Dyne

Dyne Therapeutics Announces Proposed Public Offering of Common Stock

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月曜日, 5月 20, 2024
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WALTHAM, Mass., May 20, 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 it has commenced an underwritten public offering of $300,000,000 of shares of its common stock.

Key Points: 
  • WALTHAM, Mass., May 20, 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 it has commenced an underwritten public offering of $300,000,000 of shares of its common stock.
  • Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of shares of its common stock.
  • All of the shares in the proposed offering are to be sold by Dyne.
  • The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Dyne Therapeutics Announces New Clinical Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrating Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints

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月曜日, 5月 20, 2024
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New data from both trials demonstrated compelling impact on key disease biomarkers as well as improvement in multiple functional endpoints and favorable safety profiles.

Key Points: 
  • New data from both trials demonstrated compelling impact on key disease biomarkers as well as improvement in multiple functional endpoints and favorable safety profiles.
  • “We are excited to report new clinical data from both our ACHIEVE and DELIVER trials demonstrating meaningful impact on key biomarkers and functional improvement in multiple clinical endpoints that matter to patients.
  • Our robust preclinical work is translating into clinical benefit along with favorable safety profiles for both DYNE-101 and DYNE-251.
  • In the ACHIEVE trial, DYNE-101 demonstrated robust muscle delivery and dose-dependent, consistent splicing correction while also showing improvement in multiple functional endpoints and patient reported outcomes.

Dyne Therapeutics to Host Virtual Investor Event to Review New Clinical Data from the ACHIEVE and DELIVER Trials Tomorrow, May 20 at 8:00 a.m. ET

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日曜日, 5月 19, 2024
Patient, PMO, Facial muscles, DYN, DM1, OLE, Therapy, Safety, DMD, Dyne, Event, Duchenne muscular dystrophy, LTE, Webcast, Dystrophin, Vaccine

The company intends to issue a press release prior to the start of the event.

Key Points: 
  • The company intends to issue a press release prior to the start of the event.
  • ACHIEVE is a Phase 1/2 global clinical trial evaluating DYNE-101 in adult patients with myotonic dystrophy type 1 (DM1) who are 18 to 49 years of age.
  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts.
  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts.

Dyne Therapeutics Announces Proposed Public Offering of Common Stock

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水曜日, 1月 3, 2024
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WALTHAM, Mass., Jan. 03, 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 it has commenced an underwritten public offering of $175,000,000 of shares of its common stock.

Key Points: 
  • WALTHAM, Mass., Jan. 03, 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 it has commenced an underwritten public offering of $175,000,000 of shares of its common stock.
  • Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional $26,250,000 of shares of its common stock.
  • All of the shares in the proposed offering are to be sold by Dyne.
  • The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Dyne Therapeutics Announces Positive Initial Clinical Data from ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients Demonstrating Promise of the FORCE™ Platform in Developing Therapeutics for Rare Muscle Diseases

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水曜日, 1月 3, 2024
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“We are excited that Dyne’s first clinical data in two programs have demonstrated proof-of-concept and validated the promise of the FORCE™ platform in developing targeted therapeutics for rare muscle diseases.

Key Points: 
  • “We are excited that Dyne’s first clinical data in two programs have demonstrated proof-of-concept and validated the promise of the FORCE™ platform in developing targeted therapeutics for rare muscle diseases.
  • Dyne anticipates providing its next clinical data update from the ACHIEVE trial in the second half of 2024.
  • Key initial findings from DELIVER include:
    Muscle delivery: DYNE-251 showed a mean 657 ng/g PMO muscle drug concentration at 6 months.
  • Dyne anticipates providing its next clinical data update from the DELIVER trial in the second half of 2024.

Dyne Therapeutics Reports Third Quarter 2023 Financial Results and Provides Update on Significant Progress for ACHIEVE and DELIVER Trials and Upcoming Clinical Milestones

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月曜日, 10月 30, 2023
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WALTHAM, Mass., Oct. 30, 2023 (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 reported financial results for the third quarter of 2023 and provided an update on progress and upcoming milestones for its Phase 1/2 ACHIEVE and DELIVER clinical trials.

Key Points: 
  • (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the third quarter of 2023 and provided an update on progress and upcoming milestones for its Phase 1/2 ACHIEVE and DELIVER clinical trials.
  • “We’ve made tremendous progress in our ACHIEVE and DELIVER trials with more than 72 patients enrolled and over 300 doses administered thus far.
  • General and administrative (G&A) expenses: G&A expenses were $7.0 million for the quarter ended September 30, 2023, compared to $7.6 million for the quarter ended September 30, 2022.
  • Net loss: Net loss for the quarter ended September 30, 2023 was $60.2 million, or $0.99 per basic and diluted share.

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

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水曜日, 9月 20, 2023
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WALTHAM, Mass., Sept. 20, 2023 (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 the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for DYNE-101 for the treatment of myotonic dystrophy type 1 (DM1). DYNE-101 is being evaluated in the Phase 1/2 global ACHIEVE clinical trial with initial data on safety, tolerability and splicing from the multiple ascending dose, placebo-controlled portion of the trial anticipated in the second half of 2023.

Key Points: 
  • DYNE-101 is being evaluated in the Phase 1/2 global ACHIEVE clinical trial with initial data on safety, tolerability and splicing from the multiple ascending dose, placebo-controlled portion of the trial anticipated in the second half of 2023.
  • “Receiving FDA orphan drug designation for DYNE-101 underscores the importance of bringing new treatment options to people living with DM1, a rare, devastating disease with no approved therapies.
  • We believe DYNE-101 has the potential to be a transformative therapy which is why we designed the ACHIEVE trial to be registrational,” said Wildon Farwell, M.D., MPH, chief medical officer of Dyne.
  • Under the Orphan Drug Act, orphan drug designation qualifies a company for incentives, including tax credits, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval.

Myotonic Dystrophy Drug Pipeline Research Report 2023: Comprehensive Insights About 20+ Companies and 22+ Pipeline Drugs - ResearchAndMarkets.com

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木曜日, 9月 14, 2023
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The "Myotonic Dystrophy - Pipeline Insight, 2023" report offers an extensive overview of the Myotonic Dystrophy pipeline landscape, featuring insights on over 20 companies and 22 pipeline drugs.

Key Points: 
  • The "Myotonic Dystrophy - Pipeline Insight, 2023" report offers an extensive overview of the Myotonic Dystrophy pipeline landscape, featuring insights on over 20 companies and 22 pipeline drugs.
  • For a holistic understanding, it includes a detailed disease overview and Myotonic Dystrophy treatment guidelines.
  • Currently, the drug is being investigated in the Phase II/III stage of clinical trial evaluation for the treatment of Congenital Myotonic Dystrophy.
  • This segment of the report provides insights about the different Myotonic Dystrophy drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.

Dyne Therapeutics Reports Second Quarter 2023 Financial Results and Business Highlights

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木曜日, 8月 3, 2023
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WALTHAM, Mass., Aug. 03, 2023 (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 reported financial results for the second quarter of 2023 and business highlights.

Key Points: 
  • (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today reported financial results for the second quarter of 2023 and business highlights.
  • Research and development (R&D) expenses: R&D expenses were $59.1 million for the quarter ended June 30, 2023, compared to $46.7 million for the quarter ended June 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $7.6 million for the quarter ended June 30, 2023, compared to $6.1 million for the quarter ended June 30, 2022.
  • Net loss: Net loss for the quarter ended June 30, 2023 was $64.9 million, or $1.08 per basic and diluted share.

Dyne Therapeutics Receives European Medicines Agency (EMA) Orphan Drug Designation for DYNE-101

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木曜日, 5月 25, 2023
Myopathy, DYN, Therapy, DM1, European Medicines Agency, Research, EMA, Clinical trial, European, Diagnosis, MPH, Second Half, Pharmaceutical industry, Dyne

WALTHAM, Mass., May 25, 2023 (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 the European Medicines Agency (EMA) has granted orphan drug designation for DYNE-101. DYNE-101 is being evaluated in the Phase 1/2 ACHIEVE global clinical trial in adults with myotonic dystrophy type 1 (DM1).

Key Points: 
  • DYNE-101 is being evaluated in the Phase 1/2 ACHIEVE global clinical trial in adults with myotonic dystrophy type 1 (DM1).
  • “We are pleased to receive orphan drug designation from the EMA for DYNE-101, further supporting our efforts to develop a potentially transformative therapy for DM1,” said Wildon Farwell, M.D., MPH, chief medical officer of Dyne.
  • “The DM1 community has waited far too long for a therapy that addresses the underlying cause of this devastating rare muscle disease.
  • Orphan designation allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants and up to 10 years of market exclusivity in the European Union if approved.