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ORIC Stock Surges on Upbeat Initial Data From Prostate Cancer Study
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Shares of ORIC Pharmaceuticals (ORIC - Free Report) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer.
ORIC-944, in combination with AR inhibitors, J&J’s (JNJ - Free Report) Erleada (apalutamide) and Bayer’s (BAYRY - Free Report) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mCRPC).
ORIC Pharmaceuticals reported that the phase Ib study of ORIC-944 achieved “broad and deep” prostate-specific antigen (PSA) responses, which are important early response indicators in mCRPC.
Data From ORIC’s Prostate Cancer Study in Detail
The data readout is from 17 previously-treated mCRPC patients who were treated with either of the 400 mg, 600 mg, or 800 mg doses of ORIC-944 in combination with 240 mg of J&J’s Erleada once daily or with 600 mg of Bayer’s Nubeqa twice daily.
As of May 9, 2025, 59% (10 patients) showed a 50% drop in PSA levels (PSA50 response). Most of these responses were confirmed a month later, resulting in a confirmed PSA50 rate of 47% (8 patients), with one more patient’s response still awaiting confirmation. Additionally, 24% of patients (4 out of 17) showed a 90% drop in PSA levels (PSA90 response) and all of these were confirmed.
Year to date, ORIC shares have lost 26% compared with the industry’s 4.8% decline.
Image Source: Zacks Investment Research
ORIC Pharmaceuticals further clarified that PSA responses were seen at all dose levels of ORIC-944 and occurred at similar rates when combined with either J&J’s Erleada or Bayer’s Nubeqa. The study is continuing to test different dosage levels.
ORIC-944, in combination with the AR inhibitors, was overall well-tolerated and exhibited an acceptable safety profile. All treatment-related adverse events were mild to moderate in severity.
ORIC’s Next Steps in the Prostate Cancer Program
ORIC Pharmaceuticals expects to complete the phase Ib dose exploration part of the study by mid-2025. Subsequently, the company plans to test two potential recommended phase II doses for each drug combination in the second half of 2025 during the dose optimization phase.
Results from the dose optimization phase will help determine the best ORIC-944 dose to move forward with in combination with either J&J’s Erleada or Bayer’s Nubeqa. This selected dose will be used in the first global phase III study for mCRPC, which is expected to begin in the first half of 2026.
ORIC also announced a $125 million private placement, which is expected to provide enough funding to support operations into the second half of 2027, covering expenses through the anticipated primary endpoint data readout from the impending registrational phase III mCRPC study. The deal will close subject to the fulfillment of certain customary closing conditions.
Please note that J&J’s Erleada and Bayer’s Nubeqa are both currently approved for metastatic and non-metastatic prostate cancer indications.
Apart from ORIC-944, ORIC Pharmaceuticals’ clinical stage pipeline comprises another investigational candidate, ORIC-114, which is currently undergoing early to mid-stage development for several non-small-cell lung cancer indications.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 16.4%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.
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ORIC Stock Surges on Upbeat Initial Data From Prostate Cancer Study
Shares of ORIC Pharmaceuticals (ORIC - Free Report) surged more than 20% in the pre-market hours today after announcing potentially best-in-class preliminary efficacy and safety data from the ongoing early-stage study of its novel, once-daily candidate, ORIC-944, for prostate cancer.
ORIC-944, in combination with AR inhibitors, J&J’s (JNJ - Free Report) Erleada (apalutamide) and Bayer’s (BAYRY - Free Report) Nubeqa (darolutamide), is being evaluated in the phase Ib study for treating patients with metastatic castration-resistant prostate cancer (mCRPC).
ORIC Pharmaceuticals reported that the phase Ib study of ORIC-944 achieved “broad and deep” prostate-specific antigen (PSA) responses, which are important early response indicators in mCRPC.
Data From ORIC’s Prostate Cancer Study in Detail
The data readout is from 17 previously-treated mCRPC patients who were treated with either of the 400 mg, 600 mg, or 800 mg doses of ORIC-944 in combination with 240 mg of J&J’s Erleada once daily or with 600 mg of Bayer’s Nubeqa twice daily.
As of May 9, 2025, 59% (10 patients) showed a 50% drop in PSA levels (PSA50 response). Most of these responses were confirmed a month later, resulting in a confirmed PSA50 rate of 47% (8 patients), with one more patient’s response still awaiting confirmation. Additionally, 24% of patients (4 out of 17) showed a 90% drop in PSA levels (PSA90 response) and all of these were confirmed.
Year to date, ORIC shares have lost 26% compared with the industry’s 4.8% decline.
Image Source: Zacks Investment Research
ORIC Pharmaceuticals further clarified that PSA responses were seen at all dose levels of ORIC-944 and occurred at similar rates when combined with either J&J’s Erleada or Bayer’s Nubeqa. The study is continuing to test different dosage levels.
ORIC-944, in combination with the AR inhibitors, was overall well-tolerated and exhibited an acceptable safety profile. All treatment-related adverse events were mild to moderate in severity.
ORIC’s Next Steps in the Prostate Cancer Program
ORIC Pharmaceuticals expects to complete the phase Ib dose exploration part of the study by mid-2025. Subsequently, the company plans to test two potential recommended phase II doses for each drug combination in the second half of 2025 during the dose optimization phase.
Results from the dose optimization phase will help determine the best ORIC-944 dose to move forward with in combination with either J&J’s Erleada or Bayer’s Nubeqa. This selected dose will be used in the first global phase III study for mCRPC, which is expected to begin in the first half of 2026.
ORIC also announced a $125 million private placement, which is expected to provide enough funding to support operations into the second half of 2027, covering expenses through the anticipated primary endpoint data readout from the impending registrational phase III mCRPC study. The deal will close subject to the fulfillment of certain customary closing conditions.
Please note that J&J’s Erleada and Bayer’s Nubeqa are both currently approved for metastatic and non-metastatic prostate cancer indications.
Apart from ORIC-944, ORIC Pharmaceuticals’ clinical stage pipeline comprises another investigational candidate, ORIC-114, which is currently undergoing early to mid-stage development for several non-small-cell lung cancer indications.
Oric Pharmaceuticals, Inc. Price and Consensus
Oric Pharmaceuticals, Inc. price-consensus-chart | Oric Pharmaceuticals, Inc. Quote
ORIC’s Zacks Rank & Stock to Consider
ORIC Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Amarin (AMRN - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 16.4%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.