I hold a position and something (technicals?) is moving the stock premarket. Please do your own DD. Trilaciclib is a cell division arrest compound, preserving bone marrow from toxicity during chemo, a first in class mechanism for oncology. Currently no AdCom is planned.
"The therapy’s NDA was accepted in August for Priority Review based on results from three randomized clinical studies in small cell lung cancer (SCLC), with the FDA indicating that it doesn’t plan on holding an advisory committee (AdComm) meeting.As trilaciclib is the first CDK4/6 inhibitor to be used to treat chemo-induced bone marrow toxicity, Messer argues that the lack of an AdComm is “meaningful.” Expounding on this, he stated, “We believe this reflects the agency's appreciation of the unmet need, comfort with the safety profile of the CDK4/6 class, and efficacy profile of trilaciclib.”GTHX will also focus on the inclusion of trilaciclib into NCCN guidelines. It should also be noted that a Phase 3 pivotal study evaluating the candidate in metastatic colorectal cancer (mCRC) is set to kick off by year end.Adding to the good news, GTHX and its partner, Boehringer Ingelheim, are preparing for the commercial launch of trilaciclib, with the companies covering approximately 2,500 treating oncologists and providing educational materials regarding the use of trilaciclib ahead of treatment and the benefits of multi-lineage preservation.If that wasn’t enough, the rintodestrant (its selective estrogen receptor degrader (SERD) in development for the treatment of estrogen receptor-positive (ER+) breast cancer) plus palbociclib combination study was able to wrap up enrollment earlier than expected, reflecting “the appeal of an all-oral treatment regimen during a global pandemic,” in Messer’s opinion. With a data readout slated for Q2 2021, the analyst believes a “positive readout could prove to be a significant value driver.”In line with his optimistic approach,"