This section highlights FDA-related milestones and regulatory updates for drugs developed by Erasca (ERAS).
Over the past two years, Erasca has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ERAS-0015, ERAS-4001, and Naporafenib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ERAS-0015 - FDA Regulatory Timeline and Events
ERAS-0015 is a drug developed by Erasca for the following indication: pan-RAS molecular glue.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ERAS-0015
- Announced Date:
- April 29, 2025
- Indication:
- pan-RAS molecular glue
Announcement
Erasca, Inc. today presented new preclinical data reinforcing the best-in-class profiles of Erasca's RAS-targeting franchise at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.
AI Summary
Erasca, Inc. presented exciting new preclinical data at the AACR Annual Meeting in Chicago, reinforcing the strong potential of its RAS-targeting therapies. The data showcased ERAS-0015, a pan-RAS molecular glue that demonstrated robust anti-tumor activity as both a standalone treatment and in combination therapies. Notably, ERAS-0015 exhibited superior pharmacokinetic properties, including longer residence time and greater tissue exposure, allowing it to be effective at lower doses compared to other leading pan-RAS therapies. Additionally, the presentation highlighted ERAS-4001, a pan-KRAS inhibitor with promising efficacy by selectively targeting critical KRAS mutations, thus potentially offering a better safety profile. Novel findings also included the first examples of direct SHOC2 binders, which may help block oncogenic RAS/MAPK signaling by interfering with SMP complex assembly. These results further support Erasca’s position in precision oncology and its drive to advance these promising therapies into clinical development.
Read Announcement - Drug:
- ERAS-0015
- Announced Date:
- March 25, 2025
- Indication:
- pan-RAS molecular glue
Announcement
Erasca, Inc. announced the company will present three poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30, 2025, in Chicago, Illinois.
AI Summary
Erasca, Inc., a clinical-stage precision oncology company focused on the RAS/MAPK pathway, announced it will be presenting three poster presentations at the upcoming AACR Annual Meeting in Chicago, Illinois, from April 25 to 30, 2025. The presentations will showcase innovative research including potential best-in-class therapies. One poster, Abstract 390, will detail ERAS-0015, a pan-RAS molecular glue with promising activity in RAS mutant solid tumors, scheduled for April 27, 2025. A second poster, Abstract 4367, will present ERAS-4001, a pan-KRAS inhibitor showing robust anti-tumor activity in KRAS altered tumors, slated for April 29, 2025. Additionally, Abstract 3152 will cover the identification and characterization of inhibitors targeting the SMP complex. These presentations highlight Erasca's commitment to advancing novel approaches to block the RAS/MAPK pathway in cancer treatment.
Read Announcement
ERAS-4001 - FDA Regulatory Timeline and Events
ERAS-4001 is a drug developed by Erasca for the following indication: pan-KRAS inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ERAS-4001
- Announced Date:
- June 2, 2025
- Indication:
- pan-KRAS inhibitor
Announcement
Erasca, Inc announced clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ERAS-4001, a potential first-in-class and best-in-class pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant (KRASm) solid tumors.
AI Summary
Erasca, Inc. recently announced that the FDA has cleared its IND application for ERAS-4001, a potential first-in-class and best-in-class pan-KRAS inhibitor aimed at treating patients with KRAS-mutant solid tumors. This innovative drug candidate is designed to target multiple KRAS mutations and KRAS wildtype amplification while sparing HRAS and NRAS, which may offer a better safety profile compared to traditional pan-RAS inhibitors. Preclinical studies have shown that ERAS-4001 exhibits strong potency against both active and inactive forms of KRAS and has induced tumor regression in various KRAS-mutant models. Erasca plans to initiate the BOREALIS-1 Phase 1 trial to evaluate the drug’s safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy. Initial monotherapy data from this trial is expected to be shared in 2026.
Read Announcement- Drug:
- ERAS-4001
- Announced Date:
- March 25, 2025
- Indication:
- pan-KRAS inhibitor
Announcement
Erasca, Inc. announced the company will present three poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, taking place April 25 - 30, 2025, in Chicago, Illinois.
AI Summary
Erasca, Inc., a clinical-stage precision oncology company focused on RAS/MAPK pathway-driven cancers, announced it will present three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 25–30, 2025. The posters will highlight innovative treatment approaches aimed at shutting down the RAS/MAPK pathway.
One presentation will feature ERAS-0015, a pan-RAS molecular glue with best-in-class potential in RAS mutant solid tumors, scheduled for April 27. Another poster will showcase ERAS-4001, a pan-KRAS inhibitor with robust anti-tumor activity in KRAS altered solid tumors, on April 29. Additionally, research on direct inhibitors of the SMP complex, which represents a new approach to block the RAS/MAPK pathway, will be presented on April 28. Abstracts for all studies are available on the AACR 2025 meeting website, with posters also accessible on Erasca’s website.
Read Announcement
Naporafenib - FDA Regulatory Timeline and Events
Naporafenib is a drug developed by Erasca for the following indication: Pan-RAF inhibitor naporafenib.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Naporafenib
- Announced Date:
- March 20, 2025
- Indication:
- Pan-RAF inhibitor naporafenib
Announcement
Erasca, Inc. provided business updates
AI Summary
Erasca, Inc. recently provided a business update highlighting significant progress in its RAS-targeting franchise. The company is advancing two promising candidates—ERAS-0015, a potential best-in-class pan-RAS molecular glue, and ERAS-4001, a potential first-in-class pan-KRAS inhibitor. Both agents are set to enter clinical development, with investigational new drug (IND) submissions expected in the second quarter of 2025. This progress is aimed at addressing major unmet needs in patients with RAS-mutant tumors, including those with colorectal, lung, pancreatic, and other solid cancers.
Erasca also noted the continued strength of its financial position, reporting cash, cash equivalents, and marketable securities of $440 million as of December 31, 2024—enough to fund operations into the second half of 2027. The company is optimistic about its upcoming milestones and the potential to drive value in the year ahead.
Read Announcement- Drug:
- Naporafenib
- Announced Date:
- September 25, 2024
- Indication:
- Pan-RAF inhibitor naporafenib
Announcement
Erasca, Inc announced an oral presentation of preliminary SEACRAFT-1 Phase 1 data for naporafenib plus trametinib (MEKINIST®) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics taking place October 23-25 in Barcelona, Spain.
AI Summary
Erasca, Inc. recently announced that it will orally present preliminary SEACRAFT-1 Phase 1 data at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25, 2024. This presentation focuses on the combination of naporafenib and trametinib (MEKINIST®) for patients with locally advanced, unresectable, or metastatic solid tumors harboring RAS Q61X mutations. Dr. Elisa Fontana from the Sarah Cannon Research Institute will share early results on October 24, 2024, at 10:18 AM CEST. The data discussed may provide valuable insights into the drug’s potential effectiveness for treating cancers driven by RAS mutations. This work represents an important step in advancing precision oncology treatments aimed at targeting the RAS/MAPK pathway, potentially offering new targeted therapy options for patients with these challenging solid tumors.
Read Announcement- Drug:
- Naporafenib
- Announced Date:
- June 18, 2024
- Indication:
- Pan-RAF inhibitor naporafenib
Announcement
Erasca, Inc announced the initiation of the global SEACRAFT-2 Phase 3 trial evaluating the pan-RAF inhibitor naporafenib in combination with the MEK inhibitor trametinib (MEKINIST®) in patients with NRAS-mutant (NRASm) melanoma.
AI Summary
Erasca, Inc. announced the launch of the worldwide SEACRAFT-2 Phase 3 trial to test naporafenib, a pan-RAF inhibitor, in combination with the MEK inhibitor trametinib (MEKINIST®) for patients with NRAS-mutant melanoma. This trial is designed as a two-stage study. In Stage 1, researchers will compare the combination treatment against trametinib alone, with a randomized data readout expected in 2025. The results from this stage will also determine the optimal dose for later use. Stage 2 will focus on achieving regulatory approval by comparing the drug combination to the physician’s choice of therapy. Naporafenib, considered a potential first-in-class and best-in-class treatment, has been tested in over 500 patients in earlier trials, showing promising median overall and progression-free survival rates. This trial addresses the urgent need for targeted therapies in aggressive NRAS-mutant melanoma.
Read Announcement- Drug:
- Naporafenib
- Announced Date:
- June 18, 2024
- Indication:
- Pan-RAF inhibitor naporafenib
Announcement
Erasca, Inc announced that Randomized Stage 1 readout for naporafenib plus trametinib vs. trametinib monotherapy expected in 2025
AI Summary
Erasca, Inc. has started a pivotal global Phase 3 trial called SEACRAFT-2 for its new drug, naporafenib, which is being developed for patients with NRAS-mutant melanoma. This type of cancer is aggressive and has very few targeted treatment options today. In the trial’s two-stage design, the first stage will compare the combination of naporafenib and the MEK inhibitor trametinib with trametinib given alone. The key outcome of Stage 1, which is based on randomized data, is expected to be available in 2025. The results from this stage will help determine the best dose for the combination in later parts of the study. This important milestone could lead to a promising new treatment alternative for patients suffering from RAS/MAPK pathway-driven tumors.
Read Announcement
