Announcement • 11h
Erasca Granted FDA Fast Track Designation for Pan-Ras Molecular Glue Eras-0015 in Patients with Metastatic Pancreatic Adenocarcinoma Erasca, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ERAS-0015 for the treatment of patients with metastatic pancreatic adenocarcinoma. ERAS-0015 is an oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. FTD is intended to facilitate development and expedite the review of therapies for serious conditions with unmet medical needs. Designated programs may benefit from more frequent interactions with the FDA and, if relevant criteria are met, may be eligible for benefits such as accelerated approval, priority review, and rolling review. In July 2026, Erasca reported updated preliminary data from the AURORAS-1 Phase 1 trial in the U.S. demonstrating encouraging clinical activity, including a 57% uORR8wk in patients with second-line or later (2L+) KRAS G12X pancreatic ductal adenocarcinoma (PDAC) receiving ERAS-0015 monotherapy at the recommended dose for expansion (RDE) of 32 mg once daily. All responding patients across doses remained on treatment as of the data cutoff, and ERAS-0015 continued to demonstrate favorable tolerability. Additional data from the monotherapy expansion and combination dose escalation cohorts, including the panitumumab combination, are expected in the first half of 2027. The uORR8wk is the overall response rate (ORR) (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 at least 8 weeks prior to the May 25, 2026 data cut off. ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species. Live News • Aug 12
Erasca Advances ERAS-0015 Toward Registration Trials After Strong Pancreatic Cancer Results Erasca reported updated ERAS-0015 data from a U.S. trial that showed compelling monotherapy efficacy and favorable tolerability in second-line and later KRAS G12X pancreatic cancer, and the company plans three potentially registration-enabling trials in pancreatic and lung cancers.
The company guided to additional ERAS-0015 monotherapy and combination data in the first half of 2027, and early Phase 1 monotherapy data for ERAS-4001 in the second half of 2026, which sets a clear timetable for upcoming clinical readouts.
Erasca shares trade at US$18.31, with the stock up about 410% year to date, highlighting how much of the recent move already reflects expectations around the pipeline.
This update makes ERAS-0015 a central value driver for Erasca, while the long gap to the next major data sets leaves investors exposed to clinical execution and trial-timing risk. Announcement • Aug 11
Gainey Mckenna & Egleston Announces Filling of Class Action Lawsuit Against Erasca, Inc Gainey McKenna & Egleston announced that a securities class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all persons or entities who purchased or otherwise acquired Erasca, Inc. securities between January 14, 2025 and April 26, 2026, inclusive. The Complaint alleges that Defendants failed to disclose to investors that: (1) ERAS-0015’s preclinical data was based on improper comparisons to Revolution Medicines, Inc. and placed Erasca at risk of violating patent and trade secret protections; and (2) based on the foregoing, Defendants lacked a reasonable basis for their positive statements related to ERAS-0015. The Complaint alleges that on April 27, 2026, at 8:31 a.m. EDT before the market opened, Erasca disclosed in a Form 8-K that it had received a letter from legal counsel for RevMed alleging that Erasca’s ERAS0015 infringes a RevMed patent (U.S. Patent No. 12,409,225) and is connected to alleged trade secret misappropriation. The Complaint continues to allege that RevMed also alleged that Erasca had improperly compared preclinical data of ERAS-0015 and RMC-6236 in public disclosures and demanded Erasca cease making deceptive and untrue comparative statements comparing ERAS-0015 and RMC-6236. The Complaint alleges that Erasca stated that it believes the assertions are without merit and intends to contest the allegations. The Complaint continues to allege that in response to this news, Erasca’s stock price fell from a closing price of $21.49 on April 24, 2026 to open at $20.70 per share on April 27, 2026. Erasca’s stock price continued to fall, closing at $19.15 on April 27, 2026.