Sarepta Therapeutics Inc. (SRPT) saw its shares rally in the extended session on Tuesday, after the biotech drug maker reported better-than-expected results and announced that the U.S. regulators had granted a priority review status for its muscular dystrophy drug candidate SRP-9001. The company’s shares surged as much as 14% after the closing bell, following a 3.3% increase to close at $122.13 during the regular trading session.
Sarepta reported a fourth-quarter loss of $109.2 million, or $1.24 a share, compared to a loss of $122 million, or $1.42 a share, in the same quarter of the previous year. The adjusted loss, which excluded stock-based compensation expenses and other items, was 53 cents per share. This was lower than the analysts’ consensus estimate of a loss of 66 cents per share.
Revenues for the quarter came in at $119.7 million, which was higher than the analysts’ consensus estimate of $117.3 million. The company’s revenues rose from $83.3 million in the same quarter of the previous year. The increase in revenues was mainly due to the higher sales of its Duchenne muscular dystrophy (DMD) drug Exondys 51, which brought in $110.7 million in the fourth quarter, compared to $75.4 million in the same quarter of the previous year.
Sarepta’s Chief Executive Officer Doug Ingram said in a statement, “We are pleased to have achieved a strong finish to 2019, with fourth quarter revenue of $119.7 million, representing a 44% increase over the prior year quarter. This performance reflects the continued uptake of Exondys 51 in the U.S. and the launch of our gene therapy programs.” He added, “We look forward to continued progress in 2020, including the potential approval of SRP-9001 in the U.S. and the advancement of our gene therapy programs.”
The priority review status for SRP-9001, which was granted by the U.S. Food and Drug Administration (FDA), means that the regulatory agency will complete its review of the drug within a period of six months, instead of the usual 10 months. The drug is under review for the treatment of Duchenne muscular dystrophy (DMD) in patients who are amenable to exon 51 skipping.
In addition to SRP-9001, Sarepta is also developing a gene therapy program, which includes four clinical programs in DMD. The company is also developing gene therapy programs for Limb Girdle Muscular Dystrophy (LGMD) and Myotonic Dystrophy Type 1 (DM1).
Sarepta’s Chief Medical Officer, Dr. Doug Ingram, said, “We are pleased with the progress of our gene therapy programs, and look forward to the potential approval of SRP-9001, as well as the advancement of our gene therapy programs. We remain committed to providing innovative treatments for patients with DMD, LGMD and DM1.”
Sarepta is focused on developing treatments for rare and life-threatening genetic diseases. The company is also exploring potential applications of its gene therapy platform to treat other neuromuscular diseases and has a broad pipeline of gene therapy programs in preclinical and clinical development.
Overall, Sarepta’s strong fourth-quarter results and the FDA’s granting of priority review status for SRP-9001 have driven the company’s shares higher and have raised investor optimism about the potential of its gene therapy programs. Investors will be closely watching the progress of the company’s drug candidates and gene therapy programs in the coming months.
Sarepta Therapeutics Inc. is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare and life-threatening genetic diseases. The company is developing treatments for Duchenne muscular dystrophy (DMD), Limb Girdle Muscular Dystrophy (LGMD) and Myotonic Dystrophy Type 1 (DM1). Sarepta’s lead drug candidate is SRP-9001, which is under review for the treatment of DMD in patients who are amenable to exon 51 skipping. The company also has a broad pipeline of gene therapy programs in preclinical and clinical development. The company’s shares rallied in the extended session on Tuesday, after it reported better-than-expected results and announced that the U.S. regulators had granted a priority review status for its muscular dystrophy drug candidate SRP-9001. The priority review status means that the regulatory agency will complete its review of the drug within a period of six months, instead of the usual 10 months. Investors will be closely watching the progress of the company’s drug candidates and gene therapy programs in the coming months.
