Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET Dec. 11, 2025 -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patien

Dec. 11, 2025 -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026. “We are very pleased with the collaborative dis

IMA203CD8 is a second-generation PRAME cell therapy with enhanced pharmacology in ongoing Phase 1a dose escalation Manageable tolerability across all dose levels Encouraging early clinical anti-tumor activity in advanced solid tumors after one-time infusion of IMA203CD8 at a low median dose during ongoing dose escalation, including deep and durable responses Promising dose-dependent clinical signal in ovarian carcinoma supports the strategy to position IMA203CD8 in the tumor-agnostic setting of

Dec. 11, 2025 -- ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV™ (Intravenously Deliverable Oncolytic Virus) platform, today announced the initiation of a first-in-human clinical trial evaluating IDOV-Immune, its investigational oncolytic vaccinia virus therapy, in patients with advanced solid tumors (NCT06910657). Additional trial sites across the United States are expected to begin enrolling in 2026, pending clearance of the U.S. IND. The first patient was dosed at The

Dec. 11, 2025 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced today that its next-generation TRK inhibitor, zurletrectinib (ICP-723), has received approval from the China National Medical Products Administration (NMPA) for the treatment of adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions. In the registrational clinical trial for patients with NTRK fusion-positive solid tumors, zurletrectinib demo

Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 Dec. 11, 2025 -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that the

Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years1-3 Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease1 ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or after adjuvant endocrine therapy treatment4-7 Data will be featured

The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in the U.S. and China for the treatment of idiopathic pulmonary fibrosis (IPF).4,5 China’s National Medical Products Administration (NMPA) h

Dec. 10, 2025 -- Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for the treatment of myelofibrosis, a debilitating blood cancer that affects approximately 20,000 patients in the U.S. AJ1-11095 is the first JAK2 inhibitor to enter the clinic that binds the Type II conformation of th

RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after Orphan Drug Designation, is supported by clinical data showing de