This section highlights FDA-related milestones and regulatory updates for drugs developed by Oric Pharmaceuticals (ORIC).
Over the past two years, Oric Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ORIC-944 and ORIC-114. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ORIC-944 FDA Regulatory Timeline and Events
ORIC-944 is a drug developed by Oric Pharmaceuticals for the following indication: In patients with mCRPC.
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:
- ORIC-944
- Announced Date:
- March 31, 2026
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced a rinzimetostat (ORIC-944) program update and potential best-in-disease efficacy and safety data from the Phase 1b trial of once daily rinzimetostat in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate (abiraterone).
AI Summary
ORIC Pharmaceuticals announced that rinzimetostat (ORIC-944) 400 mg once daily was selected as the recommended Phase 3 dose (RP3D) for the Himalayas-1 global registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone. Trial initiation is expected in the first half of 2026.
In a Phase 1b update, at a median follow-up of about five months, radiographic progression-free survival (rPFS) was 84% at five months in 18 efficacy-evaluable patients. PSA responses were assessed in 15 patients and ctDNA responses in 14. Earlier data in 19 patients treated after AR inhibitors showed landmark rPFS of 93%, 85%, and 85% at 3, 4, and 5 months, respectively. ORIC says these early results suggest meaningful and durable clinical benefit versus competitors and historical standards.
The safety profile appears highly differentiated, with most adverse events Grade 1–2 and fewer treatment modifications than competitor regimens. ORIC is exploring additional prostate cancer populations and will host a conference call and webcast today.Read Announcement
- Drug:
- ORIC-944
- Announced Date:
- March 27, 2026
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced that it will report combination dose optimization data from the Phase 1b trial of rinzimetostat (ORIC-944) in patients with metastatic castration resistant prostate cancer (mCRPC) in a conference call and webcast on Tuesday, March 31, 2026 at 4:30pm ET.
AI Summary
ORIC Pharmaceuticals said it will report combination dose optimization data from the Phase 1b trial of rinzimetostat (ORIC-944) in patients with metastatic castration resistant prostate cancer (mCRPC) during a conference call and webcast on Tuesday, March 31, 2026 at 4:30pm ET. The company plans to share findings from the combination portion of the study, which is designed to identify optimal dosing when rinzimetostat is given with other therapies. The update is expected to cover safety, tolerability and dose selection considerations observed so far.
This presentation could clarify the next steps for the program, including any recommended dose for future studies and plans for additional trials. Investors, clinicians and patients following mCRPC research may watch the webcast to learn whether the data support further development of rinzimetostat in combination regimens. ORIC will provide details and commentary during the call and webcast.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- March 17, 2026
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced that multiple abstracts highlighting the potential of rinzimetostat (ORIC-944), a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, have been accepted for poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting taking place April 17-22, 2026 in San Diego, CA.
AI Summary
ORIC Pharmaceuticals announced that multiple abstracts showcasing rinzimetostat (ORIC-944) have been accepted for poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22 in San Diego. Rinzimetostat is described as a potent, selective allosteric inhibitor of PRC2, a protein complex involved in gene silencing that can drive prostate cancer growth. The accepted posters are said to highlight the drug’s potential to treat prostate cancer, including data that may touch on its mechanism, activity against tumor cells, and early safety or efficacy signals.
The presentations will be shown as posters during the AACR meeting, giving researchers a chance to review the findings and ask questions. Contact: Market News and Data brought to you by Benzinga APIs. Benzinga does not provide investment advice. © 2026 Benzinga.com. All rights reserved.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- November 13, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc announced additional efficacy and safety data from the Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).
AI Summary
ORIC Pharmaceuticals reported additional Phase 1b data for once-daily ORIC-944 given with androgen receptor inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). Among 20 patients with PSA data, 55% achieved a PSA50 response (11/20) and 20% achieved PSA90 (4/20); 40% had confirmed PSA50 responses. In 17 patients with measurable circulating tumor DNA (ctDNA), 76% (13/17) had rapid >50% ctDNA reductions and 59% (10/17) achieved ctDNA clearance. At baseline, 88% had detectable ctDNA, a group usually linked to poorer outcomes.
Responses occurred across all ORIC-944 dose levels and were similar whether combined with apalutamide or darolutamide. Safety was compatible with long-term dosing: most treatment-related adverse events were Grade 1–2, one patient had a Grade 3 event, and there were no Grade 4–5 events attributed to the drugs. ORIC set provisional Phase 2 doses for combinations, is enrolling dose optimization cohorts, and expects preliminary dose-optimization data in 1Q 2026 ahead of a planned Phase 3 start in 1H 2026.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- October 27, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. presented posters at the 2025 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics highlighting preclinical data that further illustrate the potential for ORIC-944, a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, to treat prostate cancer and various other solid tumors.
AI Summary
ORIC Pharmaceuticals presented new preclinical data at the 2025 EORTC-NCI-AACR International Conference showing that ORIC-944, a potent and selective allosteric inhibitor of PRC2 via the EED subunit, may improve treatment for prostate and other solid tumors. In castration-sensitive prostate cancer models, combining ORIC-944 with androgen receptor (AR) inhibitors like darolutamide, apalutamide or enzalutamide slowed tumor adaptation, extended response duration and boosted survival. The combination worked by locking tumor cells into a luminal state and reducing chromatin accessibility at key transcription factors tied to cell plasticity.
In KRAS G12C-mutant lung and colorectal cancer models, ORIC-944 plus the KRAS inhibitor adagrasib regressed all tumors, prevented relapse and prolonged progression-free survival. Preclinical findings showed that blocking PRC2 drove tumor cell differentiation and deepened response to KRAS inhibition.
Together, these results suggest ORIC-944 could be a best-in-class PRC2 inhibitor when used alone or with AR and KRAS inhibitors across multiple tumor types.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- May 28, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc announced potentially best-in-class preliminary efficacy and safety data from the ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).
AI Summary
ORIC Pharmaceuticals, Inc. announced promising early results from its ongoing Phase 1b trial of once-daily ORIC-944 used in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). The preliminary data showed that 59% of patients experienced at least a 50% reduction in prostate-specific antigen (PSA) levels, with 47% confirmed, and 24% achieved a 90% reduction. These results were observed across all tested doses and in combination with both apalutamide and darolutamide.
The safety profile of the combination was favorable, with most side effects being mild to moderate gastrointestinal issues. The encouraging efficacy and tolerability suggest that ORIC-944 may provide a best-in-class treatment option for mCRPC. The company is continuing to explore optimal dosing, with further updates expected as they move closer to initiating a global Phase 3 trial in the first half of 2026.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- May 27, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced that the company will present initial data from the Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration resistant prostate cancer (mCRPC) in a conference call and webcast on Wednesday, May 28, 2025, at 4:30 p.m. ET.
AI Summary
ORIC Pharmaceuticals, Inc. announced it will share early results from its Phase 1b trial of ORIC-944, used together with androgen receptor inhibitors in patients with metastatic castration resistant prostate cancer (mCRPC). This data presentation will take place during a conference call and webcast on Wednesday, May 28, 2025, at 4:30 p.m. ET. Participants can join the call by pre-registering online to receive a telephone number and passcode. The webcast and its audio archive will be available on the company’s investor website for 90 days after the presentation. ORIC-944 is being developed as an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit. The early-phase trial is testing its use in combination with existing androgen receptor inhibitors, with the goal of addressing resistance mechanisms in advanced prostate cancer.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- April 28, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced the presentation of a poster at the 2025 American Association for Cancer Research (AACR) Annual Meeting, highlighting preclinical data on ORIC-944, a potent, highly selective, orally bioavailable allosteric inhibitor of PRC2, which demonstrated synergistic activity and improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in models of prostate cancer.
AI Summary
ORIC Pharmaceuticals recently presented a poster at the 2025 AACR Annual Meeting showcasing promising preclinical data on ORIC-944. This oral, highly selective allosteric inhibitor of PRC2 was shown to work well with androgen receptor pathway inhibitors (ARPIs) in prostate cancer models. The research highlights that ORIC-944 not only significantly improved progression-free survival but also demonstrated strong synergistic effects with ARPIs. The data indicated that combining these therapies helped restore the normal luminal features of prostate cells, potentially restricting the cancer’s ability to adapt and progress. These findings suggest that ORIC-944 could emerge as a best-in-class treatment option for both castration-sensitive and castration-resistant prostate cancers, supporting continued clinical exploration and development for more effective prostate cancer treatment options.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- March 25, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals, Inc. announced that a preclinical abstract highlighting the potential of ORIC-944, a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30, 2025 in Chicago, IL.
AI Summary
ORIC Pharmaceuticals, a clinical stage oncology company, announced that its preclinical abstract on ORIC-944 has been accepted for poster presentation at the 2025 American Association for Cancer Research Annual Meeting in Chicago, IL. The poster is titled “ORIC-944, a PRC2 inhibitor with best-in-class properties, restores luminal features and restricts adaptation in prostate cancer models, conferring synergy with AR pathway inhibitors” and will be presented on April 27, 2025, from 2:00 to 5:00 p.m. CT.
ORIC-944 is a potent and selective allosteric inhibitor of PRC2 and has shown promise in preclinical models by restoring normal cell features while limiting tumor adaptability. These findings suggest that the drug enhances the effects of AR pathway inhibitors, offering potential new treatment strategies for prostate cancer. The poster presentation at AACR will allow researchers and clinicians to learn more about ORIC-944’s promising role in addressing resistance in prostate cancer treatment.
Read Announcement- Drug:
- ORIC-944
- Announced Date:
- January 13, 2025
- Indication:
- In patients with mCRPC
Announcement
ORIC Pharmaceuticals today provided early Phase 1b combination data for ORIC-944, operational highlights for 2024, and anticipated upcoming milestones.
AI Summary
ORIC Pharmaceuticals announced positive early Phase 1b combination data for ORIC-944, which is being tested with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC). Early results show that several patients experienced significant prostate-specific antigen (PSA) reductions, with three out of six patients achieving confirmed PSA50 responses and two reaching PSA90 responses. Notably, one patient maintained a durable PSA90 response for up to 38 weeks. ORIC-944 works as a selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) by targeting the EED subunit, and the initial data indicate a favorable safety profile with mostly Grade 1 and Grade 2 side effects. In addition to these promising clinical findings, ORIC provided operational highlights for 2024 and outlined key upcoming milestones that include further data readouts and the anticipated start of registrational trials.
Read Announcement
ORIC-114 FDA Regulatory Timeline and Events
ORIC-114 is a drug developed by Oric Pharmaceuticals for the following indication: Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications.
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:
- ORIC-114
- Announced Date:
- December 5, 2025
- Indication:
- Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Announcement
ORIC Pharmaceuticals, Inc. announced data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025.
AI Summary
ORIC Pharmaceuticals reported Phase 1b data for enozertinib (ORIC-114) in patients with locally advanced or metastatic NSCLC bearing HER2 exon 20 mutations. The trial allowed patients with active, untreated brain metastases. As of the August 29, 2025 cutoff, 49 patients were dosed (26 at 80 mg QD, 23 at 120 mg QD), many after prior chemotherapy and HER2-directed therapy, and 47% had baseline brain metastases.
Efficacy showed systemic activity with a 35% overall response rate in 2L+ patients (26% confirmed) and responses seen in patients with active brain metastases; the 80 mg cohort had a 35% ORR and 100% disease control rate. Safety was manageable: mostly Grade 1–2 treatment-related events (paronychia, diarrhea, dermatitis acneiform), only two discontinuations, and more dose reductions at 120 mg. Based on these data, enrollment in the HER2 exon 20 cohort is complete and no further development is planned in that population; 80 mg was selected for potential later development in other mutation groups.
Read Announcement- Drug:
- ORIC-114
- Announced Date:
- December 3, 2025
- Indication:
- Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Announcement
ORIC Pharmaceuticals, Inc. announced two late-breaking oral presentations highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025 taking place December 5-7, 2025 in Singapore.
AI Summary
ORIC Pharmaceuticals announced two late-breaking oral presentations of Phase 1b data for enozertinib (ORIC-114) at the ESMO Asia Congress, held December 5–7, 2025 in Singapore. The mini-oral (Dec 5) reports results in previously treated NSCLC patients with EGFR atypical mutations, and the proffered paper oral (Dec 6) covers both previously treated and treatment‑naïve patients with EGFR exon 20 mutant NSCLC. Both presentations focus on randomized dose optimization and central nervous system (CNS) activity for this brain-penetrant, highly selective EGFR and HER2 inhibitor.
Full late‑breaking abstracts are available on the ESMO Asia Congress website. ORIC also hosted a conference call and webcast on Dec 6, 2025 (8:00 pm ET) to discuss the data, with the live webcast and audio archive available through the company’s investor website for 90 days after the presentation.
Read Announcement- Drug:
- ORIC-114
- Announced Date:
- November 6, 2025
- Indication:
- Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Announcement
ORIC Pharmaceuticals, Inc. announced the publication of a peer-reviewed research paper in Cancer Research, a journal of the American Association for Cancer Research.
AI Summary
ORIC published a peer-reviewed Cancer Research study on enozertinib, a brain-penetrant, oral EGFR exon 20 inhibitor.
The paper describes enozertinib’s discovery as an irreversible inhibitor with high kinome selectivity against EGFR exon 20 mutations.
EGFR mutations drive many NSCLC cases, and brain metastases are common, creating a need for selective, brain-penetrant therapies.
Preclinical data show enozertinib’s potency, selectivity, brain penetration, and anti-tumor activity in intracranial lung cancer models with atypical EGFR mutations.
A patient case showed sustained complete responses in both systemic and brain metastases in an NSCLC patient with an EGFR exon 20 insertion. To ORIC’s knowledge, it is the only exon 20 inhibitor to achieve both systemic and CNS complete responses.
Melissa Junttila, ORIC’s head of biology, said these findings support enozertinib’s potential, with more clinical data expected later this year and in mid-2026.
Read Announcement- Drug:
- ORIC-114
- Announced Date:
- January 13, 2025
- Indication:
- Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Announcement
ORIC Pharmaceuticals announced that the company has entered into a supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-114, a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor, in combination with subcutaneous (SC) amivantamab, Johnson & Johnson's fully-human EGFR-MET bispecific antibody, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
AI Summary
ORIC Pharmaceuticals has announced a new supply agreement with Janssen Research & Development, a Johnson & Johnson company, to evaluate a combination therapy for advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Under this agreement, ORIC will conduct a study using its experimental drug ORIC-114—a brain penetrant, orally available, and irreversible EGFR/HER2 inhibitor—in combination with Janssen’s subcutaneous (SC) amivantamab, a fully human EGFR-MET bispecific antibody. This trial focuses on first-line treatment to assess whether the combination can improve outcomes by targeting both systemic and intracranial disease, particularly since brain metastases are common in these patients. ORIC will sponsor the trial while Janssen provides SC amivantamab, and the study aims to determine the optimal dosing and early signs of safety and effectiveness in this patient group.
Read Announcement
