| | | |   | Good morning. Damian here. Quick reminder that STAT's 2022 Breakthrough Science Summit, featuring a host of smart people from around the life sciences, is tomorrow, and you can still get tickets to tune in. Do so here. | | | Today's the big day for Amylyx Amylyx Pharmaceuticals, a company with exactly one drug, is at the mercy of 10 advisers to the FDA, who will spend today debating whether its treatment for ALS should win approval.
STAT’s Adam Feuerstein will be tuned in for the debate and posting updates throughout the day. The backstory is that Amylyx ran a single, small clinical trial, finding that its drug slowed the progression of ALS compared to placebo. The FDA initially told the company it would need more data before seeking approval but later relented and invited Amylyx to file based on what it had. Earlier this week, in briefing documents posted ahead of today’s meeting, the FDA appeared to take a dim view of the supporting evidence, sending Amylyx’s share price down about 40%.
That prologue only ratchets up the drama of today’s meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, an independent body tasked with reviewing the data and issuing a nonbinding vote on whether Amylyx’s drug should be approved. If the panel finds in favor of the drug, Amylyx might yet convince the agency. If not, the company could have to wait on the results of a larger study that likely won’t read out until 2024.
Read more. | Sometimes biotech stocks go up IGM Biosciences, a small-cap biotech company developing treatments for cancer, saw its stock price double yesterday after disclosing that Sanofi was interested in both its science and its shares.
At 6:01 a.m. ET, IGM released its quarterly earnings, noting that Sanofi had agreed to pay $150 million in cash to collaborate on potential drugs and “expressed an interest in purchasing up to $100 million” of the company’s stock in a public offering. Exactly 100 minutes later, IGM issued a second press release to say it would raise $200 million in a stock sale. Sanofi was not mentioned.
Once the market opened, IGM’s share price rose by more than 115%, giving the company its highest valuation since December, when a disappointing update on its lead cancer treatment tanked the company’s value. | Rare disease patients deserve protection from Washington politics Right now, politicians need a win, but rare disease patients could lose. In Congress’ rush to pass something, therapies for rare diseases and cancers could face an increase of between 400% and 800% in Medicare Part D costs. There is a better way that protects patients. Learn more. | The good news is drugs got cheaper The bad news is everything else got more expensive.
That’s according to new data from the research firm SSR Health, which found that, in the fourth quarter of 2021, list prices for prescription drugs fell 2.3% and net prices came down 5.4%, the largest quarterly declines in 15 years. The important caveat, as Ed Silverman notes, is that those numbers are adjusted for inflation, meaning that unless consumers saw their incomes rise over the past year, they almost certainly didn’t perceive anything resembling a bargain on new medicines.
The latest numbers help explain why it’s so difficult to pin down the cost of medicine in the U.S. and, by extension, pass legislation to address it. The list prices of prescription drugs have been on a steady upward trend, but so too has been the gap between those numbers and the amount of money drug companies actually receive. The difference goes into the pockets of middlemen who, according to the pharmaceutical industry, bear the largest responsibility for rising patient costs. But just like the inflation-adjusted pricing data, it’s a distinction that makes little difference if you’re the one paying more for drugs each year.
Read more. | Despite some high-profile duds, pharma is still betting on digital therapeutics Novartis’ bet on the so-called smart contact lens never amounted to anything, and the company that sold digitized pills for Otsuka was forced to declare bankruptcy. But the moneyed class of the pharmaceutical industry hasn’t lost its interest in the nascent world of digital medicine, and there’s a new wave of partnerships that might signal a more entwined future for both sectors.
As STAT’s Mario Aguilar reports, Bayer, Novo Nordisk, and Sanofi have each lent their names and balance sheets to upstart companies hoping to transform medicine with software. The dollar amounts tend to be small in drug industry terms, but the ambitions are sweeping. Companies are working on apps meant to treat mental health conditions, software to boost patient adherence, and chatbots designed to improve the standard of care.
Read more. | More reads - U.S. approves second Covid-19 booster for people 50 and older. STAT
- Sanofi targets Dupixent peak sales of over 13 billion euros. Reuters
- Osso VR lands $66 million to grow its virtual reality platform to train surgeons. STAT
| Thanks for reading! Until tomorrow,  | | | |
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