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.
Thinly traded nano cap ADiTx Therapeutics (NASDAQ:ADTX) jumps 86% premarket on robust volume in reaction to its announcement that its AditxtScore test for COVID-19 has been validated in studies conducted at Stanford Blood Center in Palo Alto, CA.
The company says the double-multiplex assay can detect and differentiate IgG, IgM and IgA antibodies against multiple SARS-CoV-2 antigens in a single reaction, the first test able to do so [most antibody tests currently in use are qualitative (yes/no answer) and detect either IgG antibodies or IgG/IgM antibodies], while showing much lower rates of false positives/negatives.
It plans to file an application this quarter for emergency use in the U.S. aimed at commercial launch in Q1 2021.
The FDA has signed off on a Phase 2/3 clinical trial, AVICOVID-2, evaluating an inhaled formulation of Relief Therapeutics’ (OTCPK:RLFTF) lead candidate RLF-100 (aviptadil) in moderately to severely ill COVID-19 patients to prevent progression to respiratory failure.
The study, led by collaboration partner NeuroRx, will enroll ~288 subjects. The primary endpoint is the proportion of patients progressing to acute respiratory distress syndrome (ARDS) compared to placebo (both on top of standard-of-care treatment). The estimated primary completion date is October.
Aviptadil, a synthetic form of human vasoactive intestinal peptide (VIP), works by binding to receptors on alveolar cells in the lungs, the same cells that SARS-CoV-2 binds to. The company says VIP protects these cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cell death and upregulating the production of surfactant, the loss of which is believed to play a role in COVID-19 respiratory failure.
CRISPR/Cas9 gene editor Editas Medicine (NASDAQ:EDIT) and modified CRISPR gene editor Beam Therapeutics (NASDAQ:BEAM) are up 21% and 35%, respectively, premarket on chatter that a deal is imminent.
Developing….
Other CRISPR stock to watch: CRISPR Therapeutics (NASDAQ:CRSP), Intellia Therapeutics (NASDAQ:NTLA)
Update: Both companies have declined to comment on the speculation.
Bausch Health Companies (NYSE:BHC) jumps 35% premarket on light volume in reaction to a report that it plans to spin of Bausch + Lomb which accounted have its revenue last year.
It acquired the eye care business for $8.7B in 2013 under then-CEO Michael Pearson.
The Mexican Federal Committee has signed off on a Phase 2/3 clinical trial evaluating RedHill Biopharma’s (NASDAQ:RDHL) Yeliva (opaganib) in severely ill hospitalized patients with COVID-19 pneumonia.
The 270-subject study also includes sites in the UK and Russia with potential sites in Italy, Brazil and other countries.
The primary endpoint is the proportion of patients requiring mechanical ventilation by day 14 compared to placebo (both on top of standard-of-care treatment).
Shares up 1% premarket on light volume.
