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NRSN 資訊
NRSN 事件
NeuroSense Targets December 2026 for New Drug Submission
NeuroSense Therapeutics announced that it is targeting December 2026 for the filing of a New Drug Submission with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis. The filing target follows the successful finalization of the Pre-NDS process with Health Canada and the associated meeting minutes. The discussions with Health Canada provided alignment regarding the content and structure of the submission. Health Canada has also indicated that it has no concerns with the company's proposed filing timeline and advised the company to target early December.
NeuroSense Files New Drug Submission for PrimeC to Treat ALS
NeuroSense Therapeutics announced it intends to proceed with the filing of a New Drug Submission, or NDS, to Health Canada for PrimeC for the treatment of amyotrophic lateral sclerosis, or ALS, following a constructive Pre-New Drug Submission meeting with the Agency. NeuroSense expects to complete and file the submission in the coming months. The recent Pre-NDS meeting was held following the generation of substantial additional evidence from the Phase 2b PARADIGM clinical program. NeuroSense presented Health Canada with a comprehensive update to its proposed NDS package, including achievement of the study's prespecified primary TDP-43 biomarker endpoint, long-term survival, external natural history analyses, and additional mechanistic and translational data generated since the Company's initial regulatory interaction. The meeting also included an expert clinical perspective from a leading Canadian ALS specialist, as well as additional supportive analyses that will form part of the planned NDS package, further strengthening the growing body of evidence supporting PrimeC's potential in ALS. NeuroSense plans to continue to work with Health Canada as it prepares the NDS filing, and looks forward to providing further updates as the submission advances.
NeuroSense's PrimeC ALS Study Successfully Meets Primary Efficacy Endpoint
NeuroSense Therapeutics announced that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis has successfully met its primary efficacy endpoint, demonstrating a statistically significant reduction in TDP-43 levels compared to placebo. This is the first randomized, double-blind, placebo-controlled clinical study to demonstrate a treatment-associated reduction in TDP-43 in people living with ALS. The analysis was performed using the NeuroDex ExoSORT procedure, an immunoaffinity-based methodology that selectively isolates neuron-derived extracellular vesicles. This approach enables measurement of neuron-derived TDP-43, providing a CNS-relevant signal that can be distinguished from TDP-43 released by non-neuronal cells and peripheral tissues. TDP-43 is the defining pathological hallmark of ALS, present in more than 97% of cases, and is widely recognized as a central driver of disease progression. The observed reduction in TDP-43 provides biological evidence that PrimeC is engaging a core disease mechanism.
NeuroSense Secures Korean Patent for PrimeC
NeuroSense Therapeutics announced that the Korean Intellectual Property Office has issued Korean Patent Number 10-2969898 covering the composition of PrimeC, the company's lead drug candidate for the treatment of amyotrophic lateral sclerosis. The granted patent claims cover key aspects of PrimeC, including its proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for the treatment of ALS. The patent is expected to provide patent protection for such aspects of PrimeC in South Korea through 2042.
Sun Pharma to Acquire Organon for $14 Per Share
Catch up on the weekend's top five stories with this list compiled by The Fly: 1) President Trump said on social media: "I just cancelled the trip of my representatives going is Islamabad, Pakistan, to meet with the Iranians. Too much time wasted on traveling, too much work! Besides which, there is tremendous infighting and confusion within their 'leadership.' Nobody knows who is in charge, including them. Also, we have all the cards, they have none! If they want to talk, all they have to do is call!!!" 2) Sun Pharmaceutical Industries and Organon & Co. (OGN) announced that they have entered into a definitive agreement under which Sun Pharma will acquire all outstanding shares of Organon for $14.00 per share in an all-cash transaction with an enterprise valuation of $11.75B. Transaction Summary: Sun Pharma will acquire 100% of Organon's issued and outstanding shares for cash. Sun Pharma plans to fund the acquisition through a combination of available cash resources and committed financing from banks. The transaction will be effected by a merger of Organon with a subsidiary of Sun Pharma, with Organon surviving the merger. The transaction is expected to close in early 2027, subject to customary conditions, including regulatory approvals and Organon stockholder approval. The transaction has been approved by the Boards of Directors of both Sun Pharma and Organon and is subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. 3) Oracle's (ORCL) $16B financing for a giant data center in Michigan has finally wrapped after months of negotiations with investors, Davide Barbuscia, Caleb Mutua, and Natalie Wong of Bloomberg reports. Bank of America (BAC) sold $14B of bonds tied to the project. Pimco bought $10B of the bonds that priced Friday, while other investors bought the remaining debt, people with knowledge of the matter told Bloomberg. 4) NeuroSense (NRSN) announced on Friday that Dr. Ferenc Tracik will step down from his role as the company's Chief Medical Officer, effective April 27. Tracik will continue to support the company as an independent advisor, NeuroSense added. "Dr. Tracik's departure is not the result of any disagreement with the Company on matters relating to its operations, policies, or practices," it said. 5) Medtronic (MDT) announced the U.S. Food and Drug Administration granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of VT, providing an expedited regulatory pathway for the technology.
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