The risk/return equation is most pronounced in the biotech space. That brings with it the potential for very painful drops should a drug’s development go awry. Fortunately, the equation works the other way too; bring home the goods, and the rewards are unlike those in any other segment of the stock market.
Case in point: NeuroSense Therapeutics (NRSN) shares quadrupled in Monday’s session after the company announced that the FDA had approved its Investigational New Drug (IND) application for PrimeC.
The drug is an oral mix of ciprofloxacin and celecoxib, both FDA-approved drugs; PrimeC is indicated to treat amyotrophic lateral sclerosis (ALS).
The regulatory body has given the go ahead for a pharmacokinetic study of PrimeC and the company now plans to initiate a Phase 1 trial. 12 healthy adults will participate in the study which will evaluate whether there is a food effect on PrimeC’s bioavailability vs. the co-administration of ciprofloxacin and celecoxib.
Recall, the candidate has already concluded a successful Phase 2a study, and a Phase 2b global trial is also slated to begin in Q2.
Maxim’s Naz Rahman expects data readouts in 2023 and anticipates a 2026 launch for the treatment.
ALS is a rare but very debilitating neurodegenerative condition for which existing treatments are insufficient. In the United States alone, it is estimated that between 16,500 and 23,000 people suffer from the disease. Despite the fact that existing treatment options are inadequate, by 2029, the global ALS market is expected to grow to more than $1 billion.
More in the here and now, 2022 looks set to be a busy year for the ALS space. Amylyx has a PDUFA date for its treatment AMX0035 on June 29 and an Advisory Committee Meeting (AdComm) date is set for March 30.
The decision could have repercussions for other ALS treatments. “An approval for AMX0035 may positively impact the ALS space as a whole including NeuroSense, and would validate a pathway where one highly positive potentially smaller Phase 2/3 study is sufficient for FDA approval,” the analyst explained.
Overall, Rahman rates NRSN shares a Buy, while his $7 price target leaves room for 38% growth in the year ahead. (To watch Rahman’s track record, click here)
Some stocks fly under Wall Street’s radar and NRSN appears to be one right now; currently Rahman’s review is the sole one on record. (See NRSN stock forecast on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
