Summary
- GTHX stock is depressed but I don't see any reason.
- PDUFA of Feb. 15, 2021, is a major catalyst.
- Label expansion, rest of pipeline, cash runway, collaborations - everything looks good.
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We were discussing G1 Therapeutics (GTHX) in our TPT member chat yesterday. It has been a depressed stock for over a year now, and even today, despite having a PDUFA date in less than 3 months, the stock shows little sign of improvement. Lead drug candidate trilaciclib is a myelopreservation agent supporting chemo regimens that have shown enough data in phase 2 trials that the FDA has allowed GTHX to proceed to an NDA directly from there without requiring a phase 3 trial. Rintodestrant, their second asset, is in early stages of developing but targeting a larger opportunity in breast cancer and is going to announce a major update on December 9; and yet, the stock shows no sign of improvement.
Current status of pipeline
Their current pipeline looks like this:
Quick update on trilaciclib
I covered trilaciclib a year ago. There is not a lot to be added to that except that their NDA was accepted by the FDA on August 17 with a PDUFA date for February 15, 2021. The NDA was accepted under an accelerated review program, which is why PDUFA is occurring in 6 months instead of the regular 10. The Priority Review is based on positive data from three randomized clinical trials showing robust myelopreservation benefits for the drug.
“There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.”
Trilaciclib also has a Breakthrough Therapy Designation - meaning preliminary clinical evidence for trilaciclib shows a clear advantage over available therapy. In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for the drug.
