IDEAYA Biosciences, Inc. - IDYA STOCK NEWS

IDEAYA Biosciences announced the nomination of IDE034 as a development candidate, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC). The company exercised its option for an exclusive worldwide license from Biocytogen Pharmaceuticals, targeting an IND-filing in 2025 for first-in-human trials. IDE034 shows promise as both a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161. B7H3/PTK7 co-expression in lung, colorectal, and head and neck cancers has been reported at 30%, 46%, and 27%, respectively. The licensing agreement includes upfront and option exercise fees, along with additional milestone payments, totaling $406.5 million.

IDEAYA Biosciences reported significant progress in Q3 2024, including completion of a $302.4 million follow-on financing. The company highlighted positive developments across multiple clinical programs, notably darovasertib enrollment exceeding 150 patients and IDE397 showing promising results in MTAP-deletion cancers with confirmed ORR of 40% in UC and 38% in SqNSCLC. The company has $1.2 billion in cash, expected to fund operations into 2028. Key developments include FDA IND clearance for IDE275, successful Type C meeting for darovasertib's Phase 3 trial, and ongoing progress in multiple clinical trials. The company plans to nominate three new development candidates by year-end 2024.

IDEAYA Biosciences issued a correction to their Q3 2024 financial results, specifically regarding enrollment in the darovasertib + crizotinib trial for HLA-A2(-) MUM patients. Key highlights include: enrollment exceeding 150 patients ahead of schedule, successful FDA Type C meeting for darovasertib in neoadjuvant UM, and positive Phase 2 results showing ~49% patients with >30% ocular tumor shrinkage. The company reported IDE397 showed confirmed response rates of 40% in UC and 38% in SqNSCLC. With $1.2 billion in cash as of September 2024, operations are funded into 2028. The company completed a $302.4 million follow-on financing and received IND clearance for IDE275, earning a $7.0 million milestone from GSK.

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.