AKBA Inks Blockbuster Deal, AGN On Buying Spree, TSRO Gets FDA Date

(RTTNews) - ACADIA Pharmaceuticals Inc.'s (ACAD) phase II exploratory study of Pimavanserin in patients with Alzheimer's disease psychosis has met the primary endpoint showing a statistically significant reduction in psychosis.

Pimavanserin, marketed under the brand name Nuplazid, was approved by the FDA in April of this year for hallucinations and delusions associated with Parkinson's disease psychosis.

The drug is being tested for a couple of other indications too.

ACAD closed Tuesday's trading at $28.57, up 12.35%.

Shares of Akebia Therapeutics Inc. (AKBA) rose as much as 28% on Tuesday, following a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. in the U.S. for Vadadustat, valued at over $1 billion.

Vadadustat is Akebia's lead product candidate currently in phase III development for the treatment of anemia associated with chronic kidney disease (CKD).

As per the terms of the deal, Otsuka will pay $265 million or more in committed capital, $105 million or more of the costs of the global development program for Vadadustat and potential development and commercial milestones up to $765 million.

AKBA closed Tuesday's trading at $9.97, up 19.40%.

Allergan plc (AGN), which has been on a buying spree, has just announced another acquisition - this time, a regenerative medicine company LifeCell for $2.9 billion in cash.

Allergan anticipates the LifeCell assets will generate approximately $450 million in 2016 revenue, growing at a mid-single digit rate, approximately 75% gross margin and approximately 40% operating margin in 2016.

The transaction, subject to customary conditions, is expected to close during the first half of 2017.

Chase Pharmaceuticals Corp., acquired for an upfront payment of $125 million last month, Motus Therapeutics, a wholly-owned subsidiary of Rhythm Holding Company, LLC, acquired in October, Akarna Therapeutics Ltd., acquired for $50 million in September, Tobira Therapeutics Inc., purchased for $1.7 billion in September, Vitae Pharmaceuticals Inc., bought for $639 million in September, RetroSense Therapeutics LLC, acquired for a $60 million upfront payment in September, ForSight VISION5 bought for a $95 million upfront payment in August and Anterios Inc., acquired for an upfront payment of $90 million in January are some of the other deals made by Allergan this year.

AGN closed Tuesday's trading at $191.33, down 0.63%.

The FDA has approved Dexcom Inc.'s (DXCM) G5 Mobile CGM system as the first and only continuous glucose monitoring system that can be used to make daily diabetes treatment decisions without finger pricking.

The approval expands Dexcom G5 Mobile CGM system as a replacement to finger stick glucose testing for diabetes treatment decisions, positioning the device as the new standard of care in glucose monitoring for diabetes management, according to the company.

DXCM closed Tuesday's trading at $63.56, up 0.08%.

The FDA decision on Roche Group's (RHHBY.OB) Biologics License Application of OCREVUS, which was originally scheduled for December 28, 2016, has been extended by three months to March 28, 2017.

The company is seeking approval of OCREVUS for the treatment of both relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS).

The regulatory agency has sought additional time to review the additional data submitted by the company regarding the commercial manufacturing process of OCREVUS. The extension is not related to the efficacy or safety of OCREVUS, Roche noted.

RHHBY.OB closed Tuesday's trading at $28.28, up 0.07%.

TESARO Inc.'s (TSRO) New Drug Application seeking approval of Niraparib as a potential new treatment option for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy, has been granted Priority Review by the FDA - with a decision date set for June 30, 2017.

The regulatory agency is not planning to hold an advisory committee meeting to discuss the Niraparib NDA, the company said.

TSRO closed Tuesday's trading at $136.47, up 7.25%.