ARWR's Hepatitis B Drug On Clinical Hold, GMED Disappoints, A First For MYL

(RTTNews) - Arrowhead Pharmaceuticals Inc.'s (ARWR) phase 2b study of ARC-520 for the treatment of chronic hepatitis B infection, dubbed Heparc-2004, has been placed on clinical hold by the FDA.

The company noted that the clinical hold was not based on any human findings but was based on findings in an ongoing non-human primate toxicology study, in which the highest dose of the drug resulted in deaths. The cause of these animal deaths is unknown and under investigation.

ARWR closed Tuesday's trading at $6.11, up 4.09%.

Aeterna Zentaris Inc. (AEZS) (AEZ.TO) now expects top-line results from its pivotal phase clinical trial of Zoptrex in women with advanced, recurrent endometrial cancer in Q1 2017 and submission of New Drug Application to the FDA in 2017.

Another advanced compound in the company's pipeline is Macrilen, which is under a confirmatory phase III clinical study in adult patients with growth hormone deficiency. The company expects to release top-line results from this study in early 2017 and submission of New Drug Application to the FDA in the first half of 2017.

AEZS closed Tuesday's trading at $3.25, down 7.14%.

Cerecor Inc. (CERC) is all set to report top-line data from its phase 2 study of CERC-301, which is being evaluated as an oral, adjunctive treatment of major depressive disorder, this month.

Another upcoming catalyst is the top-line data from a phase II study of CERC-501 for smoking cessation that is expected to be reported in December.

CERC closed Tuesday's trading at $3.99, up 0.25%.

Shares of Globus Medical Inc. (GMED) were down over 11% in extended trading on Tuesday, following lackluster Q3 results and disappointing guidance.

Third quarter net income was $26.2 million, a decrease of 1.0% over the same period last year. Diluted EPS for the third quarter of 2016 declined to $0.27 from $0.28 for the third quarter 2015. Non-GAAP diluted EPS for the third quarter was $0.29, consistent with the third quarter of 2015, and in line with analysts' consensus estimate.

The company's third quarter sales were $135.7 million, a year-over-year decrease of 1%, and well below analysts' expectation of $139.25 million.

Looking ahead to full year 2016, Globus now expects sales of $560 million compared to earlier forecast of $575 million. The company has also trimmed its GAAP earnings per share forecast to approximately $1.13 from its earlier projection of $1.17 per share. Guidance for non-GAAP diluted EPS remains unchanged at $1.20 per share.

GMED closed Tuesday's trading at $22.33, down 1.02%. In after-hours, the stock fell 11.11% to $19.58.

Mylan N.V. (MYL) is seeking approval for its biosimilar version of Roche's Herceptin, and a biologics license application under 351(K) pathway has been filed in this regard.

Herceptin is indicated to treat certain HER2-positive breast and gastric cancers. In 2015, sales of Herceptin were $6.59 billion.

The FDA submission for biosimilar Herceptin marks Mylan's first FDA biosimilar submission.

MYL closed Tuesday's trading at $37.11, up 1.42%.

The FDA has cleared Syneron Medical Ltd.'s (ELOS) Profound when using SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III.

Profound is a minimally invasive, fractional radiofrequency microneedling device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The product is expected to be released in 2017.

ELOS closed Tuesday's trading at $7.20, down 0.69%.

Zosano Pharma Corp. (ZSAN) has completed enrollment in its registration-enabling, pivotal efficacy trial of M207, dubbed Zotrip, for the treatment of acute migraine. The results from the trial are expected to be reported in the first quarter of 2017.

ZSAN closed Tuesday's trading at $0.52, up 1.98%.