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The Readout Damian Garde

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Biotech investors’ magical thinking

A thing that happens in biotech is that a company cancels a scheduled appearance at some banking conference, and then a nonzero number of traders deduce that it must be about to get acquired, and the stock price goes up. The only problem with this phenomenon is that it has very rarely proved prescient.

The latest example is BioHaven. Back in April, Bloomberg reported that the company, developing treatments for migraine, was considering selling itself. Then, earlier this month, BioHaven pulled out of a speaking slot at the Goldman Sachs conference. This, thought some people, was a sure sign that a buyout was in the offing, and BioHaven’s share price rose 20% in a day. Finally, on Monday, came the letdown: BioHaven disclosed plans to raise $300 million in a stock sale. That is typically not the kind of thing you do when you’re about to get acquired, and so shares fell about 25%.

What’s weird about the persistence of conference-cancelation fever is that it has a terrible track record. Sarepta Therapeutics, Acadia Pharmaceuticals, and ZioPharm have all popped on cancelations only to reveal that the issue was a scheduling conflict, not a get-rich buyout. One time, shares of Alexion Pharmaceuticals rose on a cancelation, and the eventual news ended up being an internal investigation and management shakeup.

How can liquid biopsy go from hot business model to actual practice?

The many companies seeking to diagnose early-stage cancer from a blood draw have raised billions of dollars and made almost as many promises in the process. But before these so-called liquid biopsies become widely used, scientists want answers to some weighty questions.

As STAT’s Shraddha Chakradhar explains, companies in the liquid biopsy space hope that one day, such tests will be as routine as cholesterol screens. In the meantime, however, they’re focused on reducing false positives, picking which cancers to target, and proving that early detection does in fact improve patient outcomes.

Then there’s the thornier business question: If liquid biopsy lives up to the hype, does the world really need this many companies invested in it?

Read more.

We still don’t know whether ‘longevity’ is a real biotech target

Among the most tantalizing fields of life science is longevity research, the idea that tinkering with human biology can extend the amount of time people live free of pain and disease. The problem is that “longevity” is not among the FDA’s list of medical indications, and thus developing a drug for it is a fraught proposition.

That brings us to Unity Biotechnology, the first anti-aging drug developer to go public. Yesterday, the company disclosed some polarizing early data that, depending on whom you ask, either bolsters the promise of longevity science or underlines it’s serious challenges.

As STAT’s Matthew Herper explains, Unity believes its drug can dial back the symptoms of aging by killing the old, or senescent, cells that collect in the body. In a small clinical trial, Unity tested that on patients with osteoarthritis and saw only a small benefit that could have been random chance. But looking at patients’ knee fluid, Unity said it saw chemical changes that support its theory on senescent cells.

Read more.

The FDA might be overprotecting biologics

If you invent a new pill and convince the FDA to approve it, you get a roughly seven-year monopoly on selling your drug. But if you develop a biologic, that period of exclusivity is 12 years. Among the reasons for the difference is the idea that inventing biologics is more time-consuming, but a new study suggests that’s not at all the case.

In a new Nature Biotechnology paper, a group of researchers looked at the 275 therapies approved between 2007 and 2016 and concluded that the median development time was 12 years, regardless of whether they were small-molecule drugs or biologics.

Further complicating matters is the fact that, as any pharma attorney can tell you, biologics almost never face competition once their statutory exclusivity expires. Humira, first approved in 2002, won’t face biosimilars in the U.S. until 2023. That, the authors say, is evidence the FDA should take a hard look at its exclusivity rules.

More reads

  • Why Democrats reopened the debate about germline gene editing. (STAT)
  • U.K. regulator opens investigation into Woodford meltdown. (Financial Times)
  • There’s a fight brewing in Congress over pharma’s patents. (STAT Plus)
  • Chinese 'Resident Evil' fans think this biotech company's logo looks familiar. (Kotaku)

Thanks for reading! Until tomorrow,


Wednesday, June 19, 2019


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