Brainstorm Cell Therapeutics I Stock Price, News & Analysis

BrainStorm Cell Therapeutics (NASDAQ: BCLI) submitted a Type A Meeting Request to the FDA to address a refusal to file letter regarding its New Biologics License Application for NurOwn® in treating ALS. The meeting is expected within 30 days of receipt. The refusal letter points to issues related to chemistry, manufacturing, controls, and clinical data. CEO Chaim Lebovits emphasizes the importance of this meeting to advance NurOwn and anticipates a clear path toward an FDA Advisory Committee Meeting, which is crucial for therapy approval.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) reported its third-quarter financial results for 2022, revealing a net loss of approximately $6.9 million, compared to $5.3 million in Q3 2021. The company announced plans to request a Type A meeting with the FDA to address a recent refusal to file letter for its Biologics License Application (BLA) for NurOwn in ALS treatment. In clinical updates, promising biomarker analyses from ongoing trials were shared, highlighting NurOwn's potential efficacy in ALS and progressive MS.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) received a refusal to file letter from the FDA concerning its New Biologics License Application (BLA) for NurOwn, aimed at treating ALS. The FDA suggested that BrainStorm could request a Type A meeting to discuss the refusal. CEO Chaim Lebovits expressed disappointment but reaffirmed commitment to NurOwn's advancement. Despite the Phase 3 trial not meeting its primary outcome, some participants showed beneficial effects, indicating potential for further investigation and dialogue with the FDA.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) will host a conference call on November 14, 2022, at 8:00 a.m. ET, to discuss its third-quarter financial results and corporate updates for the period ending September 30, 2022. The call will feature CEO Chaim Lebovits and key executives who will answer questions from participants. Interested individuals can submit questions by November 10, 2022, and join via phone or a live webcast. BrainStorm is known for developing stem cell therapies for neurodegenerative diseases and is actively involved in clinical trials for its NurOwn® technology.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) presented new post-hoc analyses from the NurOwn Phase 3 ALS trial at the NEALS meeting, highlighting a clinically meaningful treatment effect despite the ALSFRS-R floor effect. The analyses accounted for participants with low baseline scores, revealing a treatment advantage in those with less advanced ALS. NurOwn treatment showed a nominally significant clinical response compared to placebo in pre-specified subgroups. These findings, alongside biomarker data indicating consistent treatment effects, bolster confidence in NurOwn's potential for ALS therapy.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced positive results from their NurOwn Phase 2 clinical trial on neuroprotective biomarkers in progressive multiple sclerosis (MS). An abstract titled 'NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS' will be presented at the 38th Congress of the European Committee for Treatment and Research in MS from October 26-28, 2022, in Amsterdam. The treatment showed robust increases in cerebrospinal fluid neuroprotective biomarkers, supporting the proposed mechanism of action and clinical outcomes.

BrainStorm Cell Therapeutics Inc. (BCLI) presented new biomarker analyses for NurOwn® at the 5th Annual ALS ONE Research Symposium, highlighting its efficacy in treating amyotrophic lateral sclerosis (ALS). The study indicates that NurOwn affects biomarkers related to neuroinflammation and neurodegeneration across varying disease progression levels. The data reveals a significant treatment effect in less advanced ALS patients, with a preserved functional score of 2 points over 28 weeks compared to placebo. These findings support the need for considering floor effects in clinical endpoint evaluations.

BrainStorm Cell Therapeutics (BCLI) announced the peer-reviewed publication of Phase 2 trial results for its treatment NurOwn in progressive multiple sclerosis (MS) in the Multiple Sclerosis Journal. The study, which included 20 participants, demonstrated NurOwn's safety and showed preliminary efficacy, with 19% of treated patients meeting responder criteria. Key endpoints exhibited significant improvements compared to matched control patients from the CLIMB registry. No major adverse events were reported, confirming NurOwn's favorable safety profile.

BrainStorm Cell Therapeutics (BCLI) has announced plans to submit a Biologics License Application (BLA) to the FDA for NurOwn®, a stem cell therapy aimed at treating amyotrophic lateral sclerosis (ALS). This decision follows new clinical analyses that reinforce the efficacy conclusions from the Phase 3 trial. Financial results for Q2 2022 reveal a net loss of $7.0 million, up from $6.3 million the previous year, with cash reserves decreasing to $12.2 million. The company emphasizes the significance of the upcoming regulatory submission and expresses gratitude towards the ALS community and investors.