What exactly is Biogen doing?

When is a press release worth $12 billion? And what should patients make of whiplashing news?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. We’re devoting this entire episode to Biogen’s stunning announcement that aducanumab, its once-discarded treatment for Alzheimer’s disease, is getting a second life. STAT’s Sharon Begley joins us to dissect Biogen’s case and explain how outside experts have reacted. Later, we talk to a patient with Alzheimer’s who was in an aducanumab trial and is now dealing with the roller coaster of news. Finally, STAT’s Matthew Herper dials in to illustrate what’s going on behind the scenes at Biogen and what to watch for next.

You can listen to the episode here. To listen to future episodes, be sure to sign up on Apple Podcasts, Stitcher, Spotify, or wherever you get your podcasts.

Everyone’s itching for good news in gene therapy

There’s a theory out there that the slumping performance of gene therapy stocks is to blame for the broader biotech industry’s rough autumn. And thus the news that the federal government might finally approve Roche’s acquisition of Spark Therapeutics — a long-promised deal whose delay has weighed on the sector — was warmly received.

The thing is, it’s unclear who actually read that news. Yesterday’s report that FTC staff had endorsed Roche’s merger comes from the Capitol Forum, a subscription service that covers Washington. The headline made its way to terminals on Wall Street and then to Twitter, and within minutes gene therapy stocks spiked.

The Capitol Forum report could well be accurate, and the Roche-Spark issue might be on the verge of resolution. But also these sorts of things — impending decisions from the FTC or FDA — don’t usually leak beforehand, and no other outlet has corroborated the idea. All of which is to say this might end up being an illustration of just how desperate investors are for good news in gene therapy.

Speaking of antitrust concerns

Regulators in the U.K. think the idea of Illumina buying rival Pacific Biosciences smacks of anticompetitive behavior, and that opinion “likely kills” the proposed $1.8 billion merger, in the words of Cowen analysts.

If so, that means Illumina, which has struggled to grow at its previous pace, will need to look elsewhere to expand its sales. In July, Illumina said that revenue growth would be 6% for the year, about half of what analysts previously expected. Shares are down about 20% since.

What’s particularly interesting about the news is that after months of fretting about the FTC’s apparent scrutiny of biotech mergers — like the aforementioned Roche-Spark alliance — it was the U.K.’s Competition and Markets Authority that eventually spiked the Illumina deal.

Cel-Sci’s confusing confidence

On Thursday, the CEO of Cel-Sci sent a letter to investors reaffirming his confidence that a long-awaited trial of the company’s cancer drug would soon come up positive. But just days before, the company privately pitched a stock sale to investors, STAT’s Adam Feuerstein reports, a revelation that calls into question Cel-Sci’s confidence.

That’s because if the company is correct and its drug, a treatment for head and neck cancer, will soon be vindicated, the smart move would be to wait. A successful trial would boost the stock price and thus make a future financing more lucrative for Cel-Sci.

Instead, the company shopped around for cash when the stock price was at $8, suggesting management might not be as confident in the future as it let on in public.

Read more.

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