The Readout Damian Garde & Meghana Keshavan

Sage is going to have to wait a while

Sage Therapeutics’ ambitions of winning a 2020 approval for a novel depression drug were cast aside, as a meeting with the FDA resulted in plans for more clinical trials.

As STAT’s Matthew Herper and Adam Feuerstein report, Sage is now planning to run three more studies — one in postpartum depression and two in major depressive disorder — to prove its oral treatment can improve symptoms. That means it won’t be able to make its case to the FDA until some time next year.

The news will come as a disappointment to investors betting Sage could convince regulators to consider the postpartum depression data it already has. It also might mean changes at Sage. The company said it is “currently re-assessing its resource allocation and prioritization strategy” in light of the FDA’s guidance, which could portend restructuring.

Read more.

There’s a Celgene angle to the pandemic

Here’s a not-unimportant thing that is low on the list of stuff imperiled by the novel coronavirus outbreak: the fate of Bristol Myers Squibb’s merger with Celgene.

Under that deal, every share of Celgene entitled its owner to a $9 payout if three of the company’s drugs won FDA approval on a certain timeframe. And as STAT’s Adam Feuerstein reports, timeframes have become unpredictable in the wake of a pandemic. 

The first drug in the arrangement, a treatment for multiple sclerosis, is far enough along in the FDA process to likely be safe. But the other two could be suddenly at risk. One, a cancer treatment acquired from Juno Therapeutics, is manufactured in Washington, a state hit hard by the virus. The other, licensed from Bluebird Bio, has yet to be filed with regulators.

You can read more about that and more in “Biotech in the time of the coronavirus,” a new, semi-regular column on how the pandemic is affecting the business of inventing drugs.

It’s going to be a big summer for the microbiome

Three companies — Finch Therapeutics, Seres Therapeutics, and Rebiotix — are on track to report pivotal data on microbiome therapies meant to treat a serious infection in the coming months. And those plans remain intact, outbreak or no.

As STAT’s Kate Sheridan reports, leaders from the bruised but hopeful field gathered virtually for the Chardan Microbiome Medicines Summit, initially slated for New York but moved online in the name of social distancing.

The overarching theme was that, despite some clinical disappointments and safety concerns, the microbiome space has turned something of a corner when it comes to understanding how helpful bacteria can quell infection. Manufacturing remains a challenge, and the pandemic could yet scramble schedules, but drug developers are keeping the faith. Now we wait for data.

Read more.

Meanwhile, at CureVac

The German biotech company that woke up Sunday in the middle of an international incident insists there’s nothing to see here.

CureVac executives spent an hour on the phone with reporters yesterday to dispel reports that President Trump tried to secure an exclusive right to the company’s in-development vaccine for the novel coronavirus. That story “has been hitting us like a bus,” CureVac CEO Franz-Werner Haas said, but it “is just not right.”

If you missed the saga, it began on March 2, when CureVac’s ex-CEO, Dan Menichella, attended a meeting at the White House to explain the company’s messenger RNA technology to Trump. Nine days later, Menichella was replaced by CureVac founder Ingmar Hoerr. Then came the reports that Trump made some sort of mystery overture, and then Hoerr, five days into his new job, stepped down for medical reasons. Things got stranger on Monday when billionaire Dietmar Hopp, whose investment fund is CureVac’s largest shareholder, told reporters that there was some sort of offer from the U.S. but that it was vetoed.

But “what Dietmar Hopp meant to say is he was summarizing all the information he had heard,” said Friedrich von Bohlen, a CureVac board member partner at Hopp’s fund. He was “not saying ‘I know something no one else knows,’” von Bohlen said. So there’s that.

More reads

  • Merck drug reduces cough frequency but taste alterations could cloud prospects. (STAT Plus)
  • Coronavirus turmoil throws biotechnology IPOs into question. (Wall Street Journal)
  • The White House is pinning its hopes on health tech to save the day. Can it deliver? (STAT)
  • Near-lockdown in the Bay Area ‘ratchets up’ challenges for local biotechs and labs. (STAT)

Thanks for reading! Until tomorrow,

Wednesday, March 18, 2020


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