KIT

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.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

Celldex Therapeutics Presents Positive 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

Retrieved on: 
Saturday, February 24, 2024

HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease. The studies will continue dosing patients until week 52. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who are not adequately controlled by omalizumab. The data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, in a late breaking oral presentation (L18) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024.

Key Points: 
  • HAMPTON, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease.
  • Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.
  • CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes.
  • Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.

Cogent Biosciences Announces Positive Part 1b Data from SUMMIT Trial Evaluating Bezuclastinib in Patients with Nonadvanced Systemic Mastocytosis

Retrieved on: 
Thursday, February 22, 2024

WALTHAM, Mass. and BOULDER, Colo., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported positive Part 1b data from the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting taking place February 23-26, 2024 in Washington, D.C.

Key Points: 
  • “The magnitude and speed of symptomatic reductions, along with corresponding improvements in quality-of-life, reported by patients in SUMMIT Part 1b has not been seen previously with other treatment options in this patient population.
  • Thirty-four patients in Part 1b were treated with either bezuclastinib or placebo plus best supportive care.
  • Patients were enrolled with the following sub-types: 33 patients with indolent systemic mastocytosis (ISM) and one patient with smoldering systemic mastocytosis (SSM).
  • Thirty-four patients enrolled in SUMMIT Part 1b were evaluated for signs of clinical activity over 12 weeks, including well-accepted biomarkers of disease burden.

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides a Pipeline Update

Retrieved on: 
Wednesday, February 21, 2024

Enrollment was discontinued for the Phase 3 study ARC-10 evaluating domvanalimab plus zimberelimab compared to pembrolizumab in first-line PD-L1-high NSCLC.

Key Points: 
  • Enrollment was discontinued for the Phase 3 study ARC-10 evaluating domvanalimab plus zimberelimab compared to pembrolizumab in first-line PD-L1-high NSCLC.
  • The companies also plan to initiate a Phase 2 trial to evaluate domvanalimab plus zimberelimab in a new disease setting.
  • Arcus will host a conference call and webcast today, February 21, at 2:00 PM PT / 5:00 PM ET to discuss its fourth-quarter and full-year 2023 financial results and pipeline updates.
  • To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com .

Cogent Biosciences Announces Oversubscribed $225 Million Private Placement

Retrieved on: 
Wednesday, February 14, 2024

WALTHAM, Mass. and BOULDER, Colo., Feb. 14, 2024 (GLOBE NEWSWIRE) --  Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has entered into a securities purchase agreement for a private investment in public equity financing that is expected to result in gross proceeds of approximately $225 million to the Company, before deducting placement agent fees and offering expenses.

Key Points: 
  • ET on February 23 to review the SUMMIT Part 1b data with bezuclastinib at AAAAI annual meeting
    WALTHAM, Mass.
  • J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler & Co. acted as placement agents.
  • Cogent anticipates the gross proceeds from the private placement to be approximately $225 million, before deducting any offering-related expenses.
  • The private placement is expected to close on or about February 16, 2024, subject to customary closing conditions.

Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2023 with Webcast and Conference Call Today at 4:30 p.m. ET

Retrieved on: 
Wednesday, February 7, 2024

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs in virology and immunology, today reported financial results for its fiscal first quarter ended December 31, 2023.

Key Points: 
  • Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs in virology and immunology, today reported financial results for its fiscal first quarter ended December 31, 2023.
  • “In 2024, Enanta began a year which will be marked by execution and value creation across the company.
  • For the three months ended December 31, 2022, total revenue was $23.6 million and was primarily related to royalties on AbbVie’s sales of MAVYRET®/MAVIRET®.
  • Interest expense from the royalty sale was $3.4 million for the three months ended December 31, 2023.

Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.
  • Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • Cost of Sales: Cost of sales were $1.8 million in the fourth quarter of 2023, which includes $0.9 million in cost of product sales, compared to cost of product sales of $0.7 million for the fourth quarter of 2022.

Deciphera Pharmaceuticals Presents Long-Term Follow-Up Results from INTRIGUE Phase 3 Clinical Study in Second-Line GIST Patients at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024

There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).

Key Points: 
  • There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib (55.2%).
  • Dose interruptions and reductions as well as treatment discontinuations due to TEAEs were lower with QINLOCK versus sunitinib.
  • Patients with mutations in KIT exon 11 and 17/18 had improved progression-free survival, objective response rate, and overall survival with QINLOCK versus sunitinib.
  • Based on the results of this prespecified exploratory objective in INTRIGUE, the Company is enrolling the INSIGHT pivotal Phase 3 clinical study of QINLOCK in second-line GIST patients with mutations in KIT exon 11 and 17/18 only.

FULL SWING TO DEBUT NEW TECHNOLOGY AT 2024 PGA SHOW

Retrieved on: 
Monday, January 22, 2024

CARLSBAD, Calif. and ORLANDO, Fla., Jan. 22, 2024 /PRNewswire/ -- Full Swing, the industry leader in sports technology, will be bringing their latest products and newest feature previews to the largest business gathering in golf. From Demo Day to the trade show floor, Full Swing will be giving the golf world a chance to experience Full Swing's product offering across launch monitors and simulators.

Key Points: 
  • CARLSBAD, Calif. and ORLANDO, Fla., Jan. 22, 2024 /PRNewswire/ -- Full Swing , the industry leader in sports technology, will be bringing their latest products and newest feature previews to the largest business gathering in golf.
  • From Demo Day to the trade show floor, Full Swing will be giving the golf world a chance to experience Full Swing's product offering across launch monitors and simulators.
  • Full Swing to debut new technology at 2024 PGA Show  for industry leaders to see continued innovation for all golfers.
  • Additionally Full Swing will be giving the industry a chance to experience their latest Full Swing KIT Studios that allow golfers around the world an option for a DIY Simulator to complement their outdoor use for Full Swing KIT.