IDEAYA Biosciences(IDYA)

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IDEAYA Biosciences Appoints Stu Dorman as Chief Commercial Officer
Prnewswire· 2024-11-18 11:00
Brings over 20-year global commercialization experience in oncology with leading biopharmaceutical companies Gilead Sciences and Bristol Myers Squibb, including leadership of multiple commercial launches for products including Trodelvy® and Opdivo®SOUTH SAN FRANCISCO, Calif., Nov. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Stu Dorman as Chief Co ...
IDEAYA Biosciences Announces Participation in Jefferies London Healthcare Conference and Plans for Investor R&D Day
Prnewswire· 2024-11-12 11:00
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the Jefferies London Healthcare Conference and its plans to host an Investor R&D Day in December 2024.Jefferies London Healthcare ConferenceTuesday, November 19th, 2024 at 10:00 AM GMT | 5:00 AM ET Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Maury ...
Wall Street Analysts Predict an 81.88% Upside in IDEAYA Biosciences (IDYA): Here's What You Should Know
ZACKS· 2024-11-07 16:00
IDEAYA Biosciences, Inc. (IDYA) closed the last trading session at $30.41, gaining 3.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $55.31 indicates an 81.9% upside potential.The mean estimate comprises 13 short-term price targets with a standard deviation of $10.50. While the lowest estimate of $27 indicates a 11.2% decline from the current price level, the most optimistic ana ...
IDEAYA Biosciences, Inc. Reports Third Quarter 2024 Financial Results and Provides Business Update
Prnewswire· 2024-11-04 11:00
Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients Successful FDA Type C meeting and targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025; Phase 2 neoadjuvant update with ~49% with >30% ocular tumor shrinkage & ~61% eyes preserved, and over 75 patients enrolled ENA 2024: Late-breaker oral presentation of IDE397 in MTAP-deletion UC and NSCLC with confirmed ORR b ...
Earnings Preview: IDEAYA Biosciences, Inc. (IDYA) Q3 Earnings Expected to Decline
ZACKS· 2024-10-29 15:06
Wall Street expects a year-over-year decline in earnings on lower revenues when IDEAYA Biosciences, Inc. (IDYA) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they m ...
IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma
Prnewswire· 2024-09-23 10:00
Core Insights - IDEAYA Biosciences announced positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma (UM), showing approximately 49% of patients with over 30% tumor shrinkage and a 61% eye preservation rate for enucleation patients [1][2][3] Clinical Trial Data - In the Phase 2 trials, 31 enucleation and 18 plaque brachytherapy evaluable UM patients were treated, with 59% of patients showing over 20% ocular tumor shrinkage and 49% showing over 30% shrinkage [6] - The eye preservation rate observed was 61%, with manageable adverse event (AE) profiles including 11% grade 3 or higher AEs and a 3% discontinuation rate [6] FDA Engagement - A successful FDA Type C meeting has provided a potential registrational path for darovasertib, with primary endpoints of eye preservation and time to vision loss, and no detriment to Event-Free Survival (EFS) as a secondary endpoint [3][9] - Ongoing discussions with the FDA may include Overall Response Rate (ORR) as a potential surrogate endpoint to support earlier approval scenarios [9] Future Trial Plans - IDEAYA plans to initiate a Phase 3 randomized registrational trial in neoadjuvant UM, targeting approximately 400 patients, with two cohorts: enucleation eligible and plaque brachytherapy eligible UM patients [8][9] - The primary endpoint for enucleation patients will be eye preservation rate, while time to vision loss will be the primary endpoint for plaque brachytherapy patients [9] Market Opportunity - The annual incidence of primary UM in North America, Europe, and Australia is projected to be around 12,000 patients, representing a significant market opportunity for darovasertib, as there are currently no FDA-approved therapies for this condition [1][10] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics and integrating capabilities in identifying and validating translational biomarkers [14]
IDEAYA Announces Webcast to Report Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma on Monday, September 23, 2024
Prnewswire· 2024-09-22 13:00
SOUTH SAN FRANCISCO, Calif., Sept. 22, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovaserti ...
Ideaya Biosciences Advances Synthetic Lethality With IDE397 Success
Seeking Alpha· 2024-09-20 16:45
IDEAYA Biosciences, Inc. (NASDAQ: IDYA ) is a unique precision oncology company. IDYA leverages its synthetic lethality platform to exploit genetic vulnerabilities in cancer cells. The company mainly focuses on MTAP-deleted tumors and BRCA/HRD mutations. Its pipeline includes candidates such as Darovasertib, currently My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer sci ...
IDEAYA Biosciences, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update
Prnewswire· 2024-08-06 10:00
Darovasertib achieves triple-digit enrollment in Phase 2/3 trial in 1L HLA-A2*02:01(-) MUM; and >50 patients enrolled in Phase 2 neoadjuvant UM study ASCO 2024 oral presentation of darovasertib in neoadjuvant UM; FDA Type C meeting for neoadjuvant UM in Q3'24 and targeting Phase 2 neoadjuvant UM data update in H2'24 Demonstrated preliminary proof-of-concept for IDE397 in MTAP urothelial and lung cancer; 1 PR awaiting confirmation has confirmed and 1 additional PR still awaiting confirmation, from the 2 uPRs ...
IDEAYA Biosciences to Participate in Upcoming August 2024 Investor Relations Event
Prnewswire· 2024-07-29 10:00
SOUTH SAN FRANCISCO, Calif., July 29, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations event. Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Justin Zelin, Director, Biotechnology Research Analyst About IDEAYA Biosciences Forward-Looking Statements Investor and Media Contact IDEAYA Biosciences Andres Ruiz ...