CEMP Loses Big As D-Day Nears, AVXS Catches Investors' Eyes, No Respite For OPXA

(RTTNews) - Shares of AveXis Inc. (AVXS) rose over 22% on Wednesday after the company announced that the FDA has acknowledged the company's single-arm design for U.S. pivotal study of AVXS-101 in SMA Type 1 patients.

The trial is expected to begin in the first half of 2017.

Spinal muscular atrophy, or SMA, is a genetic disorder that affects 1 in 10,000 children born, and is the number 1 genetic cause of infant death. Based on the age of initial onset of muscle weakness and severity of the disease, spinal muscular atrophy is classified into four types: Type I (Infantile), Type II (Intermediate), Type III (Juvenile) and Type IV (Adult onset).

Commenting on the Type B meeting with the FDA held on September 30, 2016, Sean Nolan, President and Chief Executive Officer of AveXis said, ""We believe the Type B meeting had a positive tone, with FDA offering a number of constructive suggestions which we believe will better enable implementation of a pivotal study design that is most appropriate for the patients suffering from this devastating disease."

AVXS touched a new high of $59.78 on Wednesday, before closing the day's trading at $58.66, up 22.18%.

Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) is planning to initiate a phase III clinical trial for Voclosporin in the treatment of lupus nephritis in the second quarter of 2017.

This phase III trial, dubbed AURORA, will be a global 52-week double-blind, placebo controlled study of approximately 320 patients. According to the company, this single study will support a New Drug Application submission.

A phase IIb clinical study of Voclosporin in patients with active lupus nephritis, known as AURA-LV, is underway. The company reported positive 24-week primary and secondary endpoints from the trial on August 15, 2016. The 48-week results from the trial are expected to be announced in Q1 2017.

AUPH closed Wednesday's trading at $2.77, down 5.78%. In after-hours, the stock was up 20.22% to $3.33.

Shares of Cempra Inc. (CEMP) tumbled over 60% on Wednesday as a preliminary review of the company's drug candidate Solithromycin by the FDA raises some serious safety suspicions.

The company's New Drug Applications for intravenous and oral Solithromycin for community-acquired bacterial pneumonia, or CABP, are scheduled to be reviewed by an FDA panel on November 4, 2016.

In briefing documents posted on its website, the FDA says that Solithromycin is closely structurally related to Telithromycin, an FDA-approved ketolide, marketed in the U.S. by Sanofi-aventis under the brand name Ketek for the treatment of community acquired pneumonia. Despite a low occurrence of hepatic events in the initial telithromycin NDA safety database of almost 3400 patients, the post-market phase was marked by the occurrence of more than 40 cases of severe telithromycin-related hepatotoxicity resulting in 4 deaths and a liver transplantation.

CEMP closed Wednesday's trading at $7.30, down 60.86%.

Shares of Eagle Pharmaceuticals Inc. (EGRX) jumped more than 18% on Wednesday, following the establishment of a unique, product-specific billing code, or J-code for Bendeka Injection the Centers for Medicare & Medicaid Services.

Bendeka is licensed to and launched jointly by Eagle Pharma and Teva Pharmaceutical Industries Ltd. (TEVA).

The new J-code, which will become effective on January 1, 2017, provides reimbursement coding clarity to outpatient facilities and physicians that administer Bendeka, facilitating access for patients and Medicare, Medicaid and commercial insurance reimbursement.

Bendeka, which is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma, was commercially launched in January 2016.

EGRX closed Wednesday's trading at $68.10, up 18.97%.

Shares of Intersect ENT Inc. (XENT) were up more than 10% in extended trading on Wednesday, following better-than-expected Q3 revenue and narrower-than-projected loss.

Net loss for the third quarter of 2016 was $6.2 million or $0.22 per share on revenue of $18.5 million. Analysts polled by Thomson Reuters expected the company to report a loss of $0.27 per share and revenue of $17.84 million. In the year-ago quarter, the company had posted a loss of $9.7 million or $0.35 per share on revenue of $14.2 million.

In morning trading, XENT plunged more than 43% as the stock was downgraded by JPMorgan Chase & Co. from an "overweight" rating to a "neutral" rating - with its price target reduced to $16 from $25.

XENT closed Wednesday's trading at $8.35, down 43.20%. In after-hours, the stock was up 10.78% to $9.25.

Shares of Opexa Therapeutics Inc. (OPXA) were down over 20% on Wednesday, after the company announced a 40% reduction in the company's workforce in light of the failed phase 2b clinical trial of Tcelna in patients with secondary progressive multiple sclerosis, dubbed Abili-T.

The company expects to incur incremental aggregate cash charges of approximately $95,000 associated with the current workforce reduction. Additional restructuring is anticipated to occur by year-end.

OPXA touched a new low of $0.61 on Wednesday before closing the day's trading at $0.64, down 20.41%.