RARE DISEASE
Stealth BioTherapeutics contemplates closure
Stealth BioTherapeutics, which has been developing a therapy for Barth syndrome, an ultra-rare disease, said it received "conflicting" signals from the Food and Drug Administration and, consequently, is making contingency plans to close the company.
The agency this past May rejected the drug but also said it may still be possible for Stealth to pursue accelerated approval. Now, according to the company, the the agency has indicated it would not have a decision for up to six months, which Stealth's CEO said may cause the company to close.
Experts note that, prior to an FDA advisory meeting last October, agency staff indicated they did not "believe that the available evidence establishes the effectiveness" of the company's drug.
Read more from STAT's Ed Silverman.
health tech
Mayo's AI tool to diagnose dementia faces major test
The approval of new amyloid-targeting therapies for Alzheimer's helped accelerate the Mayo Clinic's development of an AI tool to diagnose different types of dementia.
Through a partnership with Google and with access to clincial data and scans from patients at Mayo, researchers built a cloud-based system to store, analyze, and deliver insights from that data.
So far, the tool's performance has looked strong compared with other predictive dementia models, but the real test now will be whether the model might be useful beyond Mayo's walls — if it can, indeed, break through them.
Read more from STAT's Katie Palmer.
GLP-1s
Novo and Hims seem to give conflicting accounts on compounding demand
Telehealth company Hims & Hers reported last night that it brought in $545 million in the second quarter, falling a bit short of the $551 million expected by analysts polled by Visible Alpha. The company's quarter-to-quarter revenue also fell for the first time. Its stock plunged more than 10% in post-market trading.
On an earnings call, CFO Yemi Okupe said the company has seen declining sales of compounded GLP-1 treatments. (Compounded copies of branded drugs are no longer allowed since the branded drugs aren't in shortage, but Hims has argued it's still legal to make "personalized" compounded products.)
Elsewhere, though, Novo Nordisk has blamed "the persistent use" of compounded drugs for blocking wider usage of its branded treatment Wegovy. Last week, it slashed its growth outlook for the year, leading its stock to tumble more than 20% in a day.
The two accounts don't exactly add up, though there are many companies other than Hims that are still offering compounded treatments. Noom yesterday announced that it would start selling low-dose compounded versions of Novo's Wegovy.
wall street
A new, Swiss home for biotech's most fervently bullish stock analyst
From my colleague Adam Feuerstein: Michael Yee, the flashy, always-selling biotech stock analyst, is leaving his perch at Jefferies and moving to the Swiss bank UBS, I have learned. The move has not yet been announced.
Yee is famous (some might say infamous) for his ability to stick his thumb in the air and always detect a tailwind for the biotech stocks he covers. His almost-evangelical zeal for the buy rating, regardless of market conditions, has earned him the nickname "Yeezus."
Yee joined Jefferies from the Canadian bank RBC in 2017. At Jefferies, he flourished in the bank's proto-banking culture, pitching biotech stock forecasts in videos shot from inside his modern, art-filled Miami home (or outside by the pool). One spring, Yee had a bobblehead doll likeness of himself made, and sent to investor clients, as a pitch for votes for an institutional investor research analyst award.
UBS is hoping that hiring Yee will help revitalize its diminished stature among health care investment banks. In the mid- and late-2000s, UBS's health care investor conference, held each fall in New York City, was a must-attend event. With Yee on board, it might be once again.
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