Factors at Play SOURCE ZACKS
Sarepta’s sole marketed drug, Exondys 51, is likely to drive its revenues higher in the second quarter of 2019. The drug has shown a strong uptrend since its launch in 2016 and is the only approved treatment for Duchenne muscular dystrophy (“DMD”) in the United States.
Apart from Exondys 51, the company is developing multiple pipeline candidates, which include exon-skipping and gene therapies, for treating DMD. The company is likely to provide an update on the progress of these candidates in clinical studies.
The most advanced pipeline candidate — golodirsen, an exon-skipping candidate — is under review in the United States. A decision is expected next month. The company may provide an update on its plans for the commercial launch of the candidate following a potential approval.
Sarepta is also focused on developing gene therapies for the treatment of central nervous system (“CNS”) disorders as well as DMD.
The company is evaluating several gene therapy candidates in early- to mid-stage studies for CNS disorders and muscular dystrophy. The most advanced gene therapy candidate, LYS-SAF302 is being evaluated in a phase II/III study as a treatment for mucopolysaccharidosis Type IIIA, a progressive CNS disorder.
In May, Sarepta expanded its gene therapy pipeline to six candidates by signing an agreement with the Research Institute at Nationwide Children’s Hospital.
With several clinical studies underway, we expect operating expenses to increase in the soon-to-be-reported quarter. Moreover, commercial initiatives to support golodirsen potential launch will also drive expenses higher. Meanwhile, higher demand for Exondys 51 is also driving royalty payments to BioMarin BMRN . We expect to see the same trend in the to-be reported quarter.
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