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Christmas Comes Early For KURA, ANTH On Track, ABBV Hits All-time High

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Today's Daily Dose brings you news about Amgen's chronic migraine study; Ampio's non compliance with certain listing standards of NYSE; Kura's phase II trial of Tipifarnib; Adamas' phase Ib epilepsy trial and AbbVie's phase IIb dose-ranging study of Upadacitinib in atopic dermatitis.

Read on...

AbbVie's (ABBV) phase IIb dose-ranging study of Upadacitinib (ABT-494) in atopic dermatitis has met the primary endpoint.

According to the study results, all doses of Upadacitinib achieved the primary endpoint of greater mean percentage change from baseline in Eczema Area and Severity Index (EASI) score versus placebo at 16 weeks. Clear or almost clear skin was achieved by 50 percent of patients receiving 30 mg once-daily dose of Upadacitinib. There was a reduction in pruritus (itch) within the first week and improvement in skin within the first two weeks for all doses of Upadacitinib.

ABBV touched an all-time high of $82.45 on Thursday, before closing the day's trading at $81.78, up 6.14%.

Adamas Pharmaceuticals Inc. (ADMS) announced positive topline data from its phase Ib trial of investigational ADS-4101 modified-release capsules for the treatment of partial onset seizures in epilepsy.

The study demonstrated that a 600 mg dose of ADS-4101, taken once-nightly, provided a 1.7-fold increase in average lacosamide concentrations throughout the day compared to the maximum approved daily dose of 400 mg, taken as 200 mg twice-daily of VIMPAT immediate-release tablets in healthy volunteers, with comparable tolerability.

ADMS closed Thursday's trading at $21.26, down 0.89%.

Amgen's (AMGN) investigational biologic product Aimovig, in a pivotal phase II chronic migraine study, reduced the number of monthly migraine days in patients who have failed previous preventive therapies.

Separately, new results from a treadmill safety study showed no adverse cardiovascular effect compared to placebo in patients with coronary artery disease and stable angina.

Aimovig is under FDA review - with a decision date set for May 17, 2018. If approved, Novartis and Amgen will co-commercialize Aimovig in the U.S.

AMGN closed Thursday's trading at $180.71, up 1.31%.

Ampio Pharmaceuticals Inc. (AMPE) has been notified of not being in compliance with certain listing standards of NYSE related to stockholders' equity and sustained losses.

The Company reported a stockholders' equity of $3.73 million as of June 30, 2017, and net losses in its five most recent fiscal years ended December 31, 2016.

The Exchange has requested that the Company submit a plan of compliance by October 2, 2017, addressing how it intends to regain compliance by March 1, 2019.

AMPE closed Thursday's trading at $0.53, up 2.88%.

Anthera Pharmaceuticals Inc.'s (ANTH) screening of patients in its phase III study of Sollpura in Cystic Fibrosis has surpassed the halfway mark.

The phase III trial, dubbed RESULT, is studying the use of a more frequent and flexible dosing of Sollpura for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.

Topline data from RESULT are expected at the end of 2017 to early 2018.

ANTH closed Thursday's trading at $1.38, down 4.17%.

Coherus BioSciences Inc.'s (CHRS) all four of its petitions for Inter Partes Review of AbbVie's U.S. "619" patent related to HUMIRA has been denied by the Patent Trial and Appeal Board. The '619 patent is generally directed to formulations of Humira that do not contain a buffer.

Coherus' investigational drug CHS-1420, which is a biosimilar candidate to Humira, successfully completed phase III testing in January of this year. The Company expects to file a Biologics License Application for CHS-1420 in the first half of 2018.

CHRS closed Thursday's trading at $13.50, down 6.25%. In after-hours, the stock was up 1.63% to $13.72.

Kura Oncology Inc.'s (KURA) phase II trial of its product candidate, Tipifarnib, in patients with HRAS mutant relapsed or refractory squamous cell carcinomas of the head and neck has achieved its primary endpoint, even prior to the completion of enrollment.

Four of the first six HRAS mutant HNSCC patients enrolled on study have achieved confirmed RECIST partial responses. The Company will continue to enroll patients and plans to present data from the study at an upcoming scientific or medical conference.

KURA closed Thursday's trading at $6.85, down 1.44%. In after-hours, the stock surged more than 25% to $8.60.


TRACON Pharmaceuticals (TCON) has completed enrollment in its phase IIb study of TRC105 and Inlyta in patients with advanced or metastatic renal cell carcinoma, dubbed TRAXAR.

The TRAXAR study has enrolled 150 patients who failed one prior VEGF inhibitor.

The Company expects to report top-line progression-free survival data from the study later this year.

TCON closed Thursday's trading at $3.60, up 7.46%.

United Therapeutics Corp.'s (UTHR) phase III clinical worsening study of Orenitram in patients with pulmonary arterial hypertension receiving background oral monotherapy study, dubbed FREEDOM-EV, will continue as planned without modification.

A pre-specified interim safety and efficacy analysis by the independent data monitoring committee has not identified any new safety concerns.

Orenitram, an extended-release, oral tablet form of treprostinil, was approved by the FDA in December 2013 for treatment of pulmonary arterial hypertension patients to improve exercise capacity.

UTHR closed Thursday's trading at $133.52, down 1.12%.

by RTT Staff Writer

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