BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) Stock Soars 85% in a Month: Here is Why
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) is known for being a leading developer of adult stem-based therapies for neurodegenerative diseases. Over recent weeks, the company’s stock has been one of the notable gainers. On Thursday, the stock continued its ascent as it ended up with gains of 27% and took its gains for the past month to as much as 85%.
On November 20, BrainStorm Cell came into focus after it announced that it had been granted a meeting by the United States Food and Drug Administration for discussion about the regulatory path for its product NurOwn. The product in question is meant for the treatment of those with ALS (amyotrophic lateral sclerosis). The company revealed that the meeting would be held on December 6, 2023.
“We are pleased that the FDA has granted this expedited in-person meeting to discuss the best path forward for NurOwn for ALS,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “Our proposed plan is to conduct a confirmatory Phase 3b trial, and it is important that we are aligned with the agency on the expected requirements for re-submitting a biologics license application. We believe that reaching an agreement through a SPA on the overall protocol design and the adequacy of addressing the requirements for marketing approval will be a key step in positioning the company for success and potentially de-risking the program. We are grateful for the FDA’s support and quick response in granting this meeting, as we remain committed to our goal of making NurOwn available to the ALS community.”
At the meeting, BrainStorm Cell Therapeutics would have a discussion on the plans for a SPA (Special Protocol Assessment) with the FDA so as to reach an agreement on the overall product design ahead of the confirmatory Phase 3 trial. The President and Chief Executive Officer of the company, Chaim Lebovits, spoke about the development as well. He noted that everyone at the company was pleased at the fact that the regulatory agency had granted an in-person meeting to discuss the path forward for NurOwn for treating ALS.
On November 14, the company was in focus after it announced its financial results for the third fiscal quarter, which ended on September 30, 2023. The net loss for the period was $1.2 million, which was a significant reduction from the net loss of $6.9 million in the prior-year period. The cash, short-term bank deposits, and cash equivalents at the end of the quarter totaled $1.4 million. In the period ended on December 31, 2022, the company reported $3 million under the same overhead.