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 ...

Key Takeaways IDEAYA Biosciences reported positive results from a Phase 2 trial of its experimental drug to treat certain bladder and small-cell lung cancers on Monday, and shares soared in intraday trading. The once-a-day tablet IDE397 helped patients with MTAP-deletion solid cancers. The company noted there are no Food and Drug Administration (FDA)-approved drugs for those who have MTAP-deletion solid tumors. Shares of IDEAYA Biosciences (IDYA) took off in intraday trading Monday after the biotech announc ...

Loading... Loading... Monday, IDEAYA Biosciences Inc IDYA released clinical data for the IDE397 Phase 2 monotherapy expansion dose in methylthioadenosine phosphorylase-deletion urothelial and non-small cell lung cancer patients (NSCLC). "IDE397 is a potential first-in-class MAT2A inhibitor, that is being advanced as a monotherapy agent in priority MTAP-deletion solid tumor types and in high conviction rational combinations, including with Amgen's investigational MTA-cooperative protein arginine methytranfer ...

~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients ~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1 ~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage ~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reduction AE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day expansion dose ...

Core Viewpoint - IDEAYA Biosciences has initiated a Phase 1 clinical trial to evaluate the combination of IDE397, a MAT2A inhibitor, and Trodelvy, targeting patients with MTAP-deletion bladder cancer [12][5]. Group 1: Clinical Trial Details - The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of the IDE397 and Trodelvy combination [5][12]. - MTAP-deletion is present in approximately 26% of bladder cancer patients, indicating a significant target population for this treatment [5]. - The trial is part of a broader clinical program that includes a Phase 2 expansion arm for IDE397 monotherapy in MTAP-deletion solid tumors [1][5]. Group 2: Product Information - Trodelvy is currently approved in nearly 50 countries for second-line metastatic triple-negative breast cancer and in over 30 countries for pre-treated HR+/HER2- metastatic breast cancer [5]. - In the U.S., Trodelvy has received accelerated approval for treating locally advanced or metastatic urothelial cancer in patients who have previously undergone platinum-containing chemotherapy and anti-PD-(L)1 therapy [5]. Group 3: Future Developments - IDEAYA plans to provide a clinical data update for the IDE397 Phase 2 monotherapy expansion in MTAP-deletion bladder and lung cancer in the second half of 2024 [9]. - The company is also advancing multiple preclinical stage MTAP-deletion programs to enable wholly-owned combinations with IDE397, targeting a Development Candidate nomination in the second half of 2024 [9].

SOUTH SAN FRANCISCO, Calif., June 24, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced clinical program updates for IDE397, a potential first-in-class Phase 2 MAT2A inhibitor targeting MTAP-deletion solid tumors. There is an ongoing Phase 2 expansion of IDE397 monotherapy in MTAP-deletion solid tumors (NCT04794699), and an Amgen-sponsored Phase 1/2 trial of IDE397 and AMG 19 ...

Core Insights - IDEAYA Biosciences announced updated clinical results for darovasertib, a first-in-class oral small molecular inhibitor of protein kinase C (PKC), in the treatment of uveal melanoma (UM) [1][2] Clinical Trial Results - The ongoing Phase 2 trial of darovasertib showed promising results, with 75% of enucleation patients preserving their eyes and approximately 67% experiencing over 30% tumor shrinkage after 6 months [3][6] - Median tumor shrinkage was reported at approximately 47% for enucleation patients after 6 months [3][6] - In a separate cohort of 8 patients treated for 4 months or more, median tumor shrinkage was approximately 72% [5][6] Safety Profile - Darovasertib demonstrated a manageable adverse event (AE) profile, with no drug-related serious adverse events reported [4][7] - Drug-related AEs were primarily Grade 1 or Grade 2, with about 20% of patients experiencing at least one drug-related Grade 3 AE [4][7] Regulatory Plans - The company is targeting a Type C meeting with the FDA in H2 2024 to discuss a potential registrational trial for darovasertib in the neoadjuvant UM setting [5][6] - The Phase 2 company-sponsored trial has activated over 14 sites globally and enrolled over 40 patients as of May 24, 2024 [5][6] Market Potential - The projected global annual incidence of primary uveal melanoma is approximately 8,000 to 10,000 patients, indicating a significant market opportunity for darovasertib [6][8]