Articles from G1 Therapeutics

- Transaction Will Maximize the Access and Uptake of COSELA® (trilaciclib), the First and Only Proactive Multilineage Myeloprotection Agent -

HOLBAEK, Denmark and RESEARCH TRIANGLE PARK, N.C., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Pharmacosmos A/S, a leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia, and G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company focused on delivering next-generation therapies that improve the lives of those affected by cancer, today announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the "HSR Act") relating to Pharmacosmos’ previously announced acquisition of G1 Therapeutics. The expiration of the waiting period occurred at 11:59 p.m. EST on September 4, 2024.

- Entered into Definitive Merger Agreement to be Acquired by Pharmacosmos; Transaction Expected to Close in Late Third Quarter 2024 -

RESEARCH TRIANGLE PARK, N.C., July 25, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, will host a webcast and conference call to provide a financial and corporate update for the second quarter of 2024 on Thursday August 8, 2024, at 8:30 a.m. ET.

- PRESERVE 2 Did Not Achieve Statistical Significance in the Primary Endpoint of Overall Survival (OS) in the Intent-to-Treat (ITT) Population -

- New Positive Phase 2 Results in Metastatic Triple Negative Breast Cancer (mTNBC) Indicate That Use of Trilaciclib in Combination with a TROP2 ADC May Be Associated with Improved Median OS Compared to Historical Data for the ADC Alone -

RESEARCH TRIANGLE PARK, N.C., May 23, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that mature Phase 2 results describing the positive impact of trilaciclib administered in combination with the TROP2 antibody-drug conjugate (ADC) sacituzumab govitecan (SG) on overall survival (OS) and tolerability compared to SG alone based on historical data from the ASCENT trial will be presented in a poster session during the upcoming 2024 American Society of Clinical Oncology (ASCO) Meeting. ASCO will be held May 31 to June 4, 2024, in Chicago, IL. A copy of the poster will be made available on the G1 Therapeutics website following the presentation here.

- Jupiter Bioventures will Gain Exclusive Rights for the Clinical Development, Regulatory Submissions, and Commercialization of Lerociclib for Radioprotection in the US, Europe, Japan, and All Other Global Markets Excluding Asia-Pacific -

- Achieved $14.1 Million in Net Revenue from Sales of COSELA® (trilaciclib) for First Quarter 2024 -

- Pepper Bio will Gain Exclusive Rights for the Clinical Development, Regulatory Submissions, and Commercialization of Lerociclib in the US, Europe, Japan, and All Other Global Markets Excluding Asia-Pacific -

- Achieved $46.3 Million in Net Revenue from Sales of COSELA® (trilaciclib) for Full Year 2023, Representing 48% Growth Over 2022; Provided 2024 Net COSELA Revenue Guidance of $60 to $70 Million -

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the independent Data Monitoring Committee (DMC) recommended continuation of the pivotal Phase 3 trial (PRESERVE 2), evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer (mTNBC), to the final analysis. This final analysis evaluating Overall Survival (OS) is estimated to occur in the third quarter of 2024 and will be conducted on the intent-to-treat (ITT) population. The DMC did not express any concerns regarding safety or recommend any other changes to the study. G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.

- Initial Data from the Ongoing Phase 2 Trial in Combination with the Antibody-Drug Conjugate (ADC) Sacituzumab Govitecan (SG) Suggest a Potentially Meaningful Improvement in Overall Survival (OS) for Patients Receiving Trilaciclib -

- Analyses of Data from the Randomized Phase 2 Metastatic Triple Negative Breast Cancer (mTNBC) Trial Indicate That Prior Use of Trilaciclib with Cytotoxic Chemotherapy is Highly Correlated to Improved Long-Term Survival with Subsequent Anticancer Therapies -

RESEARCH TRIANGLE PARK, N.C., Nov. 29, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that an abstract exploring the long-term impact of trilaciclib on survival outcomes in patients with metastatic triple negative breast cancer (mTNBC) from the Company’s Phase 2 trial (NCT02978716) will be presented in a poster session during the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th through 9th in San Antonio, TX. A copy of the poster will be made available on the G1 Therapeutics website following the presentation here.

- Recognized Total Revenue of $12.3 Million, Including $10.8 Million in Net COSELA® (trilaciclib) Revenue; Vial Volume Grew 3% Over Prior Quarter -

Multiple Analyses Also Describe Significant Burden of Chemotherapy-Induced Myelosuppression and Impact on Healthcare Resource Utilization in ES-SCLC

RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that COSELA® (trilaciclib) has been recommended as a myeloid supportive agent in the updated American Society of Clinical Oncology (ASCO) small cell lung cancer (SCLC) guidelines for patients with untreated or previously treated extensive-stage small cell lung cancer (ES-SCLC) who are undergoing treatment with chemotherapy or chemoimmunotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

RESEARCH TRIANGLE PARK, N.C., Oct. 16, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that multiple abstracts have been accepted for poster presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) Quality Care Symposium, held October 27th and 28th in Boston, MA. A copy of the posters will be made available on the G1 Therapeutics website following the presentations here.

- Recognized Total Revenue of $42.4 Million, Including $11.1 Million in Net COSELA® (trilaciclib) Revenue -

- Results Confirm that Trilaciclib Reduces Single and Multilineage Grade ≥3 Myelosuppressive Hematologic Adverse Events (HAEs) Including Neutropenia, Anemia, and Thrombocytopenia -

- Phase 2 Mechanism of Action Trial Results Demonstrate the Immunomodulatory Effects of Trilaciclib in the Tumor Microenvironment -

Real-World Data Show No Association Between Patient Characteristics and Risk of Myelosuppressive Events

- On-Target Effect of Trilaciclib Reduces Rates of Multiple Adverse Events Associated with Sacituzumab Govitecan-Hziy by Over 50% Including Neutropenia, Anemia, and Diarrhea -

- Drove 18% Quarterly Net Revenue Growth of COSELA® (trilaciclib) Over the Fourth Quarter of 2022; Grew Quarterly Vial Volume by 21% Over Prior Quarter -

- Achieved $31.3 Million in Net Revenue from Sales of COSELA® (trilaciclib) for Full Year 2022, Representing 182% Growth Over 2021; Provided 2023 Net COSELA Revenue Guidance of $50 to $60 Million -

- PRESERVE 1 Achieved its Co-Primary Endpoints Showing Statistically Significant Reductions in Occurrence of Severe Neutropenia During Induction and Duration of Severe Neutropenia in Cycles 1 Through 4 -

- Initial Results from Pivotal Phase 3 PRESERVE 1 Trial in Colorectal Cancer Expected in February 2023; Positive Results Would Initiate Regulatory Interactions for Label Expansion -

RESEARCH TRIANGLE PARK, N.C., Dec. 07, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided initial results from a 24 patient Phase 2 mechanism of action (MOA) trial showing favorable alterations in the tumor microenvironment from a single dose of trilaciclib monotherapy as measured by increases in the proportions of CD8+ T cells compared to T regulatory cells (Tregs) in patients with early-stage triple negative breast cancer (TNBC). These initial study results are being presented in a poster session at the annual San Antonio Breast Cancer Symposium (SABCS), December 6 - 10, 2022.

RESEARCH TRIANGLE PARK, N.C., Nov. 22, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the closing of an underwritten public offering of 7,700,000 shares of its common stock at a public offering price of $6.50 per share. G1 Therapeutics received $50,050,000 in gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses. In addition, G1 Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,155,000 shares of common stock at the public offering price, less the underwriting discount. Cowen and Raymond James acted as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow acted as lead managers for the offering.

RESEARCH TRIANGLE PARK, N.C., Nov. 17, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the pricing of an underwritten public offering of 7,700,000 shares of its common stock at a public offering price of $6.50 per share, for total gross proceeds of $50,050,000. All of the shares in the offering will be sold by G1 Therapeutics. In addition, G1 Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,155,000 shares of common stock at the public offering price, less the underwriting discount. The offering is expected to close on November 22, 2022, subject to customary closing conditions.

RESEARCH TRIANGLE PARK, N.C., Nov. 17, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that it has commenced an underwritten public offering of its common stock. All of the shares in the offering will be sold by G1 Therapeutics. In addition, G1 Therapeutics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock at the public offering price less the underwriting discount.

- Achieved $23.6 million in Total Revenue in the Third Quarter of 2022 Including $8.3 million in Net Revenue from Sales of COSELA® (trilaciclib) -

- Data Suggest On-Target Effect of Trilaciclib May Reduce Rates of Myelosuppression, Diarrhea, and Potentially Alopecia Associated with Sacituzumab Govitecan-Hziy -

RESEARCH TRIANGLE PARK, N.C., Oct. 10, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the last patient has been randomized in PRESERVE 2, G1’s Phase 3 clinical trial of trilaciclib in patients with metastatic triple negative breast cancer (TNBC) receiving chemotherapy. The trial includes 187 patients receiving first line trilaciclib or placebo prior to gemcitabine and carboplatin (GC).