Apogee Therapeutics Inc. emerged from stealth with $169 million in financing and a pipeline of four preclinical antibody development programs that take aim at major immunological and inflammatory disorders.
Researchers from Bridgebio Pharma Inc. presented preclinical characterization of the novel next-generation KRAS G12C GTP/GDP dual inhibitor candidate, BBO-8520, being developed for the treatment of cancer.
Wall Street apparently wants to see longer-term data from Bridgebio Pharma Inc. with oral infigratinib in children with achondroplasia (ACH) before deciding about the drug’s chances against the approved therapy Voxzogo (vosoritide) from Biomarin Pharmaceutical Inc.
Bridgebio Pharma Inc. is going back to the Bristol Myers Squibb Co. (BMS) well to restore its stalled momentum as the two companies have supercharged their July 2021 collaboration to develop an SHP2 inhibitor. Bridgebio could receive up to $905 million, including an up-front payment of $90 million plus $815 million in milestone and royalty payments, expected to be in the low- to midteens, in its new BMS collaboration to develop and commercialize BBP-398 in oncology.
Discussions with regulators on a proposed phase III trial design are up next for Bridgebio Pharma Inc., which reported positive phase II data for BBP-418 (ribitol) in patients with limb-girdle muscular dystrophy type 2 (LGMD2i), the first of several clinical readouts expected in 2022, as the Palo Alto, Calif-based company looks to regain its footing after disappointing top-line data for its phase III program in transthyretin amyloid cardiomyopathy leveled the stock late last year.
Top-line results from Bridgebio Pharma Inc.’s ongoing phase III study of acoramidis are no holiday gift for the company. The clinical trial for treating symptomatic transthyretin amyloid cardiomyopathy missed its primary endpoint. The Palo Alto, Calif.-based company’s stock (NASDAQ:BBIO) plunged on the news as shares closed 72% lower Dec. 27 at $11.38 each.
Though Revolution Medicines Inc.’s SHP2 inhibitor, RMC-4630, fell short of internally set benchmarks in a pair of phase I combo trials, the prospect remains alive, as the company has been “very publicly moving towards combining the companion inhibitors that we have, which include RMC-4630 with RAS inhibitor therapies that we and others make,” said Steve Kelsey, president of R&D.
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Molybdenum cofactor deficiency (MoCD) type A, an ultra-rare metabolic disorder causing intractable seizures, brain injury and death, now has a world-first treatment in Nulibry (fosdenopterin), a new I.V. therapy developed by Bridgebio Pharma Inc. subsidiary Origin Biosciences Inc. The agency's priority review, supported by its orphan, breakthrough and rare pediatric disease programs, also yielded a priority review voucher (PRV) for Origin.
Newly founded Lianbio, with offices in Shanghai and San Francisco, aims to quickly establish a presence in China and Asia with late-stage assets in-licensed from Bridgebio Pharma Inc. and Myokardia Inc. in two deals amounting to $531.5 million and $187.5 million, respectively.
