New Food and Drug Administration (FDA) guidance on accelerated approval for drugs targeting “serious conditions” appears to be a positive move for rare diseases, analysts at Jefferies believe. The FDA earlier this month published the draft guidance on its policies and procedures for the accelerated approval (AA) pathway for drugs for serious conditions that fulfil an unmet medical need.
Dyne Therapeutics, Inc. develops treatments for muscle diseases using its FORCE platform, with promising candidates DYNE-101 and DYNE-251 targeting DM1 and DMD, respectively. DYNE-251 shows significant improvement over Sarepta's Eteplirsen in Phase 1/2 trials, potentially accelerating approval and boosting DYN's stock. Key risks include executive reshuffling and potential hidden issues with IP,...
WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to present at the following upcoming investor conferences:
WALTHAM, Mass., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that management is scheduled to participate in a fireside chat at Chardan's 8th Annual Genetic Medicines Conference being held in New Yo...
NEW YORK, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Dyne Therapeutics, Inc. (“Dyne” or the “Company”) (NASDAQ: DYN) on behalf of Dyne stockholders. Our investigation concerns whether Dyne has violated the federal securities laws and/or engaged in other unlawful business practices.
NEW YORK--(BUSINESS WIRE)---- $DYN #Investigation--The law firm of Kirby McInerney LLP is investigating potential claims against Dyne Therapeutics, Inc. (“Dyne” or the “Company”) (NASDAQ: DYN). The investigation concerns whether Dyne and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices. [Click here to learn more about the i...
Dyne Therapeutics stock crashed Tuesday after several key executives departed on the heels of what the company calls "unprecedented" in DMD.
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