Arrowhead Blunted, CERC Depressed, It's All Clear For NOVN, CPHR Leaves Nasdaq

(RTTNews) - Arrowhead Pharmaceuticals Inc. (ARWR) cratered nearly 60% in the after-hours session on Tuesday, following announcement that the development of clinical stage drug candidates ARC-520 and ARC-521, being developed for treatment of hepatitis B, and ARC-AAT, being developed to treat liver disease associated with Alpha-1 Antitrypsin Deficiency, will be discontinued.

All the above-mentioned clinical drug candidates utilize DPCiv, or EX1, delivery vehicle. There have been multiple deaths in a non-clinical toxicology study in non-human primates, which utilized EX1 intravenous delivery vehicle.

Early this month, the FDA placed a clinical hold on the company's phase II study of ARC-520 based on findings in the non-human primate toxicology study.

Because of the discontinuation of its existing clinical programs, the company is reducing its workforce by approximately 30%.

ARWR closed Tuesday's trading at $4.39, down 1.57%. In after-hours, the stock fell 59.91% to $1.76.

Cara Therapeutics Inc. (CARA) has completed patient enrollment for the multi-dose phase of its adaptive phase 2/3 trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus.

Uremic pruritus is an intractable systemic itch condition in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.

The phase 2/3 trial consists of two parts:

- Part A, which evaluates three doses of I.V. CR845 (0.5 mcg/kg, 1.0 mcg/kg, and 1.5 mcg/kg) administered three times per week after dialysis over an eight-week treatment period in 160 patients.

- Part B, which tests one optimized dose of I.V. CR845 administered three times per week after dialysis over a 12-week treatment period in up to 240 patients.

The company expects top-line data from Part A of the trial in the first quarter of 2017.

CARA closed Tuesday's trading at $9.45, up 2.49%.

Shares of Cerecor Inc (CERC) were down nearly 43% in extended trading on Tuesday as its phase II trial of CERC-301 as an adjunctive treatment for major depressive disorder failed to meet the primary endpoint of efficacy.

No significant improvement was observed on the other secondary endpoints of the trial as well.

The company has another clinical trial catalyst coming its way. The top-line data from its phase II study of CERC-501 for smoking cessation are expected in December.

CERC closed Tuesday's trading at $4.72, down 7.63%.

Cipher Pharmaceuticals Inc. (CPH.TO) (CPHR) has decided to voluntarily de-register its common shares from NASDAQ in order to do away with expenses involved in maintaining the U.S. listing. The common shares will cease trading on NASDAQ on or about December 12, 2016.

The company's common shares will continue trading on the Toronto Stock Exchange, where they have been listed since 2004.

CPHR closed Tuesday's trading at $2.82, down 10.76%.

Momenta Pharmaceuticals Inc.'s (MNTA) confirmatory phase III clinical study of M923, a biosimilar candidate for AbbVie's (ABBV) Humira, for the treatment of patients with moderate-to-severe chronic plaque psoriasis, has met its primary endpoint.

Momenta is developing M923 in collaboration with Baxalta, now part of Shire plc.

Humira generated revenue of $14 billion in 2015 compared to $12.54 billion in 2014.

MNTA closed Tuesday's trading at $14.05, up 1.08%.

Neurocrine Biosciences Inc.'s (NBIX) New Drug Application seeking approval of INGREZZA for the treatment of tardive dyskinesia will be reviewed by an FDA panel of outside experts on February 16, 2017.

INGREZZA is under priority review, and the FDA's final decision is set for April 11, 2017.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips. These symptoms are rarely reversible and there are currently no FDA approved treatments.

If approved, analysts see a blockbuster potential for INGREZZA.

NBIX closed Tuesday's trading at $48.49, down 1.42%.

Shares of Novan Inc. (NOVN) climbed more than 14% on Tuesday, following positive results from its phase II clinical trial of SB206 for the treatment of genital warts caused by human papillomavirus, or HPV.

The highest dose tested, SB206 12%, demonstrated a statistically significant improvement in the incidence of complete clearance of all baseline warts compared to vehicle treatment after 12 weeks in both the intent-to-treat and per-protocol analyses, according to the company.

Novan conducted its IPO as recently as September of this year.

NOVN closed Tuesday's trading at $27.18, up 14.25%.

Quidel Corp. (QDEL) has received FDA clearance to market its Solana molecular assay for the detection of Herpes Simplex Virus 1+2 and Varicella Zoster Virus.

According to the company, the Solana HSV-1+2/VZV Assay is an easy-to-use, accurate, molecular diagnostic test that is compatible with many commonly used transport media, requires no upfront extraction of DNA and generates three accurate results in less than an hour.

QDEL closed Tuesday's trading at $22.63, down 1.05%.

The FDA has accepted Pfizer Inc. (PFE) and its partner Merck KGaA's Biologics License Application for Avelumab for use in patients with metastatic Merkel cell carcinoma for priority review.

Since the FDA's Priority Review status reduces the review time from 10 months to a goal of six months from the day of filing, we expect the FDA to announce its decision on Avelumab by the end of May 2017.

Metastatic Merkel cell carcinoma is a rare and aggressive skin cancer, which impacts approximately 2,500 Americans a year. Currently, there are no approved drugs to treat metastatic Merkel cell carcinoma.

PFE closed Tuesday's trading at $31.92, up 1.20%.

Vascular Biogenics Ltd.'s (VBLT) exploratory phase 2 study of VB-111 in patients with advanced, differentiated thyroid cancer has shown a dose-response and evidence of an overall survival benefit too.

An analysis of the study performed in December 2014 showed that six patients (35%) in the therapeutic dose cohort met the primary endpoint of 6-month progression-free survival compared to 25% in a low-dose cohort.

VBLT closed Tuesday's trading at $5.65, up 13.00%.