Some of the most exciting opportunities can be found in biotech stocks. In fact, find one with a powerful catalyst just around the corner, and you can make a good deal of money.
Look at CRISPR Therapeutics (NASDAQ:CRSP), for example. On Oct. 31, the company announced a US FDA advisory committee green-lighted its gene editing therapy for the treatment of severe sickle cell disease. On that news, CRSP jumped from about $38.93 to a high of $57.50. But it’s run isn’t over just yet. In fact, CRSP is still one of the top biotech stocks you may want to buy heading into December 2023.
CRISPR Therapeutics (CRSP)
With CRISPR Therapeutics’ U.S. FDA advisory vote out of the way, the U.S. FDA itself will now make the final decision on the company’s treatment for sickle cell disease.
The advisory panel raised very few concerns about the safety of the treatment, which could raise the odds of a positive U.S. FDA vote. Additionally, the therapy has already shown strong efficacy in trials, offering a potential cure for sickle cell.
As of now, we’re just waiting on the company’s U.S. FDA PDUFA (Prescriptions Drug User Fee Act) date of Dec. 9. That’s the US FDA deadline to act on approval.
Granted, a good deal of positive news has been priced into the stock. However, I still see further upside based on the potential revenue. For example, as noted by Seeking Alpha, “The companies believe the addressable patient pool for exa-cel treatment will number ~20,000. If we multiply that by $2m, the mooted list price, we have a market opportunity of $40bn, and if we multiply that by 40%, CRISPR Therapeutics’ share of revenues, we get to $16bn.”
2Seventy Bio (TSVT)
Or take a look at 2Seventy Bio (NASDAQ:TSVT). The company collaborated with Bristol Myers Squibb (NYSE:BMY) on a now FDA-approved treatment for cellular therapy for advanced-stage multiple myeloma patients, Abecma.
However, the FDA did limit its approval to a narrow population of patients with the disease after four or more lines of treatment, as noted by Motley Fool contributor Cory Renauer. But the agency could widen the treatment population based on the results of a KarMMAa-3 trial with patients who have had two to four lines of treatment. That’s expected by Dec.16.
Even better, Citi analysts just initiated coverage with a buy rating, with a $13 price target. The firm noted that, “with the pending December FDA action date for label expansion into earlier lines of myeloma, it anticipates the expanded patient population will once again create a capacity-constrained environment that Abecma will benefit from,” as noted by TheFly.com.
Arcutis Biotherapeutics (ARQT)
There’s also Arcutis Biotherapeutics (NASDAQ:ARQT), a $217 million immuno-dermatology company, whose moderate-to-severe seborrheic dermatitis treatment will face FDA decision on Dec. 16.
For one, according to the company, the condition effects more than 10 million people just in the U.S. Two, if approved, its treatment— roflumilast foam — would be the first topical drug for seborrheic dermatitis in over two decades.
And three, in a Phase 3 trial, 80% of the patients achieved Investigator Global Assessment (IGA) success after eight weeks. Better, the foam had favorable safety and tolerability profiles. As we near the FDA ruling, I believe ARQT could push higher in anticipation of a positive outcome. ARQT last traded at $2.30, and could potentially retest $3 near-term.
On the date of publication, Ian Cooper did not have (either directly or indirectly) any positions in the securities mentioned. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
