CLRB Sets Agenda, FDA Authorizes Xpert Ebola, Lpath Loses Track, OCAT Eyes PSCs

(RTTNews) - Agios Pharmaceuticals Inc.'s (AGIO) investigational medicine AG-348 has been granted orphan drug designation by the FDA for the treatment of pyruvate kinase deficiency, a rare form of hemolytic anemia.

The company plans to initiate a phase 2 clinical trial of AG-348 in patients with pyruvate kinase deficiency in the first half of 2015.

AGIO closed Tuesday's trading at $101.48, down 0.85%.

Aldeyra Therapeutics Inc. (ALDX) has enrolled the first patient in its phase II clinical trial of NS2 for the treatment of Sjögren-Larsson Syndrome.

Sjögren-Larsson Syndrome is a rare disease caused by mutations in fatty acid aldehyde dehydrogenase, leading to elevated fatty aldehyde levels that are thought to contribute to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease.

The company anticipates announcing preliminary data from the phase II trial of NS2 by the end of 2015.

ALDX closed Tuesday's trading at $10.61, down 0.09%.

Atossa Genetics Inc. (ATOS), which recently launched its ForeCYTE Breast Aspirator in the EU, has now launched the product in the U.S. also.

The ForeCYTE Breast Aspirator is intended for the collection of nipple aspirate fluid (NAF) for cytological testing at a laboratory.

ATOS closed Tuesday's trading at $1.78, down 9.18%. In after-hours, the stock was up 3.37% at $1.84.

Bristol-Myers Squibb Co. (BMY) has acquired an exclusive global license to a discovery biologics research program focused on modulating the innate immune system as a therapy for autoimmune diseases from Novo Nordisk. Terms of the agreement were not disclosed.

BMY closed Tuesday's trading at $65.69, down 2.80%.

Cellectar Biosciences Inc. (CLRB), which was formerly known as Novelos Therapeutics Inc., expects to complete a phase II imaging trial of I-124-CLR1404 in patients with glioblastoma this year.

Also on this year's agenda are obtaining data from a proof-of-concept trial of its therapeutic agent I-131-CLR1404 in multiple myeloma and initiation of a proof-of-concept trial of its tumor margin illumination agent - CLR1502 - for image guided surgery.

CLRB closed Tuesday's trading at $2.74, down 0.90%.

Cepheid's (CPHD) Xpert Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours, has been granted Emergency Use Authorization by the FDA. The test will begin shipping in April 2015.

The 2014 Ebola epidemic, which mostly affected multiple countries in West Africa, is the largest in history which resulted in 10,311 deaths.

CPHD closed Tuesday's trading at $55.53, down 2.08%.

InVivo Therapeutics Holdings Corp. (NVIV.OB) is planning to effect a 1-for-4 reverse stock split of its issued and outstanding common stock in preparation for its planned uplisting to the NASDAQ Capital Market.

The company anticipates the reverse stock split to become effective and its common stock to begin trading on a post-split basis at the open of trading on April 8, 2015, contingent upon approval from the Financial Industry Regulatory Authority.

NVIV.OB closed Tuesday's trading at $2.86, down 4.03%.

Immunovaccine Inc. (IMV.V) has initiated a phase 2 clinical study of its lead cancer immunotherapy DPX-Survivac in patient with diffuse large B cell lymphoma.

The study will enroll up to 24 patients with recurrent survivin-expressing diffuse large B cell lymphoma.

IMV.TO closed Tuesday's trading at C$0.74, up 4.23%.

La Jolla Pharmaceutical Co. (LJPC) has initiated a phase III clinical trial of LJPC-501 for the treatment of catecholamine-resistant hypotension, or CRH.

CRH is an acute, life-threatening condition in which blood pressure drops to dangerously low levels in patients who respond poorly to current treatments.

The trial, dubbed ATHOS 3, is designed to enroll approximately 315 patients.

LJPC closed Tuesday's trading at $21.07.

Lipocine Inc. (LPCN) is not required to conduct a heart attack and stroke risk study or any additional safety studies prior to filing the NDA for LPCN 1021, the company's investigational oral testosterone product for hypogonadal men with low testosterone.

The labeling "food effect" study per the FDA requirement is ongoing and preliminary results from this study are scheduled to be presented to the FDA in the second quarter of 2015 for review and comment prior to submitting the NDA.

The NDA filing for LPCN 1021 is planned for the second half of 2015.

LPCN closed Tuesday's trading at $7.29, up 1.11%.

Shares of Lpath Inc. (LPTN) tumbled more than 25% in extended trading on Tuesday following failure of the company's phase 2a single-agent, open-label study of ASONEP to meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma.

Another event to watch out for is the release of data from a double-blind phase 2 study of iSONEP in wet age-related macular degeneration subjects, which is expected late in the second quarter of 2015.

Lpath has an agreement in place with Pfizer, signed in 2010, that provides Pfizer an exclusive option for a worldwide license to develop and commercialize iSONEP.

LPTN closed Tuesday's trading at $3.27, down 2.42%. In after-hours, the stock dropped another 25.11% to $2.44.

Ocata Therapeutics Inc. (OCAT) has entered into a definitive agreement with Allele Biotechnology & Pharmaceuticals, Inc. to access Allele's proprietary technology for generating human induced pluripotent stem cells.

The company noted that agreement with Allele is part of its strategy to broaden its technology platform and increase its leadership in regenerative ophthalmology.

Ocata recently confirmed proof of concept in creating photoreceptors capable of preventing blindness and restoring vision in established animal models. Data from these studies will be published later this year, according to the company.

OCAT closed Tuesday's trading at $6.11, down 0.33%.