Brainstorm Cell Therapeutics

Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. It focuses on utilizing the patients own bone marrow stem cells to generate neuron-like cells that may provide an effective treatment initially for amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis and spinal cord injury. The company was founded on September 22, 2000 and is headquartered in New York, NJ.

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Brainstorm Cell Therapeutics reports financials, faces credibility challenges on unblinding

Brainstorm Cell Therapeutics showcased financial investment in R&D and highlighted positive testimonials for NurOwn's ALS treatment.
Maintaining blinding for trial integrity and emphasizing industry best practices demonstrate commitment to ethical standards.
Challenges include balancing individual requests for unblinding with overall trial integrity and addressing concerns around credibility.
Opportunities lie in enhancing communication, addressing unblinding concerns, and leveraging community support for market access.

Brainstorm Cell Therapeutics advances NurOwn towards regulatory approval amidst financial constraints

Brainstorm Cell Therapeutics showcased progress in regulatory milestones, clinical data analysis, and organizational enhancements during the Q1 2023 Earnings Call
While demonstrating strengths in clinical efficacy and strategic leadership appointments, the company faces challenges in financial constraints and the need for further clarity in certain areas
Opportunities lie in advancing towards regulatory approval, leveraging strategic hires for growth, and exploring diversification through international expansion and innovation

BrainStorm Cell Therapeutics readies for FDA review of NurOwn

BrainStorm Cell Therapeutics is actively preparing for the FDA review of NurOwn, with a focus on commercial readiness and engaging with physicians. Despite financial challenges, the company raised funds and is optimistic about future growth. BrainStorm's expansion into new indications and potential collaborations highlight strategic opportunities for the company.

Brainstorm Cell Therapeutics adjusts strategy post BLA withdrawal

Brainstorm Cell Therapeutics navigated challenges with a strategic realignment and capital constraints.
The company is focusing on partnerships, exosome technology, and advancing their ALS program.
Opportunities lie in raising capital, exploring collaborations, and leveraging exosome technology.
Seeking regulatory de-risking and diversification through exosome tech are key strategies.

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Brainstorm Cell Therapeutics, Inc. is a biotechnology company, which develops and commercializes autologous cellular therapies for the treatment of neurodegenerative diseases, including Amyotrophic Lateral Sclerosis, Progressive Multiple Sclerosis, Alzheimer's disease, and other neurodegenerative diseases. Its pipeline, NurOwn proprietary cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells to secrete high levels of neurotrophic factors, modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival, and improve neurological function. The company was founded by Irit Arbel on September 22, 2000 and is headquartered in New York, NY.

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces it has filed a class action lawsuit on behalf of purchasers of the securities of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) between August 15, 2022 and September 27, 2023, both dates inclusive (the “Class Period”). The lawsuit seeks to recover damages for Brainstorm Cell investors under the federal securities laws. To join the Brainstorm Cell class action, go to https://rosenlegal.com/submit-form/?case.

EQUITY ALERT: Rosen Law Firm Files Securities Class Action Lawsuit Against Brainstorm Cell Therapeutics Inc. – BCLI

LOS ANGELES, CA / ACCESSWIRE / October 30, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Brainstorm Cell Therapeutics Inc. ("BrainStorm" or "the Company") (NASDAQ:BCLI) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Brainstorm Cell Therapeutics Inc. and Encourages Investors with Losses to Contact the Firm

-  Resource consumption will be reduced by 50% to accelerate ALS development -  Plans underway for registrational Phase 3b U.S. clinical trial for NurOwn in ALS NEW YORK , Oct. 24, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced a strategic realignment to enable accelerated development of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). This realignment is designed to 1) support the company plans to conduct a double-blind, placebo-controlled Phase 3b U.S. clinical trial for NurOwn in ALS with an open-label extension and 2) continue to publish data from NurOwn's Phase 3 clinical trial on: biomarkers, long-term safety and survival, and the Expanded Access Program, providing transparency around NurOwn data and progressing ALS drug development.

BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn® for the Treatment of ALS

-  Path forward for ALS is a registrational Phase 3b U.S. clinical trial - -  Biologics License Application to be withdrawn without prejudice - -  Conference call and webcast at 8:30am ET today - NEW YORK , Oct. 18, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the US Food and Drug Administration (FDA) has invited the Company to request an expedited face-to-face meeting to discuss the path forward for NurOwn® as a treatment for amyotrophic lateral sclerosis (ALS). BrainStorm remains committed to the ALS Community and is actively exploring the next steps in support of NurOwn, including publication of emerging clinical data and development of a protocol for an additional clinical study.

BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS

LOS ANGELES, CA / ACCESSWIRE / October 17, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Brainstorm Cell Therapeutics Inc. ("BrainStorm" or "the Company") (NASDAQ:BCLI) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Brainstorm Cell Therapeutics Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / October 11, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Brainstorm Cell Therapeutics Inc. ("BrainStorm" or "the Company") (NASDAQ:BCLI) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Brainstorm Cell Therapeutics Inc. and Encourages Investors with Losses to Contact the Firm

NEW YORK , Oct. 7, 2023 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) resulting from allegations that Brainstorm Cell may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Brainstorm Cell securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

ROSEN, A TOP RANKED LAW FIRM, Encourages Brainstorm Cell Therapeutics Inc. Investors to Inquire About Securities Class Action Investigation - BCLI

NEW YORK , Sept. 29, 2023 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Brainstorm Cell Therapeutics Inc.  (NASDAQ: BCLI) resulting from allegations that Brainstorm Cell may have issued materially misleading business information to the investing public.

BCLI LOSS ALERT: ROSEN, A GLOBAL AND LEADING LAW FIRM, Encourages Brainstorm Cell Therapeutics Inc. Investors to Inquire About Securities Class Action Investigation - BCLI

NEW YORK--(BUSINESS WIRE)--WHY: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) resulting from allegations that Brainstorm Cell may have issued materially misleading business information to the investing public. SO WHAT: If you purchased Brainstorm Cell securities you may be entitled to compensation without payment of any out of pocket fees or costs through.

ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Brainstorm Cell Therapeutics Inc. Investors to Inquire About Securities Class Action Investigation – BCLI

Shares of BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) plummeted by 56% in early trading after the company's treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, received the red light from advisors to the US Food and Drug Administration (FDA). The Cellular, Tissue, and Gene Therapies Advisory Committee voted 17 to 1, with one abstention, against the efficacy of BrainStorm's cell therapy, NurOwn.

BrainStorm shares plunge 56% after FDA advisers reject ALS cell therapy

BrainStorm Cell Therapeutics Inc. BCLI, -8.35% shares fell 56% premarket on Thursday after advisors to the U.S. Food and Drug Administration on Wednesday gave a thumbs-down to the company's investigational treatment for amyotrophic lateral sclerosis (ALS). The FDA advisors voted that the treatment, the mesenchymal stem cell therapy NurOwn, did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

Brainstorm Cell Therapeutics shares fall more than 50% after FDA advisors vote down ALS treatment

NEW YORK , Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn®, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS

A U.S. Food and Drug Administration advisory committee voted against a treatment from BrainStorm Cell Therapeutics BCLI, -8.35% for amyotrophic lateral sclerosis, or ALS.

FDA panel rejects ALS treatment from Brainstorm Cell Therapeutics

The U.S. health regulator's advisers on Wednesday voted against BrainStorm Cell Therapeutics' therapy for patients with amyotrophic lateral sclerosis (ALS), a neurodegenerative disease.

US FDA panel votes against BrainStorm's ALS therapy

FDA advisory committee (ADCOM) meeting to review NurOwn® for ALS NEW YORK , Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that Nasdaq has halted trading of the Company's common stock.

BrainStorm Cell Therapeutics Stock Trading Halted Today

Shares of BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) fell almost 40% on Monday morning after Food and Drug Administration (FDA) staff reviewers expressed doubts over the safety and efficacy of the biotech's therapy NurOwn for neurogenerative disease amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Brainstorm's NurOwn is being reviewed by the FDA's Cellular, Tissue and Gene Therapies Advisory Committee on Wednesday, September 2023.

BrainStorm Cell shares fall as FDA reviewers raise doubts over effectiveness of ASL therapy

The U.S. Food and Drug Administration's staff reviewers raised concerns on Monday over the safety and efficacy of BrainStorm Cell Therapeutics' amyotrophic lateral sclerosis (ALS) therapy, sending the company's shares down 50% in premarket trading.

FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy

BCLI has completed a phase 3 trial in ALS. Despite not meeting the primary endpoint BCLI is still applying for approval and an AdCom meeting is scheduled for September 27. NurOwn was significantly better than placebo in the pre-specified subgroup of patients with earlier-stage ALS as well as in post-hoc analyses accounting for the "floor effect". Supportive biomarker data and Fast Track designation mean potential for accelerated approval (similar to the recently approved tofersen, which also did not meet the primary endpoint in its phase 3).

Brainstorm Cell Therapeutics: I Anticipate A Positive AdCom But There Are Major Risks

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and Chief Executive Officer Stacy Lindborg - Co-Chief Executive Officer Alla Patlis - Interim Chief Financial Officer Kirk Taylor - Executive Vice President and Chief Medical Officer Conference Call Participants Jason McCarthy - Maxim Group Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Second Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Q2 2023 Earnings Call Transcript

FDA advisory committee (ADCOM) meeting to discuss NurOwn® for Amyotrophic Lateral Sclerosis (ALS) scheduled for September 27, 2023 BrainStorm's Biologics License Application (BLA) for NurOwn has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023 Company prepares for ADCOM date presentation and builds resources for FDA review and decision Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , Aug. 14, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.

BrainStorm Cell Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update

NEW YORK , Aug. 7, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that it will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2023, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, August 14th.

BrainStorm to Announce Second Quarter 2023 Financial Results and Provide a Corporate Update

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NEW YORK , July 17, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) (the "Company"), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 4,054,055 shares of the Company's common stock and warrants to purchase up to an aggregate of 4,054,055 shares of common stock in a registered direct offering. Each share of common stock is being offered in the offering together with a warrant to purchase one share of common stock at an offering price of $1.85 per share.

Brainstorm Cell Therapeutics Announces Pricing of $7.5 Million Registered Direct Offering

Dr. Dagher has extensive biopharma industry expertise in the development and approval of treatments for challenging neurological and rare diseases NEW YORK , July 12, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the appointment of Bob Dagher, MD, as Executive Vice President and Chief Development Officer effective July 17, 2023. Dr. Dagher will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D.

BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer

New data presented this week at Gordon Research Conference Analysis reinforces NfL levels as predictive of ALS clinical outcomes NEW YORK , July 7, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, this week presented new biomarker data from the Phase 3 trial of its late-stage investigational ALS treatment, NurOwn at the 2023 ALS and Related Motor Neuron Diseases Gordon Research Conference. These data show that treatment with NurOwn significantly elevated markers of neuroprotection and lowered markers of neuroinflammation and neurodegeneration, including neurofilament light (NfL) over time compared to placebo in all trial participants.

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