FDA Delays Decision On HRTX Drug, Trial Woes Paint EBIO Red, NVLS On Watch

(RTTNews) - Shares of Eleven Biotherapeutics Inc. (EBIO) are set to take a beating on Tuesday, following failure of the company's phase III clinical trial of its lead drug candidate, Isunakinra (EBI-005), for the treatment of severe allergic conjunctivitis.

In the trial, Isunakinra failed to meet the primary endpoint of ocular itching.

The company noted that it will now focus on submitting an investigational new drug application for EBI-031 in diabetic macular edema in the first half of 2016.

EBIO closed Friday's trading at $2.34.

Heron Therapeutics Inc. (HRTX) will now have to wait for more than a month to know the FDA's decision on its resubmitted New Drug Application of SUSTOL.

SUSTOL is being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy or highly emetogenic chemotherapy.

The resubmitted NDA for SUSTOL has been under FDA review since last September - with a decision originally slated for January 17, 2016. But the decision has now been postponed to late February 2016 as the regulatory agency has not yet completed the review.

SUSTOL was issued a Complete Response Letter twice - on March 19, 2010 and March 28, 2013.

Will third time prove a charm for SUSTOL? One will have to wait and watch.

HRTX closed Friday's trading at $22.71, down 2.20%.

Impax Laboratories Inc. (IPXL) has received FDA approval for EMVERM (mebendazole) 100 mg chewable tablets.

EMVERM is indicated for the treatment of pinworm, whipworm, common roundworm, common hookworm and American hookworm in single or mixed infections.

The company expects to commercially launch EMVERM early in the second quarter of 2016.

IPXL closed Friday's trading at $39.02, up 1.85%.

MediciNova Inc. (MNOV) has been granted Rare Pediatric Disease Designation for its drug candidate MN-166 (ibudilast) for treatment of Type 1-Early Infantile Krabbe disease.

Krabbe disease is a rare genetic degenerative disorder for which there is no cure and is generally fatal before two years of age.

Last June, the FDA had granted orphan drug designation to MN-166 for treatment of Krabbe disease.

MNOV closed Friday's trading at $3.72, down 1.59%.

Nivalis Therapeutics Inc.'s (NVLS) lead investigational drug, N91115, has been granted Orphan Drug Designation in cystic fibrosis by the FDA.

N91115 is under a 12-week phase II study in 135 adult patients with cystic fibrosis who are homozygous for F508del-CFTR mutation and being treated with FDA-approved *Orkambi, and results from this trial are planned to be reported in the second half of 2016. (Orkambi is developed by Vertex Pharmaceuticals Inc. (VRTX)).

NVLS closed Friday's trading at $5.75, up 15.46%.