Ideaya Biosciences - IDYA STOCK NEWS

IDEAYA Biosciences (NASDAQ: IDYA) announced that its Compensation Committee granted non-qualified stock options to two newly hired employees on October 31, 2024. The grants, made under the company's 2023 Employment Inducement Incentive Award Plan, total 62,800 shares with an exercise price of $28.15 per share, matching the closing price on Nasdaq that day. The options have a 10-year term and will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over three years, contingent on continued employment.

IDEAYA Biosciences announces FDA clearance of IND application for IDE275 (GSK959), a potential first-in-class Werner Helicase inhibitor, for Phase 1 clinical trials in MSI-High solid tumors. This represents IDEAYA's fifth potential first-in-class clinical program. The drug shows significant market potential with MSI-High prevalence of ~31% in endometrial, 20% in colorectal, and 19% in gastric cancers. IDEAYA will receive a $7 million payment for IND acceptance and potential future milestones up to $950 million. The company has a 50/50 US profit share agreement with GSK and an 80/20 global research and development cost share.

IDEAYA Biosciences announced positive Phase 1 expansion data for IDE397, a MAT2A inhibitor, in MTAP-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC) patients. Key findings include a ~33% overall response rate with 1 complete response and 8 partial responses among 27 evaluable patients. The drug showed a 40% confirmed response rate in UC and ~38% in squamous NSCLC. The treatment demonstrated durability with median duration exceeding 6.2 months and a high disease control rate of 93%. Safety profile was favorable with no drug-related serious adverse events at the 30mg daily dose. The company plans to expand Phase 1/2 study combining IDE397 with Trodelvy® in MTAP-deletion UC in Q4 2024.

IDEAYA Biosciences (Nasdaq:IDYA) announced a late-breaking oral presentation of Phase 1 expansion results for IDE397, a first-in-class, oral MAT2A inhibitor, in MTAP-deletion urothelial and non-small cell lung cancer (NSCLC) patients. The presentation will take place at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain, on October 25, 2024.

Dr. Benjamin Herzberg from Columbia University will present the results in a plenary session. Additionally, IDEAYA will present two posters: one on the combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors, and another on IDE161, a potential first-in-class PARG inhibitor targeting solid tumors with replication stress and DNA repair vulnerabilities.

IDEAYA Biosciences, Inc. (NASDAQ: IDYA) has announced that on September 26, 2024, its Compensation Committee granted non-qualified stock options to a newly hired employee. The options allow for the purchase of 140,000 shares of the company's common stock under the 2023 Employment Inducement Incentive Award Plan. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4) and serves as an inducement for employment.

The stock options have an exercise price of $30.50 per share, matching the closing price of IDEAYA's common stock on the grant date. They have a 10-year term and will vest over four years, with 25% vesting after one year and the remaining 75% vesting monthly over the following three years, subject to continued employment.

IDEAYA Biosciences (Nasdaq:IDYA) announced positive interim Phase 2 data for darovasertib in neoadjuvant uveal melanoma (UM) and a successful FDA Type C meeting on registrational trial design. Key highlights include:

- ~49% of patients showed >30% tumor shrinkage
- ~61% eye preservation rate for enucleation patients
- Targeting Phase 3 randomized registrational trial initiation
- FDA guidance supports eye preservation rate and time to vision loss as primary endpoints
- Potential for broad indication label in neoadjuvant UM
- Projected ~400 patients for registrational trial enrollment
- Annual incidence of primary UM in North America, Europe, and Australia is ~12k patients

The company plans to advance darovasertib to a registrational trial in neoadjuvant UM, addressing a significant unmet medical need with no current FDA-approved therapies.

IDEAYA Biosciences (Nasdaq:IDYA) has announced a webcast on September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from an FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is a protein kinase C (PKC) inhibitor being developed for primary and metastatic UM. The presentation will cover:

• Market introduction and UM incidence
• Registrational trial design based on FDA guidance
• Phase 2 clinical data update, including baseline characteristics, adverse event profile, and clinical efficacy

The webcast will feature a key opinion leader and IDEAYA management. Updated presentations will be available on the company's website at approximately 8:00 am ET on the day of the event.

IDEAYA Biosciences (NASDAQ: IDYA) has appointed Douglas B. Snyder as Senior Vice President and General Counsel, effective September 18, 2024. Snyder brings over 25 years of legal experience in healthcare, including roles at GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the FDA. His extensive commercial and international experience positions him well to lead IDEAYA's legal functions as the company prepares for potential commercialization of Darovasertib and expands its clinical pipeline efforts, including in MTAP-deletion.

Snyder's most recent role was Executive VP, Chief Legal Officer, and Secretary at GW Pharmaceuticals from 2017 to 2022, overseeing its $7.2 billion acquisition by Jazz Pharmaceuticals. He holds a J.D. from the Catholic University of America and a B.A. from Dickinson College.

IDEAYA Biosciences (NASDAQ: IDYA), a precision medicine oncology company, has announced the granting of non-qualified stock options to a newly hired employee. The Compensation Committee approved options to purchase 34,000 shares of common stock under the company's 2023 Employment Inducement Incentive Award Plan. These options, granted on August 29, 2024, have an exercise price of $39.17 per share, equal to the closing price of IDEAYA's stock on the grant date. The options have a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following three years, subject to continued employment.