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Zealand Pharma hits early efficacy goal for amylin weight loss candidate

Zealand Pharma’s amylin analogue weight loss candidate petrelintide helped patients lose a mean 8.6% of their body weight in a Phase 1b trial, meeting executives’ early goals and setting the stage for...

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Scientists just discovered a new genetic clue for delaying Alzheimer’s...

Research on one of the most famous families in neurology has shed new light on the interplay between Alzheimer’s disease and a rare gene that protects against it, as well as how that learning might one...

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Gilead's twice-a-year injection fully prevented HIV in Phase 3 study with...

There were no cases of HIV in over 2,000 cisgender women who received a twice-a-year preventive HIV injection developed by Gilead as part of a Phase 3 clinical trial. The data, announced Thursday...

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Tectonic enters public markets in one of few biotech reverse mergers this year

Tectonic Therapeutic, a biotech from renowned entrepreneur and researcher Tim Springer, completed its reverse merger with gene therapy company Avrobio on Thursday and will begin trading as $TECX on...

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FDA widens Sarepta’s Duchenne gene therapy label to older boys in significant...

The FDA has broadened the label for Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy to patients ages 4 and older. The approval goes beyond the patient population in which the company...

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Moncef Slaoui joins board at mRNA biotech; Gamida Cell retools with ex-Amryt...

Moncef Slaoui → Moncef Slaoui has reemerged this week with another board appointment, making his way to mRNA drug developer Arcturus Therapeutics. Endpoints News scooped you last September on Slaoui’s...

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US, EU pledge $2B+ to help boost vaccine manufacturing in Africa

Eyes were on Paris with the official launch of the African Vaccine Manufacturing Accelerator (AVMA) on Thursday. The EU is contributing €750 million to the accelerator, while the US is pledging $1.58...

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Obesity care startup knownwell buys an AI weight loss platform

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.)  As more startups get into the business of treating obesity, one weight loss startup acquired another to...

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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...

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Lexicon 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...

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Layoffs 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....

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FDA 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...

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#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....

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FDA'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...

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Argenx 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,...

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Sarepta'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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Schizophrenia 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...

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Blood 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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