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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. (504-1)

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. (71-0)

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. (114-0)

3 Biotechs For The January Effect

2018-01-03 seekingalpha
In my view, three biotech microcaps may yield among the best risk/reward scenarios for investors today. (182-3)

5 Reasons to Pick Emergent as an Investment-Worthy Stock

2018-01-03 zacks
Emergent BioSolutions, Inc. (EBS - Free Report) offers specialized products to health care providers and governments to fulfill the unmet medical needs as well as combat emerging public health threats. BioThrax is the company's key Biodefense product and is the sole vaccine to be marketed for general use in case of both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease. (77-0)

AcelRx Stock Looks Weak Ahead Of Revised NDA Submissions For Two Products

2017-12-29 seekingalpha
AcelRx Pharmaceuticals, Inc. (ACRX) stock lost all its gains made till October after it posted a steep decline that month. The company's lead drug candidate received a CRL from the FDA, derailing the timeline for its commercialization. Further, the CRL also raised doubts about management efficiency as its other product Zalviso got a CRL in 2014 for the same reason. (67-0)

Actinium Posts Positive DMC View on Lomab-B Phase III Trial

2017-12-28 zacks
Actinium Pharmaceuticals, Inc. (ATNM - Free Report) announced positive recommendation by an Independent Data Monitoring Committee (“DMC”) for a pivotal phase III SIERRA study, evaluating its lead pipeline candidate, Iomab-B (apamistamab). (186-2)

Free Research Report as Masimo’s Revenue Jumped 15.6%; EPS Surged 35%

2017-12-08 accesswire
LONDON, UK / ACCESSWIRE / December 08, 2017 / Active-Investors free earnings report on Masimo Corp. (NASDAQ: MASI) has freshly been issued to its members, and you can also sign up to view this report at www.active-investors.com/registration-sg/?symbol=MASI. Masimo reported its third quarter fiscal 2017 operating results on October 31, 2017. The medical technology Company exceeded top- and bottom-line expectations and raised its revenue and earnings guidance for FY17. (68-1)

AcelRx Pharmaceuticals' (ACRX) CEO Vince Angotti on Q3 2017 Results - Earnings Call Transcript

2017-11-10 seekingalpha
Welcome to the AcelRx Third Quarter 2017 Conference Call. This call is webcast live on the event stage of the Investor section of AcelRx website at acelrx.com. This call is the sole property of AcelRx and any recording, reproduction or transmission of this call without the express written consent of AcelRx is strictly prohibited. (67-2)

Your Daily Pharma Scoop: Gilead's Unappreciated Opportunity, Merck's Keytruda Stumble, Epizyme's Positive Results

2017-10-30 seekingalpha
Epizyme’s tazemetostat showed positive results in pediatric patients with relapsed or refractory INI1-negative molecularly defined solid tumors. (509-1)

Your Daily Pharma Scoop: Adamis Upside Potential, J&J's SIMPONI Label Expansion, SGEN's Adcetris Upgrade And PDUFA

2017-10-23 seekingalpha
This abridged "Daily Scoop" is published by Avisol Capital Partners, which runs the physician-managed Total Pharma Tracker healthcare investment research service on Seeking Alpha Marketplace. Please click here to read an important announcement about changes and additions to the daily scoop. (452-0)

PG&E, Foot Locker, and 3D Systems Slide Into Monday’s 52-Week Low Club

2017-10-16 247wallst
October 16, 2017: Here are five stocks trading with heavy volume among 51 equities making new 52-week lows in Monday’s session. On the NYSE, advancers vastly led decliners by more than 11 to 1 and on the Nasdaq advancers led decliners by about 4 to 1. (73-0)

Your Daily Pharma Scoop: ACRX Second Chance, AERI Rhopressa Success, Aratana ENTYCE Launch

2017-10-16 seekingalpha
This abridged "Daily Scoop" is published by Avisol Capital Partners, which runs the physician-managed Total Pharma Tracker healthcare investment research service on Seeking Alpha Marketplace. (396-2)

Biotech Forum Daily Digest: Revisiting Achaogen After A Recent Decline

2017-10-13 seekingalpha
There is not much action in the main biotech indices over the past week, although they are trending down slightly. (124-15)

Stock Research Report

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