GLSI Stock Boosts After Latest FDA Update
The latest update from the FDA has led to heavy trading in GLSI stock. As of the time of writing, more than 4 million shares have changed hands. The average daily volume is 149,000 shares. While the company has increased its share price by over 25 percent as of Tuesday, it is still down more than 54% from the beginning of the year. It has remained a strong buy as it continues to work towards obtaining FDA approval for its GP2 immunotherapy.
GLSI has 100% success preventing breast cancer recurrence
The CEO of GLSI Stock bought the drug rights from the U.S. government, according to a video presentation on 2020 Benzinga. All clinical trials for GLSI have been done at the MD Anderson Cancer Research facility, which is one of the best in the world at fighting cancer. This fact is significant because most biotech companies don’t have the resources that MD Anderson does.
The stock has already seen dramatic price movements this afternoon, with shares soaring nearly 1,000%. However, volatility has prevailed in after-hours trading. Despite the company’s positive news, there are risks involved with GLSI Stock. Its shares have been halted nearly a dozen times due to high volatility. However, investors should keep in mind that this is only a tiny percentage of its overall market cap.
In December, Greenwich LifeSciences (GLSI) released data from its Phase IIb clinical trial showing a 100% success rate in preventing breast cancer recurrence. These findings were positive and caused GLSI Stock to surge. Recently, however, GLSI gave us hints of what lies ahead. It’s awaiting new data from the American Association for Cancer Research, finalizing a clinical-trial protocol, and shipping GP2 to the first clinical sites.
GLSI’s GP2 is an immunotherapy designed to prevent the recurrence of breast cancer
In a Phase IIb clinical trial, GLSI’s GP2 generated GP2-specific immune responses in patients with advanced breast cancer, leading to no recurrence in the HER2/neu 3+ population. These findings suggest that GP2 immunotherapy may have a similar mechanism of action. The study also revealed that peak immunity was achieved after six months, as measured by the DTH skin test and Dimer Binding Assay. Future trials of GP2 immunotherapy may include the HER2/neu 1-2+ population.
The company has published two posters at the San Antonio Breast Cancer Symposium, one of which is a GP2 phase 2b trial data analysis of the immunotherapy’s ability to prevent the recurrence of patients with advanced breast cancer. These findings are particularly encouraging given the fact that GP2 could reduce recurrence rates to zero within five years, which represents a considerable clinical advantage over existing therapies. Furthermore, a Phase 3 clinical trial is expected to begin in 2021, as well as separate studies in additional cancer indications.
The company’s CEO, Snehal Patel, has been with the company since 2010. She previously worked in the Bayer biotechnology industry and has expertise in operations and business development. The company’s only drug candidate, GP2, recently completed a Phase 2b trial in women with advanced breast cancer and has no recurrences. The company expects to begin Phase 3 trials of the drug in early 2021. The company has raised at least $25.8 million in its IPO, including the CEO and many private investors.
GLSI is a clinical stage biopharmaceutical company
The stock of Greenwich LifeSciences (GLSI) surged by almost 1,000% on Wednesday after the company announced positive Phase 2b trial results. The results showed a decrease in breast cancer recurrences and a potent immune response in women. The company plans to move to Phase 3 trials by 2021. Its CEO and Board Member, Snehal Patel, explains the significance of the news.
The company is currently focusing on developing a cancer immunotherapy that targets the GP2 transmembrane peptide of the HER2/neu protein. In a multicenter Phase IIb clinical trial, GP2 prevented recurrences in patients who had undergone breast cancer surgery. The Company plans to continue the trial in patients with other HER2/neu-expressing cancers.