BrainStorm Cell Therapeutics (BCLI) Stock Spikes On FDA Trial Approval


BrainStorm Cell Therapeutics (NASDAQ: BCLI)

BrainStorm Cell Therapeutics stock (BCLI) is spiking at the market open, with shares realizing an 11% gain (10:08est) after BCLI announced that the company has concluded a successful end-of-phase-2 meeting with the FDA and will commence its phase III stem cell trial to treat adult patients with amyotrophic lateral sclerosis (ALS). Trade Ideas was quick to alert the CNA Finance team as to the spike, leading us to cover the story.

BCLI’s NurOwn Trial

BCLI’s phase III trial for NurOwn will be conducted at multiple sites in both the United States and Israel and is expected to begin enrolling patients in the second quarter of 2017.

BCLI has already demonstrated that NurOwn is safe and well tolerated in treated patients and is working to leverage off of the safety data to enhance its phase III program that may position BCLI to deliver an innovative and disease modifying treatment for patients suffering from ALS.

Additionally, BCLI said that it expects to submit an application in Israel to allow patients access to NurOwn under the country’s Hospital Exemption program. If the application is granted, BCLI would have access to an expedited pathway for approval and open the door to partnership opportunities with medical centers in Israel, allowing patients to be treated with NurOwn for a fee.

What Now For BCLI?

With the FDA approval to advance the trial, and with the potential for the Hospital Exemption likely, BCLI anticipates commencing treatments in patients as early as the second half of 2017.

If the stem cell therapy proves successful in duplicating its successful phase II results, the phase III trial may lead to a lucrative market, treating the approximately 5,600 people in the United States that are diagnosed with the debilitating disease each year.

Of late, the stem cell industry has received additional recognition as a viable application to treat a host of diseases. With the momentum in order, funding for clinical trials is becoming more available to companies like BCLI, as both the market and general public get a better understanding of the stem cell technology. The increased availability of government and private funding makes companies like BCLI even more valuable in the early stages of development, as investors acknowledge that attracting funding and partnerships is not as difficult as it may have been in years past.

The CNA Finance team will keep investors appraised of any new developments in the BCLI phase III trial.

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[Image Courtesy of Pixabay]


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