IDEAYA Biosciences, Inc. - IDYA STOCK NEWS

IDEAYA Biosciences has initiated a Phase 2 clinical trial to evaluate darovasertib as a neoadjuvant treatment for uveal melanoma (UM) before primary therapies like enucleation or radiation. The study focuses on eye preservation, reduced radiation, and functional vision. With an annual incidence of about 8,700 cases in the US and EU, UM presents a significant unmet medical need. The trial protocol allows for darovasertib treatment for up to six months, followed by primary treatment and adjuvant therapy. Clinical data updates, particularly on darovasertib combined with crizotinib for metastatic UM, are anticipated in 2023.

IDEAYA Biosciences announced FDA clearance for its IND application, enabling the Phase 1 clinical trial of IDE161, a novel PARG inhibitor for tumors with homologous recombination deficiencies (HRD), particularly in breast and ovarian cancer patients with BRCA mutations. Dosing is set to commence in Q1 2023, starting at half the estimated efficacious dose from preclinical studies. The trial focuses on ER+/Her2- breast cancer, constituting 10-14% of cases. IDEAYA will present IDE161's profile at the J.P. Morgan Healthcare Conference on January 10, 2023.

IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023. The event will feature a presentation by CEO Yujiro S. Hata at 4:30 pm PT (7:30 pm ET), followed by a Q&A session hosted by Anupam Rama. Investors can access a live audio webcast on IDEAYA's website, with a replay available for 30 days post-event. IDEAYA is focused on precision medicine and developing targeted therapeutics using molecular diagnostics, emphasizing synthetic lethality in oncology.

IDEAYA Biosciences (Nasdaq: IDYA) has appointed Dr. Karlene Cimprich and Dr. Kornelia Polyak to its Scientific Advisory Board. Dr. Cimprich, from Stanford University, specializes in replication stress mechanisms and DNA damage repair pathways relevant to cancer therapeutics. Dr. Polyak, from Dana-Farber Cancer Institute, focuses on breast cancer biology and clinical management. This expansion aims to enhance IDEAYA's expertise in synthetic lethality and advance its precision medicine oncology pipeline, particularly the clinical evaluation of IDE161, a potential first-in-class PARG inhibitor.

IDEAYA Biosciences has submitted an Investigational New Drug (IND) application to the FDA for IDE161, a potential first-in-class PARG inhibitor targeting homologous recombination deficiency in BRCA1/2-mutant breast and ovarian cancers. This submission marks a significant milestone in IDEAYA's approach to addressing the unmet medical need for patients resistant to current PARP inhibitors. The proposed clinical development plan will be discussed in an Investor R&D Day webcast on December 12, 2022.

IDEAYA Biosciences (NASDAQ: IDYA) has received Fast Track designation from the U.S. FDA for its combination therapy of darovasertib and crizotinib aimed at treating metastatic uveal melanoma (MUM). This designation facilitates an expedited regulatory process, enhancing the potential for accelerated approval. The company plans to initiate a Phase 2/3 trial in Q1 2023, pending FDA guidance. Darovasertib is also recognized as an Orphan Drug, offering IDEAYA various incentives such as tax credits and marketing exclusivity. An Investor R&D Day is scheduled for December 12, 2022.

IDEAYA Biosciences (NASDAQ: IDYA) has announced its Investor R&D Day to take place on December 12, 2022, from 8:00 am to 9:30 am ET. The event will feature key opinion leaders discussing various topics in synthetic lethality, including the Darovasertib clinical evaluation and advances in the treatment of MTAP deleted tumors. Registration is available online. The agenda aims to showcase IDEAYA’s pipeline programs and their relevance in oncology, particularly focusing on synthetic lethality therapies.

IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced the appointment of Darrin M. Beaupre, M.D., Ph.D., as Chief Medical Officer effective November 21, 2022. Beaupre brings over 25 years of experience in clinical development, previously at Pfizer and BioSplice Therapeutics. His role will focus on expanding IDEAYA's clinical pipeline, aiming to include five clinical trials across four programs in 2023. IDEAYA specializes in synthetic lethality, targeting precision medicine oncology, with plans to leverage Beaupre's expertise to enhance its drug development efforts.

IDEAYA Biosciences (IDYA) reported a robust financial position with $393.9 million in cash and securities as of September 30, 2022, projected to support operations until 2026. The company disclosed positive Phase 2 interim clinical outcomes for darovasertib and crizotinib in metastatic uveal melanoma, targeting a potential registrational trial in Q1 2023. IDEAYA is advancing multiple clinical programs, including IDE397 and IDE161, and plans to initiate several trials in 2023. Collaboration revenue surged to $29.7 million, reflecting substantial milestones achieved in partnerships.