Friday, April 13, 2018

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

A biotech podcast about The Rock

(Jennifer Keefe/STAT)

Why are biotech investors suddenly so exuberant? What does it mean when a CEO scrubs his LinkedIn profile? And can CRISPR turn your dog into a winged hellhound bent on destroying Chicago?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. Stick around for a parsing of merger mania, a history lesson on biotech breakups, and the story of how a sleepy little cancer conference became a multimillion-dollar business. Also STAT reporter Megan Thielking joins us to talk about how Dwayne "The Rock" Johnson has brought gene editing to the big screen, and Adam mentions Four Loko.

You can listen to it here. And you can expect another episode next Thursday evening — and every Thursday evening — so be sure to sign up on iTunes, Stitcher, Google Play, or wherever you get your podcasts.

Who's going to win AACR?

Next week, the warring factions of immuno-oncology will get some new cudgels with which to strike one another.

At the AACR conference, Merck will present data on how well a combination of chemotherapy and its blockbuster Keytruda can treat newly diagnosed lung cancer. The same day, Bristol-Myers Squibb will reveal how effective its Opdivo and Yervoy can be when used in tandem in a similar — but not identical — patient population.

Investors, who tend to see things in binary terms, will be comparing each company's data against the other's. All of that means it's quite likely one drug maker's stock price will outpace its rival's when trading opens on Monday morning.

So, who's going to win AACR?

Bristol-Myers Squibb

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Going to the RMAT for stem cell therapies

Among the less-discussed tendrils of the sweeping 21st Century Cures Act is the so-called regenerative medicine advanced therapy designation, a sort of "breakthrough" tag for stem cell treatments and their ilk.

STAT's Andrew Joseph went down to Houston to check up on a beneficiary of that program, an experimental stem cell therapy for patients who have experienced severe head injuries. And he found plenty of optimism about the new designation, abbreviated RMAT, but also a fair amount of skepticism. Is the FDA's criteria too loose? Might the system be gamed by light-on-ethics scam clinics?

“The big thing will be, in the long run, do any of these actually become a proven safe and effective therapy that we can say, because of RMAT, [they] got to patients three years faster?” said Paul Knoepfler, a stem cell scientist at the University of California, Davis.

Read more.

Sure, blame the IT guy

Rigel Pharmaceuticals found a strange and understated way to announce its first-ever drug approval yesterday. The drug maker slipped the announcement inside the typically boilerplate “Corporate Profile” section of its website.

Some biotech traders noticed, which naturally caused Rigel’s stock price to spike higher. But then: a problem. The FDA had not, in fact, approved Rigel’s drug. Not yet, at least. The statement was posted in error, Rigel said. Oops. The spiking stock price reversed rapidly into de-spiking mode.

How does such a colossal blunder happen? Rigel pinned the mistake on the “external host of its investor relations website.”

The rest of us would have blamed Mark Zuckerberg.

More reads

  • New migraine drugs may give insurers a headache. (STAT Plus)
  • How big biotech can win back investors. (Wall Street Journal)
  • Takeda sounds out banks for loans as it moves towards Shire bid. (Reuters)
  • Cancer surgery can awaken tumor cells, but in mice a cheap pill stops metastasis. (STAT)

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Thanks for reading! Until next week,


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