ABBV All Set, PSTI Moving Ahead, Watch Out For ADMS

(RTTNews) - AbbVie's (ABBV) New Drug Application for Venetoclax for the treatment of chronic lymphocytic leukemia in adults, who have received at least one prior therapy, including patients with 17p deletion, has been accepted for priority review by the FDA.

A priority review shortens the review period to six months from the standard review period of 10 months. Accordingly, the FDA's decision is likely to be announced in July.

Additionally, the European Medicines Agency has validated the Marketing Authorization Application for Venetoclax.

Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA's Committee for Medicinal Products for Human Use (CHMP). Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months.

ABBV closed Tuesday's trading at $54.84, up 1.78%.

Adamas Pharmaceuticals Inc. (ADMS) has a couple of catalysts lined up for this year.

The company's lead compound is ADS-5102 for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson's disease. Topline data from a phase III trial of ADS-5102, dubbed EASE LID 3, are expected in the first half of this year.

ADS-5102 is also being explored in the indication of major symptoms associated with multiple sclerosis in patients with walking impairment.

Top-line data from a phase II trial of ADS-5102 for the treatment of MS symptoms, including walking impairment, are also anticipated in the first half of this year.

ADMS closed Tuesday's trading at $23.96, up 2.09%.

Arena Pharmaceuticals Inc. (ARNA) and Germany's privately held Boehringer Ingelheim have teamed up to advance research in schizophrenia.

The collaboration aims to identify drug candidates targeting an undisclosed G protein-coupled receptor (GPCR), which belongs to the group of *orphan CNS receptors. (an "orphan receptor" is structurally related to a family of proteins that are known to act as functional cell-surface receptors but whose ligand has not yet been identified).

Per the terms of the deal, Arena is entitled to receive payments up to $262 million in success milestones in case of full commercial success of multiple drug products, including an upfront payment and research funding. In addition, Arena is eligible to receive tiered royalties on future sales of products that arise from the collaboration.

Further details of the agreement were not disclosed.

ARNA closed Tuesday's trading at $1.57, up 8.28%. In after hours, the stock was up 10.19% at $1.73.

Esperion Therapeutics Inc. (ESPR) has initiated a phase II study of Bempedoic acid in patients treated with atorvastatin 80 mg, the most commonly prescribed high-dose statin, to lower low-density lipoprotein cholesterol, or LDL-C.

The phase II study is designed to enroll 60 patients on stable atorvastatin 80 mg per day. The company expects to announce top-line results from the study by mid-year.

ESPR closed Tuesday's trading at $16.48, up 0.86%.

Ionis Pharmaceuticals Inc. (IONS) has earned a milestone payment of $2.15 million from Biogen Inc. (BIIB) for completing the target enrolment in a phase III study of Nusinersen in children with spinal muscular atrophy.

The phase III study, dubbed CHERISH, which has enrolled 117 children who are non-ambulatory with spinal muscular atrophy between the ages of 2 to 12, will evaluate the efficacy and safety of 12 mg doses of Nusinersen. The primary endpoint is a change in the Hammersmith Functional Motor Scale-Expanded (HFMSE), a validated method to measure changes in muscle function in patients with spinal muscular atrophy.

IONS closed Tuesday's trading at $48.57, down 3.23%.

Shares of beleaguered drug developer KaloBios Pharmaceuticals Inc. (KBIO) will be suspended from Nasdaq effective January 13, 2016. The company has decided not to appeal on the delisting.

The criminal indictment and arrest of Martin Shkreli, the company's controlling shareholder, former Chairman and former CEO, for securities fraud, among other things, as well as the arrest and indictment of Evan Greebel, the company's former outside counsel, and failure to file Quarterly Report on Form 10-Q for the period ended September 30, 2015, are the reasons for KaloBios' abrupt fall from grace.

Pluristem Therapeutics Inc. (PSTI) is all set to begin its phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation in the first half of 2016.

The study will be conducted in 30 subjects with incomplete hematopoietic recovery persistent for 6 months or more after Hematopoietic Cell Transplantation, said the company.

PSTI closed Tuesday's trading at $0.96, up 1.17%.