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CLVS Seeks New Use For Rubraca, TNDM Effects Reverse Stock Split, MDXG On Watch


Today's Daily Dose brings you news about AstraZeneca's lung cancer drug TAGRISSO getting Breakthrough Therapy Designation; Clovis' seeking approval for expanded indication of its ovarian cancer drug; MiMedx Group's share repurchase program and Tandem Diabetes' reverse stock split.

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AstraZeneca plc's (AZN) TAGRISSO has been granted Breakthrough Therapy Designation by the FDA for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. This marks the sixth Breakthrough Therapy Designation secured by the Company from the FDA for an oncology medicine since 2014.

TAGRISSO is currently approved in more than 50 countries, including the US, EU, Japan and China, as 2nd-line treatment for patients with advanced NSCLC who progress following treatment with an EGFR-TKI due to the EGFR T790M resistance mutation.

The use of TAGRISSO for the first-line treatment of patients with locally-advanced or metastatic EGFR mutation-positive NSCLC is not yet FDA approved.

TAGRISSO generated sales of $403 million in the first half of this year.

AZN closed Monday's trading at $34.48, up 0.64%.

Clovis Oncology (CLVS) has submitted a supplemental New Drug Application to the FDA for Rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rucaparib, whose brand name is Rubraca, was granted accelerated approval by the FDA on December 19, 2016, for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.

The net product revenue from sales of Rubraca was $21.6 million for the first six months of 2017.

CLVS closed Monday's trading at $83.50, down 1.05%.

InspireMD Inc. (NSPR) has started patient enrolment in an investigator initiated trial of CGuard Embolic Prevention Systems (EPS) in Russia.

The objective of the trial is to assess the neuro protection and clinical superiority of the minimally invasive interventional procedure with the CGuard EPS versus Abbott's RX ACCULINK Carotid Stent in subjects at high risk for Carotid Endarterectomy (CEA), a surgical procedure.

CGuard EPS is CE Marked and not approved for sale in the U.S. by the FDA. It was commercially launched in Russia in March of this year.

NSPR closed Monday's trading at $0.50, up 23.06%.

MiMedx Group Inc.'s (MDXG) Board of Directors has authorized a $10 million increase in the Company's Share Repurchase Program. This brings the total authorized share repurchase to $110 million since the Share Repurchase Program commenced in May 2014.

Two short seller articles, one by Viceroy Research and the other by Aurelius Value, were published on September 20, 2017. The Company's share price lost over 28% of its value last month.

The Company reported that in light of the short seller attacks and its strong balance sheet and cash flows, the stock repurchases continue to be an extremely positive investment for MiMedx.

MDXG closed Monday's trading at $11.72, down 3.38%.

Tandem Diabetes Care Inc. (TNDM) has effected a reverse stock split of its issued and outstanding shares of common stock at a ratio not less than 1-for-8 and not greater than 1-for-12. The exact ratio will be set within that range by Tandem's Board of Directors.

The number of authorized shares of common stock would remain at 100 million shares, according to the Company.

The reverse stock split took effect at 4:00 pm ET on October 9, 2017.

Trovagene Inc.'s (TROV) PCM-075 has been granted orphan drug designation by the FDA for the treatment of patients with acute myeloid leukemia.

The Company is initiating a Phase 1b/2 open-label trial to evaluate the safety and anti-leukemic activity of PCM-075 in combination with standard-of-care in patients with acute myeloid leukaemia at ten research sites across the U.S.

TROV closed Monday's trading at $0.89, up 4.71%.

by RTTNews Staff Writer

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