Abeona Therapeutics Inc. is on the road to filing a BLA with the U.S. FDA after posting positive top-line phase III data in wound healing and also to the bank with a new $35 million private placement financing. The data for EB-101, an autologous cell therapy, came from a pivotal study of treating recessive dystrophic epidermolysis bullosa, an ultra-rare connective tissue disorder. Results showed the study met its two co-primary endpoints in wound healing and for reducing pains in large, chronic wounds caused by the disorder.
Amplifica Holdings Group Inc. has closed a US$11.8 million series A preferred stock financing, the funds from which will be used to advance the development of its proprietary compounds for the treatment of androgenic alopecia in males and females.
Immunic Inc. plans to forge ahead with oral psoriasis therapy IMU-935 despite stock-punishing results from a phase Ib trial that showed a higher placebo response than expected. Shares of the New York-based firm (NASDAQ:IMUX) closed at $2.08, down $7.12, or 77.4% after findings were made public from a preplanned interim group-level data analysis of the ongoing experiment, which is testing patients with moderate to severe disease. The group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms failed to separate from placebo at four weeks, Immunic said. Although the active arms performed as intended, placebo decreases in PASI proved greater than hoped.
Eli Lilly and Co. has synthesized new glucocorticoid receptor (GR) agonists reported to be useful for the treatment of atopic dermatitis and rheumatoid arthritis.
Keythera (Suzhou) Pharmaceuticals Co. Ltd. has divulged new tyrosine-protein kinase JAK3 inhibitors reported to be useful for the treatment of alopecia areata, rheumatoid arthritis, lupus erythematosus, inflammation, allergy, cancer, metabolic diseases and transplant rejection, among other disorders.
Positive phase I data from Dice Therapeutics Inc. with DC-806 in psoriasis sent shares (NASDAQ:DICE) on a wild ride, closing at $40, up $15.35, or 62%, on Oct. 11, 2022, and bolstered the case for oral drugs in psoriasis – an increasingly busy indication where discouraged patients often find themselves switching between therapies.
Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing.
Connect Biopharma Holding Ltd.’s IL-4Rα binding candidate, CBP-201, yielded positive data in a pivotal trial in patients with moderate to severe atopic dermatitis in China, positioning the company to engage with Chinese regulators in the next several months to discuss a potential NDA filing.
Dice Molecules SV LLC has divulged new integrin αv/β1 and/or integrin αv/β6 antagonists reported to be useful for the treatment of fibrosis, rheumatoid arthritis, diabetic nephropathy, nonalcoholic steatohepatitis, focal segmental glomerulosclerosis, primary biliary cholangitis and cancer.