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-114 and ORIC-944. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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- Drug:
- ORIC-114
- Announced Date:
- April 15, 2024
- Indication:
- Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications
Announcement
ORIC Pharmaceuticals, Inc announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications.
AI Summary
ORIC Pharmaceuticals, Inc. announced that the dose escalation portion of their Phase 1b trial of ORIC-114 has been completed. This trial focused on patients with advanced solid tumors who have EGFR and HER2 exon 20 alterations or HER2 amplifications. The promising results allowed the company to select two provisional Phase 2 dose levels of 80 mg and 120 mg taken once daily. These doses are now being further evaluated in expansion cohorts that target non-small cell lung cancer (NSCLC) patients with EGFR exon 20 mutations (in patients who have not received an EGFR exon 20 inhibitor), HER2 exon 20, or EGFR atypical mutations.
Additionally, an extension cohort has been initiated to assess ORIC-114 in patients with first-line, treatment-naïve EGFR exon 20 NSCLC. Updated data from the trial are expected to be reported in the first half of 2025.
Read Announcement
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:
- 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
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