- Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval - - New positive clinical data from Phase 1/2 ACHIEVE trial support vHOT as early indicator of clinical benefit with DYNE-101 in DM1 - - Ongoing Registrational Expansion Cohort in ACHIEVE trial to enroll 60 participants and include sites in U.S. - - Company to host an investor and analyst conference call today, June 17, at 8:00 a.m. ET - J

U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseases Capricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection June 17, 2025 -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today anno

June 15, 2025 Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Data further demonstrates the potential of epcoritamab in combination with salvage chemoimmunotherapy to increase the proportion of patien

After a thorough clinical review, the benefit-risk for the use of Elevidys in non-ambulatory patients with Duchenne has been re-assessed, following two cases of fatal acute liver failure Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in the commercial setting Roche is working closely with relevant health authorities, investigators and prescribing physicians to ensure they are info

June 12, 2025 -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced new preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) (Cortrophin Gel) in a mouse model of murine collagen-induced inflammatory arthritis. “In a preclinical model of murine collagen-induced arthritis, repository corticotrophin injection attenuated joint swelling in mice, and decreased inflammatory cytokine response without causing additional bone turnover

Significant and clinically meaningful improvement in pain, function, and other outcomes in people with knee osteoarthritis Rapid onset of action observed Improvement in function out of proportion to pain-relieving effects First-in-class novel biologic under development as non-addictive pain treatment June 12, 2025 -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is to present new data from its large-scale Phase II tr

Proceeds to fund Phase 1/2 trial of EO2463 OncoMimics™, as a monotherapy or in combination, to treat multiple forms of indolent non-Hodgkin lymphoma (iNHL) $9 million from new investor The Institute for Follicular Lymphoma Innovation (IFLI) $10 million from existing specialist investors, including The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP) June 12, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics™ immunotherapies to treat cancer, has r

Results demonstrate potential of Company’s clustering antibody approach to address key challenges in HHT disease manifestations: restoring ALK1-mediated cellular signaling, preventing and reversing arteriovenous malformations, and preventing HHT-associated anemia Groundbreaking preclinical profile of Diagonal’s bispecific clustering antibodies supports advancement of lead program, DIAG723, in HHT and PAH June 12, 2025 -- Diagonal Therapeutics, a biotechnology company focused on correcting dysr

Nav1.8 inhibitors hold significant economic value and exhibit promising development trends in the global analgesics market. In 2022, the global market size for analgesic drugs reached approximately USD 91.14 billion, and it is projected to approach USD 90 billion by 2028. In China, the analgesics market was valued at approximately RMB 122.6 billion, with the expectation that China will become the largest and fastest-growing pain treatment market worldwide over the next decade. As a novel class o

Stockholders overwhelmingly approved liquidation and dissolution of the Company at the June 5, 2025 Annual Meeting Initial distribution currently expected in the range between approximately $5.30 and $5.35 per share of common stock, expected in the third quarter of 2025 THB335 demonstrated 85% serum tryptase reduction with an encouraging safety profile in an additional Phase 1 cohort evaluating 100mg dose with new drug product capsule formulation Company initiating a sale process of THB335 June