Neuroscience
Can Intra-Cellular succeed where the industry has largely failed?
We'll find out next month, when Intra-Cellular Therapies is expected to have Phase 3 data on whether its lead drug can benefit people with major depressive disorder, or MDD.
As STAT's Adam Feuerstein writes, MDD has long bedeviled drug developers, and many studies have been derailed by unexpectedly strong placebo responses that negate a given drug's positive effects. But Intra-Cellular's treatment, already approved for schizophrenia and bipolar depression, could have a leg up on past contenders, Adam explains in a detailed preview of the company's upcoming results.
Speaking of Adam, starting next week he's launching a newsletter, exclusive to STAT+ subscribers, that will deliver insight and analysis from the intersection of Wall Street and biotech. It's called Adam's Biotech Scorecard, and you can sign up for it right here.
Rare disease
The U.K. is trying to figure out n-of-1 medicine
A revolution in genetic medicine has made it possible to craft bespoke therapies for patients with ultra-rare conditions. But the process of turning one-off success stories into a replicable process is more than a little complicated, with research, regulatory, and financial hurdles ahead.
As STAT's Andrew Joseph reports, researchers and government agencies in the U.K. are trying to figure out a pathway to bring tailor-made treatments to as many patients as possible. That includes standardizing the process for developing such therapies, figuring out how to appropriately test their merits, and ensuring there's a way to pay for the whole endeavor.
"A lot of the barriers are no longer scientific — we can make these drugs," said Matthew Wood, a professor of pediatrics at the University of Oxford. "It's more about, can we make them at a cost that is reasonable enough? And can we get the regulators to reduce the barriers to doing this so that when a patient shows up, you can actually make a drug quickly enough to benefit that patient, rather than it costing huge amounts of money and taking two or three years to do it?"
Read more.
Financials
BioNTech is having its Pfizer moment
Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company's Covid-19 vaccine partner, is now dealing with investor malaise of its own.
Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech's cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.
Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.
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