Greenwich LifeSciences (GLSI) Receives FDA Approval for First Commercial GP2 Lot in Phase 3 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
0mins
Should l Buy GLSI?
Source: NASDAQ.COM
- FDA Approval Milestone: The FDA has approved Greenwich LifeSciences' first commercially manufactured lot of GP2 for the FLAMINGO-01 trial, marking a significant step toward a future Biologics License Application and highlighting the company's advancements in breast cancer immunotherapy.
- Clinical Trial Readiness: The newly approved GP2 vials are set to ship to 40 U.S. clinical sites in the coming weeks, expected to support the Phase 3 trial and future commercial readiness, thereby enhancing the company's competitive position in the market.
- Manufacturing Data Support: The company plans to produce additional finished GP2 lots to ensure sufficient clinical and manufacturing data for FDA review under the therapy's Fast Track designation, further propelling the BLA submission process.
- Significant Recurrence Reduction: Preliminary data from the FLAMINGO-01 trial indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series for 250 non-HLA-A*02 patients, showcasing the potential efficacy of the therapy and providing strong support for future market promotion.
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Analyst Views on GLSI
Wall Street analysts forecast GLSI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GLSI is 47.50 USD with a low forecast of 45.00 USD and a high forecast of 50.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 25.190
Low
45.00
Averages
47.50
High
50.00
Current: 25.190
Low
45.00
Averages
47.50
High
50.00
About GLSI
Greenwich LifeSciences, Inc. is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9-amino acid transmembrane peptide of the human epidermal growth factor receptor 2 (HER2) /neu protein, a cell surface receptor protein that is expressed in a variety of common cancers. It has commenced a Phase III clinical trial, Flamingo-01, an immunotherapy to prevent breast cancer recurrences. GP2 is delivered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) to induce GP2 peptide-specific immunity. GP2 treatment is administered via an intradermal injection by mixing GP2 peptide and GM-CSF at the time of administration. Its cancer immunotherapy seeks to stimulate an individual's immune system to selectively attack cancer cells while not affecting normal cells or to deliver immune system components to inhibit the spread of cancer.
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.
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- Clinical Trial Readiness: The newly approved GP2 vials are set to ship to 40 U.S. clinical sites in the coming weeks, expected to support the Phase 3 trial and future commercial readiness, thereby enhancing the company's competitive position in the market.
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- Leadership Enhancement: Oncolytics Biotech appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics, both bringing extensive late-stage clinical trial experience to drive complex multi-country registration trials.
- Impressive Clinical Data: In colorectal cancer patients, the combination of pelareorep and chemotherapy achieved a 33% response rate, significantly surpassing the traditional 6-11% response rate, showcasing its competitive edge and potential commercial value in the market.
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- Leadership Enhancement: Oncolytics Biotech announced the hiring of two key executives, John McAdory as EVP of Strategy and Operations and Yujun Wu as VP of Biostatistics, whose extensive experience will enhance the company's execution in complex multi-country registration trials.
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- Positive Market Reaction: Following the release of favorable clinical data, there was a surge in demand for Sarepta's shares, reflecting investor optimism about the biopharmaceutical sector's outlook, which may attract more capital into the industry.
- Industry Impact: Sarepta's success could inspire other biopharmaceutical companies to increase investments in rare disease research and development, thereby fostering innovation and growth across the sector.
- Investor Confidence Boost: The success story of Sarepta may bolster investor confidence in biotech stocks, particularly as market conditions continue to favor increased focus on the healthcare sector.
See More
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- FDA Approval: Greenwich LifeSciences announced that its first commercially manufactured GP2 lot received FDA approval for use in the FLAMINGO-01 Phase III clinical trial, marking a significant advancement in clinical research and expected to expedite preparations for a future Biologics License Application.
- Production Progress: The GP2 active ingredient was manufactured in an approved commercial facility in 2023, with vial filling completed in 2024 and stability programs initiated for all lots, ensuring product quality and compliance, thereby enhancing market confidence.
- Stock Performance: Currently, GLSI shares are trading 27.8% above their 20-day simple moving average and 112.5% above their 100-day simple moving average, indicating strong short-term and long-term growth momentum, with a 75.45% increase in stock price over the past 12 months.
- Market Momentum: While the RSI is in neutral territory, suggesting the stock is neither overbought nor oversold, the MACD is below its signal line, indicating some bearish pressure, prompting investors to monitor potential market fluctuations.
See More
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- FDA Approval Milestone: The FDA has approved Greenwich LifeSciences' first commercially manufactured lot of GP2 for the FLAMINGO-01 trial, marking a significant step toward a future Biologics License Application and highlighting the company's advancements in breast cancer immunotherapy.
- Clinical Trial Readiness: The newly approved GP2 vials are set to ship to 40 U.S. clinical sites in the coming weeks, expected to support the Phase 3 trial and future commercial readiness, thereby enhancing the company's competitive position in the market.
- Manufacturing Data Support: The company plans to produce additional finished GP2 lots to ensure sufficient clinical and manufacturing data for FDA review under the therapy's Fast Track designation, further propelling the BLA submission process.
- Significant Recurrence Reduction: Preliminary data from the FLAMINGO-01 trial indicates an approximately 80% reduction in recurrence rates after the Primary Immunization Series for 250 non-HLA-A*02 patients, showcasing the potential efficacy of the therapy and providing strong support for future market promotion.
See More
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- FDA Approval Milestone: Greenwich LifeSciences received FDA approval for the first commercially manufactured lot of its cancer drug candidate GP2, enabling its use in the FLAMINGO-01 trial, which is expected to significantly advance the company's breast cancer treatment efforts.
- Clinical Trial Results: In the FLAMINGO-01 trial, patients in the 250-member non-HLA-A*02 arm showed nearly an 80% reduction in recurrence rates after receiving GLSI-100 injections, providing a strong foundation for future market applications.
- Manufacturing Capability Boost: The company submitted data on the first three commercial lots of GP2 active ingredient manufactured in 2023 to regulators, with FDA approval providing crucial support for GLSI-100's marketing application and enhancing the company's competitive position in breast cancer treatment.
- International Expansion Plans: CEO Snehal Patel announced plans to start using the new GP2 vials at all 40 U.S. trial sites in the coming weeks, with intentions to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada, demonstrating the company's commitment to international markets.
See More
