Company Overview and News

 
Your Daily Pharma Scoop: Blueprint Medicines' BLU-667, Gilead Sciences' NASH Data, Celldex's Plunge

2018-04-17 seekingalpha
Today we will discuss Blueprint Medicines (BPMC), which is down more than 12% after reporting data from a phase 1 study with BLU-667 in RET-altered solid tumors. The phase 1 study was a proof-of-concept study.
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ACRX / AcelRx Pharmaceuticals, Inc. FORM 8-K (Current Report)

2018-04-12 sec.gov
acrx20180411_8k.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION
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ACRX / AcelRx Pharmaceuticals, Inc. FORM 8-K (Current Report)

2018-03-27 sec.gov
acrx20180326_8k.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION
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AcelRx Pharma Plans to Resubmit New Drug Application for Dsuvia

2018-03-09 biospace
Back in October 2017, AcelRx Pharmaceuticals received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dsuvia (sufenetanil sublingual tablet) for pain. Today, the company released the minutes from its Type A meeting with the FDA and its plans to resubmit the NDA in the second quarter of this year.
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ACRX / AcelRx Pharmaceuticals, Inc. FORM S-8

2018-03-09 sec.gov
acrx20180306_s8.htm As filed with the Securities and Exchange Commission on March 8, 2018 Registration No. 33
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AcelRx Pharmaceuticals' (ACRX) CEO Vince Angotti on Q4 2017 Results - Earnings Call Transcript

2018-03-09 seekingalpha
Welcome to the AcelRx Fourth Quarter and Full Year 2017 Conference Call. This call is being webcast live on the event stage of the Investor section of AcelRx’s website at acelrx.com. This call is the property of AcelRx and any recording, reproduction or transmission of this call without the express written consent of AcelRx is strictly prohibited. As a reminder, today’s call is being recorded. You may listen to the webcast replay of this call by going to the investor section of AcelRx’s website.
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Are Options Traders Betting on a Big Move in AcelRx Pharmaceuticals (ACRX) Stock?

2018-03-07 zacks
Investors in AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) need to pay close attention to the stock based on moves in the options market lately. That is because the Mar 16th 2018 $2.50 Call had some of the highest implied volatility of all equity options today.
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ACRX / AcelRx Pharmaceuticals, Inc. - Stock Institutional Ownership and Shareholders - Fintel.io

2018-02-14 fintel.io
AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) has 64 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 16,840,172 shares. Largest shareholders include Three Arch Partners Iv Lp, Vanguard Group Inc, Perceptive Advisors Llc, Palo Alto Investors, LLC, BlackRock Inc., Millennium Management Llc, Bridgeway Capital Management Inc, Geller Family Office Services, LLC, Susquehanna International Group, Llp, and Geode Capital Management, Llc.
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ACRX / AcelRx Pharmaceuticals, Inc. / THREE ARCH PARTNERS IV LP - SC 13D/A (Activist Investment)

2018-02-14 sec.gov
      SECURITIES AND EXCHANGE COMMISSION   Washington, D.C. 20549   Schedule 13D   INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1 (a) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2 (a)   (AMENDMENT NO. 5)*   AcelRx Pharmaceuticals, Inc. (Name of Issuer)   Common Stock (Title of Class of Securities)   00444T100 (CUSIP Number)   Mark Wan c/o Three Arch Partners 19 South B Street, Suite 14 San Mateo, CA 94401 (650) 529-8000   (Name, Address and Telephone Number of Person Aut
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ACRX / AcelRx Pharmaceuticals, Inc. / THREE ARCH PARTNERS IV LP - SC 13D/A (Activist Investment)

2018-02-14 sec.gov
      SECURITIES AND EXCHANGE COMMISSION   Washington, D.C. 20549   Schedule 13D   INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1 (a) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2 (a)   (AMENDMENT NO. 5)*   AcelRx Pharmaceuticals, Inc. (Name of Issuer)   Common Stock (Title of Class of Securities)   00444T100 (CUSIP Number)   Mark Wan c/o Three Arch Partners 19 South B Street, Suite 14 San Mateo, CA 94401 (650) 529-8000   (Name, Address and Telephone Number of Person Aut
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Omeros Inks Agreement With FDA for OMS721 Phase III Trial

2018-01-04 zacks
Omeros Corporation (OMER - Free Report) announced that it has entered into an agreement with the FDA on its protocol to start a phase III study to evaluate its lead pipeline candidate, OMS721, for treatment of patients with IgA nephropathy (IgAN). Enrollment of patients for the study is expected to start early next month.
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Merck's Keytruda Gets Approved for Bladder Cancer in Japan

2018-01-03 zacks
Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy, Keytruda (pembrolizumab), has been approved in Japan for previously-treated patients with urothelial carcinoma, a type of bladder cancer. This approval makes Keytruda eligible to be indicated for four types of cancer in Japan.
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Trevena Announces FDA Acceptance of Olinvo NDA, Shares Up

2018-01-03 zacks
Shares of Trevena, Inc. (TRVN - Free Report) rallied almost 24.5% in after-market trading on Jan 2, following the company’s announcement that the FDA has accepted the new drug application (“NDA”) for its pain therapy, Olinvo injection. Olinvo is an opioid-based analgesic administered intravenous and also the first G protein biased ligand of the mu receptor.
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ACRX : AcelRx Pharmaceuticals Stock Analysis and Research Report

2017-10-30 - Asif

AcelRx Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. Its lead product candidate, DSUVIA™ (known as ARX-04 outside of the United States), and its product candidate, ZALVISO®, utilize sublingual sufentanil, delivered via a non-invasive route of sublingual administration. The company anticipate developing a distribution capability and commercial organization to market and sell DSUVIA in the United States by itself, and potentially, in certain European Economic Area, or EEA, countries with strategic partners. In geographies where the company decide not to commercialize itself, the company may seek to out-license commercialization rights. The company intend to seek regulatory approval for ZALVISO in the United States and, if successful, potentially promote ZALVISO either by itself or with strategic partners. AcelRx Pharmaceuticals has chosen sufentanil as the therapeutic in...

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CUSIP: 00444T100