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GTHX Jumps On Regulatory Update On Trilaciclib In Small Cell Lung Cancer

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Shares of G1 Therapeutics Inc. (GTHX) rose more than 19% in extended trading on Monday, following positive regulatory update on Trilaciclib, an intravenous CDK4/6 inhibitor in development, to reduce *myelosuppression and enhance immune system function during chemotherapy.

* Myelosuppression, one of the side effects of chemotherapy, is defined as a decrease in the bone marrow activity resulting in fewer red blood cells, white blood cells, and platelets. (Source: National Cancer Institute).

Trilaciclib is being evaluated in four phase II clinical trials - three studies in patients with small-cell lung cancer (SCLC), and one study in patients with triple-negative breast cancer.

What's moving the stock?

The Company has received positive feedback from its end-of-phase II meeting with the FDA and discussions with European regulatory authorities related to Trilaciclib in small-cell lung cancer.

Based on the positive feedback, the Company plans to submit marketing applications in the U.S. and Europe for Trilaciclib for myelopreservation in small cell lung cancer.

G1 Therapeutics intends to request a pre-New Drug Application meeting with the FDA and anticipates it will be scheduled later this year. The company plans to seek European approval for Trilaciclib subsequent to an NDA filing.

GTHX has traded in a range of $13.87 to $69.57 in the last 1 year. The stock closed Monday's trading at $18.56, down 0.22%. In after-hours, the stock was up 19.88% to $22.25.

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