Taysha, Gilead, Merck, Zentalis news
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Good morning! Elaine Chen is away, so I’m right here in her stead. Take it gradual on the market, Northeast-ers, the surface temps are about to hit “depraved sizzling.”
The necessity-to-know this morning
- Zentalis Prescription drugs mentioned the FDA placed a partial hold on scientific trials involving its experimental most cancers drugs azenosertib following the deaths of two sufferers attributable to “presumed sepsis.”
- Intra-Mobile Therapies reported positive results from a second, Section 3 scientific trial searching for to broaden the usage of its antipsychotic drugs Caplyta to sufferers with main depressive dysfunction. Optimistic outcomes from the first Section 3 research had been reported in April.
- Taysha Gene Therapies reported preliminary results from a research of its gene remedy for adults and youngsters with Rett syndrome.
Ethan Weiss has raked in some money
Now we all know what the previous UCSF heart specialist and frequent Twitter/X contributor has been doing for the previous few years: beginning up a biotech firm.
The ten-person outfit known as Marea mentioned this morning that it had raised $190 million to assist develop a drug to decrease a kind of ldl cholesterol — what scientists name “remnant ldl cholesterol” — that might signify a brand new manner of attacking heart problems. Along with being a founder, Weiss is Marea’s chief scientific officer.
The story of that drug, the protein that it targets, and the gene that codes for that protein (each are known as ANGPTL4) says rather a lot about why medicines are so robust to develop and why coronary heart illness stays the most important killer within the U.S., taking 700,000 lives yearly. It additionally gives a freeze-frame photograph of the way in which by which the biotech business’s capitalist flywheel of growth and bust cycles gives glimmers of scientific hope, writes my STAT colleague Matt Herper.
Marea, which is about three years outdated, continues to be firstly of its scientific journey. Its drug, initially developed at Novartis after which licensed to the startup, is simply about to enter Section 2 trials.
Learn extra.
A biotech’s binary wager ends badly
Shares of Aerovate Therapeutics plunged 93% yesterday, for an easy purpose. A biotech firm that bets its whole future on a single drug doesn’t have a lot of a future when that drug seems to not work.
In a mid-stage scientific trial, Aerovate mentioned its lead and solely drug candidate, known as AV-101, failed to reduce blood pressure in the lungs in comparison with a placebo in sufferers with pulmonary arterial hypertension. Based mostly on the unfavorable outcomes, which prolonged to secondary endpoints as properly, Aerovate mentioned it’s halting enrollment and shutting down an ongoing Section 3 research.
Aerovate was based to develop AV-101, an inhaled formulation of the most cancers drugs imatinib repurposed for the remedy of pulmonary arterial hypertension. An oral type of imatinib had proven promising efficacy in earlier research, however its growth was blocked by insupportable negative effects. Aerovate believed delivering imatinib straight into the lungs is likely to be the way in which ahead — however yesterday’s research final result proved in any other case.
The unhealthy information induced Aerovate’s inventory worth to plunge to $1.65 yesterday from its Friday shut of just under $25. Its market worth ($49 million) is now lower than the $100 million on its stability sheet.
Merck wins approval for pneumonia vaccine
The Meals and Drug Administration yesterday permitted Merck’s new pneumococcal vaccine for adults 18 and older.
The vaccine, which will likely be offered below the identify Capvaxive, is designed to guard in opposition to pneumococcal pneumonia, which hospitalizes about 150,000 adults in the US yearly and kills about one in 20 who develop it, in response to the Nationwide Basis for Infectious Illnesses.
Capvaxive covers 21 totally different serotypes of Streptococcus pneumoniae — the micro organism that trigger pneumococcal illness — together with eight that aren’t focused by any of the opposite obtainable vaccines. Till now, the vaccine that protected in opposition to probably the most serotypes of the micro organism was Pfizer’s Prevnar 20.
Learn extra.
Gilead Sciences: Weight problems inventory?
We’ve reached the stage of the GLP-1 hype cycle the place a analysis summary describing modest modifications within the weight of monkeys is ample to label a large-cap biotech firm as having “publicity to weight problems now.”
That’s how Jefferies biotech analyst Michael Yee touted Gilead in a notice Friday, highlighting a preclinical metabolic drug known as GS-4571 that the corporate has by no means talked about publicly. The corporate is presenting monkey knowledge on GS-4571, an oral GLP-1, on the upcoming assembly of the American Diabetes Affiliation. The invention of the analysis summary on Friday by Yee and another analysts was sufficient to trigger Gilead’s inventory worth to shut 2% increased.
However later, Gilead administration clarified that there’s been no resolution on whether or not to advance GS-4571 into Section 1 research, and that the drug, for now, is likely to be into account as a possible remedy for the fatty liver illness often called MASH.
Faucet these Gilead weight problems brakes, for now.
