Shares of Sarepta Therapeutics, Inc. (SRPT - Free Report) have been rising so far this year. The biotech company’s stock has rallied 64.7%, significantly outperforming the 9.6% decline of the industry in this period.
The company has only one marketed product in its portfolio, Exondys 51, which received accelerated approval in September 2016. The drug is approved for treating patients with Duchenne muscular dystrophy (“DMD”), a rare genetic disorder affecting children, who have confirmed mutation of the DMD gene susceptible to exon 51 skipping.
The company has been progressing well with the commercialization of Exondys 51 and development of pipeline candidates in 2018 so far.
Exondys 51 Picking Up Well
The drug generated sales of $64.6 million in the first quarter of 2018, increasing 12.7% sequentially on the back of strong demand trends. Sales of the drug in 2017 were $154.6 million. Based on sales trends witnessed in 2017, Sarepta expects Exondys 51 sales to double in 2018.
The launch of a Managed Access Program in Europe and Americas in July 2017 is also having a favorable impact on sales as the drug is now available to a larger patient population.
Moreover, Sarepta also settled an ongoing global patent litigation with BioMarin Pharmaceutical Inc. (BMRN - Free Report) in mid-2017, thus removing a major overhang. BioMarin has granted Sarepta global exclusive rights to its DMD patent estate for Exondys 51.
However, Exondys 51’s approval in Europe hit a roadblock as the Committee for Medicinal Products for Human Use adopted negative trend vote on its marketing approval application. This is expected to delay the approval of the drug.
Sarepta is focused on building its DMD pipeline beyond Exondys 51 by developing other exon-skipping treatments. In fact, the company has about eight exon-skipping candidates in its pipeline, including golodirsen and casimersen, which are expected to treat 75-80% of the DMD population.
Sarepta’s lead candidate, golodirsen, has demonstrated 100% response rate with 10.7 times increase in mean dystrophin protein production from baseline in DMD patients in a phase I/II study. The data was reported in September 2017.
We remind investors that Exondys 51 had achieved nearly three times increase in mean dystrophin protein production from baseline. The better efficacy shown by golodirsen in dystrophin production increased investors’ hope about its potential approval as a new and better treatment option for DMD patients.
Sarepta remains on track to complete a rolling submission of a new drug application for this DMD candidate by the end of this year. The company has announced that it will seek an accelerated approval for the candidate for an early approval in 2019.
Earlier this month, Sarepta announced a partnership with Ohio-based Myonexus Therapeutics to develop five gene therapies for the treatment of Limb-girdle muscular dystrophies.
Zacks Rank & Stock to Consider
BioMarin currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks to consider in the pharma sector include Aeglea BioTherapeutics, Inc. (AGLE - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aeglea’s loss estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the last 30 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. Its share price has increased 96.3% so far this year.
ANI Pharmaceuticals’earnings estimates increased from $5.54 to $5.79 for 2018 and from $5.72 to $5.80 for 2019 over the last 30 days. The company came up with a positive earnings surprise in three of the four trailing quarters with an average beat of 8.69%.
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