Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) share price increased to $9.22 each in the last business day compared to a prior close of $8.74. The current price is 15.63% above its 20-day SMA and 50.87% above its 50-day SMA. The shares have advanced 31.71% over the trailing 3 months.
Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) on December 22, 2016 announced that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue.
This Phase 3 study enrolls patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.
Approximately 190 of a planned 450 patients have been enrolled in the trial to date.
A modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy. In these patients, histopathology of tissues obtained from biopsies of those patients (rather than from radical prostatectomies) will be used as the truth standard in determining the specificity and sensitivity of 1404 imaging. The modification of the protocol was proposed in response to a lower percentage of patients enrolled in the trial having clinically insignificant disease, which is likely due to the emerging trend for more men with low-grade disease to use active surveillance for the management of their prostate cancer rather than undergo radical prostatectomy. The Company plans to monitor enrollment of patients based on the prevalence of clinical significant disease before determining whether any adjustment is needed to the sample size of the study.
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) shares closed at $0.71, up 0.03 points or 5.37 percent from the previous close price. The up to date insider trading filings show Chief Medical Officer Hislop Colin has disposed of 12,500 shares,reducing the ownership to 21,044 units. The transaction occurred on Nov 13, 2015, at $5.31 per share worth a total $66,380. There was another major transaction on the insider-trading front. Hislop Colin, Chief Medical Officer at ANTH bought 5,000 common shares at a per share price of $5.38 to hold 21,044 shares. The stock recently traded at a volume of 0 shares vs. an average volume of 1.77M. The latest closing price is now lower -77.76% for the past quarter. The price is now -59.1% below its 50-day moving average and -75.45% below its 200-day moving average. The percentage change return over the last fifty two weeks remained -76.28%. The price range in the same period had a highest hit of $4.9 while lowest level in that period was $0.64.
Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) on December 28, 2016 announced the top line results of the SOLUTION clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). The study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat (mITT) analysis; however, by additional pre-specified analyses of CFA (mITT-Baseline Observation Carried Forward and Per Protocol), Sollpura met the non-inferiority criterion. The study also confirmed that the ratio of the three enzymes in Sollpura demonstrated an appropriate response in the coefficient of nitrogen absorption (CNA). CNA is a measure of protein digestion and absorption and is a key requirement of Anthera’s planned US FDA regulatory submission. Anthera expects to release data from the extension phase of the study in Q1 2017.
In analyzing the results of the SOLUTION study, patients’ ability to increase their doses during the study were hindered by time restrictions and amounts allowed per protocol, while other patients were prevented from increasing their dose due to the daily limit (10,000 lipase units/kg/day) for porcine pancreatic enzyme replacement therapies (PERTs). Sollpura was generally well tolerated compared to Pancreaze, although symptoms related to malabsorption were generally modestly more frequent in the Sollpura arm.
In addition to the challenges to dose escalation inherent in the design of the SOLUTION study, analytical techniques for measuring the activity of lipase enzymes based on duodenal pH of Cystic Fibrosis patients, indicate that Sollpura may have been under dosed versus the Pancreaze labeled dose.
Given the robust activity of Sollpura in this study, in the context of dose titration limitation and apparent reduced dosage activity, Anthera will initiate activities for an additional clinical study of Sollpura in patients with EPI due to Cystic Fibrosis, which Anthera expects will enable optimized dosing and dose titration. This study will provide investigators and patients the flexibility to adjust their Sollpura dose based upon malabsorption symptoms at any time during the study. Anthera believes that these modifications in the study design will allow patients to achieve the optimal level of fat absorption as measured by CFA. The new study will begin in 1Q’17, and Anthera anticipates only a modest delay in the filing of the BLA around Q1 2018, as the new study will complete concurrently with the completion of required CMC activities.