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Acelrx Pharmaceutica (ACRX) 3.08 $ACRX

AcelRx Pharmaceuticals Names Howard B. Rosen as Chief Executive Officer and Provides Update on Clinical Development Activities and Corporate Priorities for 2016
PR Newswire - Tue Mar 29, 3:00PM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the appointment of Howard B. Rosen as the Chief Executive Officer of AcelRx, effective April 1, 2016. Mr. Rosen has served as the interim CEO for AcelRx since April 1, 2015. Mr. Rosen is an experienced and technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Mr. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences, Inc. and ALZA Corporation. More recently he was interim CEO of Pearl Therapeutics which was subsequently acquired by Astra Zeneca for up to $1.15 billion in 2013. Mr. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra, Ltd. and two private biopharmaceutical companies.
ACRX: 3.08 (+0.01), GILD: 91.86 (-0.11), ADHD: 3.79 (+0.17)

AcelRx Publishes a Review of Hospital-Based Opioid Patient-Controlled Analgesia, Risks and Pharmacoeconomics
PR Newswire - Fri Mar 25, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, reported that a review article entitled "Evolution of Patient-Controlled Analgesia: From Intravenous to Sublingual Treatment" has been published in the peer-reviewed journal, Hospital Pharmacy. This article provides insights into patient-controlled analgesia (PCA) systems, the choice of opioid, risks, and costs associated with PCA usage in U.S. hospitals. Beyond intravenous (IV) PCA, the article also discusses noninvasive options in development, such as the transdermal, inhaled, oral and sublingual delivery of opioids. Zalviso(TM) (sufentanil sublingual tablet system) is profiled as a novel sublingual PCA system in development, and the entirety of the clinical program is reviewed.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Advances ARX-04 into Extension Phase of Open-Label Phase 3 Emergency Room Study
PR Newswire - Mon Mar 14, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced the initiation of the extension phase of the SAP302 study of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. This ongoing open-label Phase 3 study has completed the initial phase, enrolling 40 patients who each received a single dose of ARX-04. In this extension phase, up to an additional 100 patients may be enrolled, each of whom may receive multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The primary endpoint of SAP302 is the time-weighted summed pain intensity difference to baseline over one hour, or SPID-1.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2015 Financial Results
PR Newswire - Mon Mar 07, 3:01PM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a business update and reported financial results for the three and twelve months ended December 31, 2015.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Initiates Phase 3 Study of ARX-04 in Patients with Post-Operative Moderate-to-Severe Acute Pain
PR Newswire - Mon Mar 07, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today that patient enrollment and dosing in a multicenter, open-label Phase 3 clinical study, known as SAP303, has been initiated. SAP303 is being conducted in patients 40 years and older who have moderate-to-severe acute pain following a surgical procedure. SAP303 will allow patients to be administered one dose of ARX-04 (sufentanil sublingual tablet, 30 mcg) every 60 minutes, as needed for pain management, for up to 12 hours.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals to Hold Annual 2015 Financial Results Conference Call and Webcast on Monday, March 7th, 2016.
PR Newswire - Thu Mar 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that it will release fourth quarter and yearly 2015 financial results after market close on Monday, March 7th, 2016. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7th, 2016 to discuss the financial results and provide a corporate update.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals to Present at Two Upcoming Investor Events in February
PR Newswire - Wed Feb 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Chief Financial Officer and Head of Business Development, Timothy E. Morris will be presenting at the 18th Annual BIO CEO & Investor Conference and the 2016 RBC Capital Markets' Healthcare Conference in New York. Details of the conferences are as follows:
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Announces Presentation of Phase 3 Sufentanil Sublingual 30 mcg Tablet (ARX-04) Data at the European Congress of Ambulatory Surgery
PR Newswire - Thu Jan 21, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that a presentation will be made at the annual European Congress of Ambulatory Surgery to be held January 28th and 29th, 2016 at the Disneyland Hotel New York Convention Centre in Paris, France. This bilingual congress (simultaneous translation will be provided) is co-organized by AFCA (French Association for Ambulatory Surgery) and the IAAS (International Association for Ambulatory Surgery) and will bring together over 800 ambulatory surgery stakeholders from Europe, Asia and North America.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Announces Anticipated 2016 Milestones
PR Newswire - Sun Jan 10, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso(TM) (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx's corporate goals in the upcoming year are as follows:
ACRX: 3.08 (+0.01)

AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso(TM) in 1Q 2016
PR Newswire - Fri Jan 08, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported that the Company has received comments from the Division of Anesthesia, Analgesia, and Addiction Products (Division) of the U.S. Food and Drug Administration (FDA) on the Company's proposed protocol for a Phase 3 clinical study (IAP312) designed to assess the overall performance of Zalviso(TM)(sufentanil sublingual tablet system). In response to the comments, the protocol has been amended and AcelRx plans to initiate the study in the first quarter of 2016. The IAP312 study will include approximately 310 post-operative patients and collect information requested by the Division to supplement the three positive Phase 3 trials already completed. Zalviso is being developed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ACRX: 3.08 (+0.01)

Global Acute Pain Therapeutics Pipeline Review, H2 2015
M2 - Thu Jan 07, 10:44AM CST
Research and Markets (http://www.researchandmarkets.com/research/k9flzp/acute_pain) has announced the addition of the "Acute Pain - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Acute Pain, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Acute Pain and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Acute Pain Overview - Therapeutics Development - Pipeline Products for Acute Pain - Overview - Pipeline Products for Acute Pain - Comparative Analysis - Acute Pain - Therapeutics under Development by Companies - Acute Pain - Therapeutics under Investigation by Universities/Institutes - Acute Pain - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Acute Pain - Products under Development by Companies - Acute Pain - Products under Investigation by Universities/Institutes - Acute Pain - Companies Involved in Therapeutics Development - A. Menarini Industrie Farmaceutiche Riunite Srl - AcelRx Pharmaceuticals, Inc. - Adynxx, Inc. - Amorsa Therapeutics Inc. - AnaBios Corporation - Anavex Life Sciences Corp. - AngioChem Inc. - Antibe Therapeutics, Inc. - AskAt Inc. - Cara Therapeutics, Inc. - Centrexion Corporation - Charleston Laboratories, Inc. - ChironWells GmbH - Cytogel Pharma, LLC - Dompe Farmaceutici S.p.A. - Grunenthal GmbH - INSYS Therapeutics, Inc. - Iroko Pharmaceuticals, LLC - KemPharm, Inc. - Kineta, Inc. - Laboratorios Del Dr. Esteve S.A. - Mallinckrodt Plc - MEDRx Co., Ltd. - Nanomerics Ltd - Nektar Therapeutics - Nuvo Research Inc. - Orbis Biosciences, Inc. - Orexo AB - Orion Oyj - Pacira Pharmaceuticals, Inc. - Phosphagenics Limited - Recro Pharma, Inc. - Shulov Innovative Science Ltd. - Sigma-Tau S.p.A. - Syntrix Biosystems, Inc. For more information visit http://www.researchandmarkets.com/research/k9flzp/acute_pain
ACRX: 3.08 (+0.01), KMPH: 14.50 (-0.49), NKTR: 13.75 (+0.18), INSY: 15.99 (+0.11), AVXL: 4.90 (-0.04), PCRX: 52.98 (+2.12), REPH: 5.97 (+0.02), PTIE: 2.23 (+0.07)

AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review of ARX-04 from European Medicines Agency
PR Newswire - Wed Dec 23, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals Conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04
PR Newswire - Mon Dec 14, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, today reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA). The Company intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. To support this indication, based on feedback from the FDA, the Company will expand the clinical program by approximately 165 patients to include individuals from specific populations and settings. Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016
ACRX: 3.08 (+0.01)

Post-Operative Pain - Pipeline Review, Technologies & Forecasts Report H2 2015
M2 - Tue Dec 08, 3:07AM CST
Research and Markets (http://www.researchandmarkets.com/research/4dgvqs/postoperative) has announced the addition of the "Post-Operative Pain - Pipeline Review, H2 2015" report to their offering. The report Post-Operative Pain - Pipeline Review, H2 2015', provides an overview of the Post-Operative Pain's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Post-Operative Pain, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Post-Operative Pain and special features on late-stage and discontinued projects. Key Topics Covered: - The report provides a snapshot of the global therapeutic landscape of Post-Operative Pain - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Post-Operative Pain and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Post-Operative Pain products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Post-Operative Pain pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Benefits of this Report: - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Post-Operative Pain - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Post-Operative Pain pipeline depth and focus of Indication therapeutics Companies Mentioned Include: - A. Menarini Industrie Farmaceutiche Riunite Srl - AcelRx Pharmaceuticals, Inc. - Adynxx, Inc. - Amorsa Therapeutics Inc. - AngioChem Inc. - Chong Kun Dang Pharmaceutical Corp. - Colby Pharmaceutical Company - Cytogel Pharma, LLC - DURECT Corporation - Echo Pharmaceuticals B.V. - Flexion Therapeutics, Inc. - Fujimoto Pharmaceutical Corporation - Lipocure Ltd. - Trevena, Inc. - st-Operative Pain - Therapeutics Assessment For more information visit http://www.researchandmarkets.com/research/4d...toperative
ACRX: 3.08 (+0.01), TRVN: 8.27 (+0.09), FLXN: 9.20 (+0.20), DRRX: 1.35 (unch)

AcelRx Pharmaceuticals to Present at Piper Jaffray 27th Annual Healthcare Conference
PR Newswire - Mon Nov 23, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that AcelRx Co-founder and Chief Medical Officer Pamela Palmer and Chief Financial Officer Tim Morris will be presenting at Piper Jaffray 27th Annual Healthcare Conference in New York. Details of the conference are as follows:
ACRX: 3.08 (+0.01)

A Look at Equity Market Momentum - Research on Multi-Fineline Electronix, AcelRx Pharmaceuticals, CAI International and Peregrine Pharmaceuticals
ACCESSWIRE - Thu Nov 19, 7:50AM CST
NEW YORK, NY / ACCESSWIRE / November 19, 2015 / Moments ago, Trader's Choice released new research updates concerning several important developing situations including the following equities: Multi-Fineline Electronix Inc. (NASDAQ: MFLX), AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX), CAI International Inc. (NYSE: CAI) and Peregrine Pharmaceuticals Inc. (NASDAQ: PPHM). Trader's Choice has perfected the profitable art of picking stocks, cutting through the noise to deliver the top trade, every year. The full Research Packages are being made available to the public on a complimentary basis.
ACRX: 3.08 (+0.01), CAI: 9.66 (+0.21), PPHM: 0.42 (+0.02), MFLX: 23.21 (+0.45)

AcelRx Pharmaceuticals Announces Sublingual Sufentanil Data Presentation at the American Society of Regional Anesthesia and Pain Medicine Meeting
PR Newswire - Thu Nov 19, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, announced today that a moderated poster presentation will be made at the Emerging Technology session of the American Society of Regional Anesthesia and Pain Medicine (ASRA) 14th Annual Pain Medicine Meeting to be held November 19th to November 21st at the Fontainebleau Miami Beach in Miami, Florida. The annual ASRA meeting is the foremost scientific and educational event on invasive and non-invasive targeted therapies in pain medicine and brings together nearly 1,000 national and international thought leaders. Pamela Palmer, M.D. Ph.D., AcelRx Co-founder and Chief Medical Officer, will present safety and efficacy data from a Phase 3 trial, SAP301, evaluating the sufentanil sublingual 30 mcg tablet, or ARX-04, for the treatment of acute pain following ambulatory surgery.
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals to Present at Jefferies 2015 Global Healthcare Conference
PR Newswire - Tue Nov 10, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Chief Financial Officer Tim Morris will be presenting at the Jefferies 2015 Global Healthcare Conference in London. Details of the conference are as follows:
ACRX: 3.08 (+0.01)

AcelRx Pharmaceuticals to Present at Credit Suisse 24th Annual Healthcare Conference
PR Newswire - Thu Nov 05, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Chief Financial Officer Tim Morris will be presenting at the Credit Suisse 24th Annual Healthcare Conference in Phoenix, AZ. Details of the conference are as follows:
ACRX: 3.08 (+0.01)

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