KALA Strides, NKTR Plunges, RMTI In Deal With Sun Pharma, DRRX Faces FDA Panel

(RTTNews) - Today's Daily Dose brings you news about Kala Pharma's completion of enrollment in STRIDE 3 trial, Rockwell Medical's license and supply agreements with India-based Sun Pharmaceutical and upcoming regulatory catalyst of DURECT.

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Kala Pharmaceuticals Inc. (KALA) has completed enrollment in its phase III clinical trial for EYSUVIS, its product candidate for the short-term treatment of dry eye disease.

The trial, dubbed STRIDE 3, is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, comparing EYSUVIS to vehicle (placebo), each dosed four times a day (QID) for two weeks in approximately 900 patients with dry eye disease.

The top-line results from the STRIDE 3 trial are expected during the first quarter of 2020.

Kala expects that data from the STRIDE 3 trial will serve as the basis for the resubmission of the EYSUVIS NDA to the FDA.

The U.S. regulatory agency refused to approve EYSUVIS last August and had indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.

KALA closed Wednesday's trading at $5.49, up 4.17%.

Shares of Nektar Therapeutics (NKTR) plunged more than 15% on Wednesday.

On January 14, 2020, the Company announced that it is withdrawing its New Drug Application for Oxycodegol as the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee did not recommend approval of the drug candidate.

Oxycodegol, also known as NKTR-181, was proposed for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

NKTR closed Wednesday's trading at $23.49, down 15.99%.

Rockwell Medical Inc. (RMTI) has entered into license and supply agreements with a wholly-owned subsidiary of India-based Sun Pharmaceutical Industries Ltd. for the rights to commercialize Triferic in India.

Approved in January 2015, Triferic is indicated to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment.

As part of the agreements, Rockwell Medical will receive an upfront fee and will be eligible for milestone payments and royalties on net sales.

Rockwell has developed multiple formulations of Triferic - Dialysate Triferic and I.V. Triferic. The FDA has approved only the Dialysate Triferic formulation. The I.V. Triferic is under FDA review, with a decision expected on March 28, 2020.

RMTI closed Wednesday's trading at $2.79, up 20.26%.

On January 16, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee is scheduled to review DURECT Corp.'s (DRRX) resubmitted New Drug Application for POSIMIR, a post-operative pain relief depot.

POSIMIR, a nonopioid, locally-acting analgesic, is designed to be administered directly into the surgical site to deliver the anesthetic bupivacaine for up to three days after surgery.

The FDA had issued a Complete Response Letter for POSIMIR in February 2014.

DRRX closed Wednesday's trading at $2.54, up 3.25%.