Company Overview and News

14
AcelRx's Dsuvia Gets FDA Committee Approval, Shares Rally

3h zacks
AcelRx Pharmaceuticals, Inc. (ACRX - Free Report) announced that the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has voted (10-3) in favor of Dsuvia, recommending an approval for it. The company is looking to get Dsuvia tablets (30 mcg) approved for treating moderate-to-severe acute pain in medically supervised settings for adult patients.
GNMSF GMXAY GPN CLBS UTHR ACRX

9
With Opioid Abuse in Mind, FDA Advisory Committee Recommends AcelRx's Opioid Dsuvia

3h biospace
The U.S. Food and Drug Administration (FDA)’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.
ACRX

24
Top Analyst Upgrades and Downgrades: Activision Blizzard, Cleveland-Cliffs, Delphi, Lululemon, McDonald’s, Disney, Wells Fargo and More

6h 247wallst
Stocks were indicated flat to marginally higher on Monday after last week’s sell-off was slightly tempered by Friday’s rally. While the all-time highs are still within striking distance, investors have seen lower upside from buying immediately after the big market pullbacks in 2018 than in prior years. Now those investors also have to consider how to position their investments for the rest of the year and into 2019.
WFCNP ARRS ACRX ATVI CLF DLPH AEO LULU ELAN MS WFC ABUS TRI MRO

123
Your Daily Pharma Scoop: AcelRx, How Far Can It Go; Trevena's Future

7h seekingalpha - 1
AcelRx Pharmaceuticals (NASDAQ:ACRX) received the FDA Ad Com's backing by a 10-3 vote for its sufentanil sublingual tablet, DSUVIA, "for the management of moderate-to-severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate." The drug will probably be approved well before the November 3 PDUFA date. It has already been approved in the EU, and US approval will set the future for the small company in stone.
TRVN ACRX

14
UPDATE 2-AcelRx shares surge after FDA staff says opioid safe

2018-10-10 reuters - 5
(Reuters) - AcelRx Pharmaceuticals Inc’s shares surged 30 percent on Wednesday after U.S. Food and Administration staff said the company’s opioid treatment was safe and effective, bringing it one step closer to a marketing approval.
ACRX

10
CORRECTED-FDA staff says AcelRx opioid painkiller safe and effective

2018-10-10 reuters - 1
(Corrects headline and first paragraph to say AcelRx opioid was safe and effective for use, not that the painkiller offers no apparent advantage to currently available therapies; removes quote from third paragraph)
ACRX

10
Why AcelRx Is Jumping Despite FDA Update

2018-10-10 247wallst - 1
AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) shares made a solid gain on Wednesday despite a less-than-favorable update from the U.S. Food and Drug Administration (FDA). However, there is a vote for approval on Friday, and that seems to be what investors are optimistic about.
ACRX

123
FDA staff says AcelRx's opioid could be used under medical supervision

2018-10-10 channelnewsasia - 1
REUTERS: AcelRx Pharmaceuticals Inc's opioid painkiller has its advantages when used in hospitals, staff reviewers of the U.S. Food and Administration said, but warned that the small size of the pills makes it easier for patients to misplace them leading to accidental use by others.
TRVN ACRX

324
Stocks To Watch: Spotlight On Banks, Google Hardware And IPOs

2018-10-06 seekingalpha - 4
Welcome to Seeking Alpha's Stocks to Watch - a preview of key events scheduled for the next week. Follow this account and turn the e-mail alert on to receive this article in your inbox every Saturday morning.
MMS STZ.B PSX WBA ACRX AEE EGC EXXIQ IMGN SBLK WU SODA GPRE EEXXQ UTX EXXI REX SHLDW ADM MLM NIO SHIP QTT HALO LB NVDA MPC BRO ATVI KO BWXT EA SJM INPAP KBR MA DK JPM SBUX GVA WMT LEAF SHLD IP AMZN OMF EXIXQ OMC SAFM BKS YI POL SQ SBLKL INCY FAST BKE STZ SB GME WEB GOOGL PNC CURO ZUO WFCNP PG DAR TRVN GLOP PYPL GS GOGL AVEO WEED DAL WFC MGI C CMCSA COST FMC THO CGC GNK V T PEP FLR SNE TELL

154
Major Biopharma Catalysts on October’s FDA Calendar

2018-09-29 247wallst - 18
Companies in the biotech and pharmaceutical industries are subject to a sizable amount of risk with regards to their drug candidates passing clinical trials and gaining regulatory approval. But with the risk of failure, which can spell disaster for a stock, comes great reward as well. Some companies can see massive upside just from winning a single midstage trial or even achieving as much as a Fast Track designation from the U.
VRX MRK TGTX AVEO TRVN MRUS AKCA ACRX BHC BHS

48
Your Daily Scoop: Foamix Zooms, Pfizer And Merck Report Positive

2018-09-13 seekingalpha - 2
Share price of Foamix Pharmaceuticals (FOMX) had a 54.4% spike on September 11 after-hours on the news of positive topline results of third Phase 3 clinical trial of its FMX101 drug. The candidate is indicated in the treatment of moderate-to-severe acne. The trial is reported to have successfully met both primary and secondary endpoints.
MKGAF OPK GILD INCY KMPH GLPG ACRX IMNP MKGAY NVS ABBV FMI PFE ABBV FOMX

11
AcelRx Finally Has An AdCom Date. Time For A Run Up?

2018-09-13 seekingalpha - 2
On September 11, ACRX announced an AdCom date for Dsuvia had been finalized for October 12.
ACRX

9
Are Options Traders Betting on a Big Move in AcelRx Pharmaceuticals (ACRX) Stock?

2018-09-05 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 Dec 21, 2018 $5.00 Call had some of the highest implied volatility of all equity options today. What is Implied Volatility? Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other.
HDS ACRX

13
5 Speculative Biotech Analyst Picks With Upside Targets of 100% to 400%

2018-08-18 247wallst - 3
Investors have remained buyers of stocks throughout much of the summer, and a stronger than expected earnings season has kept the market near all-time highs. Still, the nine-year-old bull market of 2018 is acting differently than in the prior few years when investors were always rewarded for buying the dips in the market. Now investors have had to be careful about sticking with winners and avoiding losers.
BTAI ACRX

11
Is AcelRx Pharmaceuticals (ACRX) Outperforming Other Medical Stocks This Year?

2018-08-09 zacks - 2
The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. AcelRx Pharmaceuticals (ACRX - Free Report) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? One simple way to answer this question is to take a look at the year-to-date performance of ACRX and the rest of the Medical group's stocks.
UCTI ACRX UCTT

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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Silicon Investor Message Boards

This table lists all message boards related to ACRX / AcelRx Pharmaceuticals, Inc. on message board site Silicon Investor.

ACRX (MC $98M) Cash $72M/ FDA Decision Oct 12 (Blockbuster) ACRX (MC $98M) Cash $72M/ FDA Decision Oct 12 (Blockbuster) ACRX (MC $98M) Cash $72M/ FDA Decision Oct 12 (Blockbuster)
CUSIP: 00444T100