MEK

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Retrieved on: 
Monday, December 18, 2023

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Status: Authorised

ZOTAC's Black Friday Blitz: Power Up the Play with Exclusive Discounts on Amazon, Micro Center, Newegg, and The ZOTAC STORE

Retrieved on: 
Friday, November 17, 2023

IRWINDALE, Calif., Nov. 17, 2023 /PRNewswire-PRWeb/ -- ZOTAC USA Inc., a leading manufacturer of innovative gaming hardware solutions, announces an epic Black Friday event featuring exclusive discounts on a range of graphics cards and gaming PCs on Amazon, Micro Center, Newegg, and The ZOTAC STORE. The promotions commence on November 17 and run through November 27, 2023, on Amazon and Micro Center. Additionally, they will be available on Newegg and The ZOTAC Store until November 30, 2023.

Key Points: 
  • Additionally, they will be available on Newegg and The ZOTAC Store until November 30, 2023.
  • Top Amazon deals include a staggering 25% off on the ZOTAC GAMING GeForce RTX 3060 Ti GDDR6X Twin Edge graphics card.
  • The ZOTAC STORE features $100 off on high-performance graphics cards, including the highly anticipated ZOTAC GAMING GeForce RTX 4080 AMP Extreme AIRO and the powerful ZOTAC GAMING GeForce RTX 4070 Ti AMP Extreme AIRO to elevate gaming experience.
  • ZOTAC offers three (3) years of standard warranty coverage on ZOTAC GAMING GeForce RTX 40 series graphic cards, with no registration required.

Day One Reports Third Quarter 2023 Financial Results and Corporate Progress

Retrieved on: 
Monday, November 6, 2023

BRISBANE, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced its third quarter 2023 financial results and highlighted recent corporate achievements.

Key Points: 
  • In October 2023, Day One announced that the FDA accepted its NDA for Priority Review.
  • Day One presented two case reports at the 2023 Connective Tissue Oncology Society Annual Meeting in November 2023, documenting fusion-driven sarcoma case reports from the FIREFLY-1 and FIRELIGHT-1 studies.
  • R&D Expenses: Research and development expenses were $33.2 million for the third quarter of 2023 compared to $22.0 million for the third quarter of 2022.
  • G&A Expenses: General and administrative expenses were $18.3 million for the third quarter of 2023 compared to $17.7 million for the third quarter of 2022.

SpringWorks Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, November 2, 2023

STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.

Key Points: 
  • – PDUFA target action date for nirogacestat NDA in adults with desmoid tumors remains set for November 27, 2023 –
    STAMFORD, Conn., Nov. 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today reported third quarter financial results for the period ended September 30, 2023 and provided an update on recent business highlights.
  • SpringWorks expects to file a Marketing Authorisation Application for nirogacestat with the European Medicines Agency (EMA) in the first half of 2024.
  • SpringWorks plans to file an IND for SW-682, the Company's TEAD inhibitor development candidate, in the fourth quarter of 2023.
  • Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $79.4 million, or $1.27 per share, for the third quarter of 2023.

Ribometrix Announces Lead Program Target and Presentation of Preclinical Data at the International Congress of the Society for Melanoma Research

Retrieved on: 
Monday, November 6, 2023

eIF4E is a potent oncogene that promotes cell growth by regulating the synthesis of oncoproteins known to drive abnormal cell proliferation and tumorigenesis.

Key Points: 
  • eIF4E is a potent oncogene that promotes cell growth by regulating the synthesis of oncoproteins known to drive abnormal cell proliferation and tumorigenesis.
  • Common cancer drivers, such as mutant versions of BRAF/MEK and PI3K/AKT, are reliant on activation of eIF4E for the production of oncoproteins that lead to uncontrolled cell proliferation.
  • Ribometrix is evaluating its portfolio of eIF4E inhibitors in preclinical studies and plans to select a development candidate in 2024.
  • Additional preclinical data in other indications will be presented at upcoming medical conferences, including the San Antonio Breast Cancer Symposium in December 2023.

Immuneering Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference

Retrieved on: 
Thursday, October 12, 2023

Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.

Key Points: 
  • Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.
  • Pharmacogenomic data were used to generate a model predictive of response to IMM-1-104 and identify biomarker-aligned patient subpopulations.
  • IMM-1-104 was tested in combination with gemcitabine or paclitaxel in humanized 3D models of pancreatic cancer, demonstrating enhanced activity and combination therapy potential.
  • As monotherapy, IMM-6-415 demonstrated anti-tumor activity in over 50% (34 of 66) of the 3D-TGA models tested, including 30 BRAF mutant preclinical models in which 19 (63%) showed activity.

ZOTAC GAMING Unleashes Invincible Savings During Amazon Prime Big Deal Days

Retrieved on: 
Tuesday, October 10, 2023

IRWINDALE, Calif., Oct. 10, 2023 /PRNewswire-PRWeb/ -- ZOTAC USA Inc., a leading manufacturer of innovative gaming hardware solutions, unveils its exceptional lineup of deals and participation in the Amazon Prime Big Deal Days. Taking place from October 10th to 11th, this two-day shopping extravaganza is exclusively available to Amazon Prime members. ZOTAC GAMING is set to offer a selection of its most coveted Gaming PCs and ZOTAC GAMING GeForce RTX graphics cards.

Key Points: 
  • ZOTAC GAMING is set to offer a selection of its most coveted Gaming PCs and ZOTAC GAMING GeForce RTX graphics cards.
  • "ZOTAC GAMING has teamed up with Amazon for the 2023 Prime Big Deal Days with exclusive deals.
  • "ZOTAC GAMING has teamed up with Amazon for the 2023 Prime Big Deal Days with exclusive deals.
  • To learn more about the Amazon Prime Big Deal Days ZOTAC GAMING exclusive offers, please visit: https://amzn.to/3rAq2AN

Kinnate Biopharma Inc. Announces Pipeline Updates, Strategic Reprioritization and Workforce Restructuring

Retrieved on: 
Monday, September 18, 2023

(Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.

Key Points: 
  • (Nasdaq: KNTE) (“Kinnate” or “the Company”), a clinical-stage precision oncology company, today announced pipeline updates and a reprioritization plan, as well as a workforce restructuring, based on a strategic review of its business.
  • Additionally, Kinnate will pause development of KIN-7136 and explore strategic alternatives for exarafenib monotherapy and KIN-3248, as part of the reprioritization plan.
  • We believe that reprioritizing our programs is the most effective approach to unlock the full promise of our innovative therapies.”
    Farzan added, “The reprioritization plan unfortunately impacts our workforce.
  • Kinnate will implement a corporate restructuring by reducing the Company’s workforce by approximately 70%.

Pasithea Therapeutics Corp. Announces Final Results of Tender Offer

Retrieved on: 
Thursday, September 14, 2023

The tender offer expired at 5:00 p.m. on September 8, 2023 and was funded entirely through the Company’s cash on hand.

Key Points: 
  • The tender offer expired at 5:00 p.m. on September 8, 2023 and was funded entirely through the Company’s cash on hand.
  • Based on the final results, a total of 5,323,451 shares of common stock were validly tendered and not withdrawn.
  • Broadridge Corporate Issuer Solutions, LLC (“Broadridge”), the depositary for the tender offer, will promptly pay for all of the shares of common stock accepted for purchase in accordance with the terms and conditions of the tender offer.
  • For all questions relating to the tender offer, please contact: Secretary, Pasithea Therapeutics Corp., 1111 Lincoln Road, Suite 500, Miami Beach, Florida 33139, Email [email protected], Telephone (786) 977-3380 or Broadridge Corporate Issuer Solutions, LLC, Telephone (855) 793-5068, email [email protected].

Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in Patients with RAS Q61X Solid Tumors

Retrieved on: 
Tuesday, August 29, 2023

SAN DIEGO, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced dosing of the first patient in the SEACRAFT-1 Phase 1b trial evaluating pan-RAF inhibitor naporafenib in combination with MEK inhibitor trametinib (MEKINIST®) in patients with RAS Q61X solid tumors.

Key Points: 
  • “Naporafenib has been dosed in over 500 patients to date, establishing its safety, tolerability, and preliminary proof-of-concept (PoC) in multiple indications,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder.
  • “SEACRAFT-1 will explore the potential of naporafenib plus trametinib in patients with RAS Q61X solid tumors, which affects over 150,000 patients in the United States and Europe.
  • This tissue agnostic approach is based on the encouraging anti-tumor activity generated by Novartis in patients with NRAS Q61X melanoma or KRAS Q61X non-small cell lung cancer (NSCLC).
  • In addition, we are on track to initiate SEACRAFT-2, a pivotal Phase 3 trial to evaluate naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma, in the first half of 2024.”