The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
Artificial intelligence (AI) drug developer Insilico Medicine raised $110 million in a series E round led by an Asian private equity fund, Value Partners Group, that will see Insilico advance its pipeline and AI platform developments.
Investors wanted more from Incyte Corp.’s top-line results in hidradenitis suppurativa (HS) from its pivotal phase III Stop-HS trial program with oral small-molecule JAK1 inhibitor povorcitinib in adults with moderate to severe disease. Shares of the Wilmington, Del.-based firm (NASDAQ:INCY) closed March 17 at $62.01, down $5.85, after the company made public that Stop-HS1 and Stop-HS2 met the primary endpoint at both tested doses (45 mg and 75 mg)
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead.
The recent series A financing by Bambusa Therapeutics Inc. to fund bispecific antibodies for immunological and inflammatory disorders proved investor faith in the new approach with a proven mechanism.
Trimtech Therapeutics closed a £25 million (US$31 million) oversubscribed seed funding round to advance its targeted protein degradation treatments for neurodegenerative and inflammatory diseases.
Kyorin Pharmaceutical Co. Ltd. has out-licensed its preclinical candidate, KRP-M223, and its back-up compounds to Novartis Pharma AG in a deal worth up to $777.5 million. Under the terms, Novartis gains an exclusive worldwide license to develop, manufacture and commercialize Kyorin-discovered KRP-M223.
Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd.
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
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