BLUE, CELG Fine Tune Deal, Lightlake Cruises Ahead, HALO Shines, CPXX On Track

(RTTNews) - Amicus Therapeutics (FOLD) has submitted a marketing authorization application seeking approval of its investigational Fabry monotherapy Galafold in the European Union. Galafold has accelerated assessment in the EU.

Amicus also plans to conduct a pre-NDA meeting with the US FDA and to submit a New Drug Application for Galafold in the United States under Subpart H1 in the second half of 2015.

FOLD closed Wednesday's trading at $12.36, up 1.15%.

Ardelyx Inc. (ARDX) and AstraZeneca plc (AZN) have terminated the worldwide licensing deal for NHE3 inhibitor program that was signed in October 2012. Following this, Ardelyx has regained all rights for all NHE3 inhibitors previously licensed to AstraZeneca, including Ardelyx's lead product candidate, Tenapanor.

With the acquisition of worldwide rights from AstraZeneca, Ardelyx plans to initiate a phase III trial of Tenapanor in IBS-C (constipation from irritable bowel syndrome) patients in the fourth quarter of this year, and begin a phase 2b clinical trial of Tenapanor for the treatment of hyperphosphatemia in dialysis patients in the fourth quarter of this year.

ARDX closed Wednesday's trading at $14.95, up 39.72%.

bluebird bio Inc. (BLUE) and Celgene Corp.'s (CELG) existing collaboration, originally initiated in 2013, has now been amended to focus on developing product candidates targeting B-cell maturation antigen, or BCMA, during a three-year collaboration term. The original collaboration was focused on applying gene therapy technology to genetically modify a patient's own T cells to target and destroy cancer cells.

Under the amended agreement, Celgene and bluebird bio will work collaboratively on the initial, lead anti-BCMA product candidate (bb2121), with a phase I clinical trial expected to begin enrollment in early 2016, and develop next-generation anti-BCMA product candidates. bluebird bio retains sole rights to develop all other chimeric antigen receptor (CAR) T cell programs developed by bluebird bio under the collaboration, including ongoing undisclosed preclinical programs with opportunities in both solid tumors and hematologic malignancies.

BLUE closed Wednesday's trading at $184.77, down 1.96%. In after-hours, the stock was down 3.39% at $178.50.

Celator Pharmaceuticals Inc. (CPXX) has completed enrollment in a phase II pharmacokinetic and pharmacodynamics study evaluating CPX-351 Liposome Injection on cardiac repolarization in adult patients with acute hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome. The top-line results from this study are expected by the end of the year.

The company's phase III study comparing CPX-351 to the current standard of care, known as 7+3, which is being conducted in patients with high-risk (secondary) AML, is underway. The study's initial data from a secondary endpoint, induction response rate, is expected by the end of June 2015 while the primary endpoint data, of overall survival, is expected in the first quarter of 2016.

CPXX closed Wednesday's trading 16.74% higher at $2.65.

Chembio Diagnostics Inc. (CEMI) has received CE Mark approval for its DPP HIV 1/2 Assay, which detects HIV antibodies in oral fluid or blood. The company expects to launch sales of the product in the European Union in the fourth quarter of 2015.

CEMI closed Wednesday's trading at $4.60, unchanged from the previous day's close. In after-hours, the stock was up 2.61% at $4.72.

Halozyme Therapeutics Inc. (HALO) has entered into a global collaboration and license agreement with AbbVie (ABBV) to develop and commercialize products combining proprietary AbbVie compounds with Halozyme's ENHANZE platform.

Halozyme's ENHANZE platform is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan, a chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs. For AbbVie, this technology may allow for more rapid delivery of injectable medications through subcutaneous delivery.

Under the terms of the agreement, Halozyme will receive an initial $23 million payment, followed by milestone payments totaling roughly $130 million for each of up to nine collaboration targets. The payments are subject to AbbVie's achievement of specified development, regulatory and sales-based milestones. In addition, AbbVie will pay Halozyme tiered royalties if products under the collaboration are commercialized.

HALO, which touched a high of $19.59 on Wednesday, closed the day's trading at $19.57, up 8.78%.

Lightlake Therapeutics Inc.'s (LLTP.OB) partner Adapt Pharma Ltd. has commenced a rolling submission of a New Drug Application to the FDA for a nasal spray formulation of Naloxone, a drug intended to treat opioid overdose.

Naloxone is approved by the FDA, in injectable formulations, for the emergency treatment of known or suspected opioid overdose.

Lightlake entered into a licensing deal with a subsidiary of Adapt last December. In exchange for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit royalties.

LLTP.OB closed Wenesday's trading 21.90% higher at $7.46.

Revance Therapeutics Inc. (RVNC) is all set to initiate two key trials with its investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A, this year.

The company plans to initiate a U.S. phase III pivotal study of a single topical application of RT001 on adults with moderate to severe crow's feet lines in the second half of 2015, and a U.S. phase II study of a single application of topical RT001 on adults with moderate to severe axillary hyperhidrosis, or excessive sweating later this year.

RVNC closed Wednesday's trading at $30.72, up 18.43%.