BCRX Heartbroken, FLML Opens Wallet, SRPT In The News, CUTR Optimistic

(RTTNews) - Shares of Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) were up over 18% on Monday, following encouraging results from a small pilot study of its lead drug, Voclosporin, as a treatment for active lupus nephritis.

In the study, dubbed AURION, all the first seven patients who reached at least eight weeks of therapy achieved at least a 25% reduction in proteinuria at 8 weeks with a mean decrease of 72% compared to study entry.

The AURION study is designed to examine biomarkers of disease activity at 8 weeks and their ability to predict response at 24 and 48 weeks.

A phase 2b study evaluating Voclosporin against placebo in achieving remission in patients with active lupus nephritis, dubbed AURA-LV, is underway - with results expected later this year.

AUPH closed Monday's trading at $2.59, up 18.26%.

Shares of BioCryst Pharmaceuticals Inc. (BCRX) cratered over 71% on Monday, following disappointing results from a 12-week, three-arm, parallel cohort design trial of orally-administered Avoralstat in patients with hereditary angioedema.

In the trial, dubbed OPuS-2, treatment with 500 mg and 300 mg of Avoralstat three times daily as a liquid-filled soft gel formulation failed to demonstrate a statistically significantly lower mean attack rate versus placebo.

BCRX closed Monday's trading at $1.78, down 71.01%.

Chimerix' (CMRX) pivotal study of its antiviral candidate, Brincidofovir, in an animal model for smallpox has yielded positive results.

According to the trial results, animals that received Brincidofovir immediately had 100 percent survival, and animals that received Brincidofovir after a 24 or 48 hour delay had a 93 percent survival, statistically significant improvements compared with less than 50 percent survival in animals that received placebo.

Data from the pivotal animal model study support the potential to advance Brincidofovir as a medical countermeasure for smallpox, the company noted.

CMRX closed Monday's trading at $6.42, down 7.36%.

Corium International Inc. (CORI) expects topline interim results from a phase I trial of Corplex Memantine this month.

Corplex Memantine is the company's proprietary transdermal candidate for sustained and controlled delivery of memantine (the active ingredient in Namenda) for the treatment of moderate-to-severe dementia of the Alzheimer's type.

CORI closed Monday's trading at $5.35, down 6.30%.

After concluding 2015 with its sixth consecutive quarter of double-digit revenue growth, Cutera Inc. (CUTR) is looking forward to a strong 2016.

In the fourth quarter ended December 31, 2015, the company's revenue increased 18% to $30.0 million, with bottom-line returning to profitability.

The company plans to make a new product announcement in March of this year. Looking ahead, the company is targeting to expand the sales headcount to facilitate continued revenue growth, improve the productivity of its sales team further and continue to drive its product costs down to improve gross margins.

CUTR closed Monday's trading at $10.50, up 0.29%.

Flamel Technologies (FLML) has acquired FSC Holdings LLC, an affiliate of Deerfield CSF LLC, a Deerfield Management company.

Under the terms of the acquisition, Flamel will pay $20.25 million over a five year period to Deerfield for all of its equity interests in FSC Holdings. Accordingly, Flamel will pay $1.05 million annually for five years and will make a final payment in January 2021 of $15.0 million.

Deerfield also gets to earn a 15% royalty per annum from Flamel on net sales of the current FSC products, up to $12.5 million for a period not exceeding ten years.

FLML closed Monday's trading at $9.19, down 1.71%.

Rexahn Pharmaceuticals Inc. (RNN) has completed Stage 1 of a dose-escalation phase IIa clinical trial of Archexin in combination with everolimus, a widely used chemotherapy drug, in patients with metastatic renal cell carcinoma.

At the dose levels tested to date, Archexin appeared to be safe and well tolerated, noted the company.

The company has begun enrollment in Stage 2 of the phase IIa clinical trial to further evaluate the potential anti-cancer effects of Archexin in patients with advanced, metastatic kidney cancer.

RNN closed Monday's trading at $0.33, down 7.11%.

Shares of Sarepta Therapeutics Inc. (SRPT) plunged to a new 52-week low, following postponement of the FDA's decision date for the company's investigational therapy for Duchenne muscular dystrophy - Eteplirsen - by three months.

Accordingly, the regulatory agency is now expected to announce its decision on Eteplirsen on May 26, 2016.

An FDA panel meeting which was called upon to review Eteplirsen on January 22, 2016 was also postponed due to severe winter snowstorm then. The rescheduled date for the FDA panel meeting has not yet been determined.

SRPT closed Monday's trading at $10.74, down 12.11%.