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The Readout Damian Garde & Meghana Keshavan

STAT's latest report is a deep dive into the booming field of synthetic biology, explaining the cutting-edge tools driving progress and profiling 10 companies leading the way, including Synlogic, Twist Biosciences, eGenesis. Buy it here.

Happy J&J vaccine day

Later this morning, we’re going to see the first detailed information on just how well Johnson & Johnson’s Covid-19 vaccine works — and get a glimpse of what the FDA makes of its benefits. Here’s a guide to the news ahead.

Where do I find it? Around 9 a.m. ET, on this website, the FDA will post its in-depth review of J&J’s data alongside the company’s own explanation of the results. The timing tends to be unpredictable, and there’s no way to be sure whether the FDA will post a single PDF or upload the documents separately. Either way, that’s the link.

What do we know? Last month, J&J reported interim data from a massive trial in which the one-dose vaccine was 66% effective at preventing moderate to severe Covid-19. Drilling into those data, it was 72% effective among clinical trial volunteers in the U.S, but 66% among those in Latin America, and just 57% among those in South Africa.

What are we going to learn? J&J should have a lot more information on the vaccine’s ability to protect against novel strains of the virus that causes Covid-19, well beyond the geographic data previously disclosed. The company will also break out the safety and efficacy results by population, providing key insights into who benefits most from the vaccine. It’s also possible the data will have changed since January’s interim analysis. 

Then what? This morning’s document dump is a prelude to Friday’s scheduled meeting of independent FDA advisers, who will spend all day reviewing the data before voting on whether the agency should grant an emergency use authorization to J&J’s vaccine. 

Last call for stool at OpenBiome

OpenBiome, a pioneering firm in the world of fecal transplants, is planning to wind down its program for collecting, screening, and shipping stool for therapeutic purposes.

As STAT’s Kate Sheridan reports, OpenBiome plans to empty its current inventory starting in May, resuming shipments after a year-long hiatus brought on by Covid-19. Once the stockpile is clear, OpenBiome will stay open and pivot from fecal transplants to a full focus on microbiome research.

For the past eight years, OpenBiome has been a major source of material for academic medical centers performing the procedure, which is often used to treat a potentially fatal bacterial infection known as C. difficile. Now, FDA-regulated microbiome treatments moving closer to market, OpenBiome’s work is looking less and less necessary, said Carolyn Edelstein, executive director of the nonprofit.

Read more.

What to do when your stock price soars

Beam Therapeutics, a company focused on genome editing, is in a strange situation. The firm’s stock price has roughly quadrupled since the fall, and not because of pivotal data or an affirmational partnership but rather because of a broad and quite likely temporary boom for companies involved in editing DNA. But unlike some of its contemporaries, Beam isn’t letting its moment go to waste.

First, last month, the company raised $260 million by selling stock at $93 a share, which is six times the value at which Beam went public just 12 months ago. Then, yesterday, the company made an acquisition, buying a delivery-focused firm called Guide Therapeutics for $120 million up front and as much as $320 million more in milestone payments. But Beam didn’t spend any of its newfound cash, instead trading some of that expensive stock to absorb a company focused on novel ways of getting genome-editing therapies to their biological targets, which will be quite important. 

As analysts at Stifel pointed out, the acquisition seems like “a very expensive deal,” and shareholders presumably won’t be delighted that Beam is making a second dilutive move in as many months. But looking to the future, if there comes a broad biotech correction that sends Beam back to its humbler 2020 valuation, the company will have a bunch of cash and a new technology to show for the ride. It’s up for debate whether Beam’s stock run-up is justified, but there’s no doubt the company turned its paper gains into tangible assets.

Can you really lead HHS if you’ve never worked in pharma?

Republican senators, in their opposition to President Biden’s pick for health secretary, homed in on a curious facet of the nominee’s résumé: He has never once been employed by a pharmaceutical company?

As STAT’s Lev Facher reports, that criticism, leveled during yesterday’s confirmation hearing, is unlikely to interrupt the ascent of Xavier Becerra, currently California’s attorney general, who needs only to win over Senate Democrats to get the job. But the point is notable both because the man Becerra would replace, Alex Azar, is the only health secretary to have ever worked at a drug company, and because pharma remains a deeply unpopular industry with the American public.

Read more.

More reads

  • STAT+ Conversations: An interview with Third Rock Ventures' Abbie Celniker. (STAT+)
  • SoftBank plans to invest billions in biotech stocks. (Bloomberg)
  • Brazil approves Pfizer's COVID-19 shot, but has none to use. (Reuters)
  • Access to heart drugs improves in middle-income countries, but still lags compared to wealthy nations. (STAT+)

Thanks for reading! More tomorrow,

Damian

Wednesday, February 24, 2021

STAT

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