The FDA's top neurologist is quitting …

Billy Dunn, who presided over the FDA's polarizing approval of Aduhelm, is leaving the agency after more than 15 years.

Dunn, 53, is retiring to "explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases," according to an internal FDA email sent yesterday. Dunn notified agency officials Friday, according to a person with knowledge of the situation.

Once a behind-the-scenes bureaucrat, Dunn became the center of a damaging FDA scandal in 2021 when the agency overruled its advisers to approve Aduhelm, the Biogen-developed Alzheimer's treatment. Two years before, Dunn had an off-the-books meeting with Biogen's head scientist, setting in motion a close collaboration between the company and the agency that led to multiple federal investigations and stinging rebuke from an influential congressional committee.

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Markets

… and Wall Street is worried

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The share prices of multiple neuroscience-focused biotech companies tumbled yesterday on the news that Dunn, perceived as an industry-friendly regulator, would no longer be in charge of approving new treatments for neurological diseases.

Reata Pharmaceuticals, whose treatment for Friedreich's ataxia has an FDA decision date of today, fell more than 30%. Amylyx Pharmaceuticals, maker of a novel treatment for ALS, and Sarepta Therapeutics, at work on a gene therapy for Duchenne muscular dystrophy, declined by as much as 5%.

The fear is that the "loss of a more permissive, industry-friendly voice is a long-term negative" for neuroscience companies, as RBC Capital Markets analyst Brian Abrahams put it in a note to clients.

M&A

A shelved summer blockbuster resurfaces in February

Last year's biggest deal that wasn't, a reported $40 billion near-acquisition of Seagen, is back, this time with a different cast and some updated scenery that might bring it to fruition.

Pfizer is in early-stage talks to buy the Seattle company, the Wall Street Journal reported yesterday, which sent Seagen's stock price up about 10%. Last year, the Journal and others chronicled months of discussions between Seagen and Merck, which approached the company in the spring, haggled over a price all summer, and then eventually walked away in August.

But this time could be different, as Pfizer has a rare combination of wealth and immediacy. The success of its vaccine and treatment for Covid-19 has given the company an industry-leading pile of cash, while the steady erosion of demand for those products has left a multibillion-dollar hole in its financial future. Seagen, which has three approved cancer treatments and a pipeline of clinical candidates, could be worth paying the price that proved too steep for Merck.

The benefits of rejection

Cytokinetics is a biotech company with one promising heart drug and a stubborn insistence on trying to win FDA approval for a second, troubled heart drug. That leaves the company in the curious position in which many of its own investors are rooting for the company's plans to go awry.

As STAT's Adam Feuerstein explains, Cytokinetics has refused to give up on omecamtiv mecarbil, a medicine meant to treat heart failure, despite disappointing clinical results, an aborted partnership with Amgen, and years of pressure from investors. Now the drug is up for FDA approval, and if Cytokinetics succeeds, the company will spend yet more cash commercializing a medicine in which Wall Street has long since lost faith.

But if the FDA rejects it, Cytokinetics will have no choice but to shift its focus to aficamten, the aforementioned other heart drug that has impressed in early studies, which would streamline the company's expenses and make it more attractive to a potential acquirer.

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