Annuncio • Apr 01

ORIC Pharmaceuticals, Inc. Reports Selection Of Rinzimetostat RP3D In Combination With Darolutamide For Himalayas-1 Phase 3 Global Study With Dose Optimization Data Supporting Its Potential Best-In-Disease Profile

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). Rinzimetostat 400 mg once daily was selected as RP3D in combination with darolutamide for Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC, with initiation expected in the first half of 2026. At a median follow-up of approximately 5 months, landmark 5-month rPFS of 84% is consistent with competitor PRC2 inhibitor and substantially better than standard of care therapies in mCRPC. Highly differentiated, potential best-in-disease safety profile, with significantly lower frequency and severity of adverse events, nearly all Grade 1 or 2, and far fewer treatment modifications than competitor regimens. Patients were previously treated with a median of two prior lines of therapy, including abiraterone, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. 18 patients were treated with 400 mg of rinzimetostat once daily and 15 patients were treated with 600 mg of rinzimetostat once daily, both in combination with the standard dose of darolutamide at 600 mg twice daily. At the 400 mg dose, rinzimetostat in combination with darolutamide continues to be well tolerated and demonstrates a safety profile supportive of long-term administration and sustained patient adherence. As of the January 16, 2026 data cutoff, the vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and AR inhibition. The most common TRAEs were fatigue (39%; 17% Grade 1 and 22% Grade 2), diarrhea (22%; 17% Grade 1 and 6% Grade 2) and nausea (22%; all Grade 1). A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. The 600 mg dose of rinzimetostat in combination with darolutamide was associated with a modestly higher rate of adverse events and dose modifications. In a broader dataset of post-ARPI (androgen receptor pathway inhibitor) patients (n=72, inclusive of the post-abiraterone patients), the safety and tolerability profile was consistent with the post-abiraterone cohort. To support the selection of the recommended Phase 3 dose in accordance with the FDA's Project Optimus initiative, the company conducted a comprehensive exposure-response (E-R) analysis in over 100 patients across both the single-agent and combination data evaluating the relationship between rinzimetostat drug exposure versus efficacy and safety outcomes. The analysis demonstrated that 400 mg and 600 mg once daily provided comparable efficacy. In contrast, the E-R analysis identified statistically significant relationships between higher drug exposure and toxicities as well as increased rates of treatment modifications, clearly favoring the 400 mg dose on the basis of safety. Based on these findings 400 mg once daily in combination with darolutamide has been selected as the RP3D for rinzimetostat. As of March 6, 2026, radiographic progression-free survival (rPFS) was assessed in 18 efficacy-evaluable patients. PSA responses were assessed in a subset of 15 patients with at least one post-baseline assessment as of the January 16, 2026 clinical cutoff. ctDNA molecular response was evaluated in 14 patients with detectable ctDNA at baseline. Early efficacy data, including landmark rPFS rates, PSA reductions and ctDNA responses, are suggestive of meaningful and durable clinical benefit for rinzimetostat in combination with darolutamide compared to competitor data and historical outcomes with approved therapies. Rinzimetostat 400 mg once daily in combination with darolutamide demonstrated compelling efficacy across multiple endpoints: With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi, Jevtana, Taxotere, and Pluvicto. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%. 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction. The company expects to initiate the Himalayas-1 global Phase 3 registrational trial in mCRPC patients previously treated with abiraterone in the first half of 2026. This proposed trial will enroll approximately 600 patients from over 250 sites in over 20 countries, randomized 1:1 to receive the RP3D of 400 mg QD rinzimetostat in combination with darolutamide versus physician’s choice of an AR inhibitor or chemotherapy. The primary endpoint is rPFS, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes. In the US, the annual incidence of mCRPC patients previously treated with abiraterone is approximately 17,000, with an estimated addressable market of greater than $3,500 million and total global addressable market of $7,000 million. This market lacks oral, well-tolerated therapies with meaningful efficacy. Rinzimetostat 400 mg QD plus darolutamide is currently being evaluated in a food effect cohort. Thus far, there does not appear to be a significant food effect, consistent with previous single agent studies. Furthermore, as of March 6, 2026, early efficacy and safety are consistent with fasted results, with two confirmed PSA50 responses and one confirmed PSA90 response in the first five patients dosed, and all TRAEs reported being Grade 1 with a single Grade 2 TRAE. The company is also evaluating additional prostate cancer populations for future potential Phase 3 trials in mCRPC and mCSPC. Early data from rinzimetostat in 19 patients with mCRPC previously treated with AR inhibitors demonstrated compelling landmark rPFS rates of 93%, 85%, and 85% at 3, 4, and 5 months, respectively, with a median follow-up of 4.8 months. Rinzimetostat is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an ARPI and up to one prior chemotherapy. The primary objective of the trial is to determine the RP3D, and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

Biotechs Crescita del settore	-14.59%
Tasso di crescita dei ricavi	n/a
Rendimento del capitale proprio	-36.81%
Margine netto	n/a
Ultimo aggiornamento sugli utili	30 Jun 2026

Data	Utili	Spese G+A	Spese di R&S
30 Jun 26	-140	34	122
31 Mar 26	-135	33	117
31 Dec 25	-129	33	110
30 Sep 25	-135	32	116
30 Jun 25	-137	31	118
31 Mar 25	-133	30	117
31 Dec 24	-128	29	114
30 Sep 24	-120	28	107
30 Jun 24	-111	27	98
31 Mar 24	-102	26	88
31 Dec 23	-101	26	85
30 Sep 23	-93	24	77
30 Jun 23	-93	24	69
31 Mar 23	-90	25	64
31 Dec 22	-89	25	62
30 Sep 22	-91	25	62
30 Jun 22	-85	25	60
31 Mar 22	-85	24	62
31 Dec 21	-79	22	57
30 Sep 21	-84	20	52
30 Jun 21	-91	18	48
31 Mar 21	-81	16	40
31 Dec 20	-74	13	36
30 Sep 20	-54	11	31
30 Jun 20	-35	9	28
31 Mar 20	-30	7	25
31 Dec 19	-27	6	23
31 Dec 18	-21	3	19

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/08/07 16:37
Prezzo dell'azione a fine giornata	2026/08/07 00:00
Utili	2026/06/30
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Analista	Istituzione
Colleen Kusy	Baird
Prakhar Agrawal	Cantor Fitzgerald & Co.
Yigal Nochomovitz	Citigroup Inc

ORIC Pharmaceuticals Performance degli utili passati

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Oric Pharmaceuticals Initiates Himalayas-1 Global Phase 3 Trial in Patients with Mcrpc Previously Treated with Abiraterone

Insufficient new directors

ORIC Pharmaceuticals, Inc., Annual General Meeting, Jun 18, 2026

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ORIC Pharmaceuticals, Inc. Reports Selection Of Rinzimetostat RP3D In Combination With Darolutamide For Himalayas-1 Phase 3 Global Study With Dose Optimization Data Supporting Its Potential Best-In-Disease Profile

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President recently bought €1.2m worth of stock

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ORIC Pharmaceuticals, Inc. Provides Corporate Update

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New 90-day high: €30.20

New 90-day high: €22.80

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New 90-day low: €17.00

ORIC Pharmaceuticals, Inc. announced that it expects to receive funding from a group of investors

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