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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 trading at $0.16, down 2.08%.

Galectin Therapeutics Inc. (GALT) slumped over 30% on Tuesday as investors were not happy with the phase IIb trial results of its proprietary compound GR-MD-02 in patients with NASH with cirrhosis.

In the trial, dubbed NASH-CX, GR-MD-02 had a statistically significant and clinically meaningful effect in reducing the primary endpoint measurement of hepatic venous pressure gradient (HVPG) in the subset of patients with NASH cirrhosis who did not have baseline esophageal varices.

However, when the total group of patients, which included both with and without varices, was considered, statistical significance was not achieved for the primary endpoint.

The Company noted that NASH-CX is the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in portal hypertension or liver biopsy in patients with NASH cirrhosis without varices.

GALT closed Tuesday's trading at $1.72, down 30.65%.

Shares of Neuralstem Inc. (CUR) soared 175% on Tuesday, following positive updated data from its phase II study of NSI-189 in major depressive disorder.

On July 26, 2017, the Company had announced that the phase II study of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID) did not meet the primary efficacy endpoint of a statistically significant reduction in depression symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS). The news sent the stock plunging nearly 50% that day.

Now, the updated results suggest that NSI-189 has antidepressant effects in both core symptoms of depression and in aspects of cognition where standard antidepressants typically show very modest effects.

NSI-189 appeared to be safe and well tolerated with no serious adverse events, according to the Company.

CUR closed Tuesday's trading at $3.09, up 175.89%.

The FDA has approved Novo Nordisk's (NVO) once-weekly Ozempic as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Ozempic, known generically as semaglutide, is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched in the Ozempic Pen, the latest generation of Novo Nordisk prefilled devices.

Ozempic belongs to the same class of drugs as that of Lilly's Trulicity. This class of drugs stimulates insulin and suppresses glucagon, the two hormones that work together to regulate blood sugar.

In a head-to-head study comparing Semaglutide and Trulicity, people with type 2 diabetes treated with once-weekly Semaglutide experienced superior reduction in HbA1c and body weight compared to treatment with once-weekly Trulicity.

NVO closed Tuesday's trading at $50.70, down 0.67%.

Roche Group's (RHHBY.OB) Avastin has been granted full approval by the FDA for the treatment of adults with recurrent glioblastoma, the most aggressive form of brain cancer.

Avastin was granted accelerated approval in May 2009. The conversion to full approval was based on data from a phase III study, dubbed EORTC 26101, which evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with previously treated glioblastoma.

Avastin is now approved in the United States for nine distinct uses across six different types of cancer. The drug generated sales of $6.71 billion for Roche in 2016.

RHHBY.OB closed Tuesday's trading at $30.94, down 1.15%.

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