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The Endpoints Slack interview: Saji Wickramasekara on where AI misses the...
As a 22-year-old undergraduate, Saji Wickramasekara followed a well-worn tech world script that remains nearly unheard of in biotech — he dropped out of MIT and co-founded a startup. Twelve years...
View ArticleLexicon resubmits type 1 diabetes drug to FDA five years after rejection
Lexicon’s type 1 diabetes drug is finally getting another shot at the FDA. The biotech announced Friday morning that it had officially resubmitted a new drug application for sotagliflozin following a...
View ArticleLayoffs at Ginkgo and Xellia; Melodia and Alivexis ink $275M partnership
Plus, news about Rapafusyn Pharmaceuticals: Ginkgo Bioworks lays off 158 employees: The cuts come after the Boston, MA-based biotech said last month it would ax its labor costs by at least a quarter....
View ArticleFDA ships two Form 483s to Dr. Reddy’s for two separate sites in India
Dr. Reddy’s Laboratories has received two FDA Form 483s in the past month for two different facilities, making a total of at least seven forms sent to the company in the past year. The two open Form...
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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...
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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...
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