Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has issued two favorable decisions for Sarepta in the composition of matter patent interferences for exon 51 (Interference No. 106,008) and exon 53 (Interference No. 106,007). These decisions, subject to appeal, finally refused all of BioMarin’s claims in the exon 51 and exon 53 composition of matter interferences that, if granted, could have formed a basis for a claim of infringement against eteplirsen and SRP-4053. The PTAB decision for exon 53 allows BioMarin to obtain a narrow composition of matter claim, however, SRP-4053 does not infringe this claim. The PTAB ended the exon 51 interference in our favor based on a statute of limitations bar.
Accordingly, the PTAB did not decide the patentability of the Sarepta exon 51 patents involved in the interference (U.S. Patent Nos. 7,807,816 and 7,960,541). Although the PTAB did decide to cancel the Sarepta exon 53 patent involved in the interference (U.S. Patent No. 8,455,636), that exon 53 decision does not negatively impact Sarepta’s key composition of matter patent protection for EXONDYS 51 and SRP-4053 (U.S. Patent Nos. 9,018,368 and 9,024,007, respectively). Neither of these key patents are involved in any pending interferences and are presumed valid and enforceable. These patents expire in June 2025, not including any potential patent term extension or regulatory exclusivity that would extend this date.
BioMarin has appealed the exon 53 composition of matter interference (Interference No. 106,007) to the Court of Appeals for the Federal Circuit. The exon 51 composition of matter interference (Interference No. 106,008) decided today by the PTAB remains subject to appeal.
“We are pleased that today’s exon 51 PTAB decision provides further clarity concerning BioMarin’s interfering patent claims as we begin commercialization of EXONDYS 51” saidEdward M. Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “Moreover, we are optimistic that our key patents for eteplirsen and SRP-4053 will provide sufficient protection for the duration of further development and commercialization.”
In addition, previously decided Interference No. 106,013 concerning exon 51 methods for treating Duchenne muscular dystrophy with exon 51 skipping oligonucleotides is currently on appeal at the Court of Appeals for the Federal Circuit. BioMarin’s method claims currently on appeal involve the exon 51 skipping oligonucleotides found unpatentable in today’s exon 51 PTAB decision. (Original Source)
Shares of Sarepta closed today at $55.73, up $6.79 or 13.87%. SRPT has a 1-year high of $56.80 and a 1-year low of $8.00. The stock’s 50-day moving average is $27.32 and its 200-day moving average is $21.07.
On the ratings front, Sarepta has been the subject of a number of recent research reports. In a report released today, Piper Jaffray analyst Edward Tenthoff maintained a Buy rating on SRPT, with a price target of $64, which represents a potential upside of 15% from where the stock is currently trading. Separately, on the same day, Wedbush’s Heather Behanna reiterated a Buy rating on the stock and has a price target of $66.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Tenthoff and Heather Behanna have a total average return of -1.3% and 2.2% respectively. Tenthoff has a success rate of 37% and is ranked #3258 out of 4166 analysts, while Behanna has a success rate of 47% and is ranked #1692.
Overall, one research analyst has rated the stock with a Sell rating, 2 research analysts have assigned a Hold rating and 11 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $53.00 which is -4.9% under where the stock opened today.
Sarepta Therapeutics, Inc. is a biopharmaceutical company, which is engaged in the discovery and development of unique RNA-based therapeutics for the treatment of rare and infectious diseases. The company is primarily focused on rapidly advancing the development of its potentially disease modifying duchenne muscular dystrophy drug candidates.