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BioWorld - Thursday, May 21, 2026
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Alector stock and staff halved after phase III fail in dementia

Oct. 22, 2025
By Lee Landenberger
No Comments
The failure of Alector Inc.’s phase III study of latozinemab in treating dementia halved the company’s stock on Oct. 22. That is also about the same percentage of staff that Alector is letting go after the clinical trial stumble.
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Artificial intelligence

PTO director strikes a blow for ML patent subject matter eligibility

Oct. 22, 2025
By Mark McCarty
John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.
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Illustration of liver with DNA double helixes
ESMO 2025

Delcath’s Chemosat plus ICIs triples PFS in uveal melanoma

Oct. 21, 2025
By Annette Boyle
While positive results from the investigator-led phase II CHOPIN trial at ESMO 2025 failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath Systems Inc.’s third quarter earnings report missing a beat.
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Glass globe with documents and pen

Hologic to go private in $18.3B deal

Oct. 21, 2025
By Annette Boyle
In the largest med-tech M&A deal in nearly three years, Hologic Inc. agreed to be acquired by funds led by Blackstone and TPG in a transaction valued at $18.3 billion. After five months of rumored negotiations, the outlined deal provides Hologic shareholders with $76 per share in cash plus up to $3 per share in contingent value rights (CVR) to be paid on achievement of revenue goals for the breast health business over the next two years.
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US flag, gavel, book

Dexcom faces class action lawsuit following FDA warning

Oct. 21, 2025
By Mark McCarty
San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
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Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

Trade associations push back on Trump Section 232 review

Oct. 21, 2025
By Mark McCarty
The Trump administration’s consideration of a new round of tariffs has prompted two major med-tech trade association to advise the White House to leave medical consumables and medical devices out of any new tariffs, citing concerns about the impact on patient care.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 21, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
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ESMO 2025

Celcuity nears NDA filing with gedatolisib breast cancer win

Oct. 21, 2025
By Karen Carey
No Comments
Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – a multibillion-dollar indication in need of new treatments.
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Woman in crowd with anxiety

With a phase III loss, Neuphoria halts its social anxiety program

Oct. 21, 2025
By Lee Landenberger
No Comments
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
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Concept of business partnership
Immune

Leads Biolabs joins a $1B development deal with Dianthus

Oct. 21, 2025
By Lee Landenberger
No Comments
Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders. The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties.
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