FDA Events for Brainstorm Cell Therapeutics (BCLI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Brainstorm Cell Therapeutics (BCLI).
Over the past two years, Brainstorm Cell Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NurOwn. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NurOwn - FDA Regulatory Timeline and Events
NurOwn is a drug developed by Brainstorm Cell Therapeutics for the following indication: Progressive Multiple Sclerosis (MS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NurOwn
- Announced Date:
- July 8, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc today acknowledged that the U.S. Food and Drug Administration's (FDA) consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for amyotrophic lateral sclerosis (ALS).
AI Summary
BrainStorm Cell Therapeutics Inc. acknowledged that the U.S. Food and Drug Administration’s (FDA) consideration of a Citizen Petition presents a critical opportunity to reaffirm the potential of NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). The Citizen Petition, submitted under the Federal Food, Drug, and Cosmetic Act, calls for a new review of the data supporting NurOwn, offering a chance for an impartial evaluation of the therapy’s efficacy and safety. BrainStorm stands firmly behind the scientific integrity of its data and supports using rigorous, evidence-based reviews to explore rare disease treatments. The company respects the FDA’s independent process and welcomes the renewed scrutiny as a means to strengthen the confidence in NurOwn’s potential. This action comes as BrainStorm continues its clinical efforts, including its planned Phase 3b trial, to advance safe treatment options for individuals with ALS.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- June 16, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS).
AI Summary
BrainStorm Cell Therapeutics recently announced encouraging survival data from 10 ALS patients in its Expanded Access Program for NurOwn®, an autologous MSC-NTF cell therapy. The study involved participants who had completed a Phase 3 trial, tracking their survival from the onset of ALS symptoms. Remarkably, 9 out of 10 participants lived more than five years—a notable finding since only about 10% of ALS patients typically reach that milestone. The median survival time from symptom onset was 6.8 years, with patients surviving between 6 to 7 years overall. Only one participant, who chose elective euthanasia, did not meet the five-year benchmark. These results suggest that NurOwn may have a meaningful impact on extending survival in ALS patients and support further research, including the upcoming Phase 3b trial, to better assess the therapy’s benefits in fighting ALS.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- May 27, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc announced that it has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn® for its upcoming clinical trial.
AI Summary
BrainStorm Cell Therapeutics Inc has signed a Letter of Intent (LOI) with Minaris Advanced Therapies to manufacture its cell therapy, NurOwn®, for an upcoming clinical trial. Through this strategic partnership, Minaris, a global contract development and manufacturing organization specializing in cell and gene therapies, will manage the technology transfer and production process at its advanced facility in Allendale, New Jersey. This collaboration is designed to support BrainStorm’s planned Phase 3b clinical trial by ensuring that NurOwn® is produced to the highest quality standards.
The partnership with Minaris enhances BrainStorm’s U.S. manufacturing capabilities and highlights the company’s commitment to advancing innovative therapies for neurodegenerative diseases. By combining expertise in cell therapy manufacturing with BrainStorm’s cutting-edge research, this collaboration plays a critical role in moving NurOwn® closer to clinical success.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- May 19, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase 3b clinical trial of NurOwn® (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).
AI Summary
BrainStorm Cell Therapeutics Inc has announced that the U.S. Food and Drug Administration (FDA) has cleared the company to begin its Phase 3b clinical trial for NurOwn®, an investigational therapy using autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). The trial’s design was approved under a Special Protocol Assessment, which confirms that the study’s endpoints and statistical plans are suitable for a future Biologics License Application submission. This clearance marks a significant milestone for both BrainStorm and the ALS community.
The upcoming trial will enroll about 200 participants at major academic medical centers. It includes a 24-week double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants receive NurOwn®. The primary focus of the study is to measure changes in ALS severity using the ALS Functional Rating Scale-Revised from baseline to week 24, setting the stage for further advances in ALS treatment.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- April 29, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced the acceptance of new pharmacogenomic data for oral presentation of new findings on NurOwn® at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting, to take place from May 6 - 10, 2025 in New Orleans.
AI Summary
BrainStorm Cell Therapeutics Inc. announced that new pharmacogenomic data related to its investigational therapy, NurOwn®, has been accepted for an oral presentation at the ISCT 2025 Annual Meeting in New Orleans, scheduled for May 6‑10, 2025. The data focus on the influence of the UNC13A genotype on treatment responses in patients with amyotrophic lateral sclerosis (ALS). Researchers found that genetic differences may affect clinical outcomes, offering important insights into how personalized medicine approaches could better target ALS therapies.
This study, which will be presented on May 8, 2025, highlights a first-of-its-kind analysis from a Phase 3 trial that explores the pharmacogenomic aspects of NurOwn®. BrainStorm is excited to share these breakthrough findings with the scientific community as it continues its mission to develop effective, tailored treatments for ALS.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- April 10, 2025
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced the submission of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) for NurOwn®, the company's autologous mesenchymal stem cell therapy for amyotrophic lateral sclerosis (ALS).
AI Summary
BrainStorm Cell Therapeutics Inc. has taken a significant step by submitting an IND amendment to the FDA for NurOwn®, its autologous mesenchymal stem cell therapy aimed at treating amyotrophic lateral sclerosis (ALS). This submission is a key milestone that sets the stage for initiating a Phase 3b clinical trial and demonstrates the company’s commitment to developing innovative treatments for neurodegenerative diseases.
The IND amendment supports the upcoming trial designed in close collaboration with the FDA, which is expected to enroll around 200 ALS patients to rigorously assess the therapy’s effectiveness and safety. BrainStorm’s CEO noted that this step is crucial for advancing NurOwn® toward regulatory approval, potentially offering new hope for ALS patients. The company remains optimistic about a rapid review, which will help accelerate progress in providing a much-needed treatment option for this challenging condition.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- October 7, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced its participation in the 2024 Maxim Healthcare Virtual Summit. Chaim Lebovits, President and CEO of BrainStorm, will join Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group, for a Fireside Chat at 9:30 a.m. ET on October 15.
AI Summary
BrainStorm Cell Therapeutics Inc. announced its participation in the 2024 Maxim Healthcare Virtual Summit. At the event, President and CEO Chaim Lebovits will take part in a Fireside Chat with Jason McCarthy, Ph.D., Senior Managing Director and Head of Biotechnology Research at Maxim Group. The discussion is scheduled for 9:30 a.m. ET on October 15 and will focus on providing insights related to the upcoming Phase 3b clinical trial for NurOwn®, the company’s investigational cell therapy for ALS.
This session offers a valuable chance to engage with the investment community and share updates on BrainStorm’s progress in battling neurodegenerative diseases. The Maxim Healthcare Virtual Summit, running from October 15 to 17, brings together professionals from biotechnology, diagnostics, and medical devices, promising a platform for key discussions around emerging trends in the healthcare industry.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- July 1, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced that that it will hold a mid-year corporate update to discuss recent positive developments in the NurOwn® program on Monday, July 8, at 8:00 a.m. U.S. Eastern Time
AI Summary
BrainStorm Cell Therapeutics Inc. announced a mid-year corporate update to share positive new developments in its NurOwn® program. The event is scheduled for Monday, July 8, at 8:00 a.m. U.S. Eastern Time. During this update, the company’s leadership will discuss key progress in their work with stem cell therapeutics aimed at treating neurodegenerative diseases.
President and CEO Chaim Lebovits will lead the update alongside newly appointed COO Hartoun Hartounian, PhD, while Chief Development Officer Bob Dagher, MD, will join for a Q&A session. Investors are encouraged to submit questions in advance before Friday, July 5. This mid-year update emphasizes BrainStorm’s commitment to providing transparency regarding the promising developments in the NurOwn® program.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- June 26, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm's Phase 3b clinical trial for NurOwn®, its investigational therapy for amyotrophic lateral sclerosis (ALS).
AI Summary
BrainStorm Cell Therapeutics announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects for its Phase 3b clinical trial of NurOwn®, an investigational therapy for amyotrophic lateral sclerosis (ALS). This progress marks a key step in finalizing preparations for the trial, ensuring that all CMC-related concerns are addressed with the FDA. The agreement came after an in-person Type C meeting, where the company clarified intricate aspects of its manufacturing process, particularly given the complexities associated with cell therapy products. BrainStorm’s commitment to this close collaboration with the FDA highlights its determination to drive forward the pivotal Phase 3b trial, aiming to secure future approval of NurOwn to help meet the unmet needs of ALS patients.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- May 20, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics announced that , will present new biomarker data suggesting that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn®).
AI Summary
BrainStorm Cell Therapeutics announced that it will present new biomarker data at the Annual ALS Drug Development Summit. The data suggests that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn®). The findings come from the Expanded Access Program and Phase 3 trial, where patients receiving continuous NurOwn showed a significant reduction in neurofilament light (NfL), a key marker of nerve damage in ALS. Specifically, participants in the trial who received NurOwn had decreasing NfL levels over time, indicating a possible slowing of neurodegeneration. Even patients who initially received a placebo experienced stabilization and later improvements in NfL values once they began receiving NurOwn. BrainStorm hopes that these positive results will be confirmed in a planned Phase 3b study, supporting the potential benefits of extended treatment for ALS patients.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- April 10, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell Therapeutics Inc. announced the peer-reviewed publication of Phase 3 biomarker data in Muscle and Nerve. The paper, entitled "Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes", can be found online through the Muscle and Nerve website.
AI Summary
BrainStorm Cell Therapeutics Inc. announced that its Phase 3 biomarker study in ALS has been published in the journal Muscle and Nerve. The published paper, titled “Debamestrocel multimodal effects on biomarker pathways in amyotrophic lateral sclerosis are linked to clinical outcomes,” is now available online through the Muscle and Nerve website. The study analyzed 45 cerebrospinal fluid biomarkers and found that treatment with debamestrocel (NurOwn®) led to significant changes in 64% of them, suggesting benefits on both anti-inflammatory and neuroprotective fronts.
Researchers identified key biomarkers, including neurofilaments light (NfL), LAP/TGFb1, and Galectin-1, as predictive of clinical outcomes in treated patients. These findings provide important insights into how debamestrocel may help reduce nerve cell damage and inflammation in ALS, reinforcing its potential as a promising treatment for the disease.
Read Announcement- Drug:
- NurOwn
- Announced Date:
- April 6, 2024
- Estimated Event Date Range:
- April 9, 2024 - April 9, 2024
- Target Action Date:
- April 9, 2024
- Indication:
- Progressive Multiple Sclerosis (MS)
Announcement
BrainStorm Cell announced today that it will hold a conference call to update shareholders on the NurOwn® program tomorrow, April 9, at 8:00 AM Eastern Time.Therapeutics Inc.
AI Summary
BrainStorm Cell Therapeutics Inc. announced that it will host a conference call and webcast tomorrow, April 9, at 8:00 AM Eastern Time to update shareholders on its NurOwn® program. The update will be led by top executives, including President and CEO Chaim Lebovits, Co-CEO Stacy Lindborg, PhD, and Chief Development Officer Bob Dagher, MD. They will provide the latest insights on the progress of NurOwn®, a promising cellular therapy designed to treat neurodegenerative diseases like ALS. Interested investors and other stakeholders are invited to join the call using the provided link or phone numbers. Additionally, a replay of the conference call will be available until April 24, 2024, giving participants another chance to review the information and ask their questions about the program's advancements.
Read Announcement
Brainstorm Cell Therapeutics FDA Events - Frequently Asked Questions
As of now, Brainstorm Cell Therapeutics (BCLI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Brainstorm Cell Therapeutics (BCLI) has reported FDA regulatory activity for NurOwn.
The most recent FDA-related event for Brainstorm Cell Therapeutics occurred on July 8, 2025, involving NurOwn. The update was categorized as "Provided Update," with the company reporting: "BrainStorm Cell Therapeutics Inc today acknowledged that the U.S. Food and Drug Administration's (FDA) consideration of a Citizen Petition requesting a new review of the data supporting NurOwn will provide a critical opportunity to reaffirm its potential as therapy for amyotrophic lateral sclerosis (ALS)."
Currently, Brainstorm Cell Therapeutics has one therapy (NurOwn) targeting the following condition: Progressive Multiple Sclerosis (MS).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:BCLI) was last updated on 7/10/2025 by MarketBeat.com Staff
