PTC Therapeutics wins Sangamo bankruptcy auction with $211M bid for Fabry gene therapy
PTC outbid others to acquire Sangamo's BLA-stage Fabry disease gene therapy ST-920, with analysts viewing it as a risky high-reward bet on a treatment nearing p
BioPharma Dive · +8 outlets
FDA grants accelerated approval to Bristol Myers Squibb's first CELMoD therapy ZENBEXUS for multiple myeloma
The FDA approved the CELMoD drug combined with daratumumab and dexamethasone for patients with multiple myeloma as early as first relapse.
Bristol Myers Squibb · +1 outlets
Eli Lilly files six lawsuits targeting black market for experimental obesity drug retatrutide
Lilly is suing US companies allegedly selling unauthorized versions of its highly anticipated triple-G weight loss medicine ahead of a formal approval filing.
STAT · +14 outlets
Deaths reported after treatment with Neurocrine's approved Prader-Willi drug
Patient deaths have been reported following treatment with Neurocrine's Prader-Willi syndrome therapy, highlighting the difficult risk-benefit calculus for rare
STAT · +14 outlets
FDA fast-tracks experimental vaccine aiming to slow early Parkinson's disease
The FDA granted fast track designation to an investigational vaccine designed to slow progression of early-stage Parkinson's disease.
Parkinson's News Today · +2 outlets
Novo Nordisk's ziltivekimab misses Phase 3 primary endpoint
Novo Nordisk's investigational drug ziltivekimab failed to meet its primary endpoint in a Phase 3 trial.
drugdiscoverytrends.com · +9 outlets
New Taiho and Cullinan data heats up lung cancer drug battle with zipalertinib
New results position zipalertinib as a threat to multiple approved EGFR exon20 lung cancer medicines and set a bar for others in testing.
BioPharma Dive · +1 outlets
FDA cites significant concerns with ADC lymphoma trial
The FDA raised significant concerns regarding an antibody-drug conjugate trial in lymphoma, though specific details were not disclosed.
pharmaphorum · +2 outlets
Commure terminates payments under customer referral programs tied to AI products
General Catalyst-backed Commure ended a program that paid clinics for referrals to new customers amid an investigation into its practices.
STAT
Zealand Pharma sells rights to Takeda's blood cancer drug for $100M ahead of FDA decision
Zealand sold its royalty rights to Takeda's blood cancer drug for $100 million prior to an upcoming FDA approval decision.
Fierce Biotech
FDA approves Sagimet Biosciences IND for Phase 3 denifanstat acne trial
The FDA cleared Sagimet's investigational new drug application to begin a Phase 3 study of denifanstat for acne.
Kalkine Media · +3 outlets
PDS Biotechnology halts Phase 3 cancer therapy to focus on colorectal candidate
PDS is discontinuing a late-stage cancer program to prioritize development of its colorectal cancer contender.
Fierce Biotech · +2 outlets
Deerfield-backed Boulevard Bio launches with $65M for targeted autoimmune drugs
Co-founded by pioneering researchers, the startup is advancing a trio of antibodies with potential to treat multiple immune diseases.
BioPharma Dive · +1 outlets
Skylark Bio doses first child with GJB2 gene therapy for hearing loss
The company dosed the first pediatric patient with a gene therapy targeting GJB2-related hearing loss, a condition with no existing approved treatment.
Tech Times · +5 outlets
FDA clears PhenoNet Phase 3 trial of inhaled gene therapy for early Alzheimer's
PhenoNet received FDA clearance to begin a Phase 3 study of its inhaled PHENOGENE-1A for patients with early Alzheimer's disease.
Business Wire
Compass Pathways targets 2027 launch for COMP360 as FDA filing advances
Compass is advancing its psychedelic therapy COMP360 toward FDA submission and aims for a 2027 commercial launch.
TradingView · +7 outlets
Definium scores positive late-stage data for LSD pill in generalized anxiety disorder
Results from a Phase 3 study of Definium's LSD-based pill were called a clean win by analysts who see multibillion-dollar sales potential.
BioPharma Dive · +13 outlets
Cambridge eye cancer biotech Aura cuts 20% of staff to fund late-stage trial
Aura is laying off one-fifth of its workforce to extend cash runway and support a pivotal late-stage trial for its eye cancer therapy.
Hoodline · +3 outlets