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FDA Nod For Breast Cancer Combo Therapy, RARE Scripts History, EDAP Disappoints


Today's Daily Dose brings you news about FDA approval of Faslodex-Verzenio combo for advanced breast cancer; EDAP's disappointing Q3 results; upcoming clinical trial catalysts of TapImmune, and the first drug to be greenlighted for Sly syndrome.

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The FDA has approved AstraZeneca plc's (AZN) FASLODEX in combination with Lilly's *Abemaciclib for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

Abemaciclib, under brand name Verzenio, in combination with FASLODEX received the U.S. regulatory nod for the above indication as recently as September 28, 2017.

As monotherapy, FASLODEX was approved by the FDA for expanded use in postmenopausal women with HR+, HER2- advanced breast cancer who have not received previous endocrine therapy in August of this year.

FASLODEX is also approved as a single agent for treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy, and in combination with Pfizer's Ibrance for the treatment of women with HR+/HER2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

AZN closed Wednesday's trading at $33.39, up 0.42%.

Shares of EDAP TMS SA (EDAP) were down over 11% in extended trading on Wednesday, following disappointing third quarter financial results.

In the recent third quarter, the Company slipped to a loss of EUR 0.5 million (USD 0.6 million), or EUR 0.02 per share on revenue of EUR 7.1 million (USD 8.4 million),
The Company had reported net income of EUR 1.3 million (USD 1.4 million) or EUR 0.04 per share and revenue of EUR 8.0 million (USD 8.9 million) in the year-ago period.
The Company ended Q3, 2017 with cash of EUR 18.0 million (USD 21.3 million).

EDAP closed Wednesday's trading at $3.03, up 1.99%. In after-hours, the stock fell 11.15% to $2.71.

TapImmune Inc. (TPIV) has a couple of events to watch out for in the coming months.

-- A phase II study of TPIV200 in triple-negative breast cancer has reached its enrollment target ahead of schedule. Mayo Clinic is expected to commence dosing in this 280-patient study in the fourth quarter 2017.
-- Interim immune response data from phase II study of TPIV200 in triple-negative breast cancer are anticipated in the first half of 2018.
-- A phase II study of TPIV200 in combination with AstraZeneca's *Imfinzi in patients with platinum-resistant ovarian cancer is ongoing, and interim results from this study are expected in the first half of 2018. (Imfinzi was approved by the FDA in May of this year for the treatment of patients with locally advanced or metastatic urothelial carcinoma).
-- A phase 1b/2a study of TPIV100 in women with HER2/neu+ ductal carcinoma in situ (DCIS) breast cancer is expected to be initiated by Mayo Clinic in the first half of 2018.

TPIV closed Wednesday's trading at $2.65, up 1.45%.

The FDA has approved Ultragenyx Pharmaceutical Inc.'s (RARE) MEPSEVII for the treatment of children and adults with Mucopolysaccharidosis VII, a progressive and debilitating rare genetic disease, which is also known as Sly syndrome.

MEPSEVII, an enzyme replacement therapy, becomes the first medicine for treating Mucopolysaccharidosis VII. The drug will be available to patients in the U.S. later this month.

In Europe, the European Medicines Agency is currently reviewing MEPSEVII, and an opinion from the Committee for Medicinal Products for Human Use is expected in the first half of 2018.

Another rare disease drug of the Company is nearing the finish line. The drug, which goes by the name Burosumab, is proposed for the treatment of pediatric and adult patients with X-linked hypophosphatemia. It is under priority review by the FDA, with a decision date set for April 17, 2018.

RARE closed Wednesday's trading at $47.32, up 3.89%.

Universal Health Services Inc's. (UHS) share repurchase authorization has been increased to $1.2 billion from the previous $800 million authorization which was approved in 2014 and 2016.

The share repurchase program commenced during the third quarter of 2014, and since then, the Company has repurchased approximately 6.9 million shares at an aggregate cost of approximately $786.5 million.

The Board of Directors also voted to pay a cash dividend of $0.10 per share on December 15, 2017 to shareholders of record as of December 1, 2017.

UHS closed Wednesday's trading at $95.77, down 1.27%.

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