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IDEAYA Announces Results for Darovasertib Phase 2 IST in Neoadjuvant Uveal Melanoma at ASCO and Clinical Update for Phase 2 Company-Sponsored Neoadjuvant Study
Prnewswire· 2024-06-03 10:00
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]
IDEAYA Biosciences to Participate in Upcoming June 2024 Investor Relations Events
prnewswire.com· 2024-05-29 10:00
SOUTH SAN FRANCISCO, Calif., May 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 events. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates cap ...
IDEAYA Biosciences Appoints Daniel A. Simon as Chief Business Officer to Lead Corporate Strategy and Business Development
prnewswire.com· 2024-05-28 10:00
Over 18-years at leading life sciences and strategy consulting companies, including Revolution Medicines, Guardant Health, Onyx Pharmaceuticals, and McKinsey & Company SOUTH SAN FRANCISCO, Calif., May 28, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that Daniel A. Simon, will join the company as its Chief Business Officer in August 2024. "We are thrilled to welcome Dani ...
IDEAYA Biosciences Announces Abstract Summary Results of ASCO 2024 Oral Presentation for Phase 2 Investigator Sponsored Study of Darovasertib in Neoadjuvant Uveal Melanoma
Prnewswire· 2024-05-23 21:05
Core Insights - IDEAYA Biosciences announced preliminary clinical results for darovasertib, a first-in-class oral small molecular inhibitor of protein kinase C (PKC), in a Phase 2 trial for uveal melanoma at the 2024 ASCO Annual Meeting [1][5] Group 1: Clinical Trial Details - The Phase 2 trial involved 15 patients with localized uveal melanoma, treated with darovasertib 300mg twice daily [2] - An initial safety cohort of 3 patients was treated for one month, followed by 12 patients in an expansion cohort for up to six months [2] - As of the database lock, 11 patients completed primary treatment, with 4 remaining on neoadjuvant treatment and 6 receiving adjuvant darovasertib [3] Group 2: Efficacy and Safety Results - Approximately 67% (6 of 9 patients) had confirmed eye preservation, converting to plaque brachytherapy or external beam radiotherapy [3][8] - Median tumor shrinkage was approximately 39% after six months of treatment [3][8] - Darovasertib was generally well tolerated, with drug-related adverse events primarily Grade 1 or Grade 2; 13% reported at least one Grade 3 adverse event, with no serious adverse events observed [4][8] Group 3: Upcoming Presentation - Additional clinical data and follow-up will be presented at the ASCO 2024 oral presentation scheduled for June 3, 2024 [5][9] - The presentation will focus on the safety and efficacy of darovasertib for localized ocular melanoma [9]
IDEAYA Biosciences(IDYA) - 2024 Q1 - Quarterly Report
2024-05-07 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38915 IDEAYA Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 47-4268251 (State or oth ...
IDEAYA Biosciences(IDYA) - 2024 Q1 - Quarterly Results
2024-05-07 10:04
Exhibit 99.1 IDEAYA Biosciences, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update • ASCO 2024 oral presentation of darovasertib neoadjuvant UM Phase 2 investigator-sponsored trial on June 3rd, and targeting neoadjuvant UM update in over 30 patients from Phase 2 company-sponsored trial and regulatory guidance both in H2 2024 South San Francisco, CA, May 7, 2024– IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and developm ...
IDEAYA Biosciences, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update
Prnewswire· 2024-05-07 10:00
ASCO 2024 oral presentation of darovasertib neoadjuvant UM Phase 2 investigator-sponsored trial on June 3rd, and targeting neoadjuvant UM update in over 30 patients from Phase 2 company-sponsored trial and regulatory guidance both in H2 2024 Selected move-forward Phase 2 dose for IDE397 in MTAP squamous NSCLC, based on clinical efficacy observed in this indication, including multiple PRs by RECIST 1.1; and multiple PRs by RECIST 1.1 have also been observed in MTAP bladder cancer Enrollment is ongoing in th ...
IDEAYA Biosciences to Participate in Upcoming May 2024 Investor Relations Event
Prnewswire· 2024-05-01 10:00
SOUTH SAN FRANCISCO, Calif., May 1, 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 an upcoming investor relations event. RBC Capital Markets Global Healthcare ConferenceTuesday, May 14th, 2024 at 3:05 PM ET Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Gregory Renza, Director and Senior Biotechnology Research Analyst A live audio w ...
IDEAYA Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Prnewswire· 2024-04-26 10:00
SOUTH SAN FRANCISCO, Calif., April 26, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on April 25, 2024, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 62,800 shares of the Company's common stock to two newly hired employees. The stock options were granted under the IDEAYA Biosciences, Inc. 2 ...
IDEAYA Biosciences Announces ASCO 2024 Oral Presentation for Darovasertib in Neoadjuvant Uveal Melanoma Phase 2 Investigator Sponsored Study
Prnewswire· 2024-04-24 14:05
Oral presentation at ASCO 2024 scheduled for Monday, June 3, 2024, at 9:51 AM CDT The abstract summary will be available on Thursday, May 23, 2024 at ~5:00pm ET SOUTH SAN FRANCISCO, Calif., April 24, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that interim results from the investigator-sponsored Phase 2 trial evaluating darovasertib safety and efficacy as neoadjuvant ...