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Good day, everybody. Damian right here with the ultimate version of this text for 2023. We’re taking a break for the vacations and will likely be again in your inbox vibrant 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 accepted 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 Phase 3 clinical trials of an off-the-shelf T-cell remedy for 3 kinds of infectious illness. The choice comes after impartial examine screens concluded Allovir’s remedy was unlikely to attain its efficacy objectives.
- The FDA prescribing label for Carvykti, a CAR-T remedy for a number of myeloma made by Johnson & Johnson and Legend Biotech, has been updated to incorporate the incidence of secondary blood cancers in sufferers handled with the treatment.
- Sarepta Therapeutics stated an efficacy supplement was submitted to the FDA, searching for to broaden 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 traders wanting rosily ahead to 2024, the carefully 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 unstable finish of what has been a unstable 12 months, by which the sector has been up as a lot as 13% and down by greater than 20%. And whereas the biotech’s latest restoration is clearly tied to macroeconomic elements, Wednesday’s sudden dip gives few straightforward explanations past traders taking income, year-end tax-loss promoting, and the acquainted animal spirits.
The XBI is now up about 4% on the 12 months, 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% anticipate biotech to outperform the S&P subsequent 12 months, with 11% anticipating the sector to underperform and 17% figuring it will likely be in-line with the broader market.
Can biotech endure one other election 12 months?
What does it imply to a foul CEO? And may 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 largest tales of the 12 months, focus on the most effective and worst CEOs within the business, and make some moderately knowledgeable guesses on what 2024 has in retailer for the drug business.
Pay attention right here.
Cytokinetics is operating out of December
The final huge 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 Section 3 knowledge that can 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 suggests they need to be right here any day now. Traders appear to assume 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 industrial product. In the meantime, Cytokinetics has reportedly attracted buyout interest from larger drugmakers, a prospect that’s virtually actually contingent on aficamten’s success.
Pharma nonetheless can’t work out PTSD
Regardless of years of analysis and some promising advances, there stay solely two accepted therapies for post-traumatic stress dysfunction, a pair of now-generic SSRIs medication. And the pharmaceutical business’s newest concept, an investigational remedy from Jazz Prescription drugs, led to failure.
The drug, JZP150, missed its major and secondary endpoints in a Section 2 trial, the company said yesterday, failing to meaningfully enhance signs of PTSD relative to placebo over the course of a 12-week examine. Jazz stated it doesn’t anticipate to conduct additional trials of JZP150 in PTSD.
Probably 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.