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Stock Watch: Drug Safety In The Spotlight

Three FDA Clinical Holds In The Shortened Thanksgiving Week May Have Wider Implications

 
• By Andy Smith

Are three FDA clinical holds in less than four days a symptom of lax safety programs at some biotech companies? And what does the latest publication on Aduhelm say about the relationship between safety and accelerated approval?

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

As portfolio managers and analysts headed off to Thanksgiving family reunions, this year accompanied by clutches of lateral flow tests, the news flow in life sciences was expected to dwindle. On the Wednesday before Thanksgiving this year, that plan went awry with two companies announcing FDA clinical holds.

In a Wednesday morning update on its Phase Ib study of the menin inhibitor KO-539 in relapsed or refractory acute myeloid leukemia, Kura Oncology, Inc. disclosed that the study had been placed on partial clinical hold by the FDA, stopping enrolment. The FDA’s action followed Kuna’s report to the agency of a Grade 5 serious adverse effect and patient death due to differentiation syndrome

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Stock Watch: Market Optimism Outshines Q1 Currency And Tariff Woes

 
• By Andy Smith

The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.

Stock Watch: Sanofi, Merck Open Windows Into Geopolitical Risks

 
• By Andy Smith

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Stock Watch: Dollar Weakness, Tariffs, Biosimilars In J&J’s Q1 Mix

 
• By Andy Smith

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Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
• By Andy Smith

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

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Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
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Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.