Greenwich LifeSciences (GLSI) Secures FDA Clearance, Stock Rises Over 16%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 22 2026
0mins
Source: stocktwits
- Clinical Advancement: Greenwich LifeSciences has made significant progress in developing its breast cancer immunotherapy, advancing the FLAMINGO-01 trial aimed at reducing recurrence risk in specific breast cancer patients, showcasing the company's potential in the biotech sector.
- FDA Manufacturing Clearance: The company announced that the FDA has reviewed and authorized its first commercially produced batch of the GP2 drug product for the FLAMINGO-01 trial, providing crucial support for subsequent clinical trials and enhancing the product's market outlook.
- Stock Reaction: Following this positive news, Greenwich LifeSciences' stock rose over 16% in Thursday's premarket trading, reflecting market optimism about the company's future developments and potentially attracting more investor interest.
- Strategic Implications: This FDA approval not only lays the groundwork for the company's further development in breast cancer treatment but may also enhance its competitiveness in the biopharmaceutical industry, driving future financing and partnership opportunities.
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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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