That’s reversed in afternoon action, with the stock now down 7.5% for the day to $141.
Some profit-taking is surely in play after more than a doubling of the stock price in November seemed to anticipate Monday morning’s trial news. As for the FDA hearing, that doesn’t seem like news at all (was mRNA-1273 not going to get a quick hearing?).
In other developments, Stat News reports the White House has scheduled a Covid-19 “vaccine summit” on Dec. 8 (two days ahead of a panel that will look at the Pfizer/BioNTech vaccine candidate) in order to help pressure for quick FDA action (among other things).
FDA OKs emergency use of Roche test that measures anti-SARS-CoV-2 antibody levels
The FDA authorizes the emergency use of Roche’s (OTCQX:RHHBY +1.9%) Elecsys Anti-SARS-CoV-2 antibody blood test, a semi-quantitative assay that measures the levels of antibodies to the spike protein of the coronavirus.
Compared to results from a molecular test, the negative concordance rate (percent agreement) is 99.98% and the positive concordance rate is 96.6% [at least 15 days after diagnosis with a polymerase chain reaction (PCR) test].
Results can be generated in ~18 minutes when performed on the company’s automated cobas e analyzers.
The test is the seventh member of its line-up of COVID-19 diagnostics.
Shipments will begin next week.
FDA OKs new use of Roche’s Xolair
The FDA approves Roche’s (OTCQX:RHHBY +1.9%) Xolair (omalizumab) as add-on maintenance treatment of nasal polyps in adults who fail to adequately response to corticosteroids.
The anti-IgE antibody was first approved in 2003 for asthma in patients at least 12 years old.
Gilead’s Descovy OK’d in Canada for HIV pre-exposure prevention
Health Canada approves Gilead Sciences’ (NASDAQ:GILD) Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk of HIV acquisition.
Canada is the third country to approve the drug for this indication (U.S. in October 2019 and Taiwan in August of this year).
Tower One Wireless Corp. reports Q3 results
Tower One Wireless Corp. (OTCPK:TOWTF): Q3 GAAP EPS of C$0.00.
