This Biotech Dived After The FDA Put Its Gene Therapy Study On Pause

Regenxbio stock toppled below its 50-day moving average early Wednesday after the U.S. Food and Drug Administration put one of the biotech company's gene therapy candidates on hold.

The post This Biotech Dived After The FDA Put Its Gene Therapy Study On Pause appeared first on Investor's Business Daily.

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Regenxbio stock toppled Wednesday after the Food and Drug Administration put one of the biotech company's gene therapy candidates on hold.

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In early trading on the stock market today, shares of Regenxbio (RGNX) slumped 5.6%, near 35.50. That put Regenxbio stock below its 50-day moving average at the stock market's open.

The biotech company is working on a gene therapy, dubbed RGX-314, to treat an eye disorder called wet age-related macular degeneration. The FDA is concerned because Regenxbio is using third-party surgical devices to deliver the gene therapy.

"Regenxbio expects to delay initiation of the Phase 2b study in wet AMD and filing of (a request to begin a clinical study) for diabetic retinopathy until the first quarter of 2020," SVB Leerink analyst Mani Foroohar said in a report to clients.

Regenxbio Stock Dips On Gene Therapy Delay

Regenexbio's gene therapy, RGX-314, aims to solve a problem with treating this particular disease. Most treatments require injections in the eye every eight weeks. Regeneron Pharmaceuticals (REGN) sells a massive moneymaker called Eylea. Novartis (NVS) also has a new competing drug.

Gene therapy aims to be a one-time treatment for disease. Regenxbio has already dosed 42 patients with its gene therapy. But it uses third-party surgical devices to deliver the gene therapy to the eye. The biotech company noted discussions with the FDA are ongoing related to the partial hold.

Researchers performed regular safety assessments in earlier studies, the biotech company noted.

"The company is not aware of any delivery system concerns or complications from the Phase 1 or Phase 2a trial, nor is it aware of any concerns of actions related to these third-party device suppliers or other companies using similar devices in AAV gene therapy surgical delivery systems," the firm said.

Foroohar kept his market perform rating on Regenxbio stock. But he lowered his price target to 36 from 38.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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The post This Biotech Dived After The FDA Put Its Gene Therapy Study On Pause appeared first on Investor's Business Daily.

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