Inovio wins FDA accelerated approval for Voceryq, stock surges
The FDA's accelerated clearance, paired with a separate court win, sent Inovio shares sharply higher.
TipRanks · +7 outlets
FDA partly halts Bright Minds' BMB-101 epilepsy study IND over mouse toxicity
The clinical hold on the BMB-101-105 IND affects a planned developmental and epileptic encephalopathy study, delaying the company's lead program.
TipRanks · +2 outlets
uniQure's Huntington's gene therapy gets FDA priority review
Priority review shortens the FDA's assessment timeline for the company's gene therapy candidate in an indication with few disease-modifying options.
Mugglehead Investment Magazine · +14 outlets
Kymera eczema readout looms as high-stakes test of Dupixent challenger
A positive result would position the biotech's targeted protein degrader against a entrenched immunology franchise.
STAT
Capricor rallies into FDA decision month on launch team hiring, Lancet DMD data
Retail investors are reading commercial build-out and a peer-reviewed publication as signals for the company's DMD therapy approval.
Yahoo Finance · +1 outlets
BridgeBio prepares rare muscular dystrophy launch ahead of FDA approval decision
The company is building commercial infrastructure for an LGMD limb-girdle muscular dystrophy therapy still under FDA review.
BioSpace · +3 outlets
FDA accepts Takeda's zasocitinib NDA for psoriasis under priority review
Priority review puts an oral TYK2 inhibitor on an accelerated path toward the plaque psoriasis market.
scanx.trade · +9 outlets
Regeneron posts record Q3 results, expands Sanofi alliance to $8B
The quarter included record revenue and a large new commitment under the long-running Sanofi collaboration.
Investing.com UK · +8 outlets
Hanmi launches homegrown obesity drug EPPE at roughly 40% below Mounjaro's price
Korea's first domestically developed GLP-1 obesity treatment enters a market long dominated by imported Wegovy and Mounjaro, with uptake still uncertain.
Koreabizwire · +8 outlets
Krystal Biotech authorizes buyback of up to $400 million in shares
The repurchase authorization follows commercial growth for the company's topical gene therapies.
Stock Titan · +1 outlets
Axsome on pace for more than $1 billion in annual revenue after quarterly results
The milestone marks the psychiatry-focused company's transition into a commercial-scale operator.
Stock Titan
Tiziana says all 48 patients complete multiple sclerosis trial
The company reported full enrollment completion alongside a nasal treatment that lowered a brain inflammation marker in an MS study.
Stock Titan · +7 outlets
FDA advisers narrowly vote to add six peptides to drug compounding list
The close vote reignites the fight over compounded peptide supply as the agency weighs next steps on the shortage list.
Health Affairs · +13 outlets
Merck's monthly HIV prevention pill completes adult enrollment in two trials
A once-monthly oral PrEP option would extend dosing intervals beyond current daily and long-acting injectable regimens.
Stock Titan · +4 outlets
AstraZeneca lung cancer combo cuts progression-or-death risk 45% versus chemo
The data support regulatory reviews already under way in Europe and Japan.
Stock Titan · +6 outlets
Eli Lilly reports trial wins across diabetes, cancer and colitis pipeline
The updates span several therapeutic areas as the company broadens beyond its obesity franchise.
Yahoo Finance · +5 outlets
Multicountry AN2 study for rare blood cancer clears regulators in three countries
The company said about 155,000 people in the U.S. have the blood cancer its planned study targets.
Stock Titan
Sirolimus-coated balloon matches drug-eluting stent at one year in TRANSFORM II
The international trial result supports drug-coated balloon alternatives for coronary interventions, alongside separate one-year data from Reflow Medical's retr
Yahoo Finance