| |   | Hello, everyone. Damian here with news on a momentous FDA meeting, the latest casualty of biotech's downturn, and a curious market reaction. | | | What should the next Covid vaccines look like? That’s the question facing the FDA’s advisers today, as the agency considers the weighty decision of just what should go into the next wave of Covid-19 vaccines.
The debate, which STAT’s Helen Branswell and Matthew Herper will cover live, centers on the best way to protect people from a potential fall surge of Covid-19. Vaccines on the market are designed to mimic the original strain of SARS-CoV-2, and early data suggests boosting with an Omicron-specific vaccine increases immunity.
The question is how best to apply that information. The FDA could recommend manufacturers make a bivalent vaccine — one that covers both the original and Omicron strains — or it could advocate for Omicron-only vaccines to be used as boosters. Then there’s the question of whether companies should focus on substrains, like BA.1 or the increasingly common BA.4 or BA.5.
Follow along. | The age of the preclinical IPO might be over Biotech’s IPO boom, which saw more than 150 companies go public in 2021 alone, appears to have ended. And the era of companies going public without so much as starting a clinical trial might not soon return.
As Reuters reports, biotech investors are increasingly wary of early-stage firms, shying away from deals that would take preclinical firms public. Even venture capitalists are turning their attention toward companies with drugs already in human development, investors told Reuters, which would be a sea change from even 2021.
If that trend holds, it could put a strain on the private markets. For years, VCs have launched early-stage companies with the relative certainty that they pocket returns in a near-term IPO. If going public is no longer an option, those firms will need cash to survive the bear market, and there’s no guarantee going public will be possible in the future. | How Tech Can — and Can't — Eliminate Barriers to Good Health Care Telemedicine and big data are just a few of the technological developments that may help doctors reach patients who currently don’t get high-quality care. On June 29, Join STAT for a look at what these efforts can accomplish and also what the new technology’s limitations are likely to be. | Market-moving biotech news comes in all shapes  Yesterday, in a two-sentence filing with the SEC, Axsome Therapeutics said it had reached the next expected step in the process of winning FDA approval for its lead drug. And then its share price went up by 50%.
The outsize reaction likely has two explanations. One, the FDA’s review of Axsome’s depression drug, AXS-05, has had a few twists and turns over the past 12 months, making even incremental not-negative news a cause for celebration. On top of that, biotech is deep in the red for 2022, leaving many investors desperate for some positivity. Axsome, a small company poised to win FDA approval, is a rare sight. Its stock price might yet go up once that approval happens, SVB analyst Marc Goodman wrote in a note to clients.
But that exuberance might be getting ahead of the news. The incremental step in question is that the FDA proposed a label for AXS-05. Axsome didn’t say what that proposal entailed or whether the company agrees with it, meaning that while approval looks likely, it could happen on terms the market finds less than favorable. | The latest biotech bailout comes with a lottery ticket One year ago, Epizyme was a nearly $1 billion company with an approved cancer treatment and plans to compete in the market for soft tissue sarcoma treatments. Now it’s accepting a buyout deal for less than $1.50 per share, the latest biotech company to read the writing on the wall and take what’s available.
Epizyme and its cancer drug, Tazverik, will become the property of Ipsen in a $247 million deal, valuing the company at about 150% more than its prior trading price of about 60 cents a share. The deal, disclosed yesterday, comes with a now-familiar wrinkle: Epizyme shareholders can get up to $1 more for each share if Tazverik hits certain milestones in the future, and the rights to that potential dollar can be traded on the open market.
Such lottery tickets are called conditional value rights, or CVRs, and they have a rich albeit checkered history in biotech. Sanofi’s $20 billion acquisition of Genzyme came with a CVR, tied to the future of a multiple sclerosis treatment, which never paid out and ended up in court. Bristol Myers Squibb attached a CVR to its $74 billion Celgene takeover, which similarly failed and is now the subject of litigation. | More reads - CRISPR debuted 10 years ago, in a paper hardly anyone noticed. Jennifer Doudna reflects on the DNA scissor’s first decade. STAT
- Biotech wizard left a trail of fraud. Prosecutors allege it ended in murder. Wall Street Journal
| Thanks for reading! Until tomorrow,  | | | |
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