ACAD Gets FDA Date, Insight On BIND, Mega Deals Of Monday, PRTA On Track

(RTTNews) - ACADIA Pharmaceuticals Inc.'s (ACAD) New Drug Application for NUPLAZID for the treatment of psychosis associated with Parkinson's disease has been accepted for priority review by the FDA.

The regulatory agency is scheduled to announce its decision on NUPLAZID on May 1, 2016.

ACAD closed Monday's trading at $40.18, up 15.39%.

BIND Therapeutics Inc. (BIND) expects to report initial data from the first stage of a phase II trial of BIND-014, dubbed iNSITE 1, in KRAS mutant or squamous histology non-small cell lung cancer in the fourth quarter of 2015.

The initial stage 1 data readout from phase II trial of BIND-014, dubbed iNSITE 2, in multiple tumor types are expected in the first half of 2016.

BIND closed Monday's trading at $4.40, down 4.97%.

In a move that will strengthen its pipeline and strategic focus on heart failure, Bristol-Myers Squibb Co. (BMY) is all set to acquire Cardioxyl Pharma, a private biotechnology company, in a deal valued at over $2 billion.

Cardioxyl's lead asset is CXL-1427, under phase II clinical development as an intravenous treatment for acute decompensated heart failure (ADHF).

The transaction includes upfront and near-term milestone payments of up to $300 million and potential additional consideration of up to $1.775 billion upon the achievement of certain development, regulatory and sales milestones.

Bristol-Myers expects the deal to be dilutive to 2015 GAAP EPS by approximately $0.12, with minimal dilution to non-GAAP EPS in both 2015 and 2016.

The transaction is expected to close during the fourth quarter of 2015.

BMY closed Monday's trading at $65.75, down 0.30%.

Kite Pharma Inc. (KITE) has opened enrollment for the phase 2 portion of its ongoing phase 1/2 clinical trial of KTE-C19 in patients with refractory, aggressive Non-Hodgkin's Lymphoma.

The company looks forward to presenting top-line data from the Phase 1 portion of the trial at the American Society of Hematology (ASH), which will be held next month, and anticipate reporting interim results from the study in 2016.

KITE closed Monday's trading at $72.33, up 6.29%.

Proteon Therapeutics Inc. (PRTO) has completed enrollment in the first of two phase III clinical studies of Vonapanitase (formerly PRT-201), the company's lead development candidate intended to improve arteriovenous fistula patency for hemodialysis in patients with chronic kidney disease.

The study, dubbed PATENCY-1, has enrolled 311 patients at 31 centers in the United States, and topline data from this study are expected to be available in December of 2016.

The second phase III clinical study of Vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic AVF for hemodialysis, dubbed PATENCY-2, is enrolling patients. This study will enroll 300 patients at approximately 40 centers in the United States and Canada.

PRTO closed Monday's trading at $14.46, up 5.55%.

Prothena Corporation plc. (PRTA) has a couple of catalysts ahead to watch out for in the coming months.

The company expects topline results from the expansion cohort of a phase 1/2 study of NEOD001, its drug candidate for the potential treatment of AL amyloidosis, in the second quarter of 2016.

The topline data from a phase I multiple ascending dose study of PRX002 in patients with Parkinson's disease are expected in the first half of 2016.

PRTA closed Monday's trading at $55.05, up 6.87%.

Shire plc (SHPG) has agreed to acquire Dyax Corp. (DYAX) for $37.30 per share in cash, equivalent to an aggregate upfront consideration of approximately $5.9 billion.

Dyax's most advanced clinical program is DX-2930, a phase 3-ready compound for the prevention of attacks of hereditary angioedema.

Dyax shareholders may receive additional value through a non-tradable contingent value right (CVR) that will pay $4.00 in cash per Dyax share upon approval of DX-2930 in HAE, representing a potential additional $646 million in aggregate contingent consideration.

The proposed transaction is expected to enhance Shire's long-term top and bottom line growth profile, and is expected to be slightly dilutive to earnings in 2016 and 2017 and accretive in 2018 and beyond, assuming U.S. approval of DX-2930 in 2018.

SHPG closed Monday's trading at $224.68, down 1.04%.

Zoetis Inc. (ZTS) is all set to acquire PHARMAQ, the market leader in sales of vaccines for farmed fish, for a price of $765 million on a debt-free basis.

Zoetis is purchasing PHARMAQ from a company owned by Permira IV, a fund managed by the global investment firm Permira, which has been the majority owner of the company since 2013.

The acquisition of PHARMAQ is expected to strengthen Zoetis' core livestock business, giving it a market-leading presence in the fastest growing segment of the animal health industry.

ZTS closed Monday's trading at $44.24, up 2.86%.