Cowen Weighs In on Sarepta Therapeutics Inc (SRPT) in Light of More Regulatory Setbacks in DMD Field

Cowen analyst Ritu Baral‘s stance on eteplirsen, Sarepta Therapeutics Inc (NASDAQ:SRPT) pipeline drug for Duchenne Muscular Dystrophy, DMD, is unchanged. This comes after Santhera announced that the FDA considered Raxone’s, a competitor’s drug for DMD, data package insufficient for NDA submission.

The FDA required data from Santhera’s “Ph3 SIDEROS trial of Raxone in DMD patients either with or without concomitant glucocorticoid therapy for its NDA filing.” They initially intended to use this data as a “confirmatory study to expand the indication.”

The FDA’s strict stance on the data set they receive shows that the Agency will not be lenient with DMD indication and require a full dataset from appropriate trials. The analyst believes the FDA’s hesitation is due to “the respiratory endpoint of the pivotal DELOS trail (change in peak expiratory flow, PEF) which has not been previously validated as an endpoint in DMD.” Furthermore, this shows that a placebo-controlled, stat sig trial does not guarantee approval in DMD and rather the Agency is more focused on “demonstrable efficacy in validated, clinically meaningful measures.”

Even with the FDA’s strict stance, the analyst does not believe it will impact the FDA’s decision on Sarepta’s eteplirsen. She feels that the result depends on the PROMOVI dystrophin biomarker data with results expected back in early September. Baral anticipates that “dystrophin production at or above the levels demonstrated in the Ph2 ‘2021/202 study in the PROMOVI data would be supportive of Subpart H accelerated approval by FDA.” If this is the case, then the rest of the PROMOVI would be a confirmatory study.

Although the analyst expects to see positive results, she remains cautious because 13 patients of “even rigorous positive dystrophin data may be too little to support an acceptable NDA.” She also expects the next relevant data regarding eteplirsen t o be released when new data is submitted to the FDA.

Baral maintained her Market Perform rating for Sarepta. According to TipRanks, the analyst has a yearly average return of 4.6% and a 42% success rate. The analyst has a 20% average loss when recommending Sarepta, and is ranked #649 out of 4,064 analysts.

TipRanks shows that out of the 14 analysts who rated Sarepta in the last 3 months, 36% gave a Buy rating, 36% gave a Hold rating and 28% gave a Sell rating. The average 12-month price target for the stock is $22.27, marking a 6.30% upside from current levels.


  • careful_investor_wins

    Sarepta (symbol: SRPT) trial only had 13 patients. It was a tiny trial with a lot of problems. Readers should go to FDA web site. Type in Eteplirsen in the Search FDA box on the upper-right hand side. Read the PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS PDF document to understand why FDA Advisory Committee recommended to reject Eteplirsen from Sarepta. If it is too much to read, just go to the Summary and Conclusions at page 111 out of 115 to see the conclusions that small studies do not have the ability to provide definitive evidence for a drug’s effect, placebo group did better than Eteplirsen group in walk test and the final conclusion of the data provided no evidence to support efficacy. The drug has very high probability of being rejected. If the drug is rejected, the stock may fall to its book value below $3. SRPT is an extremely risky investment that can drop 85% any day now. Not to mention bubble stock SRPT is already trading at 4 times the market cap of competitor PTCT stock. And SRPT has NO approved drug, NO revenue and gigantic $220 million annual losses while PTCT has its DMD drug already approved in Europe and just got England market a few days ago. Go figure. Why would anyone want to pay 4 times of price to buy NOTHING? And why there are so many stupid analysts so wrong on valuation calculations when the true value of SRPT really should be below $5 if you use PTCT valuation to calculate? Why would analyst from Oppenheimer give outrageous crazy high price target of $60 when it is so obvious SRPT is only worth less than $5? Well, the dirty secret is Sarepta is a client of investment banker Oppenheimer. And why Robert Baird was also pumping the stock? Well, Robert Baird was the book runner of the Sarepta secondary stock sell offering last time and obviously big loser Sarepta will need to sell a lot more stocks again with or without drug approval. They are dirty investment banker tricks. A lot of people will lose a lot of money in this extremely expensive bubble stock SRPT. That is why people hate Wall Street investment bankers. SEC should have banned investment bankers from acting as analysts in the same time to deceive investors. And investment bankers that make outrageous false claims like Oppenheimer should be hold accountable to losses of investors. If investors lose money big time after drug rejection, they should also ask class action lawyers to put Oppenheimer on the class action lawsuits. Without irresponsible analysts like Oppenheimer analyst, this bubble would not have been this big, and people would not have risked so much money in this company that has NO approved drug and NO revenue after 35 years in business.