=6) at up to 12 months.
At the registrational dose of 6.8 mg/kg Q8W, DYNE-101 demonstrated robust and sustained improvement in myotonia as measured by vHOT and sustained improvements across multiple other endpoints.
<ul class="wp-block-list">
<li>As previously disclosed, treatment with DYNE-101 led to an improvement in vHOT of 3.3 seconds compared to placebo at 6 months.</li>
<li>New data demonstrated that mean improvements at 6 months were sustained at 12 months for vHOT, 10MWR, 5xSTS, MDHI, and QMT, which demonstrated a 10% improvement in strength at 6 months, increasing to 20% at 12 months relative to baseline.</li>
</ul>
The company expects that its $677.5 million cash, cash equivalents, and marketable securities as of March 31, 2025, will be sufficient to fund its operations into the fourth quarter of 2026.
The U.S. Food and Drug Administration (FDA) on Tuesday granted Breakthrough Therapy Designation to DYNE-101 for DM1.
Price Action: DYN stock is trading lower by 18.2% to $11.30 at last check Tuesday.
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Why Is Dyne Therapeutics Stock Trading Lower On Tuesday?

WIIM

Dyne Therapeutics shares are trading lower after the company announced it submitted revised ACHIEVE Trial protocol to the FDA, elevating vHOT to primary endpoint for DYNE-101 in DM1 with Accelerated Approval submission in late 2026 instead of H1 2026.

Chardan Capital analyst Keay Nakae maintains Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Buy and maintains $50 price target.

Chardan Capital Maintains Buy on Dyne Therapeutics, Maintains $50 Price Target

Dyne Submitted Revised ACHIEVE Trial Protocol To FDA, Elevating vHOT To Primary Endpoint For DYNE-101 In DM1; Data Planned For Mid 2026 To Support Potential Accelerated Approval Submission In Late 2026

<h3>Gainers</h3>
<ul>
<li>Acurx Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACXP#NASDAQ">ACXP</a>) stock moved upwards by 235.5% to $1.03 during Tuesday's pre-market session. The company's market cap stands at $24.1 million. </li>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) shares rose 82.37% to $1.14. The company's market cap stands at $2.4 million. </li>
<li>Verve Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERV#NASDAQ">VERV</a>) shares moved upwards by 75.93% to $11.03. The company's market cap stands at $983.3 million. </li>
<li>Azitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock increased by 38.35% to $0.37. The company's market cap stands at $6.1 million. </li>
<li>ProPhase Labs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRPH#NASDAQ">PRPH</a>) shares moved upwards by 34.0% to $0.45. The market value of their outstanding shares is at $18.5 million. </li>
<li>Prime Medicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRME#NASDAQ">PRME</a>) shares increased by 16.66% to $1.75. The market value of their outstanding shares is at $229.7 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Adial Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADIL#NASDAQ">ADIL</a>) stock fell 34.8% to $0.21 during Tuesday's pre-market session. The market value of their outstanding shares is at $1.8 million. </li>
<li>Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) shares decreased by 21.86% to $10.8. The company's market cap stands at $1.2 billion. </li>
<li>Unicycive Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UNCY#NASDAQ">UNCY</a>) shares declined by 20.66% to $0.6. The market value of their outstanding shares is at $72.1 million. </li>
<li>Synaptogenix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNPX#NASDAQ">SNPX</a>) shares decreased by 14.99% to $3.63. The market value of their outstanding shares is at $5.0 million. </li>
<li>Cyclacel Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYCC#NASDAQ">CYCC</a>) stock fell 11.06% to $0.3. The market value of their outstanding shares is at $7.2 million. </li>
<li>Surgery Partners (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGRY#NASDAQ">SGRY</a>) stock decreased by 9.8% to $20.9. The market value of their outstanding shares is at $2.6 billion. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Tuesday's Pre-Market Session

Dyne Therapeutics Granted FDA Breakthrough Therapy Designation For DYNE-101

<h3>Gainers</h3>
<ul>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) shares moved upwards by 53.0% to $0.98 during Monday's after-market session. The company's market cap stands at $2.0 million. </li>
<li>Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) shares rose 12.15% to $15.5. The company's market cap stands at $1.7 billion. </li>
<li>Clene (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLNN#NASDAQ">CLNN</a>) shares rose 8.59% to $4.8. The company's market cap stands at $43.1 million. </li>
<li>SS Innovations (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SSII#NASDAQ">SSII</a>) shares increased by 8.02% to $3.5. The company's market cap stands at $677.6 million. </li>
<li>DIH Holding US (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DHAI#NASDAQ">DHAI</a>) shares moved upwards by 7.92% to $0.23. The company's market cap stands at $11.0 million. </li>
<li>BioSig Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSGM#NASDAQ">BSGM</a>) stock rose 6.3% to $6.58. The company's market cap stands at $179.5 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>China Pharma Holding (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/CPHI#AMEX">CPHI</a>) stock fell 8.5% to $1.69 during Monday's after-market session. The market value of their outstanding shares is at $5.5 million. </li>
<li>Geovax Labs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOVX#NASDAQ">GOVX</a>) stock declined by 8.34% to $1.21. The company's market cap stands at $18.3 million. </li>
<li>Helius Medical Tech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSDT#NASDAQ">HSDT</a>) shares declined by 7.86% to $0.35. </li>
<li>Catheter Precision (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/VTAK#AMEX">VTAK</a>) stock declined by 7.22% to $0.32. The company's market cap stands at $4.0 million. </li>
<li>Alaunos Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TCRT#NASDAQ">TCRT</a>) stock fell 7.22% to $2.96. The market value of their outstanding shares is at $4.8 million. </li>
<li>Applied DNA Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APDN#NASDAQ">APDN</a>) stock decreased by 6.65% to $4.78. The market value of their outstanding shares is at $2.4 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Monday's After-Market Session

Raymond James analyst Michael Freeman assumes Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Outperform rating and announces Price Target of $37.

Initiation

Raymond James Assumes Dyne Therapeutics at Outperform, Announces Price Target of $37

Oppenheimer analyst Andreas Argyrides assumes Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Outperform rating and lowers Price Target of $34.

Oppenheimer Assumes Dyne Therapeutics at Outperform, Lowers Price Target of $34

HC Wainwright &amp; Co. analyst Andrew Fein maintains Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Buy and lowers the price target from $46 to $38.

HC Wainwright & Co. Maintains Buy on Dyne Therapeutics, Lowers Price Target to $38

Dyne Therapeutics shares are trading higher. The company reported Q1 financial results.

Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) reported quarterly losses of $(1.05) per share which missed the analyst consensus estimate of $(0.88) by 19.32 percent. This is a 29.63 percent decrease over losses of $(0.81) per share from the same period last year.

Earnings

Earnings Misses

Dyne Therapeutics Q1 EPS $(1.05) Misses $(0.88) Estimate

- Recently presented data demonstrated sustained functional improvement with DYNE-251 treatment through 18 months -
- Data from the fully enrolled DELIVER registrational expansion cohort is planned for late 2025 -
WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=HjhKNRK7GccpZoGiYxmFX8bQf1e2BAfI3iZOk8MvkQV2Ny2-Bl2M70_NEOCmqiKsDzhJtjn4xjlnulG3KhZth2Gq0XWyp-EXz0iDm673c_E=">Dyne Therapeutics, Inc</a>. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>), a clinical-stage company focused on advancing life-transforming therapeutics for people living with genetically driven neuromuscular diseases, today announced that the European Commission (EC) has granted orphan drug designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD). DYNE-251 is being evaluated in the Phase 1/2 DELIVER global clinical trial in individuals with DMD who are amenable to exon 51 skipping. <a href="https://www.globenewswire.com/Tracker?data=BHkd4l5qn3AdVzgVo0OUPLTmtt3i9JDPiBryQnLGIMrX8sfwc3CtL9K1Or7hmVi7ac09qUu94yRcJzT2F7PAAJEQEbRBbKIdcC-hAXpp69wMxCK3emx-G1V6_TKQt9zp1_PVDetzbUvNPYVLFBKcCVtNMaZFuFbxIYbiqSn0IMQ=">Long-term clinical data</a> from the ongoing DELIVER trial of DYNE-251 that demonstrated unprecedented and sustained functional improvement at the selected registrational dose were presented in March at the 2025 Muscular Dystrophy Association (MDA) Clinical &amp; Scientific Conference. Functional assessments in the DELIVER trial include Stride Velocity 95th Centile (SV95C), an objective digital outcome that is accepted as a primary endpoint for DMD clinical trials in Europe.

EC Grants Orphan Drug Designation For Dyne Therapeutics' DYNE-251 For Treatment Of Duchenne Muscular Dystrophy

U.S. stock futures were higher this morning, with the Dow futures gaining around 0.2% on Friday.
Shares of Booz Allen Hamilton Holding Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BAH#NYSE">BAH</a>) fell sharply in today's <a href="https://www.benzinga.com/quote/BAH/analyst-ratings">pre-market trading</a>.
Goldman Sachs analyst Noah Poponak downgraded Booz Allen Hamilton from Buy to Neutral and lowered the price target from $150 to $109.
Booz Allen Hamilton shares dipped 2.9% to $105.66 in the pre-market trading session.
Here are some other stocks moving lower in pre-market trading.
<ul>
<li>Nexa Resources S.A. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NEXA#NYSE">NEXA</a>) shares dipped 32% to $4.01 in today's pre-market trading.</li>
<li>Betterware de México, S.A.P.I. de C.V. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BWMX#NYSE">BWMX</a>) shares declined 24% to $8.21 in pre-market trading. Betterware de México will report its first quarter results after the U.S. market close on Thursday, April 24.</li>
<li>Solaris Resources Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SLSR#NYSE">SLSR</a>) shares fell 22.3% to $2.20 in pre-market trading.</li>
<li>InnovAge Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INNV#NASDAQ">INNV</a>) declined 14.9% to $2.35 in pre-market trading.</li>
<li>Costamare Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CMRE#NYSE">CMRE</a>) fell 14.3% to $7.42 in pre-market trading after falling 5% on Thursday.</li>
<li>Maze Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MAZE#NASDAQ">MAZE</a>) shares tumbled 12.8% to $6.62 in pre-market trading after falling 5% on Thursday.</li>
<li>Mesoblast Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MESO#NASDAQ">MESO</a>) dipped 9.5% to $9.41 in pre-market trading after dipping 6% on Thursday.</li>
<li>Dyne Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) fell 6.2% to $6.55 in pre-market trading after dipping around 8% on Thursday.</li>
<li>Movado Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MOV#NYSE">MOV</a>) fell 4.9% to $13.14 in pre-market trading. Movado Group, will report fourth quarter and fiscal year 2025 earnings results on Wednesday, April 16.</li>
</ul>
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Booz Allen Hamilton, Movado Group And Other Big Stocks Moving Lower In Friday's Pre-Market Session

JPMorgan analyst Tessa T Romero remains engaged in discussions about Dyne Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) and its DYNE-101 program in DM1, addressing questions about the next step <a href="https://www.benzinga.com/general/biotech">and potential value creation.</a>
Romero&#8217;s note, issued Thursday, highlights Dyne&#8217;s plan to initiate a global Registrational Expansion Cohort in<a href="https://www.benzinga.com/25/01/42923575/why-is-neuromuscular-focused-dyne-therapeutics-stock-trading-lower-on-friday"> the first half of 2026</a>. This move aims to support a submission for U.S. Accelerated Approval based on biomarker and functional data.
The update follows Dyne&#8217;s January announcement of new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 in DM1 patients, reinforcing the company&#8217;s progress toward key clinical milestones.
&#8220;From our perspective, we continue to ponder management&#8217;s decision to proceed with the registrational expansion cohort for DM1 without receiving regulatory blessing on the protocol and relying on prior dialogue from May 2024 to pursue an accelerated approval path in the U.S,&#8221; Romero writes.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44286904/dyne-therapeutics-4-3-billion-peak-sales-potential-analyst-highlights-key-strengths-and-risks" rel="noreferrer noopener">Dyne Therapeutics&#8217; $4.3 Billion Peak Sales Potential? Analyst Highlights Key Strengths And Risks</a>
&#8220;Based on our conversations, it seems like investors generally share our sentiment and are looking for regulatory sign-off to gain more comfort,&#8221; the analyst added.
Romero still has concerns about the existing data and the absence of a recent update or near-term plans for another data release (the last one was on Dec. 6, 2024).
JPMorgan is also considering how these results might impact the expansion cohort, the confirmatory trial, and the broader competitive landscape.
&#8220;Overall, the additional results from the phase 1/2 ACHIEVE trial evaluating DYNE-101 in DM1 raised more questions than answers for us around the emerging clinical profile, and we look for progress that definitively derisks the lead asset and regulatory strategy,&#8221; the analyst writes.
JPMorgan maintains the Neutral rating on DYN, lowering the price target from $18 to $17.
Price Action: DYN stock is down 1.6% at $12.06 at the last check Friday.
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Analyst Color

JPMorgan Seeks Clarity On Dyne Therapeutics' DYNE-101 Expansion, Regulatory Path

JP Morgan analyst Tessa Romero maintains Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Neutral and lowers the price target from $18 to $17.

JP Morgan Maintains Neutral on Dyne Therapeutics, Lowers Price Target to $17

Press Releases

Dyne Therapeutics to Present New Preclinical Data in Facioscapulohumeral Muscular Dystrophy at the FSHD Society International Research Congress

Dyne Therapeutics to Host Investor Conference Call and Webcast to Provide Update on DYNE-101 for Myotonic Dystrophy Type 1, Tomorrow Tuesday, June 17 at 8:00 a.m. ET

Dyne Therapeutics Announces FDA Breakthrough Therapy Designation for DYNE-101 and Updated Plan for Accelerated Approval in DM1 Following Type C Meeting

Small Cap

Dyne Therapeutics Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – DYN

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dyne Therapeutics, Inc. - DYN

Legal

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Dyne Therapeutics, Inc. – DYN

Dyne Therapeutics Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights - DYN

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Dyne Therapeutics, Inc.  - DYN

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