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The Readout Damian Garde

Sarepta’s rough stretch might only coarsen


Sarepta Therapeutics is worth just about half of what it was as recently as July, and the latest news suggests things may not get any better in 2020.

As STAT’s Adam Feuerstein reports, a Sarepta rival called NS Pharma filed for FDA approval with a treatment for Duchenne muscular dystrophy. The NS therapy would treat DMD patients whose disease is caused by a mutation in the DNA sequence known as exon 53, the exact population Sarepta targeted with a drug that got rejected in August.

This sets up a situation in which Sarepta, which is yet to disclose a plan to address the FDA’s concerns, gets beat to the market. And, if the NS therapy is approved by the time Sarepta gets its act together, the company’s case for a second chance with the FDA might be that much less compelling.

Read more.

A new genetic test built on DNA's cousin

Plenty of companies have seen success in DNA testing. Now a California-based company is betting that it can do the same with RNA testing as well.
That company, Ambry Genetics, announced this week that it is launching a test to turn up more at-risk patients by looking at ribonucleic acid, which carries out orders for making proteins. The test will screen RNA transcripts for 18 genes, alongside with the usual DNA analysis.
The key questions, as STAT’s Rebecca Robbins points out, are whether the test can get traction and whether insurers will consider paying more for it. In other words, how useful will the test be for patients?

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It’s (maybe) a big day for IPOs

That late-summer paucity of biotech IPOs gave way to a September boomlet, and now, just in time for a rough week on the market, we’re in for another test of investor appetite for money-losing drug companies.

Three biotechs are expected to begin trading on the Nasdaq today. There’s the immunology startup Viela Bio, seeking a valuations of $1 billion, followed by hearing loss biotech Frequency Therapeutics and the oncology company Aprea Therapeutics, which are aiming a bit lower. In what might be an omen, the cancer-focused ADC Therapeutics, once expected to go public today, withdrew its IPO plans last night.

The biotech bolus arrives amid some macro handwringing about whether private valuations have exceeded public realities, underlined by the real-time cautionary tale that is WeWork. Subleasing commercial real estate is not, so far as we can discern, analogous to developing drugs, but the performance of today’s IPOs could be instructive on whether the long-forcasted unicorn reckoning will apply to biotech.

An old debate, a fresh response on drug ads

The drug lobby PhRMA is out with a new brief arguing drug makers spend three times more on research and development than on advertising. The question of how drug companies really spend their money has been a topic of fierce debate peppering the pages of peer-reviewed journals for years, and PhRMA’s brief is unlikely to put the issue to bed. But it’s a not-so-subtle response to a common refrain from drug industry critics, who take every opportunity to slam drug makers’ hokey TV ads, and their massive budgets.

Even if you don’t enjoy those pesky Cialis commercials, PhRMA says it shouldn’t be faulted for advertising its drugs. The group argues marketing attracts capital and reduces stigma for patients. “R&D and marketing are NOT a zero-sum game,” PhRMA writes.

More reads

  • Judge tosses suits alleging Lilly and Bayer used nurses to push drugs. (STAT Plus)
  • Former Google CEO Eric Schmidt believes biology is the next frontier in computing. (CNBC)
  • 'The Dark' graphic novel explores future of biotech. (Hollywood Reporter)

Thanks for reading! Until tomorrow,

Thursday, October 3, 2019


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