Sarepta Therapeutics Inc (NASDAQ:SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has issued a decision in the patent interference proceeding (Interference No. 106,013) concerning methods for treating Duchenne muscular dystrophy with certain exon 51 skipping oligonucleotides claimed in BioMarin’s pending U.S. Patent Application No. 14/198,992 and Sarepta’s granted U.S. Patent No. 8,486,907. The PTAB has not yet issued a decision in the two pending composition of matter patent interference proceedings relating to (i) the exon 51 skipping oligonucleotides underlying the methods that are the subject of this decision (Interference No. 106,008) or (ii) the exon 53 skipping oligonucleotides (Interference No. 106,007).
The PTAB decision was based on a procedural matter and did not include a decision on the substantive motions of unpatentability at issue in the pending interferences for exon 51 and 53 oligonucleotides. Additionally, the decision did not address the patentability of BioMarin’s method claims in pending U.S. Patent Application No. 14/198,992 in the course of ordering the cancellation of Sarepta’s U.S. Patent No. 8,486,907.
Sarepta intends to appeal this decision to the U.S. Court of Appeals for the Federal Circuit. Until there are final decisions in the appeal to this decision, the remaining interference proceedings, and any other potential future legal proceedings, it is unclear what potential importance, if any, this USPTO decision may ultimately have.
The PTAB decision does not impact Sarepta’s key patent protection for eteplirsen and SRP-4053. Sarepta’s primary patent protection for eteplirsen and SRP-4053 (United States Patent Nos. 9,018,368 and 9,024,007, respectively) is not the subject of any pending interferences and these patents are presumed valid and enforceable. United States Patent Nos. 9,018,368 and 9,024,007 both expire in June 2025 not including any potential patent term extension or regulatory exclusivity that would extend this date.
“We await the decisions for the two remaining composition interferences. We maintain confidence in our legal position and believe that the BioMarin patent claims should not be entitled to grant prior to completion of the appeals process, which we look forward to pursuing and which typically takes twelve to eighteen months,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “In the meantime, our focus remains on our regulatory milestones for our New Drug Application for eteplirsen, including the upcoming advisory committee meeting and our PDUFA date of February 26, 2016, as well as on our continued development efforts towards advancing product candidates targeting Duchenne muscular dystrophy.” (Original Source)
Shares of Sarepta Therapeutics Inc. closed yesterday at $31.90. SRPT has a 1-year high of $41.47 and a 1-year low of $11.33. The stock’s 50-day moving average is $35.69 and its 200-day moving average is $26.01.
On the ratings front, Sarepta has been the subject of a number of recent research reports. In a report released today, William Blair analyst Tim Lugo maintained a Buy rating on SRPT, with a price target of $52, which implies an upside of 63.0% from current levels. Separately, on September 28, Oppenheimer’s Christopher Marai reiterated a Buy rating on the stock and has a price target of $45.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Tim Lugo and Christopher Marai have a total average return of -15.6% and 12.1% respectively. Lugo has a success rate of 26.7% and is ranked #3643 out of 3754 analysts, while Marai has a success rate of 45.5% and is ranked #228.
The street is mostly Bullish on SRPT stock. Out of 8 analysts who cover the stock, 7 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $46.00, which represents a potential upside of 44.2% from where the stock is currently trading.
Sarepta Therapeutics Inc is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases.