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The Readout Damian Garde & Meghana Keshavan

At least one small biotech had a good quarter

The early days of 2021 have provided a stinging reminder that, for small drug companies, actually selling your products can prove more difficult than executives let on. That makes Biocryst, which managed to exceed Wall Street’s expectations in the first quarter, look that much more remarkable.

As STAT’s Adam Feuerstein reports, Biocryst reported a better-than-expected $10.9 million in sales for its drug, Orladeyo, in the three months since the treatment’s December approval. That’s a small number relative to the balance sheets of major drug companies, but it represents a solid start to Biocryst’s uphill task of commercializing Orladeyo, a treatment for the rare hereditary angioedema. The company’s share price rose 21% on the results.

It’s also a stark contrast to the commercial performances of Biocryst’s peers. Take, for example, Aurinia Pharmaceuticals, which reported last week that its recently approved treatment for lupus generated just $900,000 in the first quarter, below the $3 million consensus project. 

Read more.

Are investors nervous about gene therapy?

Gyroscope Therapeutics, a London-headquartered gene therapy company, had filed to raise $100 million in an IPO, taking advantage of record Wall Street demand for early-stage drug companies. Then, on Friday, Gyroscope pulled its IPO, saying in a statement that the company would wait for “more favorable market conditions” to go public.

The word “market” there probably doesn’t refer to biotech, where conditions are about as favorable as could be imagined, but rather Gyroscope’s specific focus on gene therapies for ocular disease. Late last month, Adverum Biotechnologies disclosed that one patient in its gene therapy study lost vision in one eye due to an increase in ocular pressure after treatment, news that decimated the company’s share price.

Gyroscope is developing a different gene therapy with a different biological goal in trials recruiting patients with a different disease. But, like Adverum, the company does rely on injections into the eye. And that commonality might have been enough for Gyroscope’s bankers and advisers to suggest pressing pause on the IPO plan.

It’s May 10 and we’re still waiting on Novavax data

The results of Novavax’s Phase 3 Covid-19 vaccine study have been an any-day-now expectation since March, and yet week after week has passed with no news on that front. Today, with Novavax slated to present its first-quarter financials at 4:30 p.m. ET, we might at least get an update.

As a reminder, Novavax’s vaccine was dramatically effective in a U.K. study. The company started a North American trial in December and finished enrolling all 30,000 participants in the last week of February. That study is designed to take an interim look at efficacy once there have been 72 confirmed cases of Covid-19 in the trial, Novavax has said.

Meanwhile, the dynamics of the vaccination push have shifted since Novavax first disclosed positive data. In the U.S., the supply of vaccines appears to be exceeding demand, and the country is facing global pressure to donate doses from its stockpile to nations in desperate need. That means that if Novavax’s vaccine proves effective in Phase 3, the roughly 100 million doses the U.S. has reserved might end up getting exported.

Biogen’s other major binary

While the commercial future of Biogen is heavily reliant on whether the FDA approves its treatment for Alzheimer’s disease this summer, we’re weeks away from learning if another of the company’s major bets can become an actual medicine.

Last year, Biogen paid about $1.5 billion for a 50% stake of zuranolone, a Sage Therapeutics-invented drug that could become a fast-acting blockbuster for the treatment of severe depression. Analysts expect data from zuranolone’s Phase 3 study in major depressive disorder in May or June. The study is something of a do-over for Sage, which tried and failed to demonstrate zuranolone’s benefits at a lower dose in an earlier study.

It’s the first of three pivotal trials for zuranolone, each designed to prove the drug’s worth in a different depression indication. If all three turn out positive, analysts expect the drug to bring in about $2 billion in annual revenue. For Biogen, that’s a chance to diversify away from its shrinking multiple sclerosis business and plateauing sales in spinal muscular atrophy, regardless of how the FDA rules on its Alzheimer’s treatment.

More reads

  • How David beat Goliath: Advocacy groups seized a moment, and found allies, in bid to loosen vaccine patent rights. (STAT+)
  • U.S. wants COVID vaccine patent waiver to benefit world, not boost China biotech. (Reuters)
  • Vaccine stocks take wild ride amid political clash, earnings. (Bloomberg)
  • Eli Broad’s medical research legacy will ‘touch almost the whole world.’ (Boston Globe)

Thanks for reading! Until tomorrow,

Monday, May 10, 2021

STAT

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