Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Hello, everyone. Damian here. I’d like to heartily recommend you check out Part 1 of The War on Recovery, a yearlong STAT investigation into how the U.S. denies lifesaving medications to people with opioid addiction.
The need-to-know this morning
- Novo Nordisk’s diabetes medication Ozempic cut the risk of patients developing advanced kidney disease or dying from kidney or heart complications, adding to the evidence the wildly popular drug has broader health benefits for patients beyond addressing their diabetes.
- Alnylam Pharmaceuticals said its experimental medicine zilebesiran lowered blood pressure on top of current standard treatments, achieving the goal of a mid-stage clinical trial. Full results will be presented on April 7 at the American College of Cardiology meeting. Zilebesiran is being developed in a partnership with Roche.
Biotech VC is shrinking
The bad news, according to the latest data from Pitchbook, is that biotech companies are raising less money across fewer deals with worse terms. The good news, potentially, is that the venture capital’s renewed focus on quality might smooth out a market prone to booms and busts.
Biotech firms inked 204 deals in the fourth quarter of 2023, a 24% decline over the same period last year. For the full year, there were 920 deals, a roughly 20% decrease from 2022. In dollar terms, the amount of money raised fell 21% in the fourth quarter and 19% on the year, according to Pitchbook.
All the red numbers fortify something that was already clear: It’s harder to raise money in biotech today than it was during the industry’s mid-pandemic boom. But, considering that boom led directly to a biotech downturn, a little added selectivity among VCs is probably not a bad thing for the sector.
Even Phase 1 data move markets in 2024
At least if you’re Apogee Therapeutics, whose stock traded up on the results of a study testing its long-acting anti-inflammatory in a group of healthy volunteers.
The news is that Apogee’s antibody treatment, APG777, had a half-life of about 75 days and hit biological targets for roughly three months. That supports Apogee’s plan to administer the drug, under development for atopic dermatitis and other inflammatory diseases, between two and four times a year. Dupixent, Regeneron Pharmaceuticals’ blockbuster anti-inflammatory, is dosed every two weeks, and Eli Lilly’s similar lebrikizumab is administered once a month.
The next step is to enroll patients with moderate to severe atopic dermatitis in a Phase 2 study in the first half of this year, with data expected in 2025, the company said.
There’s no escaping the ‘takeout thesis’
Yesterday, BridgeBio Pharma traded the European rights to one of its drugs for $310 million and a roughly 30% royalty on future sales, a deal that gives the company short-term cash and a long-term commercial partner. Then its stock price fell by about 10%, driven by some simplistic but powerful logic: BridgeBio had become that much less likely to get acquired.
Analysts and investors have long bemoaned the so-called takeout thesis, in which everything a biotech company does is filtered through the lens of dealmaking. If the market values a company based solely on whether it’ll get bought, any move with a long-term focus is definitionally bad for a stock, regardless of whether it’s good for the actual company that stock represents.
BridgeBio’s one-day move is a reminder that, despite a strong upswing over the past month, investor sentiment remains fickle in biotech. An obsession with M&A is good for the sector when deals are getting done, but it promises volatility when, inevitably, the pace of acquisitions slows down.
Where’s Lilly’s Alzheimer’s approval?
First it was supposed to happen by the end of 2023. Donanemab, Eli Lilly’s treatment for Alzheimer’s disease, succeeded in its Phase 3 trial and was up for a sure-thing FDA approval in the fourth quarter. Then that timeline shifted to the first quarter of 2024, with no explanation. And now we’re two-thirds into that quarter with no news on what could be among the most important drugs in Lilly’s lengthy history.
It seems unlikely the FDA has issues with donanemab’s data, which, according to the standard set by recent approvals in Alzheimer’s, seem to meet the criteria for authorization. If the process is indeed delayed, it could relate to manufacturing.
In October, the FDA rejected lebrikizumab, an autoimmune treatment with blockbuster potential, citing issues from an inspection of Lilly’s third-party manufacturer. Six months before, the agency rejected another prized new medicine, the ulcerative colitis treatment mirikizumab, because of issues with Lilly’s in-house manufacturing.
More reads
- White House touts incremental step in Medicare drug price negotiation: counteroffers, STAT
- Animal testing for vaccines relies on a cruel monkey supply chain, Bloomberg
- White House is told the big three PBMs are ‘everything wrong with this industry,’ STAT