What’s the future of Sage’s depression drug?

In a pivotal clinical trial, Sage Therapeutics’ lead pipeline drug met its primary goal of improving symptoms of major depressive disorder. But the size of that improvement — 1.4 points on a 17-point scale — left investors skeptical Sage’s treatment has a bright future.

As STAT’s Adam Feuerstein reports, the question now is whether the drug, called zuranolone, has demonstrated enough promise to convince the FDA to approve it. The company said it would meet with regulators to discuss the path forward for zuranolone, which could include waiting on results from a second pivotal study slated to read out later this year.

Sage’s stock price fell about 18% on the news, erasing more than $500 million from Sage’s market value. That’s a strong reaction to what was, technically, a positive study, but as SVB Leerink analyst Marc Goodman noted, the sudden concern about zuranolone’s commercial viability means investors need to adjust their expectations for the drug’s eventual sales, which means Sage is suddenly a less valuable proposition.

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Hahn on going from FDA to VC: Nothing to see here

This week’s news that former FDA Commissioner Steve Hahn will soon join Flagship Pioneering — the venture firm that founded Moderna, whose vaccine won authorization during his tenure — was not terribly well received among government watchdogs. But according to Hahn, there was no overlap between his time at the FDA and his conversations with Flagship, and Moderna had nothing to do with it.

Speaking to STAT’s Kate Sheridan, Hahn said his post-FDA “journey” to Flagship began after he was introduced to Noubar Afeyan, the firm’s founder. “And really I'm so impressed by Noubar's vision,” he said. “I've been impressed with where Flagship has been in terms of innovation, and asking that really critical question. So that's how it happened, and it sort of naturally flowed.”

What about people who see something untoward in an FDA commissioner immediately taking a job so closely related to a company he recently regulated? Hahn said taking a role in the private sector “is part of a natural sort of progression” after a career in academic medicine. “I can't control what people think,” he said. “What I can tell you is the truth.”

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Regeneron’s Covid antibody treatment can save lives in the hospital, major study finds

An infusion of Regeneron Pharmaceuticals’ antibody cocktail reduced the rate of death by 20% for patients hospitalized with Covid-19, according to a new study.

As STAT’s Matthew Herper reports, doctors enrolled patients who had not yet developed their own antibodies to Covid-19 and randomly assigned them to receive either Regeneron’s treatment or placebo, on top of standard care. The addition of Regeneron’s cocktail reduced the percentage of patients who died from 30% to 24%. That is a 20% relative reduction, and it means that for every 100 patients who were treated with the antibody cocktail, six fewer died.

The data mark the first time a treatment targeting the Covid-19 virus has proved to reduce mortality. The steroid dexamethasone, which has been shown to save lives, works by tamping down the body’s immune response to the virus, and the antiviral remdesivir has never demonstrated a significant effect on mortality.

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Biotech’s June gauntlet delivered mixed results

Thanks to Sage Therapeutics, we now have answers to the biggest questions facing biotech heading into June. And, like the Sage data, each one is complicated enough to render the glass half full or half empty, depending on whom you ask.

Biogen was always the biggest domino poised to fall, and last week’s news that the FDA approved its contentious treatment for Alzheimer’s disease is an unassailable positive for the company. But the ensuing days have brought rebukes from the scientific community, outrage over the price, and concerns about the logistics of selling an intravenous medicine that requires a multitude of costly brain scans. Biogen’s treatment still looks like a moneymaker, but billions of dollars in sales are by no means guaranteed.
Vertex Pharmaceuticals was set to deliver a referendum on the state of its internal research, and the result was disappointment. The company shelved a would-be treatment for the genetic disease alpha-1 antitrypsin deficiency, or AATD, after it failed to show a clinical benefit in a key trial. But the drug, VX-864, did have a measurable biological effect on its target, and the study met its primary endpoint. Those facts do little for VX-864, but they do suggest a scientific breadcrumb trail for Vertex’s next AATD drug.

What’s the future of Sage’s depression drug?

Hahn on going from FDA to VC: Nothing to see here

Chemistry, manufacturing, and controls considerations for biotech

Regeneron’s Covid antibody treatment can save lives in the hospital, major study finds

Biotech’s June gauntlet delivered mixed results

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