Press Releases

IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune modulating therapeutic cancer vaccines based on its T-win® platform, announced today that the first patient has been dosed in its Phase 2 trial (NCT05280314) studying treatment with IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in neoadjuvant and adjuvant patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) befo

Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announces additional new clinical and biomarker results from its Phase 2a CLEAR MIND trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer&rsqu

Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Marking a significant milestone

uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced updated interim data including up to 30 months of follow-up from 39 patients enrolled in the ongoing U.S. and European Phase I/II clinical trials of AMT-130 for the treatment of Huntington’s disease. “The clinical assessment trends in the ongoing studies of AMT-130 look very promising and continue to show disease stability

Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, headquartered in Holon, Israel, to exclusively license its potential first-in-class, pre-clinical antibody program against IL-18 binding protein, including the COM503 drug candidate. Compugen utilizes its broadly applicable predictive computational discovery capabilities to ide

Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported patients have received their first doses of efruxifermin (EFX) in the SYNCHRONY Phase 3 program. Two parallel, randomized, placebo-controlled trials have commenced: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic nonalcoholic steatohep

Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody candidate, for the prevention of symptomatic COVID-19. “We are pleased to share positive initial topline results from CANOPY which bolster our belief that VYD222 holds the po

Agno Pharma (“Agno”), a US-based, global pharmaceutical contract development and manufacturing organization, announced today that it will acquire the Lubrizol Particle Sciences Inc. business (“Particle Sciences”). The acquisition includes the drug product formulation technology behind the Particle Sciences Inc. business as well as the Bethlehem, PA, development and manufacturing site with approximately 65 employees. Founded in 1991, Particle Sciences speciali

Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has received a positive review from the independent Data and Safety Monitoring Board (DSMB) on its phase 3 program for DONESTA®, its investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of menopause. All clinical investigations involving greater than minimal risk to participants are, at a minimum, required to develop a

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). If approved, exa-cel would be the only genetic therapy