Latest news with #Romvimza
Yahoo
29-05-2025
- Business
- Yahoo
Merck KGaA (MKGAF) Files for Global Approval of Pimicotinib After Positive Phase III TGCT Results
Merck KGaA (OTC:MKGAF) is seeking worldwide regulatory approval for its CSF-1R inhibitor pimicotinib following robust Phase III results in tenosynovial giant cell tumour (TGCT). The MANEUVER trial, conducted with Abbisko Therapeutics, showed a 61.9% overall response rate (ORR) by tumour volume score (TVS) after 25 weeks, far surpassing placebo (3.2%). This efficacy outperformed Daiichi Sankyo's Turalio (56% ORR) and was just behind Ono Pharmaceutical's Romvimza (67% ORR), which received FDA approval in February 2025. Quality of life improvements were notable, with significant gains in range of movement, stiffness, and pain reduction. Importantly, pimicotinib demonstrated a favorable safety profile: while all patients experienced some adverse events, only 4.8% were serious, and there were no signs of liver toxicity, a key differentiator from other therapies. TGCT, a rare non-cancerous joint tumour, often recurs after surgery, making effective drug options crucial. Merck KGaA (OTC:MKGAF), having secured global rights from Abbisko in March 2025, has filed for approval in China and plans an FDA submission by year-end. Full results will be presented at ASCO 2025 in Chicago. While we acknowledge the potential of MKGAF to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MKGAF and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-05-2025
- Business
- Yahoo
Merck & Co., Inc. (MRK) Files for Global Approval of Pimicotinib After Positive Phase III TGCT Results
Merck & Co., Inc. (NYSE:MRK) is seeking worldwide regulatory approval for its CSF-1R inhibitor pimicotinib following robust Phase III results in tenosynovial giant cell tumour (TGCT). The MANEUVER trial, conducted with Abbisko Therapeutics, showed a 61.9% overall response rate (ORR) by tumour volume score (TVS) after 25 weeks, far surpassing placebo (3.2%). This efficacy outperformed Daiichi Sankyo's Turalio (56% ORR) and was just behind Ono Pharmaceutical's Romvimza (67% ORR), which received FDA approval in February 2025. Pixabay/Public Domain Quality of life improvements were notable, with significant gains in range of movement, stiffness, and pain reduction. Importantly, pimicotinib demonstrated a favorable safety profile: while all patients experienced some adverse events, only 4.8% were serious, and there were no signs of liver toxicity, a key differentiator from other therapies. TGCT, a rare non-cancerous joint tumour, often recurs after surgery, making effective drug options crucial. Merck & Co., Inc. (NYSE:MRK), having secured global rights from Abbisko in March 2025, has filed for approval in China and plans an FDA submission by year-end. Full results will be presented at ASCO 2025 in Chicago. While we acknowledge the potential of MRK to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRK and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
