Greenwich LifeSciences Receives FDA Approval for First Commercial Lot of GP2
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
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Source: Newsfilter
- FDA Approval Milestone: The FDA has approved the first commercial lot of GP2 for use in the FLAMINGO-01 clinical trial, capable of producing approximately 200,000 doses, marking a significant step in de-risking the BLA filing process.
- Clinical Trial Expansion: The FLAMINGO-01 trial has screened over 1,000 patients, with all 250 patients in the non-HLA-A*02 arm fully enrolled, showing an approximately 80% reduction in recurrence rates compared to the Phase IIb trial, laying a solid foundation for future market launch.
- Production Capacity Enhancement: The company plans to manufacture at least two additional GP2 lots over the next three years to ensure comprehensive clinical and manufacturing data for FDA review, potentially securing up to 12 years of market exclusivity.
- International Market Strategy: Greenwich LifeSciences aims to submit the same manufacturing data to regulatory agencies in Europe, the UK, and Canada, with plans to expand FLAMINGO-01 to 150 clinical trial sites for an efficient transition to product launch.
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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: 28.590
Low
45.00
Averages
47.50
High
50.00
Current: 28.590
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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Greenwich LifeSciences (GLSI) Gains FDA Approval for GP2, Stock Rises 27.8%
- 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.
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