Synox Therapeutics Ltd. is preparing to file for FDA approval of emactuzumab in treating tenosynovial giant cell tumor (TGCT), after announcing positive top-line phase III results.
Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).
Merck KGaA is exercising its option for a global license to commercialize Abbisko Therapeutics Co. Ltd.’s pimicotinib for $85 million. As previously reported by BioWorld, Abbisko out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck in a deal worth up to $605.5 million in December 2023.
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
Synox Therapeutics Ltd. extended its series B by a further $17 million as it announced the first patients have been dosed in a phase III study of emactuzumab in the treatment of tenosynovial giant cell tumor, a rare condition in which benign tumors grow in the soft tissue lining of joints and tendons.
Synox Therapeutics Ltd. has raised $75 million in a series B round to fund phase III development of emactuzumab, an antibody in-licensed from Roche Holdings AG. The product, a colony stimulating factor 1 receptor inhibitor, was tested by Roche in a number of indications. Synox is taking it into a phase III registrational trial in tenosynovial giant cell tumor on the basis of phase II data showing an overall objective response rate of 71%.
Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
