One of our advisers just sent:
For the next 10 days, our attention will be focused on the American biopharmaceutical company G1 Therapeutics, which is developing low-molecular-weight therapeutics for the treatment of cancer patients.
Their portfolio includes treecycle and intumescent. In 2020, G1 transferred the exclusive rights to its third drug, lerocyclib, to EQRx and Genor Biopharma to market the drug in the US, EU, and Asia-Pacific. As a result, G1 should receive over $300 million and royalties from future sales of the drug.
On Friday, GTHX shares were trading at around $28. In the near future, we can expect a significant increase in the share price, given the high probability of approval by the FDA of the main drug G1 for patients receiving chemotherapy — trilaciclib (trilaciclib).
It is a small molecule inhibitor of cyclin-dependent kinases (CDK4/6) - enzymes involved in cell cycle control and oncogenesis. The first drug in its class to be awarded the status of "breakthrough therapy" by the FDA. Trilaciclib is a myeloprotector designed to improve the immune system of patients on the background of chemotherapy by reducing myelosuppression caused by chemotherapy drugs. Positive data on the effectiveness of the drug were obtained as a result of randomized trials in small cell lung cancer (SCLC) and in metastatic breast cancer with a triple-negative phenotype (mTNBC).
The FDA in August 2020 has already accepted an application for treatment with trilacyclib in patients with SCLC and assigned the drug Priority Review status, which means that the drug will be considered by the FDA in the next 6 months.
On February 15, 2021, in accordance with US laws, G1 is scheduled to pay a fee for new prescription drugs (the so-called PDUFA procedure) in order to conduct a review procedure and possible approval of tetracyclib. This means that there is a high chance of obtaining approval from the FDA for trilacyclib in the near future.
Prior to FDA approval, trilacyclib is already used for patients with SCLC in the United States who cannot participate in CI and for whom there are no suitable alternative therapies. CI with the use of trilaciclib is also performed in other types of tumors and chemotherapy regimens, in order to assess the effectiveness of the drug in maintaining the state of the immune system (reducing myelosuppression) and antitumor effectiveness in combination with chemotherapy.
Rintodestrant is the second G1 drug in the earlier stages of development. It is an oral SERD inhibitor that selectively degrades estrogen receptors, leading to effective blocking of the estrogen signaling pathway, which is important in the treatment of certain estrogen-dependent cancers, primarily for breast cancer with the ER+ phenotype (estrogen-receptor positive). However, rintodestrant already has a strong competitor — the FDA-approved drug fulvestrant.
And here is another argument in favor of G1 Therapeutics-collaboration with such giants as Pfizer. If approved tilatequila, we would not be surprised if G1 shares will be traded in the range of $90-130 per piece.