FDA Approves Instil Bio’s ($TIL) AXN-2510 IND Submission
Instil Bio, Inc. (TIL) announced that the U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for AXN-2510. Instil Bio...
Promising Preclinical Data from Alpha Cognition Inc. ($ACOG) on ALPHA-1062
Alpha Cognition Inc. (ACOG) announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury. The data provides...
Moderna, Inc. ($MRNA) Shows Strong Efficacy of mRNA-1010 in Phase 3 Influenza Study
Moderna, Inc. (MRNA) announced positive results from a Phase 3 efficacy study evaluating the relative vaccine efficacy of mRNA-1010 against influenza illness. Strong relative...
Nuvalent, Inc. ($NUVL) advances front-line strategies for ROS1 and ALK-positive NSCLC programs
Nuvalent, Inc. (NUVL) announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer...
Longeveron Inc. ($LGVN) Advances Cellular Therapy Laromestrocel for Rare Heart Condition
Longeveron Inc. (LGVN) has completed full enrollment in its Phase 2b clinical trial for laromestrocel, targeting Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric...
Vidofludimus Calcium Shows Strong Efficacy in RRMS, Immunic, Inc. ($IMUX) Reports
Immunic, Inc. (IMUX) announced new long-term open-label extension data from its phase 2 EMPhASIS trial. The trial involved their lead asset, vidofludimus calcium, an...
Incyte (INCY) Gains FDA Nod for Monjuvi in Relapsed or Refractory Follicular Lymphoma (FL)
Incyte (INCY) announced that the U.S. Food and Drug Administration has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, for use in...
SENTI-202 by Senti Biosciences ($SNTI) Secures FDA Orphan Drug Designation for Rare Hematologic Malignancies
Senti Biosciences (SNTI) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to SENTI-202 for relapsed/refractory hematologic malignancies including AML.SENTI-202...
Deramiocel Scores FDA Orphan Drug Designation, Boosting Capricor Therapeutics ($CAPR) Pipeline
Capricor Therapeutics (CAPR) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Deramiocel. Deramiocel is the lead cell therapy...
CERo Therapeutics ($CERO) Advances AML Treatment with FDA Orphan Drug Status
CERo Therapeutics Holdings, Inc. (CERO) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its lead drug candidate CER-1236, targeting...