Últimas noticias sobre Dyne Therapeutics (NASDAQ:DYN) Bolsa

Dyne Therapeutics

Dyne Therapeutics Inc is a biotechnology company focused on providing therapeutics for patients with genetically driven diseases. The company overcomes the limitations of muscle tissue delivery and modern oligonucleotide therapeutics for muscle diseases. The company is developing therapies for muscle disorders like Myotonic dystrophy, Duchenne muscular dystrophy, and Facioscapulohumeral muscular dystrophy. The company's product candidates are DYNE-101 and DYNE-251, both are in the ongoing phase 1/2 clinical trial.

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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>) from Buy to Buy.

News

Reiteration

Analyst Ratings

Guggenheim Reiterates Buy on Dyne Therapeuticsto Buy

WIIM

Dyne Therapeutics shares are trading higher after the company announced it received FDA Fast Track designation for DYNE-101 to treat myotonic dystrophy type 1.

Health Care

General

Dyne Therapeutics Given FDA Fast Track Designation For DYNE-101 To Treat Myotonic Dystrophy Type 1

RBC Capital analyst Luca Issi reiterates Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) with a Outperform and maintains $45 price target.

Price Target

RBC Capital Reiterates Outperform on Dyne Therapeutics, Maintains $45 Price Target

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 $55 price target.

HC Wainwright & Co. Reiterates Buy on Dyne Therapeutics, Maintains $55 Price Target

<h3>Gainers</h3>
<ul>
<li>Precision BioSciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DTIL#NASDAQ">DTIL</a>) shares moved upwards by 49.8% to $6.74 during Friday's pre-market session. The company's market cap stands at $51.7 million. </li>
<li>ZyVersa Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZVSA#NASDAQ">ZVSA</a>) stock increased by 36.44% to $1.61. The market value of their outstanding shares is at $4.0 million. </li>
<li>Conduit Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) shares rose 32.8% to $0.11. The market value of their outstanding shares is at $13.0 million. </li>
<li>Akoya Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKYA#NASDAQ">AKYA</a>) stock rose 24.06% to $3.3. The market value of their outstanding shares is at $163.5 million. </li>
<li>Scinai Immunotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SCNI#NASDAQ">SCNI</a>) shares rose 22.83% to $4.25. The market value of their outstanding shares is at $3.6 million. </li>
<li>Senseonics Holdings (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/SENS#AMEX">SENS</a>) stock increased by 18.33% to $0.51. The company's market cap stands at $303.2 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>IGM Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IGMS#NASDAQ">IGMS</a>) stock fell 67.8% to $2.0 during Friday's pre-market session. The market value of their outstanding shares is at $118.9 million. </li>
<li>Calidi Biotherapeutics (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/CLDI#AMEX">CLDI</a>) stock declined by 31.8% to $0.92. The company's market cap stands at $17.3 million. </li>
<li>Mersana Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRSN#NASDAQ">MRSN</a>) shares decreased by 18.47% to $1.06. The company's market cap stands at $130.9 million. </li>
<li>Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) stock declined by 13.8% to $19.87. The market value of their outstanding shares is at $2.0 billion. </li>
<li>TransMedics Gr (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TMDX#NASDAQ">TMDX</a>) stock declined by 13.18% to $62.99. The market value of their outstanding shares is at $2.1 billion. </li>
<li>DIH Holding US (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DHAI#NASDAQ">DHAI</a>) stock declined by 12.36% to $1.49. The company's market cap stands at $60.4 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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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

On Friday, Dyne Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) revealed new data from its ongoing Phase 1/2 ACHIEVE trial of DYNE-101 in patients with <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42908297/dyne-therapeutics-reports-new-clinical-data-showing-compelling-impact-on-multiple-measures-of-myot" rel="noreferrer noopener">myotonic dystrophy type 1 (DM1)</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.
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 reported efficacy 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=8) at up to 6 months.
At the 6.8 mg/kg Q8W dose, DYNE-101 resulted in significant splicing correction at 3 months compared to baseline, which was associated with progress in multiple functional endpoints, beginning at 3 months and continuing at 6 months.
<ul>
<li>Analysis of muscle biopsy data for the 6.8 mg/kg Q8W cohort showed a substantial knockdown of Drug Metabolism and Pharmacokinetics (DMPK) (DYNE-101 molecular target) RNA levels. Splicing correction at 3 months for the 6.8 mg/kg Q8W cohort was robust. It was associated with improvement in multiple functional endpoints, supporting CASI-22 at 3 months as a surrogate endpoint for potential U.S. Accelerated Approval.</li>
<li>Early and sustained improvement in myotonia as measured by video hand opening time (vHOT) was seen in the 6.8 mg/kg Q8W cohort and at low doses with modest splicing correction, deepening with more time on the drug.</li>
<li>Functional measures showed early and sustained clinical benefit at the 6.8 mg/kg Q8W dose.</li>
</ul>
Dyne also reported safety and tolerability data from 56 patients. Most of the treatment-emergent adverse events were mild or moderate, and no related serious treatment-emergent adverse events have been identified.
Based on previous dialogue with the FDA&#8217;s Center for Drug Evaluation and Research division, Dyne continues to pursue accelerated approval in the U.S. based on splicing as a surrogate endpoint.
Dyne anticipates completing enrollment in the Registrational Expansion Cohort in mid-2025 and submitting for U.S. Accelerated Approval in H1 2026.
Price Action: DYN stock is down 35.3% at $14.91 at last check Friday.
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Image via Shutterstock.

Biotech

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Why Is Neuromuscular-Focused Dyne Therapeutics Stock Trading Lower On Friday?

Dyne Therapeutics Reports New Clinical Data Showing Compelling Impact On Multiple Measures Of Myotonic Dystrophy Type 1; Company Plans To Initiate Registrational Expansion Cohort To Support Potential Submission For U.S. Accelerated Approval For DYNE-101 in DM1 In H1 2026

Dyne Therapeutics shares are trading higher after the company announced it will release new clinical data from its Phase 1/2 ACHIEVE trial.

Dyne Therapeutics To Release New Clinical Data From Phase 1/2 ACHIEVE Trial On January 10, 2025; Investor Conference Call And Webcast Scheduled For 8:00 AM ET

Baird analyst Brian Skorney 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 $46.

Initiation

Baird Initiates Coverage On Dyne Therapeutics with Outperform Rating, Announces Price Target of $46

Insider Trades

Dyne Therapeutics Director Kersten Dirk Sells 138,845 Shares At An Average Price Of $29.38 Per Share

RBC Capital analyst Luca Issi 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 $45.

RBC Capital Initiates Coverage On Dyne Therapeutics with Outperform Rating, Announces Price Target of $45

Dyne Therapeutics shares are trading higher. The company reported Q3 financial results and provided updates on its balance sheet.

Earnings

Guidance

Dyne Therapeutics' Cash, Cash Equivalents And Marketable Securities Were $723.7M As Of September 30, 2024, Which Is Anticipated To Fund Operations At Least Into The Second Half Of 2026

Dyne Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYN#NASDAQ">DYN</a>) reported quarterly losses of $(0.96) per share which missed the analyst consensus estimate of $(0.78) by 23.08 percent. This is a 3.03 percent increase over losses of $(0.99) per share from the same period last year.

Dyne Therapeutics Q3 2024 GAAP EPS $(0.96) Misses $(0.78) Estimate

Press Releases

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

Dyne Therapeutics to Present at Upcoming Investor Conferences

Dyne Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Dyne Therapeutics to Host Investor Conference Call and Webcast to Review New Clinical Data from the ACHIEVE Trial Friday, January 10 at 8:00 a.m. ET

Dyne Therapeutics to Present at 43rd Annual J.P. Morgan Healthcare Conference

Dyne Therapeutics Reports New Clinical Data Showing Compelling Impact on Multiple Measures of Myotonic Dystrophy Type 1 (DM1); Dyne Plans to Initiate Registrational Expansion Cohort to Support Potential Submission for U.S. Accelerated Approval for DYNE-101 in DM1 in H1 2026

Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1

Dyne Therapeutics to Present at Oppenheimer 35th Annual Healthcare Life Sciences Conference

Dyne Therapeutics Announces Upcoming Presentations at the 2025 MDA Clinical & Scientific Conference

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