Why Is IDYA Stock Surging Over 20% Overnight?

• The company will release a joint premarket announcement with Servier, its commercialization partner for Darovasertib, on Monday.
• The trial is evaluating Darovasertib plus Crizotinib as a first-line treatment for HLA A2-negative metastatic uveal melanoma.
• Analysts flagged the readout as a near-term catalyst, with Citigroup maintaining a 'Buy' rating and Wedbush reiterating 'Outperform.' 

Shares of Ideaya Biosciences, Inc. (IDYA) surged 20% overnight on Sunday ahead of topline data due Monday from its late-stage Darovasertib combination study in metastatic uveal melanoma, a rare eye cancer with limited treatment options.

IDYA stock jumped 20% in after-hours trading on Friday after shares snapped a two-session winning streak to close the regular session down 2%.

Eye Cancer Trial Readout In Focus 

The company said it will issue a joint announcement in premarket hours on Monday with Servier, its commercialization partner for Darovasertib, to report topline results from the registrational Phase 2/3 Optimum-02 trial. The trial is evaluating Darovasertib in combination with Crizotinib as a first-line treatment for patients with HLA A2-negative metastatic uveal melanoma, a rare eye cancer with limited treatment options.

Optimum-02 compares the Darovasertib-Crizotinib combination with standard treatments, including Pembrolizumab, Ipilimumab plus Nivolumab, or Dacarbazine, in patients receiving initial therapy for metastatic disease.

The trial’s primary endpoints are progression-free survival and overall survival. Ideaya said progression-free survival results from Optimum-02 could support a potential accelerated approval filing in the U.S., while overall survival data could support a potential full approval filing. In December, the company said it had completed targeted enrollment of 435 patients.

Earlier results from the Phase 1/2 Optimum-01 trial showed that the Darovasertib-Crizotinib combination hit a median overall survival of 21.1 months and a median progression-free survival of 7 months in previously untreated metastatic uveal melanoma patients.

Darovasertib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) in the neoadjuvant treatment setting for primary uveal melanoma, as well as Fast Track designation in combination with Crizotinib for adults with metastatic disease. The therapy also holds an Orphan Drug designation in uveal melanoma.

Analysts Flag Optimum-02 As Key Catalyst

Analysts have flagged the Optimum-02 readout as a major near-term catalyst for Ideaya shares. Last month, Citigroup placed the stock on an 'upside 90-day catalyst watch' while maintaining a 'Buy' rating and a $65 price target, citing expectations around the same Phase 2/3 Optimum-02 data. This was the second price target raise since February, when the brokerage said it was positive on IDYA shares into the trial readout. 

In February, Wedbush Securities raised its price target on IDYA to $52 from $49 and maintained an 'Outperform' rating ahead of the Optimum-02 readout.

How Do Retail Traders Feel About IDYA?

On Stocktwits, retail sentiment for IDYA jumped to ‘extremely bullish’ from ‘bearish’ levels a week ago amid ‘extremely high’ message volume.

One user said, “Monday will be a very good day. My TP is $50 but I suspect this may do better than that.”

Another user said, “Well, announce the most important data in company friday after hours for Monday premarket does not sound too bearish after all.”

IDYA stock has jumped 93% over the past year.

For updates and corrections, email newsroom[at]stocktwits[dot]com.

Read Next: Dow, S&P 500, Nasdaq Futures Slide After US-Iran Talks Collapse: Why SNDK, PATH, INTC, PLTR, IDYA Are In Focus