Pyramid Biosciences Inc. has in-licensed Genequantum Healthcare Co. Ltd.’s preclinical trophoblast cell surface antigen 2 (TROP2)-targeting antibody-drug conjugate (ADC), GQ-1010, in a deal worth up to $1 billion in potential milestones. Under the terms, Pyramid gains exclusive rights to develop and commercialize GQ-1010 globally, excluding greater China (mainland China, Hong Kong, Macau and Taiwan). In exchange, privately held Genequantum, of Suzhou, China, will receive an up-front payment of $20 million and up to an additional $1 billion in milestone payments. Genequantum will also be eligible to receive tiered-based sales royalties. Read More
Torl Biotherapeutics LLC has raised $158 million in a series B round as it seeks to nudge its anti-Claudin-6 antibody-drug conjugate candidates, TORL-123 and TORL-2307, beyond phase I trials for the treatment of ovarian and gastric cancers, respectively. Claudin-6, or CLDN6, is a molecule that forms tight junctions around cells. It is highly expressed in a range of solid tumor types, so is a popular target for drug development. Read More
During what has become one of the slowest IPO years in recent memory, cancer immunotherapy company Cytomed Therapeutics Ltd. debuted on Nasdaq, raising $9.65 million, while inflammatory disease firm Acelyrin Inc. filed to list its stock for a potential $100 million. Up to this point, there were only six biopharma IPOs completed this year – the fewest since 2013. Cytomed, which priced 2.4 million shares at $4 apiece, is now the seventh for 2023, and the fifth on Nasdaq. Two other IPOs have closed on Chinese markets. Read More
Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization. Read More
Manufacturing deficiencies stand in the way of two BLAs as complete response letters (CRLs) were issued to Eli Lilly and Co. and to Alvotech Holdings SA. The U.S. FDA issued the CRL to Lilly regarding the BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. There’s a similar problem with Alvotech’s biosimilar candidate for Abbvie Inc.’s Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik, Iceland, manufacturing facility before it could approve the application. Read More
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aldeyra, Amylyx, Atai, Anacardio, Bridge, Regenerx, Regulus, Tonix, Totus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allegro, Astrazeneca, Atma, Aviceda, Fusion, Merck & Co., Sab. Read More
