FDA and BrainStorm to Discuss Regulatory Path for ALS Therapy
December 18, 2023
🌥️Trending News
BRAINSTORM ($NASDAQ:BCLI): BrainStorm Cell Therapeutics Inc. is a biotechnology company that develops innovative therapies for neurodegenerative diseases such as ALS. The company has recently announced that it will be holding a BrainStorm session with the US Food and Drug Administration (FDA) to discuss the regulatory path for its ALS therapy. This meeting is significant as it could potentially pave the way for the approval of the therapy, which would be a major breakthrough for patients suffering from ALS.
The meeting will be an opportunity for the FDA to provide feedback on the clinical data and safety findings related to the therapy, as well as discuss the specific regulatory pathway that would be required for approval. If successful, this could represent a major milestone in the development of the therapy and a major benefit for ALS patients worldwide.
Market Price
The FDA and BrainStorm Cell Therapeutics will hold discussions regarding the regulatory pathway for its ALS therapy, NurOwn. On Monday, the stock of BrainStorm opened at $0.2 and closed at $0.2, slightly up by 0.1% from its prior closing price. This indicates investors are keeping an eye on the developments associated with the FDA meeting and the potential approval of its ALS therapy. The upcoming meeting between the two parties could be a major breakthrough for BrainStorm Cell Therapeutics and the ALS community as a whole. Live Quote…
About the Company
Income Snapshot
Below shows the total revenue, net income and net margin for BCLI. More…
| Total Revenues | Net Income | Net Margin |
| 0 | -16.63 | – |
Cash Flow Snapshot
Below shows the cash from operations, investing and financing for BCLI. More…
| Operations | Investing | Financing |
| -21.82 | 3.04 | 15.86 |
Balance Sheet Snapshot
Below shows the total assets, liabilities and book value per share for BCLI. More…
| Total Assets | Total Liabilities | Book Value Per Share |
| 5.68 | 8.26 | -0.05 |
Key Ratios Snapshot
Some of the financial key ratios for BCLI are shown below. More…
| 3Y Rev Growth | 3Y Operating Profit Growth | Operating Margin |
| 0.0% | – | – |
| FCF Margin | ROE | ROA |
| – | 416.7% | -237.0% |
Analysis
At GoodWhale, we analyzed BRAINSTORM CELL THERAPEUTICS’ financials and identified that they are strong in liquidity and weak in asset, dividend, growth, and profitability. Our Star Chart gave them a health score of 2/10, which means they are less likely to safely ride out any crisis without the risk of bankruptcy. We classified BRAINSTORM CELL THERAPEUTICS as an ‘elephant’, a type of company that is rich in assets after deducting off liabilities. Investors who are looking for a stable long-term investment in companies with a strong balance sheet may be interested in investing in BRAINSTORM CELL THERAPEUTICS. More…
Peers
The competition in the cell therapy market is heating up as more and more companies are vying for a piece of the pie. Among the major players are Brainstorm Cell Therapeutics Inc, TCR2 Therapeutics Inc, Adicet Bio Inc, and Iovance Biotherapeutics Inc. All of these companies are working on cutting-edge cell therapies that have the potential to change the way we treat diseases.
– TCR2 Therapeutics Inc ($NASDAQ:TCRR)
TCR2 Therapeutics Inc is a clinical-stage immuno-oncology company, which focuses on the development of novel T cell therapies for the treatment of cancer. The company has a market cap of $54.51M and a ROE of -24.78%. TCR2 is developing two novel T cell therapies, which are designed to target different types of cancer. The first therapy, which is in clinical trials, targets solid tumors, while the second therapy is in preclinical development and targets blood cancers.
– Adicet Bio Inc ($NASDAQ:ACET)
Adicet Bio Inc is a clinical-stage biopharmaceutical company focused on the development of immune cell therapies for cancer and other diseases. The company’s most advanced product candidate is a T cell therapy for solid tumors, which is currently in a Phase 1/2 clinical trial. The company has a market cap of $871.6M as of 2022 and a Return on Equity of -11.39%.
– Iovance Biotherapeutics Inc ($NASDAQ:IOVA)
Iovance Biotherapeutics Inc is a late-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products based on tumor-infiltrating lymphocyte (TIL) technology.
The company’s lead product candidate, lifileucel, is a TIL therapy that is in Phase III clinical trials for the treatment of metastatic melanoma and recurrent or metastatic squamous cell carcinoma of the head and neck. Iovance is also evaluating lifileucel in a Phase II clinical trial for the treatment of cervical cancer.
Iovance has a market cap of 1.19B as of 2022. The company’s Return on Equity is -56.45%.
Summary
BrainStorm Cell Therapeutics is a biotechnology company focused on developing innovative adult stem cell therapies for neurodegenerative diseases. The company has recently been in discussions with the US Food and Drug Administration (FDA) to establish a regulatory path forward for its potential therapeutic treatment based on Mesenchymal Stem Cells for the treatment of Amyotrophic Lateral Sclerosis (ALS). Investors considering BrainStorm as an opportunity should analyze the safety, efficacy, and cost of the therapy compared to existing treatments, as well as the company’s financials and intellectual property portfolio.
