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Good morning, everybody. Damian right here with information on biotech’s belt-tightening, the advance of xenotransplantation, and the escalating Ozempic panic.
The necessity-to-know this morning
Biotech VC is nearing a six-year droop
Enterprise capital dealmaking within the life sciences is on tempo for its slowest yr since 2017, in response to new information, each in variety of offers and sum of money raised.
As STAT’s Allison DeAngelis reports, there have been roughly 1,300 life sciences VC offers this yr, in response to an evaluation from Pitchbook and the Nationwide Enterprise Capital Affiliation. Meaning the sector is on tempo for a roughly 20% decline in offers in comparison with 2022.
Precise funding ranges are trending at a six-year low, and the variety of exit alternatives — the acquisitions, mergers, or IPOs that assist VCs recoup their funding — are at their lowest level in additional than a decade. There have been simply 56 VC exits to this point this yr, in comparison with 89 final yr and 195 in 2021.
CRISPR’d pig organs transfer nearer human transplant
The long-struggling science of xenotransplantation took a step ahead yesterday when the startup eGenesis reported a genome-edited breed of miniature pig produced kidneys that have been efficiently transplanted into monkeys.
As STAT’s Megan Molteni reports, the organs, derived from pigs containing as much as 69 genetic modifications, functioned nicely of their simian recipients for a median of 176 days and in a single animal for greater than two years. The outcomes, printed in Nature, are a part of a traditionally massive experiment meant to develop CRISPR-edited pig organs that may be safely transplanted into people.
That objective stays years away. Within the U.S., eGenesis plans to conduct one other long-term survival research in non-human primates, a multi-year course of, earlier than asking the FDA for permission to start a human medical trial.
Cell and gene therapies could possibly be a safer wager than different medicine
One of many drug business’s most generally cited stats is that 90% of medicine that enter medical trials fail to win approval. However a brand new evaluation means that cutting-edge cell and gene therapies are extra seemingly than extra conventional remedies to reach most cancers and uncommon illness trials.
Researchers pulled previous information from IQVIA, the Biotechnology Innovation Group, and ClinicalTrials.gov and located that CAR-T and T cell receptor therapies for blood cancers that reached medical trials have been twice as prone to be authorized as the common drug on this house (17.2% vs 7.5%). Additionally they discovered that gene therapies for uncommon illness have been twice as prone to win approval in comparison with medicine developed to deal with uncommon hematologic, autoimmune, metabolic, eye, and neurological issues (28% vs. 13%).
The outcomes, reported in a research brief by NewDigs, a drug improvement assume tank at Tufts Medical Middle, include caveats. The variety of authorized cell and gene therapies is comparatively small. And the research was impressed and partially funded by the Alliance for Regenerative Drugs, a gaggle that advocates for cell and gene remedy. However Mark Trusheim, one of many research’s leaders, believes the evaluation is an encouraging signal that scientific discoveries on this house may be translated into precise medicine: “They appear to be an affordable be an affordable wager,” he mentioned of cell and gene therapies. “Hopefully, it’s encouraging for future traders to have a look.”
Wall Road is reaching peak Ozempic panic
Earlier this week, it was NASH. Corporations growing medicines for the prevalent fatty liver illness noticed their share prices tumble partially as a result of the market believes medicines like Ozempic, with their dramatic results on physique weight, will decimate demand for NASH medicine.
And now it’s dialysis. Davita and Fresenius, makers of dialysis machines, lost about 20% of their value yesterday on the information that Novo Nordisk’s drug had succeeded in a study testing whether or not it may sluggish the development of kidney illness for sufferers with Kind 2 diabetes.
Each reactions appear greater than a bit of hasty. Neither Ozempic nor another GLP-1 remedy is authorized for NASH, and producers are struggling to maintain up with present demand, a lot much less the form of market saturation that may be required to displace dialysis.
The Ozempic panic is hardly restricted to well being care. Executives from Walmart, Pepsi, and McDonald’s have all faced recent investor questions on whether or not the rise of GLP-1 medicines poses a risk to their companies. And whereas the impacts stay each hypothetical and questionable, that doesn’t maintain inventory costs from transferring on the specter of GLP-1.
- Peter Marks on creating Operation Warp Velocity, however for uncommon ailments STAT
- Medicare could plan to barter drug costs, however some states are taking their very own steps to decrease prices, STAT
- Humana CEO Bruce Broussard to step down subsequent yr, STAT
- Biogen cuts nearly one-third of Reata’s employees following $7 billion buyout, Endpoints