This summer’s IPO by Artiva Biotherapeutics Inc. highlighted early stage efforts with natural killer cells in autoimmune disease, where a handful of companies are advancing programs. The firm raised $167 million through an upsized financing, with funds aimed at the development of its lead AlloNK program for systemic lupus erythematosus and other indications in the same category.
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
South San Francisco-based Septerna Inc. filed an S-1 with the U.S. SEC to conduct an IPO on Nasdaq about two years and eight months after launching operations with a $100 million series A led by Third Rock Ventures. The company is focused on G protein-coupled receptor oral small molecules derived from its Native Complex Platform, aimed at treating diseases within the endocrinology, immunology and inflammation, and metabolic diseases realms.
South San Francisco-based Kezar Life Sciences Inc. voluntarily stopped its phase IIb Palizade trial of zetomipzomib in active lupus nephritis, following four fatal, or grade 5, serious adverse events of patients enrolled in the Philippines and Argentina.
Apimeds Pharmaceuticals US Inc., a subsidiary of Seoul, South Korea-based Inscobee Inc., is “counting down” to an official IPO on the New York Stock Exchange with its S-1 filing showing a targeted offering of $11.5 million.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
One of Australia’s newest biotech investment funds is set to triple investments on the back of its success and strong investor demand. The three-year old Merchant Biotech Fund (MBF) invested in several high growth ASX-listed and private life sciences companies and finished the past financial year up more than 70%. It is up 10% for the current financial year, Portfolio Manager Reece O'Connell told BioWorld.
Despite a phase IIa failure in 2018 for lupus, Biogen Inc. and UCB Inc. maintained their collaboration and now have new positive data for their anti-CD40L candidate. Top-line phase III data show dapirolizumab pegol, along with the standard of care (SOC), met the primary endpoint in demonstrating an improvement in moderate to severe systemic lupus erythematosus compared to placebo and SOC at 48 weeks.
The specter of elevated liver enzymes, a known problem with the drug class, became a topic of talk with regard to Sanofi SA’s tolebrutinib, the central nervous system-penetrating Bruton's tyrosine kinase (BTK) inhibitor for multiple sclerosis (MS). Meanwhile, another player in the space, Immunic Inc., has caught the eye of Wall Street lately.
Three biopharmas debuted on Nasdaq Sept. 13, raising a combined $703 million for two Massachusetts-based companies focused on bifunctional antibodies for autoimmune diseases and cancer, and one Midwestern firm developing peptide therapies for endocrine and metabolic disorders.
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