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Selecta's (SELB) Gene Therapy Gets Orphan Drug Tag From FDA

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Selecta Biosciences, Inc. (SELB - Free Report) along with privately-held company Asklepios BioPharmaceutical, Inc. (AskBio) announced that the FDA has granted an orphan drug designation to their investigational gene therapy candidate MMA-101.

This candidate is currently being developed in pre-clinical studies for the treatment of isolated methylmalonic acidemia (MMA), an inherited rare metabolic disorder caused by methylmalonyl-CoA mutase (MMUT) gene mutation.

The FDA’s orphan drug designation is granted to the drugs capable of treating rare diseases that affect less than 200,000 people in the United States. This designation also makes the company entitled to certain other benefits including tax credits related to clinical trial expenses and an exemption from administrative fees. Moreover, upon its potential approval, MMA-101 will be eligible for seven years of marketing exclusivity in the United States.

Shares of Selecta were up 3.2% on Thursday following the above-mentioned news. In fact, the stock has surged 34.4% so far this year against the industry’s decrease of 2.7%.

price chart for Selecta


Notably, the FDA granted the Rare Pediatric Disease (RPD) designation to MMA-101 in October 2020 for the treatment of isolated MMA.

Selecta and AskBio plan to initiate a phase I study on MMA-101 in the first half of 2021 for treating patients with MMA.

We note that apart from AskBio, Selecta inked several deals with other companies for its pipeline development.

The company has a strategic license agreement with Swedish Orphan Biovitrum AB (Sobi) to help advance the development and commercialization of its lead pipeline candidate SEL-212. The candidate is being developed to treat patients with chronic refractory gout and resolve its debilitating symptoms including flares and gouty arthritis.

SEL-212 is a combination of Selecta’s ImmTOR immune tolerance platform and a therapeutic uricase enzyme pegadricase.

Meanwhile, In June 2020, Selecta entered into a research and license option agreement with Sarepta Therapeutics, Inc. (SRPT - Free Report) , which granted the latter an option to in-license the rights to use the ImmTOR immune tolerance platform of the former for developing therapies to address neuromuscular diseases like Duchene muscular dystrophy and certain limb-girdle muscular dystrophies.

Zacks Rank & Stocks to Consider

Selecta currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Abeona Therapeutics Inc. (ABEO - Free Report) and Cara Therapeutics, Inc. (CARA - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Abeona Therapeutics’ loss per share estimates have narrowed 8.3% for 2020 and 7.2% for 2021 over the past 60 days.

Cara Therapeutics’ loss per share estimates have narrowed 14.2% for 2020 and 22.5% for 2021 over the past 60 days.

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