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 FDA has signed off on emergency use of PerkinElmer’s (PKI +1.5%) Anti-SARS-CoV-2 ELISA (IgG) blood test developed at subsidiary EUROIMMUN.
The company says the test has 100% sensitivity (correctly identifying true positives) and 99% specificity (correctly identifying true negatives) after 21 days following the onset of COVID-19 symptoms.
Enrollment is underway in a pivotal Phase 2/3 clinical trial evaluating Athersys’ (NASDAQ:ATHX) MultiStem cell therapy in COVID-19 patients with acute respiratory distress syndrome.
Target enrollment is 400 subjects. The primary endpoint is the number of ventilator-free days through day 28 versus placebo.
Shares up 3% premarket on light volume.
Pluristem Therapeutics (PSTI -0.2%) inks agreements with two institutional investors for the direct sale of ~1.6M common shares at $9.45 per share.
Net proceeds of ~$15M will fund a Phase 2 study evaluating its PLX cell therapy in COVID-19 patients, other trials, capex and general corporate purposes.
The FDA approves Galderma’s Restylane Kysse, a hyaluronic acid filler, for lip augmentation and correction of upper perioral rhytids (wrinkles around the upper lip) in adults at least 21 years old.
According to the company, Restylane Kysse, designed specifically for the lips, lasts up to one year.
Aesthetic skin treatment-related tickers: Allergan (AGN +0.8%), Evolus (EOLS +2.0%), Revance Therapeutics (RVNC +2.3%)
SG Blocks pops (SGBX +43.7%) on one year, non-exclusive distributor agreement with OSANG Healthcare for OHC’s GeneFinder COVID-19 Plus RealAmp Kit now available in the US under the FDA’s Emergency Use Authorization
SG Blocks will have sales, marketing and distribution rights to OHC’s product in the US.
GeneFinder COVID-19 Plus RealAmp Kit is a test designed to detect SARS-CoV-2; the kit can provide up to 100 tests results in just over two hours.
In connection with the agreement, OHC has the right to participate, in up to 19.9% of SGBX’s stock offering during the next six months.
