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4DMT lays off staff, reshuffles team as it doubles down on Phase 3 plans

As 4D Molecular Therapeutics prepares to shift into a late-stage clinical biotech, it is letting go of a quarter of its staffers and pruning its leadership team. The California drugmaker will lay off...

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Sage talked to 43 'counterparties' before inking Supernus deal

Sage Therapeutics talked with 43 "counterparties" over the course of last year and early 2025 as the 15-year-old company sought a lifeline for its grand ambitions, according to new regulatory

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BioSpring embarks on €100M+ nucleic acid factory in Germany

German oligonucleotide CDMO BioSpring is expanding its footprint in its home country, budgeting over €100 million ($106 million) to build a new nucleic acid factory in Offenbach. The...

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Structure in partnering talks for oral GLP-1 as mid-stage readout nears

It is a truth universally acknowledged that a biotech in possession of a mid-stage GLP-1 must be in want of a partner. Structure Therapeutics is no exception. With Phase 2 trials of its obesity pill ...

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Number of megarounds drops 38% in first half as biotechs struggle against...

Even biotech's "haves" are struggling. The sector's fraught funding environment has been in a slump going on three years, and it's created a world of "haves and have-nots" for private drug development...

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The Trump administration is promoting wearable health devices — with or...

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Torrent Pharma’s $1.38B JB Chemicals takeover; Future Pak to buy...

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Torrent Pharmaceuticals will purchase roughly a 46% stake in JB...

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Cloudbreak’s shares stumble in Hong Kong debut; Sinovac squares off against...

Plus, news about BrainEver, Clinigen, MaaT Pharma, Dyadic and Nektar Therapeutics: Cloudbreak Pharma shares fall in Hong Kong debut: The ophthalmology biotech, which has offices in California and...

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Novartis' Cosentyx fails Phase 3 study for autoimmune disease

Novartis faced a setback in its ambition to expand its blockbuster drug Cosentyx and compete in an autoimmune condition with products from Roche and AbbVie. The company said Thursday that the drug...

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Judge rules against Trump administration's removal of HHS web content

The Trump administration's actions to remove a broad swath of HHS webpages in late January were arbitrary and not the “product of reasoned decisionmaking,” a federal district court ruled Thursday. The

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Apple Tree says its biotechs face ‘imminent collapse’; Advocates urge J&J to...

Happy July 4th weekend! We’ve got a condensed version of Endpoints Weekly for you this week, so let’s dive right into the biggest stories. First up, a key investor for Apple Tree Partners is allegedly ...

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European Commission fines Alchem, closes API ‘cartel’ investigation 

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Roche-backed Chugai taps into longevity field with Pfizer-allied Gero

Japanese drugmaker Chugai is wading into the aging-related disease landscape, an area of drug R&D that’s gaining more traction among pharmaceutical giants. The Tokyo-headquartered company, part of...

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FDA approves KalVista's HAE drug after review delay

The FDA has approved KalVista Pharmaceuticals' drug for a rare swelling disease, the company announced on Monday, in a key win for the small biopharma. The drug, called sebetralstat, will be ...

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Apogee reports Phase 2 success for IL-13 drug in eczema

Apogee Therapeutics said on Monday that its atopic dermatitis candidate, which has the potential to offer a more convenient alternative to Sanofi and Regeneron's Dupixent and Eli Lilly’s Ebglyss, has...

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Compromised drug lot impacts Jasper's chronic hives study, stock falls

Jasper Therapeutics’ stock crashed on Monday morning after the biotech said issues with a drug product lot impacted data in a Phase 1b/2a clinical trial for its lead program. The specific problem isn’t...

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Denali's Hunter syndrome therapy gets priority review; LENZ inks Canada deal

Denali gets priority review for rare disease therapy: The program, called tividenofusp alfa, is designed to treat Hunter syndrome, a protein misfolding disease that begins as early as 18 months old....

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Cogent’s mastocytosis drug hits ‘home run’ in registrational mid-stage trial

Cogent Biosciences said it’s working on an FDA submission for its systemic mastocytosis (SM) drug after breezing through a Phase 2 trial in an indolent form of the disease. The biotech’s bezuclastinib...

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Health tech startups raise $6.4B in first half of 2025 in AI frenzy

Investors bullish on AI have been pouring more money into digital health startups. Digital health startups in the US raised $6.4 billion across 245 deals over the first half of this year, according to...

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FDA chief calls for 'meaningful' reduction of animal testing for new drugs

FDA Commissioner Marty Makary pledged to "meaningfully reduce" unnecessary animal testing that's currently used to bring new drugs to market and to test them in early developmental stages. While...

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KalVista CEO talks FDA drug approval, review delay

The CEO of KalVista Pharmaceuticals described the behind-the-scenes discussions with FDA reviewers as "appropriate," "thorough" and "productive" in what led to an approval for its drug. The company...

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The fight over state PBM laws will continue after Supreme Court denial 

The Supreme Court recently declined to wade into a fight over a state’s regulation of pharmacy benefit managers. But legal experts say it likely won’t be the last time the broader issue makes its way ...

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Trump's tax cut law expands orphan drug exclusions, could upend 340B program

President Donald Trump on July 4 signed into law his wide-ranging tax cuts and reconciliation package, including an expansion of orphan drug protections from Medicare negotiations, and nearly $1...

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Doctors sue RFK Jr., HHS over changes to Covid-19 vaccine schedule

A group of organizations representing thousands of doctors nationwide sued HHS Secretary Robert F. Kennedy Jr. over his decision to change Covid-19 vaccine recommendations for kids and pregnant women....

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