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Sarepta Inks Manufacturing Deal for Gene Therapy Program


Sarepta Therapeutics, Inc. SRPT announced that it has entered into a long-term strategic manufacturing partnership with privately-held Brammer Bio for the manufacturing and commercial supply of its potential micro-dystrophin gene therapy and other neuromuscular pipeline products.

The partnership will help Sarepta to focus on process development by leveraging Brammer Bio’s world-class manufacturing capabilities for clinical and commercial supply of its micro-dystrophin Duchenne muscular dystrophy (“DMD”) gene therapy products. Sarepta will also access Brammer Bio’s manufacturing facilities for future gene therapy programs such as Limb girdle muscular dystrophy (“LGMD”).

Sarepta is planning to initiate clinical studies to evaluate gene therapies by mid-2018.

Brammer Bio is a biotech company, which provides services for development and early phase to commercial manufacturing services for cell and gene therapies.

So far this year, Sarepta’s shares have rallied 73.9% against a 6.5% decrease registered by the industry. The rally can be attributed to strong product sales and its key pipeline candidate’s progress.

Sarepta has only one product in its commercial portfolio, Exondys 51, which is available for the treatment of DMD in the United States. The drug has performed well in 2017, generating sales of more than $150 million in its first full year of commercialization. The sales are expected to double in 2018. The drug is under review in EU.

Moreover, Sarepta’s most advanced pipeline candidate, golodirsen, demonstrated encouraging results in a mid-stage clinical study evaluating it in DMD patients. The candidate has also shown better efficacy than Exondys 51. Sarepta is planning to file regulatory application seeking golodirsen’s approval in the United States by the end of this year.

Apart from golodirsen, there are several other DMD candidates in early to mid-stage studies.

We remind investors that Pfizer PFE is also developing a gene therapy for the treatment of DMD. An early-stage study was initiated in April.

Zacks Rank & Stocks to Consider

Sarepta currently carries a Zacks Rank #4 (Sell).

A couple of better-ranked stocks in the pharma sector include Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. 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 60 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 86.5% 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 60 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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