Company Overview and News
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.
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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.
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.
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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.
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.
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)
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.
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.
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.
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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.
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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.
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2018-09-13 seekingalpha - 2
On September 11, ACRX announced an AdCom date for Dsuvia had been finalized for October 12.
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.
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.
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.
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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...
2018-10-01 - Asif
Overview The following discussion and analysis should be read in conjunction with its unaudited interim condensed consolidated financial statements and the related notes that appear elsewhere in this quarterly report on Form 10-Q. This discussion contains forward-looking statements reflecting its current expectations that involve risks and uncertainties. Actual results may differ materially from those discussed in these forward-looking statements due to a number of factors, including those set forth in the section entitled “Risk Factors” in its most recent annual report on Form 10-K. For further information regarding forward-looking statements, please refer to the “Special Note Regarding Forward-Looking Statements and Projections” immediately after the index to this quarterly report on Form 10-Q. Alimera Sciences, Inc., and its subsidiaries (we or Alimera), is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharma...
2018-09-25 - Asif
Background DelMar Pharmaceuticals, Inc. is a clinical stage drug development company with a focus on the treatment of cancer. The company's mission is to benefit patients and create shareholder value by developing and commercializing anti-cancer therapies for patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently available therapies, particularly for orphan cancer indications where patients have failed, or are unlikely to respond to, currently available therapy. DelMar Pharmaceuticals is developing VAL-083, a novel, DNA-targeting agent, for the treatment of glioblastoma multiforme (“GBM”) and potentially other solid tumors, including ovarian cancer. VAL-083 is a first-in-class, DNA-targeting chemotherapeutic that demonstrated activity against a range of tumor types in prior Phase 1 and Phase 2 clinical studies sponsored by the US National Cancer Institute (“NCI”). The company's recent research has highlighted the opportunit...
2018-09-18 - Asif
Overview Rigel Pharmaceuticals is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. The company's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA-approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The company's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy, and a Phase 1 study for its IRAK program. In addition, Rigel Pharmaceuticals has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics. Since inception, Rigel Pharmaceuticals h...
Silicon Investor Message Boards
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|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)|
as of ET