NVO Gets FDA Nod, GALT Down But Not Out, BIOC Gets A Boost, CUR Excited

Today’s Daily Dose brings you news about Avastin getting full approval for the most aggressive form of brain cancer; FDA action date for Clovis’ Rucaparib sNDA; InspireMD’s 24-month follow-up results of CGuard; Biocept’s patent; Neuralstem’s phase II study results of NSI-189 in major depressive disorder; Galectin’s NASH trial results and Novo Nordisk’s FDA approval.

Read on…

Shares of Biocept Inc. (BIOC) surged more than 69% on Tuesday, following the receipt of the first U.S. patent for its “switch-blocker” technology, taking the number of patents issued for its highly sensitive methods of detecting cancer biomarkers on circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA) to 21.

The switch blocker technology is designed to improve detection rates for cancer-associated mutations, allowing physicians to make informed decisions for the selection of therapy and monitoring of treatment response over time for patients with cancer.

BIOC closed Tuesday’s trading at $1.15, up 69.12%.

Clovis Oncology’s (CLVS) supplemental New Drug Application for Rucaparib has been granted priority review status by the FDA – with a decision date set for April 6, 2018.

The Company is seeking expanded approval of Rucaparib as maintenance treatment in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are platinum sensitive, and in a complete or partial response to platinum-based chemotherapy, regardless of their BRCA mutation status.

Last december, Rucaparib was granted accelerated approval by the FDA for treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer who have been treated with two or more chemotherapies.

Rucaparib is under review in the Europe Union, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in late 2017.

CLVS closed Tuesday’s trading at $57.69, down 2.73%.

InspireMD Inc. (NSPR) has reported exciting 24-month follow-up results of its PARADIGM 101 Clinical Study utilizing CGuard.

PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard EPS in 101 consecutive all-comer patients with symptomatic or high-risk asymptomatic carotid artery stenosis.

According to the trial data, no periprocedural or postprocedural intervention related death, major stroke, or myocardial infarction had occurred in the study patients at 24-month follow-up.

CGuard EPS is CE Mark approved. But it is not approved in the U.S. yet.

NSPR closed Tuesday’s…

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