Gold Declines by More Than 1%; Darden Reports Disappointing Earnings
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 18 2025
0mins
Source: Benzinga
U.S. Stock Market Performance: U.S. stocks saw gains, with the Dow Jones up 0.37%, NASDAQ rising 1.07%, and S&P 500 increasing by 0.62%. Information technology shares led the rise, while materials stocks fell by 0.7%.
Darden Restaurants Financial Results: Darden Restaurants reported disappointing first-quarter earnings of $1.97 per share, missing the expected $2.00, and quarterly sales of $3.004 billion, below the $3.040 billion estimate.
Notable Stock Movements: 89bio, Inc. shares surged 86% after an acquisition announcement, while Intel Corporation's stock rose 27% following a partnership with NVIDIA. Conversely, Replimune Group, Inc. shares dropped 39% due to FDA feedback evaluation.
Economic Indicators: U.S. initial jobless claims fell to 231,000, lower than expected, and the Philadelphia Fed Manufacturing Index rose to +23.2, marking its highest level since January.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy REPL?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on REPL
Wall Street analysts forecast REPL stock price to rise
7 Analyst Rating
4 Buy
3 Hold
0 Sell
Moderate Buy
Current: 8.470
Low
3.00
Averages
11.43
High
18.00
Current: 8.470
Low
3.00
Averages
11.43
High
18.00
About REPL
Replimune Group, Inc. is a clinical-stage biotechnology company engaged in the development of novel oncolytic immunotherapies. Its proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to ignite a systemic response. Its lead product candidate, RP1, is a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF. Its lead indication for its lead product candidate, RP1, is the potential treatment of advanced melanoma. Its pipeline product candidates include RP2 and RP3. It has designed its RP2 product candidate to express an anti-CTLA-4 antibody-like protein intended to block the inhibition of the immune response.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Replimune's Cancer Immunotherapy Shows Promising Early Data
- Tumor Shrinkage Observed: Replimune noted tumor shrinkage in both injected and non-injected lesions during the RP2 trial, indicating that RP2 can trigger a systemic anti-tumor immune response, thus providing new treatment hope for patients.
- Impressive Efficacy Data: The response rate for RP2 alone was 19%, while the combination with Nivolumab achieved a 19.1% response rate, with nearly 49% of patients maintaining disease control, showcasing the therapy's potential in treating advanced tumors.
- FDA Review Priority: The FDA has decided to prioritize the review of Replimune's application, citing a lack of treatment options for patients with advanced melanoma, reigniting market confidence after two previous rejections.
- Earnings Forecast and Market Reaction: Although a fourth-quarter loss of $0.72 per share is expected, slightly better than last year's $0.82, Replimune's stock surged 13% in pre-market trading, reflecting investor optimism about the company's future performance.
See More
Replimune Receives FDA Support for BLA Resubmission
- BLA Resubmission Progress: Replimune Group Inc. announced an agreement with the FDA to resubmit its Biologics License Application (BLA) for RP1 in advanced melanoma within days, which is expected to boost the company's stock price and enhance market confidence.
- Patent Filing Success: Clearmind Medicine Inc. successfully filed a patent in Japan for its 5-Methoxy-2-aminoindan (MEAI) aimed at treating depression, strengthening its global intellectual property portfolio and potentially laying the groundwork for future market expansion.
- Clinical Data Update: C4 Therapeutics Inc. is set to present updated clinical data on Cemsidomide on June 12, 2026, which is anticipated to positively impact its application in treating multiple myeloma, further increasing investor interest in the company.
- Optimistic Financial Outlook: Alpha Teknova Inc. reported total revenue of $11.1 million for Q1 2026, a 13% increase year-over-year, and expects full-year revenue to range between $42 million and $44 million, indicating strong growth potential in the bioreagent market.
See More
Replimune Presents Final Data for RP2 Oncolytic Therapy
- Clinical Trial Results: At the 2026 American Society of Clinical Oncology annual meeting, Replimune presented final Phase 1 data for RP2 alone and in combination with nivolumab, showing a 19.0% objective response rate in 85 heavily pretreated patients with advanced solid tumors, indicating its potential in treating late-stage cancers.
- Combination Therapy Efficacy: The combination of RP2 with nivolumab achieved a 19.1% objective response rate and a disease control rate of 48.9%, highlighting the clinical significance of this combination in improving patient survival, particularly in uveal melanoma patients.
- Good Tolerability: Both RP2 monotherapy and its combination with nivolumab demonstrated good tolerability with no unexpected toxicities and no Grade 4 or 5 treatment-related adverse events, indicating a safety advantage for this therapy.
- Immune Response Mechanism: The study revealed that RP2 reprograms the tumor microenvironment from
See More
Replimune Reports Landmark Three-Year Survival Data
- Clinical Trial Results: Replimune presented three-year survival data from its IGNYTE trial at the 2026 ASCO annual meeting, revealing that nearly half of treated patients were alive at three years, underscoring the durability and effectiveness of the treatment.
- Survival and Response Rates: The combination therapy achieved a median overall survival of 32.9 months, with an objective response rate of 33.6% and a median duration of response of 24.8 months, indicating that almost 45% of responders maintained their response at three years, showcasing broad applicability among patients.
- Safety Profile Analysis: The regimen demonstrated consistent survival benefits across key patient subgroups and maintained a favorable safety profile, primarily consisting of Grade 1-2 side effects with no new safety signals, further enhancing its clinical application potential.
- Company Development Strategy: Founded in 2015, Replimune is advancing its RPx platform to develop versatile oncolytic immunotherapies that can be used alone or in combination with other treatments, marking significant innovation progress in the field of cancer therapy.
See More
Replimune Secures FDA Approval to Resubmit RP1 Application
- FDA Resubmission: Replimune successfully convinced the FDA to reconsider its Biologics License Application for RP1, despite two prior rejections, thanks to intervention from White House officials, highlighting government concern for terminally ill patients.
- Positive Market Reaction: Following the announcement of an agreement with the FDA to resubmit the RP1 application, Replimune's shares surged on Friday, reflecting increased investor confidence in the treatment, particularly in combination with Bristol Myers' nivolumab.
- New Data Submission: Replimune plans to present new data not previously shared with the FDA in its upcoming application, which could significantly influence the review outcome and provide new support for RP1's approval.
- Regulatory Investigation Findings: Although the White House requested an investigation into the previous rejections, the report found no procedural errors, indicating that the FDA's review process remains stringent, and Replimune must provide compelling evidence in its new application to secure approval.
See More
Replimune Secures FDA Agreement, Shares Surge 80%
- FDA Prioritization: Replimune has reached an agreement with the FDA to resubmit its Biologics License Application for RP1, with the FDA treating this as an urgent matter, highlighting the significant unmet needs of advanced melanoma patients and potentially accelerating the review process.
- Stock Surge: Following the agreement, Replimune's shares surged 80% on Friday, breaching the 200-day moving average and marking the largest single-day gain in over seven months, reflecting renewed investor optimism regarding the company's prospects.
- Regulatory Uncertainty: The FDA had previously rejected the application twice, leading CEO Sushil Patel to criticize the review process as inconsistent, which forced the company to cut jobs and scale back U.S. manufacturing operations, indicating the substantial impact of regulatory environments on business operations.
- Leadership Change Impact: The agreement comes after a leadership shakeup at the FDA, with former head Marty Makary stepping down, which has drawn widespread criticism regarding the agency's handling of drug reviews, further exacerbating industry concerns about delays in the approval of new treatments.
See More
Replimune's Cancer Immunotherapy Shows Promising Early Data
- Tumor Shrinkage Observed: Replimune noted tumor shrinkage in both injected and non-injected lesions during the RP2 trial, indicating that RP2 can trigger a systemic anti-tumor immune response, thus providing new treatment hope for patients.
- Impressive Efficacy Data: The response rate for RP2 alone was 19%, while the combination with Nivolumab achieved a 19.1% response rate, with nearly 49% of patients maintaining disease control, showcasing the therapy's potential in treating advanced tumors.
- FDA Review Priority: The FDA has decided to prioritize the review of Replimune's application, citing a lack of treatment options for patients with advanced melanoma, reigniting market confidence after two previous rejections.
- Earnings Forecast and Market Reaction: Although a fourth-quarter loss of $0.72 per share is expected, slightly better than last year's $0.82, Replimune's stock surged 13% in pre-market trading, reflecting investor optimism about the company's future performance.
See More
Replimune Receives FDA Support for BLA Resubmission
- BLA Resubmission Progress: Replimune Group Inc. announced an agreement with the FDA to resubmit its Biologics License Application (BLA) for RP1 in advanced melanoma within days, which is expected to boost the company's stock price and enhance market confidence.
- Patent Filing Success: Clearmind Medicine Inc. successfully filed a patent in Japan for its 5-Methoxy-2-aminoindan (MEAI) aimed at treating depression, strengthening its global intellectual property portfolio and potentially laying the groundwork for future market expansion.
- Clinical Data Update: C4 Therapeutics Inc. is set to present updated clinical data on Cemsidomide on June 12, 2026, which is anticipated to positively impact its application in treating multiple myeloma, further increasing investor interest in the company.
- Optimistic Financial Outlook: Alpha Teknova Inc. reported total revenue of $11.1 million for Q1 2026, a 13% increase year-over-year, and expects full-year revenue to range between $42 million and $44 million, indicating strong growth potential in the bioreagent market.
See More
Replimune Presents Final Data for RP2 Oncolytic Therapy
- Clinical Trial Results: At the 2026 American Society of Clinical Oncology annual meeting, Replimune presented final Phase 1 data for RP2 alone and in combination with nivolumab, showing a 19.0% objective response rate in 85 heavily pretreated patients with advanced solid tumors, indicating its potential in treating late-stage cancers.
- Combination Therapy Efficacy: The combination of RP2 with nivolumab achieved a 19.1% objective response rate and a disease control rate of 48.9%, highlighting the clinical significance of this combination in improving patient survival, particularly in uveal melanoma patients.
- Good Tolerability: Both RP2 monotherapy and its combination with nivolumab demonstrated good tolerability with no unexpected toxicities and no Grade 4 or 5 treatment-related adverse events, indicating a safety advantage for this therapy.
- Immune Response Mechanism: The study revealed that RP2 reprograms the tumor microenvironment from
See More
Replimune Reports Landmark Three-Year Survival Data
- Clinical Trial Results: Replimune presented three-year survival data from its IGNYTE trial at the 2026 ASCO annual meeting, revealing that nearly half of treated patients were alive at three years, underscoring the durability and effectiveness of the treatment.
- Survival and Response Rates: The combination therapy achieved a median overall survival of 32.9 months, with an objective response rate of 33.6% and a median duration of response of 24.8 months, indicating that almost 45% of responders maintained their response at three years, showcasing broad applicability among patients.
- Safety Profile Analysis: The regimen demonstrated consistent survival benefits across key patient subgroups and maintained a favorable safety profile, primarily consisting of Grade 1-2 side effects with no new safety signals, further enhancing its clinical application potential.
- Company Development Strategy: Founded in 2015, Replimune is advancing its RPx platform to develop versatile oncolytic immunotherapies that can be used alone or in combination with other treatments, marking significant innovation progress in the field of cancer therapy.
See More
Replimune Secures FDA Approval to Resubmit RP1 Application
- FDA Resubmission: Replimune successfully convinced the FDA to reconsider its Biologics License Application for RP1, despite two prior rejections, thanks to intervention from White House officials, highlighting government concern for terminally ill patients.
- Positive Market Reaction: Following the announcement of an agreement with the FDA to resubmit the RP1 application, Replimune's shares surged on Friday, reflecting increased investor confidence in the treatment, particularly in combination with Bristol Myers' nivolumab.
- New Data Submission: Replimune plans to present new data not previously shared with the FDA in its upcoming application, which could significantly influence the review outcome and provide new support for RP1's approval.
- Regulatory Investigation Findings: Although the White House requested an investigation into the previous rejections, the report found no procedural errors, indicating that the FDA's review process remains stringent, and Replimune must provide compelling evidence in its new application to secure approval.
See More
Replimune Secures FDA Agreement, Shares Surge 80%
- FDA Prioritization: Replimune has reached an agreement with the FDA to resubmit its Biologics License Application for RP1, with the FDA treating this as an urgent matter, highlighting the significant unmet needs of advanced melanoma patients and potentially accelerating the review process.
- Stock Surge: Following the agreement, Replimune's shares surged 80% on Friday, breaching the 200-day moving average and marking the largest single-day gain in over seven months, reflecting renewed investor optimism regarding the company's prospects.
- Regulatory Uncertainty: The FDA had previously rejected the application twice, leading CEO Sushil Patel to criticize the review process as inconsistent, which forced the company to cut jobs and scale back U.S. manufacturing operations, indicating the substantial impact of regulatory environments on business operations.
- Leadership Change Impact: The agreement comes after a leadership shakeup at the FDA, with former head Marty Makary stepping down, which has drawn widespread criticism regarding the agency's handling of drug reviews, further exacerbating industry concerns about delays in the approval of new treatments.
See More
