BIOSECURE Act may be at a make-or-break moment

We're coming up on a pivotal moment for the BIOSECURE Act. The legislation, which would restrict U.S. companies from working with certain Chinese companies for contract manufacturing and other important services,
must be passed by Congress by December in order to sidestep some major obstacles. Perhaps the primary one: The bill faces opposition from Sen. Rand Paul (Ky.), who is set to chair the Homeland Security and Governmental Affairs Committee in the Republican-led Senate next year.

Despite bipartisan support for the legislation and long-standing buzz, it's unclear whether BIOSECURE could pass this year thanks to shifting political dynamics, STAT's John Wilkerson explains. The current chair of the committee, Gary Peters (D-Mich.), said a lot depends on Paul.

Biotech

Recursion cuts more jobs after finalizing merger

Recursion Pharmaceuticals, one of the most advanced companies using artificial intelligence and machine learning tools to expedite drug development, laid off employees after closing a merger last week, STAT's Allison DeAngelis reports exclusively.

In the days immediately after Recursion and startup Exscientia closed the merger deal, the company cut employees from both organizations, according to one employee who had been laid off. Company spokesperson Ryan Kelly confirmed the layoffs, saying that less than 20% of the 800 combined staffers were affected.

Recursion has faced challenges this year, and the stock has tumbled about 40%.

stem cells

Policing the ethics of embryo models

An influential U.K. bioethics group says policymakers and scientific groups need clear guidelines and legal reforms to regulate the growing field of stem cell-based embryo models. It emphasized in a report that ethical boundaries are critical to prevent these models from being used to start pregnacies, or to allow them to develop to a stage where these embryo models might feel pain or awareness.

The current models are still too primitive for these sorts of concerns, but the advances are moving lightning quick — which highlights the need for governance in this space, STAT's Andrew Joseph writes. The report, written by the U.K.'s Nuffield Council on Bioethics, could ultimately influence global policy on the ethical use of embryo models.

rna therapy

Sarepta's deal with Arrowhead expands pipeline

Sarepta Therapeutics is paying Arrowhead Pharmaceuticals $500 million upfront and possibly many millions more in milestone payments to gain access to a series of experimental RNA-based drugs. This expands Sarepta's pipeline to include RNA-based drugs that target rare diseases like muscular dystrophy, idiopathic pulmonary fibrosis, and spinocerebellar ataxia. The announcement prompted a 25% stock surge.

Arrowhead's technologies improve RNA delivery to hard-to-reach tissues, STAT's Jason Mast writes, which helps address some of the limitations of Sarepta's earlier RNA therapies, such as Exondys. These medicines only reached muscle cells at very low levels, which cast their efficacy into doubt. Four of Arrowhead's programs are already in trials.

obesity

Investors debate the Amgen MariTide obesity data

Expectations going into the Phase 2 study readout were high, so once Amgen reported the results yesterday morning, arguments erupted all over Wall Street over MariTide's future.

With weight loss and tolerability that looks in-line, perhaps slightly worse, compared to rival drugs, the MariTide debate centered mostly around the advantage (or not) of a once-monthly injection schedule, possibly even less frequent, compared to current once-weekly offerings. Others questioned whether Amgen was being fully transparent about the rates of nausea and vomiting seen in the study — since tolerability has emerged as a major issue for patients.

At one point yesterday, Amgen shares were down 11%, erasing $18 billion in market value. But the stock rallied at the end of the day and closed down just under 5%.

Meanwhile, Lilly's stock jumped 5% and Novo's by 1.5%, though this may be linked to news yesterday that the Biden administration proposed to expand Medicare and Medicaid coverage of obesity drugs.

"While MariTide is clearly effective and will offer less frequent dosing, the bar for efficacy in the class continues to move higher and tolerability for the drug will likely remain a question until more data at the lower titration doses is available," said J.P. Morgan pharma analyst Chris Schott, in a research note.

In his own research note, Piper Sandler analyst Chris Raymond said, "We do think Amgen has a differentiated offering in this massive and growing category."

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