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

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

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 it now plans to report new efficacy and safety data from its Phase 12 ACHIEVE and DELIVER clinical trials on May 20, 2024, and to host a virtual event at 8:00 a.m. ET. This represents an update to Dyne's prior guidance for the second half of 2024. The company intends to issue a press release prior to the start of the event.

Phase 1/2 ACHIEVE Trial of DYNE-101 in DM1

  • 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. ACHIEVE, which is designed to be a registrational trial, consists of a 24-week multiple ascending dose (MAD), randomized, placebo-controlled period, a 24-week open-label extension (OLE) and a 96-week long-term extension (LTE). Enrollment is complete through the 6.8 mg/kg (approximate ASO dose) cohort evaluating once every eight-week dosing. A total of 56 patients have been enrolled in the study with approximately 500 doses administered to date.

  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts. Additionally, pharmacokinetic and pharmacodynamic data, including change from baseline in splicing, measures of muscle strength and function, and patient reported outcomes will be shared. Efficacy data will be shared from the 1.8 mg/kg Q4W cohort (n=16) at 12 months, 3.4 mg/kg Q4W cohort (n=16) at 6 months, and 5.4 mg/kg Q8W cohort (n=8) at 3 months.

Phase 1/2 DELIVER Trial of DYNE-251 in DMD

  • DELIVER is a Phase 1/2 global clinical trial evaluating DYNE-251 in ambulant and non-ambulant males with Duchenne muscular dystrophy (DMD) who are ages 4 to 16 and have mutations amenable to exon 51 skipping. DELIVER, which is designed to be a registrational trial, consists of a 24-week MAD, randomized, placebo-controlled period, a 24-week OLE and a 96-week LTE. Enrollment is complete through the 40 mg/kg (approximate PMO dose) cohort evaluating once every eight-week dosing. A total of 48 patients have been enrolled in the study with approximately 480 doses administered to date.

  • In the upcoming clinical update, Dyne plans to report safety and tolerability data from all enrolled cohorts. Additionally, pharmacokinetic and pharmacodynamic data, including dystrophin expression measured by Western blot, will be shared from the 10 mg/kg Q4W cohort (n=8) at 6 months.

Virtual Investor Event

The live event webcast will be available on the Events & Presentations page of the Investors & Media section of Dyne's website and a replay will be accessible for 90 days following the presentation. An accompanying slide presentation will also be available. To register for the live webcast and replay, please visit https://investors.dyne-tx.com/news-and-events/events-and-presentations .

About Dyne Therapeutics

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

Contacts:

Investors
Amy Reilly
areilly@dyne-tx.com
857-341-1203

Media
Stacy Nartker
snartker@dyne-tx.com
781-317-1938


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

DYN
The Conversation (0)
Dyne Therapeutics to Present at Jefferies Global Healthcare Conference

Dyne Therapeutics to Present at Jefferies Global Healthcare Conference

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 the Jefferies Global Healthcare Conference in New York on Thursday, June 6, 2024 at 3:00 p.m. ET.

A live webcast will be available in the Investors & Media section of Dyne's website at https://investors.dyne-tx.com/news-and-events/events-and-presentations and a replay will be accessible for 90 days following the presentation.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Dyne Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

Dyne Therapeutics Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares

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 the closing of its previously announced underwritten public offering of 12,075,000 shares of its common stock at a public offering price of $31.00 per share, which includes 1,575,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The gross proceeds to Dyne from the offering were approximately $374.3 million, before deducting underwriting discounts and commissions and offering expenses payable by Dyne. All of the shares in the offering were sold by Dyne.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Dyne Therapeutics Announces Pricing of $325.5 Million Public Offering of Common Stock

Dyne Therapeutics Announces Pricing of $325.5 Million Public Offering of Common Stock

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 the pricing of an underwritten public offering of 10,500,000 shares of its common stock at a public offering price of $31.00 per share. The gross proceeds to Dyne from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Dyne, are expected to be $325.5 million. All shares in the offering are being sold by Dyne. The offering is expected to close on or about May 24, 2024, subject to customary closing conditions. In addition, Dyne has granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Dyne Therapeutics Announces Proposed Public Offering of Common Stock

Dyne Therapeutics Announces Proposed Public Offering of Common Stock

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.

Morgan Stanley, Jefferies, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering. Oppenheimer & Co. and Raymond James are acting as co-managers for the offering. 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.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
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

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

- In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose Dependent 27% Mean Splicing Correction Across All Patients in the 5.4 mg/kg Cohort at 3 Months -

- DYNE-101 Showed Improvement in Myotonia, Muscle Strength, and Timed Function Tests and in DM1-ACTIV c and MDHI Patient Reported Outcomes -

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Longboard Pharmaceuticals Announces Positive Interim Results from the Open-Label Extension  of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies

Longboard Pharmaceuticals Announces Positive Interim Results from the Open-Label Extension of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies

  • Bexicaserin achieved an overall median seizure reduction of 56.1% in countable motor seizures over an approximate 6-month treatment period; participants randomized to the PACIFIC placebo group achieved a median seizure reduction of 57.3%
  • Favorable safety and tolerability results observed
  • 100% of participants who completed the PACIFIC Study entered the OLE
  • End of Phase 2 Meeting scheduled for this summer

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive interim results from its ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin (LP352) in participants ages 12-65 years old with Developmental and Epileptic Encephalopathies.

"We are thrilled to see a sustained, durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients. Additionally, we saw compelling seizure reduction in the PACIFIC placebo patients who transitioned to bexicaserin in the OLE. These data provide further support to bexicaserin's potential to offer a highly differentiated and best-in-class profile," stated Dr. Randall Kaye, Longboard's Chief Medical Officer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver  in Milan

Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver in Milan

SZN-043 is a novel biotherapeutic shown to potentiate Wnt signaling and induce proliferation of hepatocytes in preclinical models

Treatment with SZN-043 in the Phase 1a trial was safe and well tolerated in healthy volunteers and patients with a history of liver cirrhosis

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Annexon Announces Pricing of $125 Million Underwritten Public Offering

Annexon Announces Pricing of $125 Million Underwritten Public Offering

Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced the pricing of its previously announced underwritten public offering of 13,001,120 shares of its common stock at a price to the public of $6.25 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 7,000,000 shares of common stock at a purchase price of $6.249 per share, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
MiNK Therapeutics Announces Virtual Annual Shareholders Meeting

MiNK Therapeutics Announces Virtual Annual Shareholders Meeting

MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (INKT) cell therapies to treat cancer and other immune-mediated diseases, today announced that its Annual Shareholders Meeting will begin at 9:30 a.m. ET. on June 12, 2024, and will be conducted in a virtual format only. Registration for attendees will start at 9:15 a.m. ET.

To participate in the Annual Shareholders Meeting, shareholders should visit www.virtualshareholdermeeting.com/INKT2024 and enter the 16-digit control number found in their proxy materials. Guests may also access the meeting in listen-only mode. No control number is required for guests.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Atea Pharmaceuticals Presents Positive Initial Phase 2 Data for Bemnifosbuvir and Ruzasvir Combination for Treatment of Hepatitis C Virus at EASL Congress 2024

97% SVR12 Rate Observed with 8 Weeks of Treatment in Lead-In Cohort of HCV-Infected Patients in Ongoing Phase 2 Clinical Study

EASL Presentations Continue to Support Best-in-Class Potential with High Antiviral Potency, Short Treatment Duration, Low Risk of Drug Interaction and High Barrier to Resistance

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy.

The clinical poster presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×