Ideaya Biosciences Stock Price, News & Analysis

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.

IDEAYA Biosciences (NASDAQ: IDYA), a precision medicine oncology company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will feature a fireside chat with Yujiro S. Hata, CEO of IDEAYA, hosted by Judah Frommer, Executive Director and Senior Equity Research Analyst at Morgan Stanley.

The conference is scheduled for Wednesday, September 4th, 2024 at 5:35 PM ET. Investors and interested parties can access a live audio webcast of the event through the 'Investors/Events' section of IDEAYA's website or via the conference host. The webcast replay will be available for 30 days following the live event, providing an opportunity for those unable to attend to catch up on the discussion.

IDEAYA Biosciences (NASDAQ: IDYA) has announced the granting of non-qualified stock options to a newly hired employee. The Compensation Committee approved options to purchase 150,000 shares of common stock under the company's 2023 Employment Inducement Incentive Award Plan. These options, granted on August 19, 2024, have an exercise price of $39.06 per share, matching 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 one year and the remaining 75% vesting monthly over the following three years, subject to continued employment.

IDEAYA Biosciences (NASDAQ: IDYA) reported Q2 2024 financial results and provided a business update. Key highlights include:

• Darovasertib achieved triple-digit enrollment in Phase 2/3 trial for 1L HLA-A2*02:01(-) MUM and over 50 patients enrolled in Phase 2 neoadjuvant UM study
• IDE397 demonstrated preliminary proof-of-concept in MTAP urothelial and lung cancer
• Targeting Werner IND and MTAP/KAT6 pathway DCs in H2'24
• $952.7 million cash position as of June 30, 2024, supplemented by $283.8 million from July 2024 public offering
• Anticipates funding operations into at least 2028

The company made significant progress across its precision medicine oncology pipeline and is on track to deliver its fifth potential first-in-class program to the clinic this year.

Biocytogen and IDEAYA Biosciences have entered into an option and license agreement for a potential first-in-class B7H3/PTK7 bispecific antibody drug conjugate (BsADC) program. The agreement grants IDEAYA an option for an exclusive worldwide license for the program, which targets B7H3/PTK7 co-expression found in multiple solid tumor types. Biocytogen will receive an upfront fee and potential milestone payments totaling $406.5 million, including $100 million in development and regulatory milestones, plus single-digit royalties on net sales.

The BsADC program has the potential to be developed as a monotherapy and in combination with IDEAYA's DNA Damage Repair (DDR) pipeline, including IDE161 (PARG inhibitor). A development candidate nomination is targeted for H2 2024. This collaboration leverages Biocytogen's RenLite® platform and proprietary linker-payload technology to enhance ADC precision and potency.

IDEAYA Biosciences (NASDAQ: IDYA), a precision medicine oncology company, has announced its participation in the upcoming 2024 BTIG Virtual Biotechnology Conference. The event is scheduled for Monday, August 5th, 2024 at 10:00 AM ET.

The conference will feature a fireside chat with Yujiro S. Hata, Chief Executive Officer of IDEAYA Biosciences, hosted by Justin Zelin, Director of Biotechnology Research Analysis at BTIG. This virtual event provides an opportunity for investors to gain insights into IDEAYA's latest developments in targeted therapeutics for oncology.

A live audio webcast of the conference event will be made available through the conference host, allowing interested parties to tune in remotely.