FDA Accepts Priority Review for Merck's SAC-TMT, Sets June 2027 PDUFA
MRK sits 72% above its 52-week low of $82.01.
Summary
The FDA accepted Merck's Biologics License Application for sacituzumab tirumotecan (SAC-TMT) under Priority Review and set a PDUFA target action date of June 15, 2027. The filing is supported by data showing SAC-TMT cut the risk of death by 32% and the risk of disease progression or death by 41% versus chemotherapy in certain patients with advanced or recurrent endometrial cancer. Safety was consistent with prior studies, with no new signals. Merck said it is hopeful for approval before the PDUFA date based on discussions with the FDA. The Priority Review designation shortens the standard review clock and puts another oncology launch candidate in the pipeline alongside Keytruda, though the June 2027 date means no near-term revenue impact.
At the time of this announcement, MRK was trading at $141.23 on NYSE in the Life Sciences sector, with a market capitalization of approximately $348.4B. The 52-week trading range was $82.01 to $156.92. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Reuters.