MNK Opens Wallet, CYNA Awaits Parkinson's Drug Data, 3rd Time's A Charm For HRTX

(RTTNews) - aTyr Pharma Inc. (LIFE) expects to report data from the first four patients enrolled in Stage 1 of its phase 1b/2 trial of Resolaris in patients diagnosed with early-onset FSHD in the fourth quarter of 2016. The Stage 1 group includes patients ages 16 to 25, and a Stage 2 comprises of patients ages 12 to 15.

Facioscapulohumeral muscular dystrophy, or FSHD, is a rare genetic myopathy affecting approximately 19,000 people in the United States for which there are no approved treatments.

A phase 1b/2 trial of Resolaris in adult patients diagnosed with either FSHD or LGMD2B has enrolled a total of 18 patients (8 with FSHD and 10 with LGMD2B), exceeding the target enrollment of 16 patients. Results from the trial are expected to be announced in the fourth quarter of 2016.

LIFE closed Wednesday's trading at $2.97, down 6.60%.

Cynapsus Therapeutics Inc. (CYNA) expects to report top-line data from its phase III efficacy study of APL-130277 in Parkinson's disease patients, who have at least one OFF episode every 24 hours, in the third quarter or early in the fourth quarter of 2016.

APL-130277 is being studied to convert a patient from the OFF to the ON state and convert all types of OFF episodes associated with PD. Parkinson's disease (PD) is a chronic, progressive neurodegenerative disease characterized by motor symptoms including tremor at rest, rigidity and impaired movement as well as significant non-motor symptoms such as cognitive impairment and mood disorders. The reemergence of PD symptoms is referred to as an OFF episode.

The company anticipates sharing longer-term safety data from the trial in the first half of 2017 and intends filing the NDA for APL-130277 in the first half of 2017.

CYNA closed Wednesday's trading at $16.88, down 0.30%.

Heron Therapeutics Inc. (HRTX) has finally received FDA approval for SUSTOL extended-release injection, nearly 6 years after it was first turned away.

SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

SUSTOL was issued a complete response letter twice, in 2013 and 2010, with the FDA requesting additional data.

HRTX closed Wednesday's trading 2.37% higher at $20.33.

Mallinckrodt Public Ltd Co. (MNK) is all set to acquire Stratatech Corp., a privately held regenerative medicine company, focused on the development of unique, proprietary skin substitute products. The financial terms aren't disclosed.

The acquisition brings to Mallinckrodt's fold StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. StrataGraft is under phase III development for treatment of severe, deep partial thickness burns. If approved, StrataGraft could be the first biological "off-the-shelf" skin substitute product for treatment of severe burns.

MNK closed Wednesday's trading at $78.77, down 1.50%.

vTv Therapeutics Inc.'s (VTVT) phase 2b clinical study of TTP399, which is under development for the treatment of Type 2 diabetes, has achieved the primary endpoint - showing sustained meaningful reduction in HbA1c with well-tolerated treatment regimen.

In the phase 2b trial, dubbed AGATA, 190 subjects with Type 2 diabetes were enrolled.

VTVT closed Wednesday's trading at $5.85, up 6.36%.