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Bristol Myers wins approval for KRAS drug Krazati in colorectal cancer
Bristol Myers Squibb won accelerated approval on Friday to take its KRAS inhibitor to colorectal cancer patients. Krazati will now be available for use with Eli Lilly’s Erbitux (cetuximab) for certain...
View Article#ADA24: Lilly’s Zepbound resolves sleep apnea in some obese patients
ORLANDO — Eli Lilly said Zepbound helped at least 43% of patients with obstructive sleep apnea and obesity resolve symptoms of the breathing disorder in late-stage trials. At the American Diabetes...
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#ADA24: Three of Vertex’s islet cell therapy patients go insulin-independent
ORLANDO — Vertex Pharmaceuticals said a third patient in a Phase 1/2 trial assessing its islet cell therapy as a treatment for type 1 diabetes has been fully insulin-independent for at least a year....
View ArticleFDA's Peter Marks single-handedly approved Sarepta’s gene therapy — what does...
Is Sarepta special? Or has the FDA set a new precedent for how it approaches treatments for devastating diseases with few options? On Thursday, the FDA announced it was expanding the allowed use of...
View ArticleArgenx wins second FDA approval for Vyvgart in another autoimmune nerve disease
After a string of clinical failures, the Dutch biotech argenx landed a much-needed win on Friday when the FDA approved its autoimmune disease drug, Vyvgart, for a second rare condition. The disease,...
View ArticleSarepta's big gene therapy expansion; Inside Iambic's AI cycle; Vertex, Lilly...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View Article#ADA24: Fractyl pitches potential of GLP-1 gene therapy, but pushes clinical...
A small biotech company is developing a one-time gene therapy that could turn the pancreas into its own GLP-1 drug factory and eliminate the need for frequent injections of medicines like Ozempic or...
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Alnylam’s ATTR therapy succeeds in Phase 3 heart trial
In one of the most highly anticipated clinical trial readouts this year, an RNA silencing treatment developed by Alnylam Pharmaceuticals reduced the risk of death, heart-related hospital visits and...
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#ADA24: Altimmune says pemvidutide has even better lean mass preservation...
ORLANDO – Altimmune is back with a full Phase 2 analysis of its “double G” drug pemvidutide, with the company touting it is much better in preserving lean mass and regulating lipids than previously...
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Alumis aims for this year’s third-largest biotech IPO as it readies for Phase 3
Clinical-stage immunology biotech Alumis is eyeing $274 million in net proceeds from its planned initial public offering, the biotech said in a securities document Monday morning. The South San...
View ArticleAmylyx makes $35.1M deal for Eiger’s GLP-1 drug after ALS setback
Several months after a major trial setback forced Amylyx Pharmaceuticals to pull its only approved drug from the market, the company is diving into the GLP-1 space with a $35.1 million acquisition of a...
View ArticleSchizophrenia biotech LB Pharmaceuticals eyes near-term IPO filing — source
New York-based LB Pharmaceuticals is preparing to file for an initial public offering as investor and pharma enthusiasm grows for the neuroscience space, a source familiar with the company’s plans told...
View ArticleBlood cancer biotech Ascentage Pharma files for US dual listing
Ascentage Pharma, a Hong Kong-listed blood cancer biotech, is planning a dual listing in the US as it prepares for additional drug launches, it said Sunday evening. The biotech, which has offices in...
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Lykos’ pain is others’ gain as psychedelic biotechs take notes from adcomm vote
Lykos’ near-unanimous rejection from an FDA advisory panel earlier this month jolted a psychedelics industry that seemed to be finally hitting its stride. But the race to market is far from over. “Our...
View ArticleUK taps Pfizer over hometown GSK to supply RSV vaccine doses
The UK government has selected Pfizer to supply millions of respiratory syncytial virus (RSV) vaccine doses, snubbing local pharma company GSK and its competing product. The New York-based pharma...
View ArticleCorrected: Entrada raises $100M for Duchenne development; eFFECTOR winds down
Plus, news about NeuroBo, Vico Therapeutics, Takeda, Checkpoint Therapeutics, CombiGene, Spark Therapeutics, ANI, Alimera Sciences and OSE Immunotherapeutics: Entrada Therapeutics raises $100M from...
View Article#ADA24: Gilead, Viking and Biohaven detail promising preclinical research in...
In a twist, preclinical research in metabolic disease is peaking more investor interest at the American Diabetes Association’s annual meeting than in past years. As the GLP-1 and weight loss market...
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Novo reveals more hemophilia A data showing superiority in annualized...
Ahead of an FDA filing later this year, Novo Nordisk on Sunday offered up more detailed hemophilia A data from its Phase 3a trial investigating Mim8, a factor VIIIa mimetic bispecific antibody. The...
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Phase 3 breast cancer failure leads to staff cuts, stock drop at G1 Therapeutics
G1 Therapeutics said its lung cancer drug Cosela didn’t fare better than a placebo in extending the lives of breast cancer patients. In the Phase 3 trial of metastatic triple-negative breast cancer...
View ArticleNovo Nordisk budgets $4.1B for new US manufacturing site as it abandons plans...
Novo Nordisk is further boosting manufacturing in the US for its obesity drugs as it injects $4.1 billion for a second fill-finish facility in Clayton, NC. But the Danish company is pulling back...
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