RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
The White House coronavirus task force will “continue indefinitely,” President Trump said via Twitter, adding that he may “add or subtract people to it, as appropriate.”
The task force’s focus will be on “SAFETY & OPENING UP OUR COUNTRY AGAIN.”
It will also be “very focused” on vaccines and therapeutics, Trump said.
Sinovac Biotech Ltd. (SVA) announces encouraging results from a preclinical animal study for its inactivated SARS-CoV-2 vaccine candidate.
The challenge study in mice, rats and rhesus macaques showed that it was safe and provided complete protection against SARS-CoV-2 strains (in the primates) according to Chairman Weidong Yin.
A Phase 1 study in healthy human volunteers is underway.
Trading in the U.S. has been suspended since February 22, 2019, pending the submission of additional information requested by Nasdaq.
The FDA approves Dr. Reddy’s Laboratories’ (RDY +2.3%) Elyxyb (celecoxib oral solution 25 mg/mL) for the acute treatment of migraine in adults with or without aura.
The company plans to commercialize the product through partners.
Incyte (INCY -1.9%) announces that the FDA has approved exclusive licensee Novartis’ (NVS +1.2%) Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. The nod applies to a first-line setting as well as previously treated patients regardless of prior treatment type.
The approval triggers a $70M milestone payment to Incyte who will also receive 12-14% royalties on net sales.
METex14 occurs in 3-4% of newly diagnosed NSCLC cases. Capmatinib, an oral MET inhibitor, is the first such drug approved in the U.S. for these patients.
SmileDirectClub (NASDAQ:SDC) inks agreements with UnitedHealthCare (NYSE:UNH), Aetna (NYSE:CVS) and Anthem Blue Cross Blue Shield (NYSE:ANTM) (starting this month) enabling in-network access to its clear aligner treatments via telehealth.
Payment levels are not disclosed.
Shares up 10% premarket on average volume.
