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Regulation

Jan. 12 Quick Takes: U.S. releases all doses of mRNA vaccines; more Regeneron mAb under HHS deal, plus Black Diamond

Jan 13, 2021 | 2:16 AM GMT

Azar says all COVID vaccine doses released
HHS Secretary Alex Azar said Tuesday on Good Morning America that every dose of Moderna COVID-19 Vaccine from Moderna Inc. (NASDAQ:MRNA) and Comirnaty from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) has been made available. The government had been holding second doses in reserve as a safety stock, but “we now believe that our manufacturing is predictable enough that we can ensure second doses are available for people from ongoing production.” The move echoes the incoming Biden administration’s stance on vaccine distribution, which it made public last week.

Doses under Regeneron deal with HHS, DOD swells to 1.5M
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said HHS and the Department of Defense (DOD) will purchase up to an additional 1.25 million doses of its casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. The government has said it will provide these doses at no cost to patients, although healthcare facilities may charge fees related to administration. Under a previous agreement, Regeneron is supplying doses to treat about 300,000 people. Roche (SIX:ROG; OTCQX:RHHBY) is collaborating with Regeneron to increase global supply of the cocktail with a goal of having more than 2 million doses available annually. Roche is primarily responsible for ex-U.S. development and distribution of the therapy.

With ‘meaningful’ ORR unlikely soon, Black Diamond sheds value
Cancer company Black Diamond Therapeutics Inc. (NASDAQ:BDTX) slipped 15% to $29.46 Tuesday, losing more than $180 million in market cap, after President and CEO David Epstein said early data from a Phase I/II trial of BDTX-189 are unlikely to produce a “meaningful” overall response rate. More than half of the study’s 40-50 patients have received “sub-efficacious exposures,” and with patients enrolled displaying a range of mutations, the company believes an informative ORR will require further study. The trial is seeking a recommended Phase II dose of BDTX-189, a small molecule inhibitor that targets undrugged oncogenic driver mutations of the ErbB kinases EGFR and HER2. Epstein's remarks came at the virtual 2021 J.P. Morgan Healthcare Conference.

TARGETS
EGFR (ErbB1; HER1) - Epidermal growth factor receptor
HER2 (EGFR2; ErbB2; neu) - Epidermal growth factor receptor 2

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