crudeoil24
8 years ago
Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
Now - DJNF
Supernus Announces Positive Results from Phase IIb Clinical Trial For SPN-812 in Children with ADHD
-- Study confirms efficacy and tolerability of SPN-812, a novel
non-stimulant product, in children with ADHD
-- Study meets primary endpoint with statistically significant reduction in
ADHD symptoms
-- Conference call and webcast to discuss results at 9:00 a.m. ET, October
11, 2016
ROCKVILLE, Md., Oct. 11, 2016 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from its Phase IIb dose-ranging clinical trial of SPN-812 in children for the treatment of attention deficit hyperactivity disorder (ADHD).
The trial was successful in meeting the primary endpoint, demonstrating that SPN-812 at daily doses of 400 mg, 300 mg and 200 mg achieved a statistically significant improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-IV. All SPN-812 doses tested in the trial were well tolerated. Based on these positive results in children with ADHD and the positive Phase IIa results in adults with ADHD, Supernus plans to have an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) after which it will initiate Phase III clinical testing.
"We are very excited about these results and that SPN-812 met the objectives of the study with an encouraging and strong clinical profile, " stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "We believe SPN-812 has the potential of being a well differentiated treatment for ADHD that sets itself apart from current treatment options."
Phase IIb Study Design
The study was a randomized, double-blind, placebo controlled, multicenter, dose-ranging clinical trial in children 6 to 12 years of age diagnosed with ADHD. Each treatment was administered orally once a day over five weeks, after a three week titration phase. A total of 222 patients were randomized in the study across placebo and four doses of SPN-812 (100/200/300/400mg). The primary objective of the study was to assess the effect of SPN-812 in reducing the symptoms of ADHD in children. The primary outcome measure was the change from baseline to the end of the study in the ADHD-RS-IV total score. Safety and tolerability of SPN-812 were assessed by the monitoring of adverse events, clinical laboratory tests, vital signs, ECGs, suicidality and physical examinations. Patients who completed the study were offered the opportunity to continue into an open-label phase that is currently on-going.
Topline Results
At the end of the study, SPN-812 400 mg, 300 mg and 200 mg doses were statistically significant compared to placebo in the primary endpoint. Patients receiving SPN-812 400 mg, 300 mg and 200 mg had a -19.0 point change (p=0.021), -18.6 point change (p=0.027) and a -18.4 point change (p=0.031) from baseline, respectively, in the primary endpoint vs. -10.5 for placebo.
This primary analysis using the Intent-To-Treat (ITT) population with last observation carried forward (LOCF) was confirmed with sensitivity analyses using the Per Protocol population and Mixed Model Repeated Measures (MMRM).
With respect to the effect size, patients receiving SPN-812 400 mg, 300 mg and 200 mg had a median effect size of 0.63, 0.60 and 0.55, respectively. Patients receiving SPN-812 100 mg had a -16.7 point change from baseline in the primary endpoint and a median effect size of 0.46, which did not quite reach statistical significance (p=0.089) in this relatively low number of patients.
In addition, SPN-812 400 mg, 300 mg and 200 mg met the Clinical Global Impression Severity (CGI-S) secondary endpoint with p- values of 0.014, 0.015 and 0.031, respectively, compared to placebo.
"These results exhibit a strong clinical efficacy profile with effect sizes that are typically not seen with non-stimulants. In addition, of the 160 patients who completed the trial, 87% or 139 patients chose to enter the open-label phase showing a high level of confidence in SPN-812," stated Dr. Stefan Schwabe, Executive Vice President R&D, Chief Medical Officer of Supernus Pharmaceuticals.
SPN-812 was well tolerated in the study. All four active doses were well tolerated, with adverse events almost entirely mild or moderate in severity. Two subjects experienced three adverse events that were classified as severe and related to the medication; one on 400 mg with easy tearfulness and intermittent irritability and another on 200 mg with decreased appetite. There were no serious adverse events or deaths in the study. The most frequent adverse events across all the active doses were primarily somnolence, headache, decreased appetite, fatigue, vomiting and nausea. On average, the percentage of patients discontinuing the study due to adverse events for all active doses of SPN-812 was low at 6.7%.
"We believe this side effect profile compares very well with existing treatments in the market," added Dr. Schwabe.
Product Pipeline
SPN-812 is the company's second psychiatry product in late stage development. Supernus is also developing SPN-810 (molindone hydrochloride), a novel treatment for impulsive aggression in patients with ADHD. SPN-810 is currently in clinical development with two Phase III trials in children with ADHD.
"We are excited about our psychiatry pipeline, with two late-stage novel product candidates with positive Phase II clinical results. With SPN-812 now proceeding towards Phase III clinical testing, Supernus expects to have two product candidates in Phase III testing in 2017. We believe these two product candidates represent a significant platform for future growth for Supernus in multi-billion dollar markets," added Jack Khattar.
stocktrademan
9 years ago
$SUPN recent news/filings
bullish optionable
crossing moving average
stochastics oversold and crossing up
## source: finance.yahoo.com
Fri, 28 Aug 2015 20:33:00 GMT ~ SUPERNUS PHARMACEUTICALS INC Files SEC form 8-K, Other Events, Financial Statements and Exhibits
read full: http://biz.yahoo.com/e/150828/supn8-k.html
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Thu, 27 Aug 2015 20:44:18 GMT ~ Supernus to Attend FBR Healthcare Conference on September 9th
[at noodls] - ROCKVILLE, Md., Aug. 27, 2015 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of ...
read full: http://www.noodls.com/view/C7DBBC34B525142F14EAE4E49F979929AA833DC5
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Thu, 27 Aug 2015 20:32:00 GMT ~ Supernus to Attend FBR Healthcare Conference on September 9th
[GlobeNewswire] - ROCKVILLE, Md. -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, ...
read full: http://finance.yahoo.com/news/supernus-attend-fbr-healthcare-conference-203200972.html
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Thu, 20 Aug 2015 17:04:16 GMT ~ SUPERNUS PHARMACEUTICALS INC Financials
read full: http://finance.yahoo.com/q/is?s=supn
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Fri, 07 Aug 2015 11:07:24 GMT ~ SUPERNUS PHARMACEUTICALS INC Files SEC form 10-Q, Quarterly Report
read full: http://biz.yahoo.com/e/150807/supn10-q.html
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$SUPN charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$SUPN company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/SUPN/company-info
Ticker: $SUPN
OTC Market Place: Not Available
CIK code: not found
Company name: Supernus Pharmaceuticals, Inc.
Incorporated In:
Business Description:
$SUPN share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$SUPN extra dd links
Company name: Supernus Pharmaceuticals, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=SUPN+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=SUPN+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=SUPN+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/news - http://finance.yahoo.com/q/h?s=SUPN+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/SUPN/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=SUPN+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/SUPN
DTCC (dtcc.com): http://search2.dtcc.com/?q=Supernus+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Supernus+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Supernus+Pharmaceuticals%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/SUPN
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=SUPN&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=SUPN
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=SUPN+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=SUPN+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=SUPN
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=SUPN
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=SUPN+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/SUPN/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=SUPN+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/SUPN.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=SUPN
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/SUPN
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/SUPN
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/SUPN:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=SUPN
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=SUPN
$SUPN DD Notes ~ http://www.ddnotesmaker.com/SUPN
stocktrademan
10 years ago
$SUPN recent news/filings
bullish
## source: finance.yahoo.com
Thu, 21 May 2015 20:31:25 GMT ~ SUPERNUS PHARMACEUTICALS INC Files SEC form 8-K, Submission of Matters to a Vote of Security Holders, Other Events, F
read full: http://biz.yahoo.com/e/150521/supn8-k.html
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Tue, 19 May 2015 21:16:20 GMT ~ Supernus to Present at June Jefferies Healthcare Conference
[at noodls] - ROCKVILLE, Md., May 19, 2015 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of ...
read full: http://www.noodls.com/view/280BE4BC15A9CD7D80DEF942035FF411925E0757
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Tue, 19 May 2015 20:30:00 GMT ~ Supernus to Present at June Jefferies Healthcare Conference
[GlobeNewswire] - ROCKVILLE, Md. -- Supernus Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced ...
read full: http://finance.yahoo.com/news/supernus-present-june-jefferies-healthcare-203000705.html
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Fri, 15 May 2015 17:04:25 GMT ~ SUPERNUS PHARMACEUTICALS INC Financials
read full: http://finance.yahoo.com/q/is?s=supn
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Wed, 06 May 2015 21:33:56 GMT ~ SUPERNUS PHARMACEUTICALS INC Files SEC form 10-Q, Quarterly Report
read full: http://biz.yahoo.com/e/150506/supn10-q.html
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$SUPN charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$SUPN company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/SUPN/company-info
Ticker: $SUPN
OTC Market Place: Not Available
CIK code: not found
Company name: Supernus Pharmaceuticals, Inc.
Incorporated In:
Business Description:
$SUPN share structure
## source: otcmarkets.com
Market Value: Not Available
Shares Outstanding: Not Available
Float: Not Available
Authorized Shares: Not Available
Par Value: Not Available
$SUPN extra dd links
Company name: Supernus Pharmaceuticals, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=SUPN+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=SUPN+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=SUPN+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/news - http://finance.yahoo.com/q/h?s=SUPN+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/SUPN/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=SUPN+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/SUPN
DTCC (dtcc.com): http://search2.dtcc.com/?q=Supernus+Pharmaceuticals%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Supernus+Pharmaceuticals%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Supernus+Pharmaceuticals%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/SUPN
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=SUPN&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=SUPN
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=SUPN+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=SUPN+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=SUPN
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=SUPN
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=SUPN+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/SUPN/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=SUPN+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/SUPN.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=SUPN
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/SUPN/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/SUPN/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/SUPN
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/SUPN
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/SUPN:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=SUPN
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=SUPN
$SUPN DD Notes ~ http://www.ddnotesmaker.com/SUPN
TheFinalCD
11 years ago
8-k Item 5.02 Departure of Directors and Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(b) Resignation of Director
On December 23, 2013, Michael Bigham tendered his resignation from the board of directors of Supernus Pharmaceuticals, Inc. (the “Company”), effective immediately. Mr. Bigham was the designee of Abingworth Bioventures IV LP and its affiliates (“Abingworth”), an original investor in the Company. His resignation was consistent with Abingworth’s general practice of limiting the time its representatives spend on a portfolio company’s board of directors after it becomes a public company. The Company is presently searching for a replacement to fill the remainder of Mr. Bigham’s term, which expires at the next annual meeting of stockholders in 2014. A copy of the press release regarding the resignation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Mr. Bigham was a member of the Company’s Compensation Committee and Governance and Nominating Committee. John M. Siebert, Ph.D. will fill the vacancy on the Company’s Compensation Committee and M. James Barrett, Ph.D. will fill the vacancy on the Company’s Governance and Nominating Committee.
Item 8.01 Other Events.
On December 23, 2013, Supernus issued a press release announcing that the Food and Drug Administration approved Orenitram™ (treprostinil), Extended Release Tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity. Supernus developed the extended release formulation of Orenitram™ under a Development and License Agreement with United Therapeutics Corporation (NASDAQ: UTHR). The product uses EnSoTrol, Supernus’ novel osmotic technology platform. A copy of the press release is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following document is furnished as an Exhibit pursuant to Item 5.02 hereof:
Exhibit 99.1 — Press Release Dated December 24, 2013 of the Company providing details regarding the resignation of Michael Bigham from the Company’s board of directors.
Exhibit 99.2 — Press Release Dated December 23, 2013.