ENTITY
FDA Approves Tonix’s Tonmya: First New Fibromyalgia Drug in Over 15 Years
Tonmya; FDA approval; fibromyalgia; Tonix Pharmaceuticals; non-opioid analgesic; cyclobenzaprine HCl sublingual tablets; chronic pain; phase 3 clinical trials
Merck KGaA Forms $2 Billion Neurological Disease Pact with Skyhawk Therapeutics
Merck KGaA; Skyhawk Therapeutics; neurological diseases; RNA splicing; SkySTAR platform; drug discovery; strategic collaboration; milestone payments
FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring
Wegovy; FDA approval; MASH; semaglutide; GLP-1 receptor agonist; liver fibrosis; Novo Nordisk; ESSENCE trial; noncirrhotic; accelerated approval
Genentech to End $2B Cell Therapy Collaboration with Adaptive Biotechnologies
Genentech; Adaptive Biotechnologies; cell therapy; collaboration termination; T-cell receptor; TruTCR platform; personalized cancer therapy; $2 billion deal
FDA Delays Draw Contrasting Responses: Neurizon Cites Agency Strain, Omeros Takes Softer Tone
FDA delays; Neurizon Therapeutics; Omeros Corporation; regulatory review; NUZ-001; narsoplimab; ALS; transplant drugs; agency staffing shortages; clinical hold
FDA Grants Full Approval to Precigen’s Papzimeos for Rare Disease RRP
Precigen; Papzimeos; FDA approval; recurrent respiratory papillomatosis (RRP); gene therapy; immunotherapy; rare disease; Orphan Drug designation
Eli Lilly Endorses Trump’s Goal by Raising Drug Prices Abroad to Align with U.S. Levels
Eli Lilly; drug prices; Donald Trump; international pricing; Mounjaro; U.K.; Europe; pharmaceutical tariffs; Project 2025
Sarepta Sells $174 Million Stake in Arrowhead to Fund Milestone Payment Amid Cash Crunch
Sarepta Therapeutics; Arrowhead Pharmaceuticals; cash crunch; stake sale; milestone payment; RNAi collaboration; SRP-1003; myotonic dystrophy; private block trade
Eli Lilly and Superluminal Ink $1.3B Pact Targeting GPCRs in Obesity, Cardiometabolic Diseases
Eli Lilly; Superluminal Medicines; GPCRs; obesity drugs; cardiometabolic diseases; AI drug discovery; MC4R; partnership; milestones; equity investment
CytomX Continues Phase I ADC Study After Patient Death
CytomX; CX-2051; Phase I; ADC; colorectal cancer; patient death; acute kidney injury; clinical trial; safety; FDA; trial continuation