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GILD Quits IPF Study, PURE On Watch, Black Letter Day For MNKD, CNAT Leaps


Shares of Conatus Pharmaceuticals Inc. (CNAT) were up more than 22% in extended trading on Tuesday, following positive 3-month data with Emricasan in initial stage of phase II liver cirrhosis clinical trial.

According to the trial results, there was a statistically significant reduction in caspase-cleaved cytokeratin 18 (cCK18) compared to placebo in the overall patient population after three months of treatment. cCK18 is a mechanism-specific biomarker of caspase-driven cell death.

The company expects to report six-month data from patients who continued treatment and three-month data from placebo patients who crossed over to Emricasan treatment in the second quarter of 2016.

CNAT closed Tuesday's trading at $2.87, down 2.05%. In after hours, the stock was up 22.30% at $3.51.

Gilead Sciences Inc. (GILD) has pulled the plug on its phase II clinical study of its drug candidate Simtuzumab in patients with idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis, or IPF, is a fatal disease caused by progressive scarring (fibrosis) of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly. About 100,000 people in the U.S. have IPF.

The decision to terminate the trial was taken after the Data Monitoring Committee, or DMC, recommended that the study be terminated early due to lack of efficacy.

However, phase II studies of Simtuzumab are ongoing in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis - with the DMC recommending the continuation of the studies, which have a 96-week endpoint.

GILD closed Tuesday's trading at $99.26, up 1.28%.

January 5 is a black-letter day for MannKind Corp. (MNKD) - with the shares of the company plunging to an all-time low on termination of its license and collaboration agreement with sanofi-aventis U.S. LLC related to Afrezza Inhalation Powder.

Afrezza, a drug-device combination product, is a novel, ultra rapid-acting mealtime insulin therapy to improve glycemic control in adult patients with type 1 or type 2 diabetes that was approved in June 2014.

Mannkind licensed the global rights to Afrezza to Sanofi under an agreement signed in August 2014.

Sales of Afrezza have been disappointing since its launch. In the nine months of 2015, Afrezza sales totalled just 5 million euros.

With Afrezza failing to gain acceptance by patients and physicians, it remains to be seen if it will also suffer the same fate that the pioneer Exubera did or will it see a revival in sales?

Exubera was the first inhaled insulin to be approved by the FDA for use in type 1 and type 2 diabetic patients. Exubera was developed by Nektar Therapeutics (NKTR) and licensed to Pfizer Inc. (PFE) in 1995. Approved by the FDA in January 2006, Exubera reached pharmacy shelves nearly a year after the regulatory approval.

In October of 2007, Pfizer abandoned Exubera, which had barely one full year of sales, as it failed to gain acceptance by patients and physicians and announced its decision to quit the inhaled insulin market.

MannKind is reviewing its strategic options for Afrezza as a result of the termination of the collaboration with Sanofi.

MNKD touched an all-time low of $0.70 on Tuesday before closing the day's trading at $0.75, down 48.44%.

Shares of PURE Bioscience Inc. (PURE.OB) touched a new high on Tuesday, following FDA approval of the company's patented silver dihydrogen citrate antimicrobial as a fresh produce processing aid.

Last month, the FDA had approved the proposed use of silver dihydrogen citrate as a raw poultry processing aid.

Silver dihydrogen citrate is the active ingredient in PURE Control. The company expects to launch PURE Control in the first quarter of this year.

PURE.OB touched a new high of $1.17 on Tuesday before closing the day's trading 17.35% higher at $1.15.

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