The stock market finished the month of February lower, giving back some of its gains from January. However, as investors prepared for the first day of March, the Nasdaq Composite (^IXIC -0.99%) tried to rebound, with gains of about 0.2% in futures trading before the market opened Wednesday morning.
A pair of companies listed on the Nasdaq were big winners in early morning premarket trading. Sarepta Therapeutics (SRPT 3.42%) saw a nice gain after reporting favorable financial results and giving an upbeat update on a key candidate treatment, but Reata Pharmaceuticals (RETA) was the big winner on the day. Read on to learn more about why shareholders in these biotechnology stocks were so happy.
Sarepta looks ahead
Shares of Sarepta Therapeutics jumped 16% in premarket trading early Wednesday. The genetic medicine specialist announced fourth-quarter financial results that showed continued growth and made an announcement that had its investors more optimistic about its future.
Sarepta's latest financials were solid. Revenue for the fourth quarter came in at $258 million, up 28% year over year on a 32% rise in product sales. Sarepta continued to lose money, but adjusted losses of $46.5 million were down from the $66 million in losses from the year-earlier period. For the full year, adjusted losses amounted to $3.06 per share, down from $3.80 per share in 2021.
Sarepta is particularly excited about the prospects for its SRP-9001 candidate treatment for Duchenne muscular dystrophy. Back in November, the U.S. Food and Drug Administration (FDA) granted priority review to Sarepta's biologics license application for SRP-9001, with a regulatory action date in late May. On the conference call following its earnings release late Tuesday, Sarepta said that it had provided all the answers the FDA wanted, and it believes that the FDA will have no need for an advisory committee meeting before moving forward.
SRP-9001 is just one treatment in Sarepta's pipeline, but investors are anticipating success there that could provide further growth. If the FDA approves the candidate treatment, it could spur another wave higher in Sarepta's stock price.
Reata gets an FDA win
The big winner in Wednesday's premarket session was Reata Pharmaceuticals, whose shares jumped 175%. The biotech company got great news from the FDA on an important treatment with huge implications for Reata's long-term business strategy.
Reata announced late Tuesday that the FDA had approved its Friedreich's ataxia treatment, Skyclarys, for adults and adolescents 16 and older. Of particular note, the FDA granted a rare pediatric disease priority review voucher in making Skyclarys the first therapy specifically indicated for treatment of the disease.
Friedreich's ataxia is an inherited neurodegenerative disorder that primarily gets diagnosed during adolescence. It affects about 5,000 diagnosed patients in the U.S., and estimates put the size of the market to treat the disease at roughly $3 billion annually. The FDA's approval means Reata will effectively have an initial monopoly in that market, and the biotech company expects to make Skyclarys available to patients by the second quarter of 2023.
The news was also interesting because the data supporting Reata's application to the FDA spanned a much longer timeframe than most research. With more candidate treatments in its pipeline, shareholders are getting a lot more excited about Reata, especially as the company prepares to earn the first substantial revenue its business has ever generated.
