| | | |   | Good morning, all. Damian here with news on Moderna's mounting cash pile and the dismal state of small-cap biotech. | | | Moderna could buy Alnylam At least in theory. Like BioMarin and Incyte, Alnylam Pharmaceuticals has a market value below Moderna’s roughly $19 billion of cash on hand as of March 31.
Moderna, which hosted its first-quarter earnings call yesterday, has again declined to pay shareholders a dividend, saying instead that it will invest the money in its own science, look for “attractive external investment opportunities,” and buy about $3 billion of its own shares.
But the good times aren’t expected to last. While Moderna expects to make about $21 billion for the full year, analysts project the company’s revenue to markedly decrease in 2023 and beyond. The question now is whether Moderna’s wisest move is continuing to spend its cash on small, early-stage deals or take a big swing while the money is still pouring in. | Congress considers reforms to accelerated approval pathway House lawmakers are closer to cracking down on companies that game the FDA’s accelerated approval pathway, moving forward with reforms that would make it easier for the agency to rescind approvals.
As STAT’s Nicholas Florko reports, it’s all part of the must-pass legislation that funds the FDA. The House Energy and Commerce Committee is proposing to include new rules allowing the agency to penalize companies that don’t complete follow-up studies after accelerated approvals and, after a bureaucratic process, pull their products from the market.
The text is substantially more pharma-friendly than an earlier bill from New Jersey Democrat Frank Pallone, which would have automatically revoked certain drugs’ approvals once confirmatory studies were one year overdue.
Read more. | With $1B city investment and unmatched biotech workforce, NYC primed to be a life sciences hub Driven by the largest biotech workforce in the US, a diversity of science and talent, abundant commercial lab space, and a robust VC & startup ecosystem, NYC has all the makings of an innovation hub. LifeSci NYC is a $1B city initiative to support the industry and help companies expand and grow in NYC. Discover more about life sciences in NYC. | Vertex’s chance to explain Things were going so well for Vertex Pharmaceuticals. In March, the company’s investigational pain treatment met its goals in two mid-stage trials, a sign the drug might yet succeed where so many have failed. Then, in April, an AbbVie-developed challenger to Vertex’s cystic fibrosis franchise failed in clinical trials, indefinitely delaying competition.
Then, this week, the FDA suspended development of VX-880, Vertex’s promising early-stage treatment for Type 1 diabetes, a setback that seemed to catch the company by surprise. Today, at 4:30 ET, Vertex will take questions as part of its quarterly earnings call, giving the company a chance to explain its read on the situation and assuage Wall Street’s concerns that VX-880 has a troubled path ahead.
At the time, Vertex said only that the FDA cited “insufficient information” to support moving forward with development. Expect analysts to pry for any further details and even a loose timeline for when VX-880 might get back on track. | Some biotech stocks are worth less than the paper they’re printed on There are now nearly 200 biotech companies that are worth less than the cash they have in the bank, according to Bloomberg, a dismal milestone that just might get worse.
The year’s roughly 32% decline in the XBI biotech index has been especially rough on the crop of small, early-stage firms that went public so easily in 2020 and 2021. Cancer-focused small-cap companies have fared the worst, according Truist analyst Asthika Goonewardene, with 53% now trading at or below cash.
And the nadir could be yet to come. Despite plunging valuations, major pharmaceutical firms have so far been loath to buy up foundering biotechs. One major impediment, as the CEOs of Merck, Bristol Myers Squibb, and Pfizer have said, is that many biotech management teams are still clinging to their yesteryear valuations, and it might take months for them to come around to the new reality. | More reads - Race is often overlooked in key clinical trial data used to win new drug approvals in Europe. STAT+
- The DEA is investigating Cerebral as the $4.8 billion mental-health startup faces growing scrutiny. Business Insider
- Researchers describe the human element in the alchemy behind the Moderna vaccine and other new medicines. STAT+
- Regeneron's Covid-19 drug sales outside U.S. help revenue beat. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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