Ultime notizie per Dyne Therapeutics (NASDAQ:DYN) Azioni

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.

Dyne Therapeutics Inc

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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.

News

Price Target

Initiation

Analyst Ratings

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

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

WIIM

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.
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<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>
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Pre-Market Outlook

Markets

Movers

Trading Ideas

BWMX

CMRE

INNV

MAZE

MESO

NEXA

SLSR

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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Photo: Shutterstock

Analyst Color

Biotech

Health Care

General

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

Management

Dyne Therapeutics Appoints Erick J. Lucera As Chief Financial Officer, Effective March 31, 2025

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

Reiteration

HC Wainwright & Co. Reiterates Buy on Dyne Therapeutics, Maintains $46 Price Target

- Continued favorable safety profile for DYNE-251 -
- DELIVER Registrational Expansion Cohort is fully enrolled;&nbsp;data from this cohort planned for late 2025 -
- Potential for Biologics License Application submission for U.S. accelerated approval&nbsp;in early 2026 -

Reported Earlier, Dyne Therapeutics Phase 1/2 Trial Update Highlights Sustained Functional Improvement In Duchenne Muscular Dystrophy With Exon 51-Skipping Candidate; Regulatory Submission Targeted For Early 2026

On Tuesday, BMO Capital Markets initiated coverage on Dyne Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>), focused on developing therapies for genetically <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">driven neuromuscular diseases</a>.
The company&#8217;s FORCE platform is designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS).
Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
In January, Dyne Therapeutics revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101, the company&#8217;s lead candidate, in patients with&nbsp;<a target="_blank" href="https://www.benzinga.com/25/01/42923575/why-is-neuromuscular-focused-dyne-therapeutics-stock-trading-lower-on-friday" rel="noreferrer noopener">myotonic dystrophy type 1 (DM1)</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40692261/muscle-disease-drug-developer-dyne-therapeutics-stock-plunges-after-updated-data-from-duchenne-mu" rel="noreferrer noopener">Muscle Disease Drug Developer Dyne Therapeutics Stock Plunges After Updated Data From Duchenne Muscular Dystrophy</a>
Dyne plans to begin a global Registrational Expansion Cohort with the potential to support a submission for U.S. Accelerated Approval based on biomarker and functional data in H1 2026.
Dyne leverages TfR1 Fab-conjugation for drug delivery to muscles. TfR1 is highly expressed in muscle cells. BMO analyst Kostas Biliouris acknowledges potential safety risks associated with TfR1-targeting (anemia, hemorrhage, kidney injury) but notes that the safety in Dyne&#8217;s clinical data appears acceptable.
Analyst Biliouris says Dyne&#8217;s major catalyst and investor debate revolves around the FDA&#8217;s decision on the DM1 regulatory pathway, as this dictates whether Dyne could enter the DM1 market concurrently or behind its competitor Avidity Biosciences, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RNA#NASDAQ">RNA</a>)
BMO assumes a traditional approval pathway and sees the DM1 market as large enough to accommodate multiple players, and Dyne could differentiate via potential CNS benefits.
BMO has initiated with an Outperform rating and <a target="_blank" href="https://www.benzinga.com/quote/DYN/analyst-ratings" rel="noreferrer noopener">a price target of $50</a>.
The analyst models around $4.3 billion DYNE-101 peak-risk unadjusted WW sales in 2035.
Price Action: DYN stock is up 2.16% at $12.29 at the last check Wednesday.
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Photo via Shutterstock.

Equities

Dyne Therapeutics' $4.3 Billion Peak Sales Potential? Analyst Highlights Key Strengths And Risks

BMO Capital analyst Kostas Biliouris initiates coverage on 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 $50.

BMO Capital Initiates Coverage On Dyne Therapeutics with Outperform Rating, Announces Price Target of $50

Scotiabank analyst Louise Chen initiates coverage on Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Sector Outperform rating and announces Price Target of $50.

Scotiabank Initiates Coverage On Dyne Therapeutics with Sector Outperform Rating, Announces Price Target of $50

Piper Sandler analyst Edward Tenthoff maintains Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Overweight and lowers the price target from $53 to $48.

Piper Sandler Maintains Overweight on Dyne Therapeutics, Lowers Price Target to $48

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 $55 to $46.

HC Wainwright & Co. Maintains Buy on Dyne Therapeutics, Lowers Price Target to $46

Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) reported quarterly losses of $(0.88) per share which beat the analyst consensus estimate of $(0.99) by 11.11 percent. This is a 19.27 percent increase over losses of $(1.09) per share from the same period last year.

Earnings Beats

Dyne Therapeutics Q4 2024 GAAP EPS $(0.88) Beats $(0.99) Estimate

Press Releases

Dyne Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

Dyne Therapeutics to Present at Stifel 2025 Virtual CNS Forum

Dyne Therapeutics Announces New Long-Term Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented and Sustained Functional Improvement Through 18 Months

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