Archive snapshot · Biotech
Fri, Sep 11, 9:30 PM ET
FDA approves Takeda's MIMRYLO (rusfertide) for polycythemia vera, a first-in-class treatment
First-ever FDA approval of an injectable hepcidin mimetic for polycythemia vera, marking a shift in the treatment paradigm for the rare blood cancer.
CancerNetwork · +12 outlets
Eli Lilly's Mounjaro wins FDA approval for cardiovascular risk reduction in type 2 diabetes
FDA expands Mounjaro's label to include reducing risk of heart attack and stroke in type 2 diabetes patients, broadening the GLP-1 drug's market.
Sahm · +14 outlets
Pancreatic cancer drug daraxonrasib (Revolution Medicines) gets FDA approval, nearly doubling survival
The FDA approves Revolution Medicines' oral RAS inhibitor daraxonrasib (now RMC-4630) for pancreatic cancer, a landmark for a notoriously hard-to-treat cancer.
The Eastern Herald · +13 outlets
Alnylam's vutrisiran cuts decline risk by 52% in heart amyloidosis analysis
New analysis of Phase 3 data shows vutrisiran significantly reduces risk of decline in transthyretin amyloidosis with cardiomyopathy.
Stock Titan · +1 outlets
Hair loss drugs become Wall Street focus as Bloomberg calls them the next goldmine
Growing investor interest in alopecia treatments as a potential blockbuster market, with some related stocks surging.
Bloomberg.com · +7 outlets
Intellia Therapeutics (NTLA) jumps on positive late-stage data for gene-editing therapy
Premarket surge for NTLA after positive late-stage trial readout for its CRISPR-based gene-editing therapy.
Stocktwits · +5 outlets
Ascletis starts global Phase III trials of oral GLP-1 drug ASC30 for chronic weight management
First participant dosed in global Phase III program for Ascletis' once-daily oral small molecule GLP-1 receptor agonist for obesity.
TipRanks · +5 outlets
Travere Therapeutics wins FDA approval for kidney disease drug
FDA approves Travere's drug for a rare kidney disease after a much-awaited regulatory decision.
Stocktwits · +11 outlets
BioXcel Therapeutics files Chapter 11, lines up $125M Teva asset sale
BioXcel enters bankruptcy proceedings with a planned sale of assets to Teva for $125 million.
ElevenFlo · +2 outlets
Compass Pathways (CMPS) stock climbs as analyst sees depression drug approval by H1 2027
After strong trial data, an analyst projects FDA approval for COMP360 psilocybin therapy for depression by the first half of 2027.
Stocktwits · +2 outlets
Cytokinetics drug outperforms metoprolol in 175-patient heart failure trial
Cytokinetics' cardiac myosin inhibitor showed superior results compared to metoprolol in a Phase 2 heart failure study.
Stock Titan · +6 outlets
Fifth Circuit rejects PhRMA Medicare pricing lawsuit, marking 25th court loss for big pharma
The Fifth Circuit Court of Appeals ruled against PhRMA in its challenge to Medicare drug price negotiation, the industry's 25th consecutive legal defeat.
londoninsider.co.uk · +1 outlets
Eli Lilly expands Alzheimer's research with new drug collaboration
Lilly enters a new collaboration to advance Alzheimer's disease research, expanding its neuroscience pipeline.
simplywall.st · +14 outlets
FDA approves rusfertide for polycythemia vera after Takeda acquisition
The FDA approval of MIMRYLO (rusfertide) provides a new treatment option for patients with polycythemia vera.
CancerNetwork · +10 outlets
Protagonist Therapeutics drops 6.5% after FDA approval triggers $275M milestone payment
Despite an FDA approval milestone worth $275 million to Protagonist, the stock declined, attributed to market dynamics.
simplywall.st
SRRK stock gains after company drops troubled Novo Nordisk-owned plant from FDA filing
Shares of Scholar Rock rose after the company removed a Novo Nordisk-owned manufacturing plant with quality issues from its regulatory submission.
Stocktwits · +4 outlets
Sellas Life Sciences (SLS) stock rises on AML survival data and CEO media appearance
Sellas shares surged after new overall survival data in acute myeloid leukemia was called 'huge' by retail traders ahead of the CEO's Fox Business interview.
Stocktwits · +1 outlets
Jazz Pharmaceuticals could be 13% undervalued on FDA approval of Ziihera
Analysts suggest Jazz Pharma is undervalued following the FDA approval of Ziihera (zanidatamab) for biliary tract cancer.
simplywall.st · +1 outlets

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