Aridis Pharmaceuticals Inc. has taken a few knocks in the past year but its new agreement with the U.S. FDA is giving it an opportunity to move forward. The company’s stock (NASDAQ:ARDS) rose 115% on May 31 to close at 39 cents per share as the company and agency agreed on the design of a single confirmatory phase III superiority study of AR-301 (tosatoxumab), an adjunctive therapy for treating pneumonia caused by gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients. Read More
Medicinal cannabis company Zelira Therapeutics Ltd.’s stock shot up 224% on May 31 on the heels of news that its cannabinoid product, ZLT-L-007, outperformed Lyrica (pregabalin, Pfizer Inc) in a head-to-head trial in diabetic nerve pain. Read More
Coave Therapeutics aims to move its lead gene therapy program, CTx-PDE6b, for a form of retinitis pigmentosa (RP) into a pivotal trial in 2025 on the back of a phase I/II study, which uncovered a preliminary efficacy signal in one patient subgroup. Read More
Immunotherapy-focused biotech company LTZ Therapeutics Inc. raised more than $10 million in a pre-A+ financing that will be used to continue establishing the company’s platform and pipeline that is initially focused on solid and liquid tumors. Read More
Snipr Biome ApS has published initial clinical data showing its Crispr-Cas modified bacteriophage product selectively kills Escherichia coli – including strains that are resistant to antibiotics – with no effect on the rest of the gut microbiome. That paves the way to test Snipr-001 in the prevention of bloodstream infections in hematological cancer patients who, as a result of increased intestinal permeability caused by chemotherapy, are at high risk of gut bacteria getting into the bloodstream. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affamed, Boehringer Ingelheim, J Inst Bio, Jiangsu Nhwa,MEI, Nestlé, Pfizer, Seres, Trethera, Trevena, Yuhan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Amylyx, Beigene, Bristol Myers Squibb, Inhibrx, Iovance, Janssen, Lexicon, Metriopharm, SK, Valneva. Read More
