During its recent R&D Day, Prometheus Biosciences announced new strong trial data, another new indication for its lead therapeutic candidate and progress in developing a subcutaneous formulation of it, according to an Oppenheimer report.
The partnership allows Hansa Biopharma to "enter new markets without the cost and risk of building out country-specific commercial organizations for a single product," an H.C. Wainwright & Co. report indicated.
Shares of contract research organization Inotiv Inc. traded higher after the company reported select preliminary unaudited financial results for Q4/21 and FY/21 which included a 90.7% YoY increase in revenue and a 123.0% increase in gross profit.
Adicet Bio Inc. shares traded 37% higher after the company reported positive interim data from its Phase 1 GLEAN Study of ADI-001, which the firm noted is the first-ever allogeneic, off-the-shelf, gamma delta CAR T investigational cell therapy.
Just a few days after the WHO deemed the COVID-19 Omicron variant a serious global health concern, leading mRNA-based vaccine developers BioNTech and Pfizer, along with rival Moderna, advised that if needed, the companies would be capable of developing a vaccine for the new mutating strains within roughly 100 days. H.C. Wainwright & Co. commented in a research note that it reiterates its "Buy" rating for BioNTech SE.
Shares of NRx Pharmaceuticals Inc. traded 50% higher after the company commented on new data released by the Israel Institute for Biological Research regarding the effectiveness of its BriLife® COVID-19 Vaccine against the SARS-CoV-2 "Delta" variant.
Shares of Krystal Biotech Inc. reached a new 52-week high after the company reported it met both primary and secondary endpoints in its pivotal GEM-3 trial of VYJUVEK™ in patients diagnosed with Dystrophic Epidermolysis Bullosa, a rare and severe skin disease.
Shares of Longeveron Inc. traded 50% higher after the company reported that the U.S. FDA approved its Lomecel-B for Rare Pediatric Disease Designation to treat a rare and life-threatening defect in infants called Hypoplastic Left Heart Syndrome.
Shares of Novavax Inc. traded 10% higher after the firm confirmed that the European Medicines Agency is now reviewing its COVID-19 vaccine filing for conditional marketing authorization. The firm advised that an opinion from the agency is expected within a few weeks.
Shares of EyePoint Pharmaceuticals Inc. reached a new 52-week intraday high after the company reported positive data from its Phase 1 DAVIO study of EYP-1901 in Wet AMD and announced plans to move forward to additional Phase 2 clinical trials in 2022.
Invitae Corp. reported Q3/21 financial results that highlighted an 89% YoY increase in billable volume to 296,000 tests. Ladenburg Thalmann & Co. Inc. stated in a research note that it has a "Buy" rating for the company with a $55.00/share price target.
Shares of Seres Therapeutics Inc. traded 20% higher after the company reported Q3/21 financial results and announced it is partnering with Bacthera in Switzerland to manufacture medicine for use in c.Diff treatment.