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Ocular Therapeutix OCUL issued CRL; FOLD green light to file NDA without additional trials - shares +26%

Price and Volume Movers

Amicus Therapeutics (NASDAQ:FOLD) shares surged to close up 26% to $12.92 following its announcement that the FDA no longer requires the company to initiate a Phase 3 trial prior to submitting its New Drug Application (NDA) for migalastat in patients with Fabry disease. In light of the positive news, the company plans to file the NDA in 4Q 2017. The FDA had previously requested Amicus to complete an additional Phase 3 trial, with data from the proposed trial not available until 2019 so today’s news is a significant positive for the company.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced today that it received a Complete Response Letter (CRL) from the FDA for its NDA of DEXTENZA for the treatment of ocular pain following ophthalmic surgery. The CRL noted manufacturing deficiencies identified during a pre-NDA approval inspection of its manufacturing facility. The company previously received a CRL in July 2016 also due to manufacturing deficiencies.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) shares closed the normal session up 41% to $26.00 following its release Monday after-hours that its Phase 2 trial of ralinepag for the treatment of pulmonary arterial hypertension (PAH) met the primary endpoint. Shares have pulled back 2.1% in Tuesday’s after-hours session following its announcement that that it intends to issue $150m of shares of its common stock in an underwritten public...


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