FGFR2

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, February 26, 2024

WALTHAM, Mass. and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.

Key Points: 
  • and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.
  • SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
  • Cash and Cash Equivalents: As of December 31, 2023, Cogent had cash, cash equivalents and marketable securities of $273.2 million.
  • During the quarter Cogent also completed and paid for bulk manufacturing campaigns of bezuclastinib to continue supporting the company’s clinical trials.

Powered by Its Industry-Leading Comprehensive Multi-Modal Database, Caris Life Sciences to Showcase Research at ASCO Gastrointestinal Cancers Symposium 2024

Retrieved on: 
Wednesday, January 17, 2024

IRVING, Texas, Jan. 17, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, announced today that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 11 studies across six solid tumor types at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco. The findings demonstrate the power of Caris' comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment.  

Key Points: 
  • "We are proud to again present a wide array of precision oncology research at this year's ASCO GI.
  • Strikingly, patients with early-onset CCA experience better outcomes from immunotherapy even though immune-oncology-relevant markers like MSI and TMB favors average-onset CCA.
  • Two posters use EGFRi-treated CRC samples from the Caris multi-modal database to explore two promising possibilities: APC mutation status and CTX sensitivity score (CTX-S).
  • The POA includes 90 cancer centers, academic institutions, research consortia and healthcare systems, including 42 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research.

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

Retrieved on: 
Tuesday, January 16, 2024

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

Eisai Furthers Oncology Research in Gastrointestinal Cancer Treatment with New Data at ASCO GI 2024

Retrieved on: 
Tuesday, January 16, 2024

NUTLEY, N.J., Jan. 16, 2024 /PRNewswire/ -- Eisai announced today the presentation of gastrointestinal cancer research during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place in-person in San Francisco, California and virtually from January 18-20.

Key Points: 
  • "We look forward to convening in San Francisco to share longer-term efficacy and safety results from the Phase 3 LEAP-002 trial with the scientific community at ASCO GI 2024.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective TKI of FGFR1-3.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • These abstracts will be made available via the ASCO website on Tuesday, January 16, 2024, at 5:00 PM EST (2:00 PM PST).

Cogent Biosciences Announces Planned 2024 Milestones for Bezuclastinib and Emerging Portfolio of Selective and Potent Targeted Therapeutics

Retrieved on: 
Tuesday, January 9, 2024

ET

Key Points: 
  • ET
    WALTHAM, Mass.
  • and BOULDER, Colo., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today highlighted the company’s key 2024 milestones ahead of its presentation at J.P. Morgan’s 42nd annual healthcare conference.
  • “Given the foundation that was established in 2023, we are well positioned to move Cogent forward aggressively this year, including a cash runway expected to carry us into 2026,” said Andrew Robbins, President and CEO of Cogent Biosciences.
  • A live webcast will be accessible in the “Investors & Media” section of the company’s website, www.cogentbio.com , and will be archived for 30 days following the event.

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Retrieved on: 
Tuesday, December 19, 2023

TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.

Key Points: 
  • TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.
  • In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW).
  • This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) in Japan and China conducted by Eisai.
  • Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy.

Knight Therapeutics Reports Third Quarter 2023 Results

Retrieved on: 
Thursday, November 9, 2023

Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.

Key Points: 
  • Gross margin: For the quarter ended September 30, 2023, gross margin, as a percentage of revenues, was 49% compared to 42% in Q3-22.
  • Selling and marketing (“S&M”): For the quarter ended September 30, 2023, S&M expenses were $11,924, a decrease of $1,532 or 11%, compared to the same period in prior year.
  • General and administrative (“G&A”): For the quarter ended September 30, 2023, G&A expenses were $11,080, an increase of $664 or 6%, compared to the same period in prior year.
  • For the quarter ended September 30, 2023, interest income was $3,055, an increase of $593 or 24%, compared to the same period in prior year.

Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

WALTHAM, Mass. and BOULDER, Colo., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • and BOULDER, Colo., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2023.
  • Cogent will host an investor webcast to review the results on Monday, December 11, 2023 at 8:00 a.m.
  • G&A Expenses: General and administrative expenses were $9.5 million for the third quarter of 2023 as compared to $6.9 million for the third quarter of 2022.
  • G&A expenses include non-cash stock compensation expense of $4.8 million for the third quarter of 2023 compared to $2.6 million for the third quarter of 2022.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

Retrieved on: 
Wednesday, October 25, 2023

1527P)

Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

Cogent Biosciences Presents Preclinical Data Highlighting Precision Oncology Pipeline at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Retrieved on: 
Saturday, October 14, 2023

WALTHAM, Mass. and BOULDER, Colo., Oct. 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, announced updated preclinical data from the Company’s next-generation selective fibroblast growth factor receptor 2 (FGFR2) program being presented today in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston.

Key Points: 
  • and BOULDER, Colo., Oct. 14, 2023 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, announced updated preclinical data from the Company’s next-generation selective fibroblast growth factor receptor 2 (FGFR2) program being presented today in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston.
  • “We are excited to share these new data on our internally discovered and developed FGFR2 candidate, highlighting the strength and scientific expertise of the Cogent Research Team,” said Andrew Robbins, Cogent’s President and Chief Executive Officer.
  • Exploratory pharmacokinetics (PK) studies conducted across species showed CGT4859 to be a low-clearance compound with high oral bioavailability.
  • Cogent plans to file an IND, and pending clearance from the FDA, initiate clinical trials in 2024.