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 companies say they are on track to seek regulatory review for the vaccine as early as this October, with a goal of manufacturing up to 100M doses for use globally by the end of 2020.
Earlier this week, Pfizer and BioNTech announced the start of late-stage human trials for their BNT162b2 vaccine candidate.
The FDA has signed off on a Phase 3 clinical trial evaluating Revive Therapeutics’ (OTCPK:RVVTF) Bucillamine in patients with mild-to-moderate COVID-19.
The study will enroll up to 1,000 subjects who will be randomized 1:1:1 to receive either 100 mg of Bucillaine 3x/day (TID), 200 mg TID or placebo TID on top of standard-of-care treatment for up to 14 days.
The primary endpoint will be the proportion of patients meeting a composite endpoint of hospitalization or death through day 28.
An interim analysis will be conducted after 210 patients have been treated and followed for 28 days. Additional interim analyses will be performed after 400, 600 and 800 patients have reached the same post-treatment time point.
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), a derivative of the amino acid cysteine, has been marketed for the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years.
The FDA has signed off on a Phase 3 clinical trial evaluating RedHill BioPharma’s (NASDAQ:RDHL) RHB-204 in adults with pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) infection, a rare type of lung infection affecting ~110K Americans that is difficult to treat.
RHB-204 is a fixed-dose capsule of clarithromycin, rifabutin, and clofazimine specifically designed to treat pulmonary NTM infections caused by MAC.
Shares up 6% premarket on light volume.
Merck (MRK) Q2 results:
Revenues: $10,872M (-7.6%).
Net Income: $3,002M (+12.4%); EPS: $1.18 (+14.6%); non-GAAP Net Income: $3,484M (+3.8%); non-GAAP EPS: $1.37 (+5.4%).
Shares are up 3% premarket.
Regeneron Pharmaceuticals (NASDAQ:REGN) will collaborate with BioNTech SE (NASDAQ:BNTX) on a clinical trial evaluating the combination of PD-1 inhibitor Libtayo (cemiplimab) and the latter’s BNT111 FixVac candidate for the second-line treatment of patients with advanced cutaneous melanoma.
The parties will equally share development costs for the trial and will supply their respective products. Each will also retain full commercial rights for their respective products.
BNT111, comprised of four melanoma antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE), is the most advanced FixVac candidate in the BNTX’s pipeline.
The study should launch in Q4.
REGN is up 3% and BNTX is up 5%, both on light volume.