Related coverage linked through entity extraction aliases.
Jul 29, 2026
FDA granted rolling review for Palvella's QTORIN rapamycin NDA. Also covered: global expedited approval pathways, accelerated approval scrutiny, and multi-regional CDx strategies.
Jun 28, 2026
FDA granted early access to a pancreatic cancer drug; final ARROW data for pralsetinib in RET+ NSCLC were published. A Sarah Cannon Research Institute official outlined a tissue-agnostic vision and highlighted new oncology research.
Jun 16, 2026
Sensei Biotherapeutics has changed its name to Faeth Therapeutics following its February 2026 acquisition of the biotechnology company. The name change accompanies a $200 million private placement financing to advance PIKTOR, an investigational all-oral multi-node inhibitor targeting the PI3K/AKT/mTOR pathway in endometrial and breast cancer. Topline Phase 2 data in endometrial cancer is anticipated in the second half of 2026.
May 07, 2026
Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
May 05, 2026
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
Mar 17, 2026
Recent studies demonstrate high response rates for antibody-drug conjugate in rare blood cancer, improved outcomes with metastasis-directed radiation in prostate cancer, and a novel drug combination strategy for ovarian cancer resistance.
Mar 04, 2026
Can-Fite BioPharma's drug candidate namodenoson met its primary endpoint in a Phase 2a pancreatic cancer trial and demonstrated anti-obesity effects in a peer-reviewed preclinical study published in the International Journal of Obesity.
Nov 17, 2025
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
