EVOK Expects Data In Q3, PRTA Has Its Hands Full, SUPN Awaits FDA Decision

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) expects to submit EU and U.S. Marketing Application for Cerliponase alfa, intended for the treatment of children with CLN2 disease, a form of Batten disease, by mid-2016.

The company's request for accelerated assessment for the planned Cerliponase alfa Marketing Authorization Application has been granted by the EMA.

BMRN closed Tuesday's trading at $85.09, down 2.08%.

In just another two months, Corcept Therapeutics Inc. (CORT) will be reporting results from a phase 1/2 trial of mifepristone in combination with an approved chemotherapy drug Eribulin to treat triple-negative breast cancer.

The phase 1/2 trial is investigating whether the addition of mifepristone, the active ingredient in Corcept's approved medication, Korlym, will enhance the effect of Eribulin in patients whose triple-negative breast cancer tumors express GR, one of the receptors to which Korlym bind.

The other developments in the company include recruitment in a phase 1/2 trial of selective cortisol modulator CORT125134 in combination with nab-paclitaxel to treat solid-tumor cancers, advancement of selective cortisol modulators CORT118335, CORT122928 and CORT125281 towards phase I testing, and plans to initiate phase II trial of CORT125134 to treat patients with Cushing's syndrome this quarter.

CORT closed Tuesday's trading at $4.83, down 4.36%.

Evoke Pharma Inc. (EVOK) expects to provide top line data results from its pivotal phase III clinical trial of EVK-001 in women with symptoms associated with diabetic gastroparesis early in the third quarter of 2016.

The study was designed to enroll approximately 200 subjects and the company has confirmed that 205 subjects have now been randomized in the trial.

EVOK closed Tuesday's trading at $4.94, up 2.70%.

Foamix Pharmaceuticals Ltd. (FOMX) has completed enrollment in its phase II clinical trial of FMX103 for the treatment of papulopustular rosacea.

According to the company, the study has enrolled 233 patients in 18 sites throughout Germany. The company expects to report results later this year.

FOMX closed Tuesday's trading at $6.75, up 5.63%.

Shares of Marina Biotech Inc. (MRNA.OB) surged over 60% on Tuesday after the company announced that it would acquire intranasal ketamine program, under phase III testing, from privately-held Turing Pharmaceuticals.

Marina will pay to Turing up to $95 million in success- and sales-based milestones plus a mid-single digit royalty on net sales. Further terms of the proposed transaction were not disclosed.

MRNA.OB closed Tuesday's trading 64.47% higher at $0.25.

Prothena Corp. plc (PRTA) has a couple of catalysts to watch out for in the coming months, related to its three lead protein immunotherapy programs - NEOD001, PRX002 and PRX003.

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

A phase III study of NEOD001 in newly-diagnosed, treatment-naïve patients with AL amyloidosis with cardiac dysfunction, dubbed VITAL, is underway - with enrollment expected to be completed in the second quarter of 2017.

The company expects to report topline results from a phase IIb study of NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction, dubbed PRONTO, in late 2017 or early 2018.

Prothena anticipates topline results from its phase I multiple ascending dose study of PRX002 in patients with Parkinson's disease in the fourth quarter of 2016.

Another lead program of the company is PRX003, under development for the potential treatment of inflammatory diseases, including psoriasis.

The company expects topline results from its phase I single ascending dose study of PRX003 in healthy volunteers in the second quarter of 2016, and topline results from a phase 1b multiple ascending dose, proof-of-biology study in patients with psoriasis in the second half of 2017.

PRTA closed Tuesday's trading at $41.56, down 5.27%.

Supernus Pharmaceuticals Inc. (SUPN) expects to hear the FDA decision on label expansion of Trokendi XR to include treatment for adults for prophylaxis of migraine headache this quarter. The drug was approved in August 2013 for the treatment of epilepsy, and it raked in sales of $110.3 million for full year 2015, an increase of 70% from 2014.

The advanced clinical candidates in the company's pipeline are SPN-810, which is under phase III trial for Impulsive Aggression in patients who have ADHD, and SPN-812, which is under phase IIb trial for ADHD.

The company expects phase III data for SPN-810 to be available by mid 2017 and phase IIb data for SPN-812 to be available by early 2017.

SUPN closed Tuesday's trading at $16.54, down 1.96%.

TherapeuticsMD Inc. (TXMD) expects to report topline data from its phase III trial of TX-001HR for the treatment of moderate-to-severe vasomotor symptoms due to menopause, dubbed Replenish, in the fourth quarter of 2016.

The company also expects to file a NDA for TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause by end of June 2016.

TXMD closed Tuesday's trading at $8.43, up 0.24%.