What happened
Shares of Sarepta Therapeutics (SRPT 1.08%) rose 24% this week as of Thursday afternoon, according to data provided by S&P Global Market Intelligence. The biotech company, which focuses on precision gene therapies, closed out at $123.06 a share last week, then rose to a 52-week high of $152.30 on Wednesday. The catalyst for the move up was the company's fourth-quarter and full-year earnings report, or rather something that was in it.
So what
Sarepta's revenue numbers were up for the quarter and for the year, and its earnings per share (EPS) improved in the quarter, if not for the year. It wasn't the company's financials, though, that spurred the stock, but news regarding the company's gene therapy, SRPT-9001.
The company, in its earnings release on Tuesday, said it had been told that the Food and Drug Administration isn't requiring an advisory committee meeting regarding the therapy, meaning SRPT-901 may be on an accelerated approval process as a therapy to treat Duchenne muscular dystrophy.
The FDA has granted priority review for SRPT-901, with a regulatory action date of May 29. The therapy is being developed in a partnership with Roche. SRP-9001 targets the cause of Duchenne muscular dystrophy by delivering a gene that offers a functional form of dystrophin, needed for muscular development. The news is big for Sarepta, which has said the therapy could be worth $4 billion in peak annual sales.
Now what
The news regarding SRPT-901 was delivered on top of a strong earnings report. The company reported quarterly revenue of $258.4 million, up 28.3%, year over year and yearly revenue of $933 million, up 32.9%. Quarterly EPS was reported as a loss of $1.24, compared to an EPS loss of $1.42 in the same period a year ago. The yearly EPS was a loss of $8.03, compared to an EPS loss of $5.15 in 2021. Investors will now be watching to see what happens in May regarding the FDA's decision on SRP-9001.
