EYEG Catches Investors' Eyes, FDA Approves GILD's HIV Pill, KBIO Lays Off Staff

(RTTNews) - BioLineRx Ltd. (BLRX) has reported positive results from the dose escalation part of its phase II trial of BL-8040 in relapsed or refractory acute myeloid leukemia (r/r AML).

BL-8040, as a single agent and in combination with Cytarabine (Ara-C) has been found to be safe and well tolerated at all doses tested up to and including the highest dose level of 1.5 mg/kg, with no major adverse events, according to the company.

The company expects topline results from the full study by early next year.

BLRX closed Thursday's trading at $1.45, up 5.84%.

Celldex Therapeutics Inc. (CLDX) has a couple of catalysts to watch out for in the coming months.

The second interim analysis of a phase III study of investigational RINTEGA plus GM-CSF added to standard of care Temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma, dubbed ACT IV, is expected in early 2016.

The company expects enrollment in its phase 2b randomized study of Glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB to be completed in the second half of 2016.

CLDX closed Thursday's trading at $12.51, down 4.28%.

Shares of Eyegate Pharmaceuticals Inc. (EYEG) surged over 50% on Thursday following positive response in some patients with macular edema in a phase 1b/2a clinical trial of Iontophoretic EGP-437 Ophthalmic Solution.

Jeffrey Heier, Director of Vitreoretinal Service and Retina Research at Ophthalmic Consultants of Boston and the principal investigator of the trial said that the data is encouraging, and warrants an extension to the trial to continue to work on the ideal dose and dosing regimen for the iontophoretic delivery of EGP-437.

Additional data from the extension of this trial is expected in mid-2016.

EYEG closed Thursday's trading at $4.11, up 58.08%.

Gilead Sciences Inc.'s (GILD) Genvoya has received FDA approval for the treatment of HIV-1 infection. Genvoya is a single tablet regimen, which is a combination of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF.

The drug will carry a boxed warning about the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.

GILD closed Thursday's trading at $107.83, down 1.06%.

As part of a plan to reduce operating costs, KaloBios Pharmaceuticals Inc. (KBIO) will lay off up to 17 employees, or 61% of its workforce. The company will also pause enrollment in a phase II cohort expansion phase of its ongoing clinical study of KB004 in certain hematologic malignancies.

Strategic alternatives, including potential sale of the company or its assets, or a corporate acquisition are also being considered by KaloBios.

The company suffered a setback in January of this year when its phase II study of drug candidate KB001-A to treat Pseudomonas aeruginosa lung infections in subjects with cystic fibrosis failed to meet the primary endpoint.

KBIO closed Thursday's trading at $1.93, up 2.66%. In after-hours, the stock plunged 51.81% to $0.93.

The initial data from OXiGENE Inc.'s (OXGN) phase 1b/2 study of its lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient, in patients with advanced recurrent ovarian cancer have been encouraging.

The phase 1b portion of the study enrolled 12 patients, of which 9 were evaluated for objective response. According to the trial results, 2 patients showed partial responses, 5 stable diseases and 2 progressive diseases.

The phase 2 portion of the study will commence in early 2016.

OXGN closed Thursday's trading at $0.90, up 0.37%. In after hours, the stock was up 9.61% to $0.99.

pSivida Corp. (PSDV) now expects to report top-line results from its first phase III trial of lead product candidate Medidur for posterior uveitis in December 2015.

Enrollment in the second trial continues on schedule, with the NDA filing expected in the first half of 2017.

PSDV closed Thursday's trading at $3.93, up 1.03%.

Sage Therapeutics (SAGE) expects topline results from its placebo-controlled proof-of-concept clinical trial of SAGE-547 in patients with Postpartum Depression to be reported in the first half of 2016.

A phase 1 single ascending dose trial evaluating SAGE-217 in healthy volunteers is underway, and initial top-line results from the study are also expected in the first half of 2016.

SAGE-217 is being developed for high frequency seizures associated with select neurological disorders, including orphan epilepsies, and other GABAA dysfunction-related disorders, such as essential tremor.

SAGE closed Thursday's trading at $53.03, down 2.80%.