Ann: PTX-100 receives U.S. FDA Fast Track Designation, page-68

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-combination-avutometinib-and-defactinib-kras-mutated-recurrent-low

OVERALL RESPONSE RATE: 44%
DURATION OF RESPONSE: 3.3 to 31.1 months
ADVERSE REACTIONS: >25%

Based on 57 adult patients in a multi-centre trial.


https://finance.yahoo.com/news/fda-grants-accelerated-approval-verastems-184709785.html

In April, Verastem Oncology announced a private placement of approximately $24 million of shares at $7.00 per share and, in lieu of common stock, $51 million of pre-funded warrants at $6.9999 per pre-funded warrant.

Verastem expects to receive gross proceeds from the offering of approximately $75 million.The company said it would use the proceeds to fund the potential launch of avutometinib and defactinib, as well as continued clinical research and development of product candidates, including VS-7375, working capital, and other general corporate purposes.

In April, the FDA cleared Verastem Oncology’s Investigational New Drug application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation.