AXSM On Fast Track, MRK Halts Alzheimer's Drug Study, HOLX Snaps Up CYNO

(RTTNews) - Axsome Therapeutics Inc.'s (AXSM) drug candidate AXS-05 has received Fast Track status from the FDA for treatment resistant depression.

AXS-05 is currently being evaluated in a phase III study, dubbed STRIDE-1, for the treatment of treatment resistant depression.

AXSM closed Tuesday's trading at $4.75, up 3.26%.

Axovant Sciences (AXON) has a couple of catalysts to watch out for this year.

The topline results from the company's phase III study of Intepirdine in patients with mild-to-moderate Alzheimer's disease, dubbed MINDSET, are expected in the third quarter of 2017.

Results from a phase 2b study of Intepirdine in patients with dementia with Lewy bodies, known as HEADWAY-DLB, are anticipated in the fourth quarter of 2017.

Another product in the pipeline is Nelotanserin. Results from a phase 2 study of Nelotanserin for treatment of REM Behavior Disorder (RBD) in patients with DLB are expected in the second half of 2017.

AXON closed Tuesday's trading at $11.74, down 0.93%.

Gilead Sciences Inc.'s (GILD) single-tablet regimen HIV medication Genvoya, through 3 years of treatment, demonstrated significantly higher rates of virologic suppression and favorable renal and bone laboratory parameters compared to Stribild.

Stribild is also a single tablet HIV regimen from the stable of Gilead. Genvoya was approved by the FDA in November 2015 and Stribild was approved in August 2012. In 2016, Genvoya raked in total sales of $1.48 billion and Stribild $1.91 billion.

According to the trial results, at Week 144, 84.2 percent of patients taking Genvoya and 80 percent of patients taking Stribild achieved HIV-1 RNA levels less than 50 copies/mL. Additionally, at Week 144, 81.1 percent of patients taking Genvoya and 75.8 percent of patients taking Stribild achieved HIV-1 RNA levels less than 20 copies/mL, a secondary endpoint.

GILD closed Tuesday's trading at $67.55, down 0.15%.

Hologic Inc. (HOLX) is all set to acquire Cynosure Inc. (CYNO) for $66.00 per share in cash, which corresponds to an equity value of approximately $1.65 billion and an enterprise value of $1.44 billion net of cash.

The transaction is expected to be dilutive to Hologic's GAAP earnings per share. On a non-GAAP basis, however, Hologic forecasts the deal will be immediately accretive, adding approximately $0.03 to $0.05 to the company's non-GAAP EPS in the balance of fiscal 2017, adding approximately $0.13 to $0.15 in non-GAAP EPS in fiscal 2018, and becoming increasingly accretive in fiscal 2019 and beyond.

HOLX closed Tuesday's trading at $39.03, down 2.47%.

Merck (MRK) has decided to pull the plug on its phase 2/3 study evaluating Verubecestat in people with mild-to-moderate Alzheimer's disease due to lack of efficacy.

During a recent interim safety analysis of the phase 2/3 study, dubbed EPOCH, the external Data Monitoring Committee found that there was "virtually no chance of finding a positive clinical effect".

However, two pivotal Phase 3 clinical trials of Verubecestat - one in mild-to-moderate AD, and the other in prodromal Alzheimer's disease are underway.

MRK closed Tuesday's trading at $65.66, up 1.37%. In after-hours, the stock was down 1.72% to $64.53.

Prothena Corporation plc. (PRTA) looks to busy year ahead.

The company's most advanced investigational drug is NEOD001. A phase III study of NEOD001 in newly-diagnosed, treatment-naïve patients with AL amyloidosis and cardiac dysfunction, dubbed VITAL, is expected to complete enrollment during the second quarter of this year.

A phase 2b study of NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction, known as PRONTO, is underway. Enrollment in this trial is anticipated to be completed during the last week of February 2017 - with top line results expected in the second quarter of 2018.

Also in the pipeline are:

-- PRX002 for Parkinson's disease, which is expected to enter phase II testing this year.

-- PRX003, which is under a phase 1b multiple ascending dose, proof-of-biology study in patients with psoriasis, with top line results expected in the third quarter of 2017.

PRTA closed Tuesday's trading at $52.04, down 0.21%.