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Hiya, everybody. Damian right here with the ultimate version of this article for 2023. We’re taking a break for the vacations and will probably be again in your inbox vivid and early on Jan. 3.
The necessity-to-know this morning
- Bristol Myers Squibb is buying Karuna Therapeutics, developer of a drug for schizophrenia, for $14 billion.
- The FDA permitted a novel drugs for a uncommon and devastating nerve illness known as ATTR-PN, clearing a remedy that guarantees to be extra handy than out there therapies. The brand new drug, known as Wainua, is made by AstraZeneca and Ionis Prescription drugs.
- Allovir is shutting down Part 3 scientific trials of an off-the-shelf T-cell remedy for 3 forms of infectious illness. The choice comes after unbiased research displays concluded Allovir’s remedy was unlikely to realize its efficacy targets.
- The FDA prescribing label for Carvykti, a CAR-T remedy for a number of myeloma made by Johnson & Johnson and Legend Biotech, has been up to date to incorporate the prevalence of secondary blood cancers in sufferers handled with the medicine.
- Sarepta Therapeutics stated an efficacy complement was submitted to the FDA, searching for to develop the prescribing label of its gene remedy for Duchenne muscular dystrophy to all sufferers with out restrictions on age or ambulatory standing.
Biotech’s inexperienced 2023 is unsure
After an prolonged bull run that had buyers trying rosily ahead to 2024, the intently watched XBI biotech index had its worst day since February on Wednesday, falling greater than 4%. Then it recovered most of these losses yesterday in one other dramatic transfer that didn’t seem tied to the precise fundamentals of growing new medicines, a lot much less a single firm’s misfortunes.
Biotech appears to be heading to a risky finish of what has been a risky yr, wherein the sector has been up as a lot as 13% and down by greater than 20%. And whereas the biotech’s current restoration is clearly tied to macroeconomic components, Wednesday’s sudden dip provides few simple explanations past buyers taking earnings, year-end tax-loss promoting, and the acquainted animal spirits.
The XBI is now up about 4% on the yr, which is healthier than 2022 however far worse than the S&P 500’s 24% return since January. Traders appear to consider issues are going to look higher in 2024. Mizuho surveyed 70 fund managers and located that 71% count on biotech to outperform the S&P subsequent yr, with 11% anticipating the sector to underperform and 17% figuring it is going to be in-line with the broader market.
Can biotech endure one other election yr?
What does it imply to a nasty CEO? And might you go to too many J.P. Morgan events?
We cowl all that and extra this week on “The Readout LOUD,” STAT’s biotech podcast. It’s our final episode of 2023, so we glance again on the most important tales of the yr, focus on one of the best and worst CEOs within the business, and make some moderately knowledgeable guesses on what 2024 has in retailer for the drug business.
Hear right here.
Cytokinetics is working out of December
The final large biotech catalyst for 2023 belongs to Cytokinetics, which has spent greater than 25 years working towards a primary FDA approval, and the clock is ticking.
The corporate has promised Part 3 information that may decide whether or not its drug, aficamten, can enhance the lives of sufferers with a kind of inherited coronary heart illness. These outcomes are due in “late December,” the corporate has stated, which implies they need to be right here any day now. Traders appear to suppose the information goes to be good, as Cytokinetics inventory worth rose 25% yesterday.
The stakes are excessive. If aficamten performs higher than a rival drug from Bristol Myers Squibb, Cytokinetics may roughly double in worth. If the drug merely measures as much as its competitors, the corporate will nonetheless be on tempo to launch its first business product. In the meantime, Cytokinetics has reportedly attracted buyout curiosity from bigger drugmakers, a prospect that’s virtually definitely contingent on aficamten’s success.
Pharma nonetheless can’t determine PTSD
Regardless of years of analysis and some promising advances, there stay solely two permitted therapies for post-traumatic stress dysfunction, a pair of now-generic SSRIs medicine. And the pharmaceutical business’s newest concept, an investigational remedy from Jazz Prescription drugs, resulted in failure.
The drug, JZP150, missed its major and secondary endpoints in a Part 2 trial, the corporate stated yesterday, failing to meaningfully enhance signs of PTSD relative to placebo over the course of a 12-week research. Jazz stated it doesn’t count on to conduct additional trials of JZP150 in PTSD.
Essentially the most promising pipeline medicines for PTSD come from the world of psychedelics. MAPS, a public profit company, is searching for FDA approval for an MDMA remedy that, mixed with psychotherapy, has led to constructive ends in PTSD.
Extra reads
- 3 points to observe in international well being in 2024, STAT
- FDA declines to approve Merck’s continual cough drug, Reuters
- Well being shares get shot at redemption after Ozempic-fueled losses, Bloomberg