Monday, March 21, 2022 7:17:07 PM
NeuroSense surges on FDA nod to study ALS candidate in healthy subjects
Mar. 21, 2022 9:03 AM ETNeuroSense Therapeutics Ltd. (NRSN)
By: Dulan Lokuwithana, SA News Editor
Israel-based, clinical-stage biotech, NeuroSense Therapeutics (NASDAQ:NRSN) has added ~32% in the pre-market Monday after announcing that the U.S. Food and Drug Administration (FDA) greenlighted a pharmacokinetic study for its lead asset, PrimeC in healthy adult subjects.
An oral combination of FDA-approved drugs, ciprofloxacin, and celecoxib, PrimeC is designed to target amyotrophic lateral sclerosis (ALS).
With its Investigational New Drug (IND) application, NeuroSense (NRSN) has sought the FDA nod to run a pharmacokinetic study to evaluate the effects of food on the bioavailability of PrimeC as opposed to the bioavailability of co-administered ciprofloxacin and celecoxib. The Phase 1 study is set to involve 12 healthy adults in the US.
NeuroSense (NRSN) has already completed a successful Phase IIa trial for the candidate, and a Phase IIb global study is expected to start in Q2 2022.
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Recent NRSN News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/22/2024 01:25:59 PM
- NeuroSense Reports Additional Positive Results from its ALS Phase 2b PARADIGM Trial • PR Newswire (US) • 02/21/2024 01:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/13/2024 06:20:37 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/13/2024 03:14:40 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/07/2024 02:38:16 PM
- NeuroSense Regains Compliance with NASDAQ Minimum Bid Price Rule • PR Newswire (US) • 02/07/2024 02:27:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/09/2024 01:49:26 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/09/2024 01:48:26 PM
- NeuroSense Recaps Positive 2023 Achievements Including Statistically Significant Slowing of Disease Progression in Phase 2b ALS Trial of PrimeC and Highlights Anticipated 2024 Catalysts • PR Newswire (US) • 01/09/2024 01:45:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/27/2023 10:03:10 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/27/2023 10:01:06 PM
- NeuroSense Announces Receipt of Nasdaq Notice Regarding Minimum Stockholders' Equity Requirement • PR Newswire (US) • 12/27/2023 10:00:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/21/2023 01:45:08 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/14/2023 09:30:17 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/14/2023 02:41:42 PM
- NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial • PR Newswire (US) • 12/14/2023 02:24:00 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/05/2023 08:15:03 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/05/2023 08:00:13 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 12/05/2023 01:01:03 PM
- NeuroSense's Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints • PR Newswire (US) • 12/05/2023 01:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 12/05/2023 05:15:29 AM
- NeuroSense to Report Phase 2b ALS Topline Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints on December 5, 2023 • PR Newswire (US) • 12/04/2023 09:01:00 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 12/04/2023 11:17:09 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/28/2023 02:00:04 PM
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