The mRNA therapeutics market has experienced explosive growth over the past few years. According to estimates by QY Research, the global mRNA therapeutics market reached a total sales value of RMB 248.4 billion (approx. USD 35 billion) in 2023. Preventive mRNA vaccines are projected to achieve a 20% penetration rate in the USD 50.3 billion vaccine market by 2025, corresponding to a market size of USD 10.1 billion. Meanwhile, mRNA cancer vaccines are expected to reach a 0.5% penetration rate by 2

June 18, 2025 -- Diagonal Therapeutics, a biotechnology company focused on correcting dysregulated signaling with clustering antibodies that address the underlying cause of intractable genetic diseases, today announced that both the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to DIAG723, a novel, bispecific antibody, for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the European Medicines Agency (EMA) provided a positive opinio

- 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