Medera Receives FDA Fast Track Designation for Gene Therapy Targeting Duchenne Muscular Dystrophy-Associated CardiomyopathyBOSTON, April 16, 2026 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company developing next-generation cardiovascular therapeutics, and its clinical development division Sardocor, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AAV-SERCA2a, an investigational gene therapy drug designed to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD-CM), building on prior human clinical experience with SERCA2a gene therapy and Medera’s ongoing clinical programs. AAV-SERCA2a is currently being evaluated in the first-in-human MUSIC-DMD clinical trial and aims to restore cardiac calcium handling by increasing expression of SERCA2a, a key regulator of heart muscle contraction and relaxation, using Medera's targeted intracoronary gene delivery approach designed to achieve therapeutic cardiac exposure at substantially lower vector doses than conventional systemic gene therapy approaches.
Medera Announces Completion of Patient Enrollment in Cohort B of MUSIC-HFpEF Phase 1/2a Clinical TrialBOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that the final patient has been dosed in Cohort B (high-dose cohort, 4.50×10¹³ viral genomes (vg) per patient) of the ongoing MUSIC-HFpEF Phase 1/2a clinical trial evaluating SRD-002 gene therapy for heart failure with preserved ejection fraction (HFpEF). The patient was successfully treated using Medera's proprietary minimally invasive intracoronary infusion methodology and tolerated the procedure well. Completion of enrollment in Cohort B underscores the clinical feasibility of targeted intracoronary cardiac gene therapy in complex HFpEF with substantial unmet medical need.
Medera to Participate in Oppenheimer Movers in Rare Disease Summit 2025BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that James Kim, Chief Corporate Officer of Medera, will participate in the Oppenheimer Movers in Rare Disease Summit on Thursday, December 11, 2025, at the Sofitel New York, 45 West 44th Street in New York City.
Medera Presents Late-Breaking Data from First-In-Human Gene Therapy Trial for Heart Failure with Preserved Ejection Fraction at American Heart Association Scientific Sessions 2025BOSTON, Nov. 09, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that positive interim data from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial was presented at the American Heart Association (AHA) Scientific Sessions 2025 taking place November 7-10, 2025, in New Orleans, Louisiana.
Medera Announces First Patient Dosed in Phase 2 Portion of MUSIC-HFrEF Phase 1b/2 Trial Evaluating SRD-001 Gene Therapy for Heart Failure with Reduced Ejection FractionBOSTON, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that the first patient has been dosed in the Phase 2 portion of the MUSIC-HFrEF Phase 1b/2 clinical trial evaluating the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HFrEF). The patient was successfully treated on September 5, 2025, and additional patients are scheduled for treatment.
Medera Strengthens Leadership Team with Three Key Executive AppointmentsClinical operations, regulatory affairs, technical expertise, and corporate leadership additions support advancing gene therapy pipeline for cardiovascular diseases
