Synageva BioPharma Corp.’s (GEVA) shares gained 3.6% immediately after the company announced the completion of the rolling submission of a biologics license application (BLA) to the FDA for its lead candidate, sebelipase alfa. Although shares were down 0.5% in the subsequent trading session, overall, shares are up 3% since the announcement.
Synageva, which started rolling the BLA submission in Oct 2014, has completed the submission earlier than expected (previously expected to be completed by the end of Jan 2015). The company is looking to get sebelipase alfa approved for the treatment of patients suffering from lysosomal acid lipase deficiency (LAL deficiency).
Synageva said that it has requested the FDA to grant priority review which, if granted, would reduce the review period for the candidate from the standard 12 month span to 8 months. Apart from fast track status and Breakthrough Therapy designation for LAL deficiency in infants, sebelipase alfa has orphan designation in the U.S.
Simultaneously, Synageva has submitted a marketing authorization application in the EU for sebelipase alfa for the same indication. We note that the European Medicines Agency has already granted accelerated assessment for the candidate. Sebelipase alfa also enjoys orphan designation in the EU.
Meanwhile, Synageva is working on strengthening its pipeline. The company is developing SBC-103 as an enzyme replacement therapy for mucopolysaccharidosis type IIIB (MPS IIIB) or Sanfilippo B syndrome. SBC-103 has orphan drug status in both the U.S. and the EU. The company intends to initiate patient dosing in a phase I/II study on SBC-103 for MPS IIIB by the end of 2014 or early 2015.
With sebelipase alfa being the lead candidate at Synageva, its successful development and approval would be a major boost for the company. According to the company, LAL deficiency affects children and adults in the range of approximately 1 in 40,000 people to 1 in 300,000 people. With no approved treatments, we believe Sebelipase alfa has a good opportunity in the market for LAL deficiency. We expect investor focus to remain on pipeline updates from the company.
Synageva carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the biotech sector are Biogen Idec Inc. (BIIB), Amgen Inc. (AMGN) and Cytokinetics, Inc. (CYTK). All these stocks carry a Zacks Rank #1 (Strong Buy).
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