- Axsome (AXSM) has met regulatory challenges recently but should turn things to the best.
- The marketplace hasn’t been friendly to this stocks lately.
The stock market might not have what it takes to attract individuals at the moment. Economic issues such as supply chain problems and inflation plus market volatility continue to repel many people from the market. Nevertheless, there are multiple gems within the market, and choosing the right firm can mean impressive rewards down the line.
Let us check whether this stock has what it takes to bounce back from recent struggles – Axsome Therapeutics (AXSM).
Few facets can ensure havoc on biotech firms besides supervisory denials for their pipeline candidates. That is what occurred to Axsome Therapeutics. The company saw its shares butchered within the past year as it could not earn the regulatory acceptance of its two crucial products.
First and foremost, it was the possible therapy for MDD (major depressive disorder), the AXS-05. That was to receive a regulator node in August last year.
Meanwhile, FDA (Food & Drug Administration) delayed the assessment process. The agency prohibited Axsome’s AXS-07 application last month, a possible acute migraines treatment. The best thing is the FDA didn’t question the efficacy or safety of either AXS-07 or AXS-05. The agency highlighted deficiencies for AXS-05, whereas manufacturing issues triggered AXS-07 rejection.
It doesn’t appear either therapy will require more clinical trials to achieve approval. Axsome already got FDA’s post-marketing need for AXS-05, and the agency might reveal its decision before the Q2 end. It might be challenging to predict AXS-07’s acceptance, but the therapy might eventually earn approval.
With about 56 million potential clients, AXS-07 and AXS-05 medicines might generate millions of dollars for Axsome annually at its peak. Moreover, the firm boasts several attractive pipeline candidates, like the AXS-14, a possible fibromyalgia medicine.
Finally, Axsome acquired Sunosi, a narcolepsy medicine, from Jazz Pharmaceuticals. Sunosi will allow Axsome to earn revenue as it awaits FDA acceptance for AXS-07 and AXS-05. With $865.8 million market capitalization, the stock remains at an impressive discount, and the biotech company seems prepared for a lucrative feature. It could be the time to join the craze.
Editorial credit: T. Schneider / shutterstock.com