NeuroSense Therapeutics Ltd. (NRSN) stock surged in the current market after announcing a green signal of IND from FDA for PrimeC. NRSN values $6.32, gaining more than 304% from the previous closing price. NRSN stock closed at $1.56 at the end of the last trading session. NRSN stock volume traded in the previous trading session was around 955.63K shares. The current market cap of the company is about $33.76 million.
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NRSN Got Approval for IND from FDA
The FDA has given NeuroSense Therapeutics Ltd. (NRSN) approval to begin a pharmacokinetic study of PrimeC in healthy adult volunteers. A unique fixed-dose combination of ciprofloxacin and celecoxib, PrimeC is a revolutionary extended-release oral formulation. PrimeC is intended to effectively target many major ALS pathways, including motor neuron degeneration, inflammation, iron buildup, and defective RNA regulation.
The FDA and the European Medicines Agency (EMA) designated PrimeC as an orphan drug. NeuroSense has completed just one Phase IIa clinical trial, which met all of its primary safety and effectiveness goals, including a reduction of respiratory and functional decline and statistically significant improvements in ALS-related biomarkers indicative of PrimeC activation. An improved dosage and a unique upgraded formulation will be studied in a Phase IIb double-blind placebo-controlled global research starting Q2 2022.
NRSN CEO’s Remarks
Our Phase IIa clinical trial demonstrated that PrimeC is a unique therapy with the power to affect patients with ALS and address a $3 billion market in need of more effective treatment, according to NeuroSense CEO Alon Ben-Noon. Our pharmacokinetic research under FDA IND aims to collect further data on PrimeC’s bioavailability in relation to food consumption in healthy persons as we prepare to begin our Phase IIb investigation within the next few months. A novel therapy for ALS is something we’re thrilled to be working on, and we’re dedicated to improving the lives of those affected by this debilitating illness.
NRSN is gaining significantly in the market after getting approval from the FDA of IND for PrimeC. Any pharmaceutical or biotech companies in the later stage of the drug or treatment development are likely to get approval for its use on a mass level. As soon as they get approval from FDA, its stock skyrockets in the market. The same happened with NRSN today.