| | | |   | Albert Bourla. Ken Frazier. Tony Fauci. Nora Volkow. These and more than 30 other speakers will be presenting at the STAT Summit in Boston on Nov. 15 and 16. Click here to buy a virtual pass, and to apply to attend in person. | | | The next act for a colorful biotech veteran Jeff Jonas, the longtime Sage Therapeutics executive unafraid to speak his mind, has left the company to help seed the next generation of biotech startups.
As STAT’s Allison DeAngelis reports, Jonas joined the global investment giant CBC Group to lead ABiox-X, a new biotech incubator with $150 million of the parent company’s money to spend. Jonas stepped away from the CEO role at Sage back in 2020 after the emergence of a heart murmur led to a mitral valve replacement. He has since recovered, he said, with his fitness, ambition, and sense of humor intact.
"Please say I’m back to my marathon weight,” Jonas told STAT. “I want to flip the bird to people.”
Read more. | The FDA’s experts left it in a bind The FDA is facing a thorny decision on sabizabulin, a cancer treatment from a company called Veru that appeared to show dramatic survival benefits in a small study involving patients hospitalized with Covid-19. Yesterday, the agency convened a panel of outside experts for help, and the results were less than definitive, as STAT's Jason Mast reports.
Eight of the FDA’s advisers voted that sabizabulin’s benefits don’t outweigh its risks, while five voted that they did. The mixed result followed hours of debate over Veru’s study, which enrolled just over 200 patients and showed that the drug reduced death by 55% compared to placebo. Panelists repeatedly took issue with the trial design and the limited amount of safety data supporting Veru’s application for an emergency-use authorization, but many argued that sabizabulin’s apparent survival benefit simply couldn’t be dismissed.
That leaves the FDA staff, which outlined a litany of concerns about Veru’s study in briefing documents ahead of the meeting, with the difficult decision of whether to authorize sabizabulin despite outstanding questions about its safety, or ask the company to run a confirmatory trial and potentially delay the availability of what could be a beneficial medicine.
Read more. | The tech-enabled model reshaping healthcare A new breed of tech players is poised to transform the US healthcare model. Providers are getting the technology and financial services they need to move towards a value-based system vs. the existing model of rewarding providers for the number of patients they treat. This move is inevitable, given unsustainable costs and less-than-optimal outcomes incurred in healthcare today, but value-based care is still in its early stages. Get RBC’s perspective on this potentially huge market. | The problem with mortgaging the future Arrowhead Pharmaceuticals is $250 million richer today after selling a royalty interest in its investigational medicine for cardiovascular disease. But the deal, which sent Arrowhead’s stock price down about 10%, could make it that much harder to raise cash next time.
In an agreement with Royalty Pharma, Arrowhead took the cash in exchange for royalties “up to the low double digits” on future sales of olpasiran, an RNA-based treatment soon to enter a Phase 3 trial. Royalty will pay as much as $160 million more if olpasiran hits certain milestones, and Arrowhead is still entitled to up to $400 million in payments from its partner Amgen.
As a protracted downturn in biotech stocks has made raising cash more difficult for money-losing firms, companies like Royalty Pharma have found more and more willing counterparties for such back-loaded agreements. The downside for Arrowhead, as the market reaction suggestions, is that selling royalties now constrains future dealmaking and, perhaps most important to investors, makes it seem less likely someone will buy the company outright. | A yesteryear standout circles the drain Back in 2015, the cancer drugmaker Clovis Oncology was a star in the biotech world, trading at more than $100 a share on the widespread belief that its management, which had sold a prior company for billions, would engineer yet another investor-friendly deal. Seven years and one data scandal later, Clovis is on the path to bankruptcy.
As STAT’s Adam Feuerstein reports, the company said yesterday that it doesn’t have the resources to remain financially solvent beyond January. The company, which has lost 99% of its value since 2015, said it will likely file for Chapter 11 protection due to dwindling sales of its sole product, mounting financial losses, and a crushing debt load.
Clovis has limped along for years following a data-manipulation scandal in 2015 that forced it to halt development of a targeted treatment for lung cancer. It later won approval for a drug called Rubraca to treat ovarian cancer and prostate cancer, but it was a commercial disappointment largely due to a competing medicine marketed by AstraZeneca and Merck.
Read more. | More reads - ‘The tipping point is coming’: Unprecedented exodus of young life scientists is shaking up academia, STAT
- Much of biopharma industry yet to set any climate impact targets, Reuters
- Shares of Merrimack, a dormant drugmaker, soar after cancer drug succeeds in trial, STAT
| Thanks for reading! Until tomorrow,  | | | |
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