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 ...

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]

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, 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 ...

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 ...

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 ...

The public offering was made by IDEAYA pursuant to an automatically effective shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. ...

SOUTH SAN FRANCISCO, Calif., July 9, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA) today announced the pricing of an underwritten public offering of common stock and pre-funded warrants. IDEAYA is selling 7,228,572 shares of common stock and pre-funded warrants to purchase 285,715 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $35.00 per share, before underwriting discounts and commissions, and the pre-funded warrants are being ...

___________________ ___________________ SOUTH SAN FRANCISCO, Calif., July 9, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA) today announced that it intends to offer and sell up to $200.0 million of shares of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase its common stock in an underwritten public offering. In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $30.0 million of shares of its c ...

Management believes that theIDE397 study data demonstrates important clinical proof-of-concept in MTAPdeletion solid tumors to deliver meaningful responses and encourage preliminary durability of response with a convenient 30mg once-a-day tablet. The reported clinical efficacy and tolerability data are preliminary, drawn from an investigator-reviewed unlocked database as of the cutoff date of Jun 21, 2024. Per the data readout, the study achieved an overall response rate of 39%. Among the 18 evaluable patie ...