Public biotechs mostly avoid SVB trouble

With a few exceptions — here's looking at you, Ginkgo Bioworks — publicly traded biotech companies have largely avoided the collateral damage wrought by the failure of Silicon Valley Bank, disclosing that they have no or minimal cash deposits at the bank.

Alnylam Pharmaceuticals, Moderna, Argenx Pharmaceuticals, and Vertex Pharmaceuticals told covering sell-side analysts that they had no money tied up at SVB. Gilead Sciences, Beam Therapeutics, and Biogen reported "immaterial exposure." EQRx said it withdrew a small amount of cash before the bank's failure and now has minimal exposure.

Allogen Therapeutics filed an 8-K with the Securities and Exchange Commision disclosing no business with SVB. There were dozens of similar SEC filings Friday, including from Iveric Bio, Esperion Therapeutics, and Prothena. Karuna Therapeutics said it had less than $1 million in uninsured funds tied up.

Now, those exceptions: Ginkgo reported its wholly owned subsidiary Zymergen has $74 million in cash deposits at SVB; Sangamo has $34.4 million in deposits, "substantially all" of it uninsured. Axsome Therapeutics said it had "material cash deposits" at SVB, although capital held elsewhere was sufficient to fund operations. Agenus is holding a conference call later this morning to provide more information about "minority cash holdings" at the underwater bank.

In Europe, Dutch drugmaker Pharming Group said it had $45 million in deposits, mostly uninsured, held at SVB and its UK subsidiary. Danish drugmaker Zealand Pharma reported 163 million Danish krone (approximately $23 million) deposited at SVB, representing about 15% of its cash.

departures

Biogen exec largely responsible for Aduhelm leaves

Samantha Budd Haeberlein, a top Biogen exec who oversaw the development and approval of the embattled Alzheimer's drug Aduhelm, left the company Friday, STAT's Adam Feuerstein and Damian Garde report. Her departure was voluntary. It was also convenient for new CEO Chris Viehbacher, who wants new blood at Biogen after the Aduhelm debacle.

The news comes just two weeks after the FDA's Billy Dunn, who worked closely with Budd Haeberlein on Aduhelm's path to approval, abruptly left the agency. Between 2019 and 2021, when Aduhelm was approved, the two worked closely together in a process "rife with irregularities," according to a subsequent congressional report.

"We wish her the best in her future endeavors," a Biogen spokesperson told STAT.

orphan disease

First drug for Rett syndrome approved

The FDA has approved the first-ever drug for Rett syndrome, an inherited neurodegenerative disease affecting mostly girls. Daybue, made by Acadia Pharmaceuticals, isn't curative but helps improve behavioral symptoms associated with the disease — though causes gastrointestinal upset, so that might hamper its use. It's projected to cost between $400,000 and $600,000 per year. Acadia estimates between 6,000 and 10,000 people in the U.S. have the disease — meaning peak sales could hit $1 billion, some analysts project. That said, physicians are split over the drug's efficacy.

"Rett syndrome is a profoundly debilitating and complex, rare neurodevelopmental disorder," one Daybue clinical trial investigator said. "Now, for the first time after decades of clinical research, health care providers finally have a treatment option to address a range of core behavioral, communication, and physical symptoms for their patients living with Rett syndrome."

obesity

Can Medicare afford the new weight loss drugs?

The stunning demand for highly effective obesity drugs like Wegovy and Ozempic could put a huge strain on Medicare, a new NEJM perspective piece notes. There's been a push to have the government payer cover these drugs, but the risks may outweigh the benefits for older people — Medicare's core population. "It's really just prudent for Congress and CMS to weigh the tradeoffs and do more thorough analysis of the potential impacts of such large legislation," the paper's lead author said.

Depending on how you slice it, if just 10% of obese adults on Medicare use Wegovy, it would cost Medicare somewhere between $14 billion and $27 billion per year — or between 9% and 18% of the insurer's spending on Part D in 2019. "This study raises really important questions about the cost burden of these drugs," one health policy analyst said. The drugs could "pose real financial challenges for the Medicare program, and for beneficiaries in the form of premiums and taxpayers."