FDA Says No To Elite, SGYP Now Expects Data In Q4, Another Death In ZIOP's Trial

(RTTNews) - Abbott Laboratories (ABT) has received FDA approval for its Tecnis Symfony Intraocular Lenses for the treatment of cataracts.

The first in a new category of intraocular lenses, the Tecnis Symfony lenses are the only lenses in the United States that provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia (long sightedness) by helping people focus on near objects, noted the company.

ABT closed Friday's trading at $42.10, down 0.43%.

Elite Pharmaceuticals Inc. (ELTP.OB) on Friday announced that the FDA has issued a Complete Response Letter for SequestOx, the company's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.

The company plans to meet with the FDA and determine the appropriate next step forward for SequestOx.

ELTP.OB closed Friday's trading at $0.31, down 10.14%.

Emergent BioSolutions Inc. (EBS) has been authorized by its Board of Directors to repurchase up to $50 million of its common stock from time to time on the open market or in privately negotiated transactions. The term of the board authorization of the repurchase program is until December 31, 2017.

Commenting on the repurchase program, Daniel Abdun-Nabi, president and CEO of the company said, "This $50 million stock repurchase program is an opportunity to potentially create long-term shareholder value while maintaining our financial flexibility to invest in our business and to continue to pursue our acquisition strategy."

EBS closed Friday's trading at $31.18, up 1.27%.

Synergy Pharmaceuticals Inc. (SGYP) now expects to report top-line data from two ongoing phase III clinical trials with Plecanatide in irritable bowel syndrome with constipation, or IBS-C, in the fourth quarter of this year - with NDA filing planned for the first quarter of 2017.

Earlier, the company was expecting to report results from the two trials this quarter (Q3, 2016).

The company's New Drug Application for Plecanatide in chronic idiopathic constipation is under review by the FDA - with a decision date set for January 29, 2017.

SGYP closed Friday's trading at $3.61, down 5.74%.

Shares of ZIOPHARM Oncology Inc. (ZIOP) were down over 11% on Friday, following a third patient death in the company's ongoing multicenter phase I study of Ad-RTS-hIL-12 + orally administered Veledimex in recurrent or progressive glioblastoma.

According to the company, the first two patient deaths, which occurred 6.7 months and 3.9 months after treatment, were unrelated to study drug - Ad-RTS-hIL-12.

The company is collecting and analyzing information about the third death, the cause of which is said to be intracranial hemorrhage, which occurred sometime after the patient had been discharged from the treating center.

ZIOP closed Friday's trading at $5.01, down 11.64%.