FDA Snubs SPPI, OCUL Feels Pressure, It's Thumbs Up For MACK, But With Rider

(RTTNews) - CryoLife Inc. (CRY) will be paying a quarterly cash dividend of $0.03 per share on December 18, 2015 to all common stockholders of record as of December 11, 2015. The company is scheduled to report Q3 results on October 27, 2015.

CRY closed Thursday's trading at $9.90, down 1.10%.

Seeking to reflect its ongoing transformation, IGI Laboratories Inc. (IG) has decided to take on a new name - Teligent Inc. - and will begin trading under a new symbol "TLGT" on October 26, 2015.

For the third quarter ended September 30, 2015, total revenues were $11.6 million, an increase of 74% over the same quarter in 2014.

Looking ahead to the full year of 2015, the company now expects total revenue between $41.0 million and $43.0 million, up from its earlier forecast range of $35.0 million and $40.0 million.

IG closed Thursday's trading at $6.27, down 6.56%.

Merrimack's (MACK) ONIVYDE has been approved by the FDA to be used in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

ONIVYDE is not indicated for use as a single agent, the company noted. The labeling for ONIVYDE sports a boxed warning about the risk of severe neutropenia and severe diarrhea associated with its use.

In a phase III trial, there was a 45% improvement in median overall survival of 6.1 months for patients receiving the ONIVYDE combination regimen compared to 4.2 months for patients who received 5-FU and leucovorin alone.

Merrimack expects ONIVYDE to be available in the United States next week.

The marketing authorization application for ONIVYDE was submitted to the European Medicines Agency by Baxalta Inc. (BXLT) in May of this year, and is under review. Baxalta is responsible for the development and commercialization of ONIVYDE outside of the United States and Taiwan under an exclusive licensing agreement signed between Merrimack and Baxalta last September.

MACK closed Thursday's trading at $8.71, down 12.99%.

Ocular Therapeutix Inc.'s (OCUL) phase 2b clinical trial of OTX-TP (sustained release travoprost) for the treatment of glaucoma and ocular hypertension has demonstrated clinically meaningful intraocular pressure reduction and improvement in depot retention with OTX-TP at day 75.

The study, which enrolled 73 patients at 11 clinical sites in the United States, is designed to assess the efficacy and safety of OTX-TP compared to commonly used glaucoma treatment Timolol, and is not powered to show statistical significance between study groups.

According to the study results, at day 60, which was the primary efficacy measure, the OTX-TP group had an IOP lowering effect of 4.8 mmHg, compared with IOP lowering of 6.4 mmHg for the Timolol arm. At day 90, which was a secondary efficacy measure, the OTX-TP group had an IOP lowering effect of 5.2 mmHg, compared with an IOP lowering effect of 7.3 mmHg in the timolol arm.

Complete results on safety and efficacy through the end of the study are expected to be available in the first quarter of 2016.

Separately, the company announced that a phase III trial evaluating the safety and efficacy of its product candidate DEXTENZA (sustained release dexamethasone) 0.4 mg, Intracanalicular Depot for the treatment of allergic conjunctivitis successfully met primary endpoint for treatment of ocular itching associated with allergic conjunctivitis.

However, the primary endpoint of conjunctival redness, typically an endpoint included in phase III trials for allergic conjunctivitis but not required for approval, was not met in the phase III trial.

Based on the results from the phase III trial, the company expects to advance DEXTENZA into a second phase III clinical trial in allergic conjunctivitis before the end of 2015.

OCUL closed Thursday's trading at $15.06, down 1.70%. In after hours, the stock fell 7.04% to $14.00.

Spectrum Pharmaceuticals (SPPI) has been issued a Complete Response Letter by the FDA for its product candidate EVOMELA that is being developed for patients with multiple myeloma undergoing hematopoietic stem cell transplant.

The FDA has not raised any clinical deficiency concern for Spectrum's NDA package.

Spectrum Pharmaceuticals gained global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals Inc. (LGND) in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.

SPPI closed Thursday's trading at $6.64, down 0.75%. Watch out how the disappointing news plays out for SPPI and LGND.

Supernus Pharmaceuticals Inc.'s (SUPN) supplemental new drug application for Trokendi XR seeking approval to include treatment for adults for prophylaxis of migraine headache has been accepted for review by the FDA. The regulatory agency's decision on the expanded indication is expected in the second quarter of 2016.

Trokendi XR, a once-daily extended release formulation of topiramate, was approved by the FDA for the treatment of epilepsy in August 2013.

For the full year 2014, Trokendi XR had raked in sales of $64.9 million.

SUPN closed Thursday's trading at $15.27, down 3.42%. However, in after hours, the stock was up 11.33% at $17.00.