IDEAYA reports promising Phase 2 uveal melanoma trial data

SOUTH SAN FRANCISCO, Calif. - IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology firm, shared interim data from a Phase 2 clinical trial indicating that its drug darovasertib showed significant tumor shrinkage and eye preservation in patients with neoadjuvant uveal melanoma (UM). The study found that approximately 49% of the 49 evaluable patients experienced over 30% tumor shrinkage, and about 61% of those at risk of eye removal maintained their eyesight.

The company, following a recent FDA Type C meeting, is looking to initiate a Phase 3 randomized registrational trial in neoadjuvant UM. The trial will have eye preservation rate and time to vision loss as primary endpoints for patients at risk of enucleation and those eligible for plaque brachytherapy, respectively. A secondary endpoint will be to demonstrate no detriment to Event-Free-Survival (EFS) in the treatment arms.

Ongoing discussions with the FDA include the possibility of using Overall Response Rate (ORR) as an additional endpoint to support earlier approval scenarios. The trial is projected to enroll roughly 400 patients, with the aim to address the needs of subjects across the spectrum of low, intermediate, and high risk for metastatic disease.

Darovasertib is a protein kinase C (PKC) inhibitor, currently being evaluated in several clinical trials, two of which are in collaboration with Pfizer (NYSE:PFE). The drug has received FDA Fast Track designation for its combination with crizotinib in metastatic UM.

The Phase 2 data also indicated a manageable adverse event profile, with the most common side effects being diarrhea, nausea, vomiting, and fatigue. The study's discontinuation rate was 3%.

The annual incidence of primary UM is estimated to be around 12,000 patients in North America, Europe, and Australia, representing a significant market opportunity for darovasertib, a drug for which there are currently no FDA-approved therapies.

IDEAYA holds all commercial rights to darovasertib, subject to certain obligations to Novartis (SIX:NOVN). The company and key opinion leaders discussed the clinical trial data and the upcoming registrational trial during a webcast today.

This report is based on a press release statement from IDEAYA Biosciences, Inc.

In other recent news, financial services firms have been adjusting their outlooks on Ideaya Biosciences, following the release of promising interim Phase 2 data and the successful completion of a public offering. Stifel raised its stock price target for Ideaya Biosciences to $68.00, up from the previous $63.00, due to optimism about the potential of the company's drug combination involving IDE397 and AMG193 for treating cancer. Similarly, Goldman Sachs increased the price target for Ideaya Biosciences to $47.00, up from $44.00, following recent clinical data presented by the company regarding IDE397.

Oppenheimer reduced its price target to $53 from the previous $60, while maintaining an Outperform rating on the company's stock, following Ideaya's recent updates on their drug candidate IDE397 and a new licensing deal for a B7-H3 antibody-drug conjugate. Mizuho also increased its price target for Ideaya Biosciences from the previous $50.00 to $55.00, based on the promising interim Phase 2 data.

These adjustments come as Ideaya Biosciences completed a public offering, raising approximately $283.8 million, which is expected to support its ongoing pharmaceutical research and operations. The company also reported a strong financial position with approximately $952.7 million in cash, cash equivalents, and marketable securities as of June 30, 2024. These are among the recent developments at Ideaya Biosciences.

InvestingPro Insights

In the wake of IDEAYA Biosciences' promising clinical trial results for darovasertib, investors may be considering the company's financial health and market potential. According to InvestingPro, IDEAYA holds a significant advantage by having more cash than debt on its balance sheet, which may offer the company some financial flexibility as it progresses through costly clinical trials and potential commercialization phases. This is a critical factor for biotech companies that often face long periods before generating revenue from their products.

However, the optimism from the clinical trial must be balanced against several financial metrics and analyst expectations. Notably, analysts have revised their earnings downwards for the upcoming period, and anticipate a sales decline in the current year. This could reflect the market's cautious stance on the company's short-term revenue prospects. Additionally, InvestingPro data highlights a substantial market capitalization of $2.96 billion, despite a negative revenue growth of -73.51% in the last twelve months as of Q2 2024, which may suggest a high revenue valuation multiple.

For investors looking for more in-depth analysis, there are 11 additional InvestingPro Tips available for IDEAYA Biosciences that could provide further insights into the company's financials and market expectations. These tips can be found at: https://www.investing.com/pro/IDYA. It's worth noting that the company's stock has seen a 26.67% return over the past year, despite some negative short-term price movements. As of the previous close, the stock was trading at $35, with an InvestingPro Fair Value estimate at $29.32, which suggests that investors should carefully consider the company's valuation in their investment decisions.

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