| 01.26.22 | Gilead’s $4.9B C D47 bet slams into wall with F DA; CytoDyn ousts CEO, leaving tough job ahead for successor

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Today's Rundown

Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47 CytoDyn board ousts CEO after a wild year, leaving an albatross of a C-suite job to fill Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit Cortexyme forced to pivot hopes to 2nd Alzheimer's hopeful after FDA slaps hold on failed effort Ziopharm hopes to put a rough year behind it with rebrand to Alaunos Therapeutics Gilead tags along again to support cell therapy biotech Kyverna in $85M fundraising To be or not to be: A tumor growth dilemma offers clue to pancreatic cancer drug development FDA chides Eli Lilly for second misleading ad in 2 months, this time for diabetes blockbuster Trulicity Call for nominations: The Most Influential People in Biopharma Anthem reports $1.1B in profit for Q4, doubling its haul year over year Akili inks $1B SPAC deal to take prescription video game tech public Clarify Health launches software to expand diversity in clinical trials TriNetX acquires software maker Advera Health Analytics

Featured Story

Gilead's $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47

By Nick Paul Taylor

Gilead’s $4.9 billion oncology bet has hit a late-phase setback. Spooked by an “apparent imbalance” in adverse reactions between study arms, the FDA has imposed a partial clinical hold on a handful of trials of magrolimab—raising questions about the program and the billions biopharma has bet on CD47.

This week's sponsor is Eurofins BioPharma Product Testing.

CytoDyn board ousts CEO after a wild year, leaving an albatross of a C-suite job to fill

By Annalee Armstrong

CytoDyn CEO Nader Pourhassan, Ph.D., is out, and CFO Antonio Migliarese is in, at least for the interim, in the latest twist in one of the wildest tales in biotech. The embattled company, which has been trying for the past year to prove its therapy leronlimab can work in diseases from cancer to COVID-19 to HIV, unveiled the leadership change Tuesday morning.

Incyte pulls FDA filing for cancer drug approval over confirmatory study, following Gilead out of the exit

By Nick Paul Taylor

The follicular lymphoma market is thinning out fast. Days after Gilead pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies.

Cortexyme forced to pivot hopes to 2nd Alzheimer's hopeful after FDA slaps hold on failed effort

By Kyle LaHucik

The FDA has stopped Cortexyme from studying its lead drug atuzaginstat any further in Alzheimer's and other conditions, dealing a blow to the pipeline and sending shares cratering 30% Wednesday morning. The biotech will now have to focus on its second bet at treating the neurodegenerative disease.

Ziopharm hopes to put a rough year behind it with rebrand to Alaunos Therapeutics

By Kyle LaHucik

Ziopharm Oncology will start trading as Alaunos Therapeutics on Thursday as the biotech rebrands after a rocky 2021.

Gilead tags along again to support cell therapy biotech Kyverna in $85M fundraising

By Annalee Armstrong

Gilead has tagged along on Kyverna Therapeutics’ journey as a startup since the beginning, and now the Big Pharma has helped stock up the cell therapy biotech in an $85 million financing round to prepare for a launch into the clinic this year.

To be or not to be: A tumor growth dilemma offers clue to pancreatic cancer drug development

By Angus Liu

Pancreatic cancer is one of the most aggressive tumor types with few effective treatment options. Now, a team of scientists has provided new insights into how targeting a common type of cells could have conflicting implications in treating the devastating disease.

FDA chides Eli Lilly for second misleading ad in 2 months, this time for diabetes blockbuster Trulicity

By Fraiser Kansteiner

The FDA has given Lilly a slap on the wrist for an Instagram post about its top-selling diabetes med, Trulicity, STAT News first reported. This marks the second round of advertising trouble since December for the Indianapolis-based drugmaker. That prior entanglement was over TV spots for Lilly's migraine treatment Emgality and was quickly resolved.