AcelRX (ACRX)

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AcelRX wacht op goedkeur van de FDA voor Zalviso, op 27 juli valt de beslissing. Het bedrijf toont veel vertrouwen in de uitkomst.

www.bizjournals.com/sanfrancisco/blog...

Zalviso is een systeem voor het door de patient zelf toedienen van sufentanyl, een krachtige niet-opioide pijnstiller.

Het gaat om meer dan 10 miljoen gevallen per jaar in de VS, die nu met intraveneuze toediening van bijvoorbeeld morfine behandeld worden. De patient drukt op een knopje bij pijn en krijgt een dosis. Hiervoor moet de machine goed afgesteld worden. Daar worden veel fouten bij gemaakt, daarnaast raken patienten resistent tegen morfine en is er een gevaar van verslaving.

De kosten van de huidige techniek liggen rond 200 dollar voor twee dagen, ex faalkosten.

Zalviso is duurder maar het elimineert de ruimte voor fouten.

Na de indiening van het NDA steeg ACRX naar 13 dollar. Inmiddels weer onder de 9. Wat mij betreft het moment om in te stappen.

Yahoo Finance analyst estimates

Price Target Summary
Mean Target: 18.56
Median Target: 16.25
High Target: 33.00
Low Target: 14.00
No. of Brokers: 8
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Recommendation Trends
Current Month Last Month Two Months Ago Three Months Ago
Strong Buy 3 3 2 2
Buy 6 6 5 5
Hold 0 0 0 0
Underperform 0 0 0 0
Sell 0 0 0 0
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www.nasdaq.com/article/funds-are-buyi...

Quote

We decided to screen for companies in the biotech industry that are also experiencing spikes in institutional purchasing from groups like pensions or hedge funds. Since there were a lot of companies that fit that description, we narrowed the screen further to stocks priced between $5 and $10 dollars. We also screened out all the companies that had a 'hold' rating or lower, according to Finviz.

That left us with 7 healthcare, biotechnology, and medical device stocks that are experiencing a surge in institutional purchasing this year. Do you see a healthy future for the biotech industry? Use the list below to begin your analysis and let us know what you think in the comments.

1. AcelRx Pharmaceuticals, Inc. ( ACRX , Earnings , Analysts , Financials ): AcelRx Pharmaceuticals, Inc., a development stage specialty pharmaceutical company, engages in the development and commercialization of therapies for the treatment of acute and breakthrough pain in the United States and internationally. Market cap at $422.33M, most recent closing price at $9.71.

Net institutional purchases in the current quarter at 3.2M shares, which represents about 16.99% of the company's float of 18.84M shares.

Major holders include BlackRock Fund Advisors at a 2.72% stake.
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Waarschuwing, buy the news and sell the rumor

AcelRX shelf registration accepted by SEC

www.sec.gov/Archives/edgar/data/14279...

Common Stock
Preferred Stock
Debt Securities
Warrants


3,070,000 Shares Common Stock


From time to time, we may offer and sell any combination of the securities described in this prospectus, either individually or in combination, for total gross proceeds of up to $150,000,000. We may also offer common stock or preferred stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock, preferred stock or debt securities upon the exercise of warrants.
In addition, selling stockholders to be named in a prospectus supplement may also offer and sell, from time to time, up to 3,070,000 shares of our common stock. To the extent that any selling stockholder resells any securities, the selling stockholder may be required to provide you with this prospectus and a prospectus supplement identifying and containing specific information about the selling stockholder and the terms of the securities being offered. We will not receive any proceeds from the sale of our common stock by selling stockholders.
We will provide the specific terms of these offerings and securities in one or more supplements to this prospectus. We may also authorize one or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplement and any related free writing prospectus may also add, update or change information contained in this prospectus. You should carefully read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference, before buying any of the securities being offered.
Our common stock is listed on The NASDAQ Global Market under the trading symbol “ACRX.” On May 15, 2014, the last reported sale price of our common stock was $8.78 per share. The applicable prospectus supplement will contain information, where applicable, as to other listings, if any, on The NASDAQ Global Market or other securities exchange of the securities covered by the prospectus supplement.



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143 views... Kijke kijke niet kope, is er dan verder niemand die dit aandeel heeft...?
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Run up naar 27 juli is goed begonnen. Let op dat er een stevige sell off na de bevestiging door de FDA kan ontstaan.

Zalviso zal waarschijnlijk tijd nodig hebben om door te breken in de markt voor post-operatieve pijnstillers.
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Grunenthal Group kondigt indiening goedkeuringsaanvraag bij EU autoriteiten aan. Voor AcelRX betekent dit 5 miljoen dollar cash milestone payment.

Goedkeur in EU wordt verwacht binnen 12 tot 18 maanden.

Reminder: goedkeur beslissing VS volgt deze maand (27 juli, wellicht eerder, met de FDA weet je het maar nooit).

Volledig bericht:


AcelRx and Grunenthal Announce Submission of European Marketing Authorization Application for ZALVISO™



Mon July 7, 2014 3:00 AM|PR Newswire | About: ACRX


REDWOOD CITY, Calif. and AACHEN, Germany, July 7, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (ACRX) and Grunenthal Group announced today that Grunenthal has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for ZALVISO" for the management of moderate to severe acute pain in adult patients in a medically supervised environment. ZALVISOTM is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device. AcelRx and Grunenthal entered into license and supply agreements for ZALVISOTM in the EU, Australia and certain other countries in December 2013.

Under the terms of the license agreement, AcelRx will receive a cash payment of $5 million for the MAA submission. AcelRx is eligible to receive an additional $15 million milestone payment upon the approval of the MAA. After approval by EMA, AcelRx is eligible to receive approximately $200 million in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements. Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the twenty percent range, on net sales of ZALVISOTM in the Grunenthal territory. With the partnership Grunenthal, a family-owned global pharmaceutical company headquartered in Aachen, Germany, significantly strengthens its hospital franchise and underlines its strong market position as a pain specialist in the pharmaceutical market.

"We are pleased with the timely progress and collaborative nature of our relationship with Grunenthal which has enabled the ZALVISO MAA to be submitted on schedule," said Richard King, President and CEO of AcelRx Pharmaceuticals, Inc. "We look forward to the time when the benefits of ZALVISO might be available to all medically supervised patients in moderate to severe pain in the European Union."

"This important step is a key milestone in bringing a new treatment option to patients. Through the license agreement with AcelRx Grunenthal is again emphasizing its commitment to pain patients as an independent, global pharmaceutical company with long-time experience in the development of innovative and effective pain treatments," said Prof. Dr. Eric-Paul Paques, Grunenthal's Chief Executive Officer.

Under the terms of the collaboration, Grunenthal will be responsible for all commercial activities for ZALVISO, including obtaining and maintaining pharmaceutical product regulatory approval in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory and manufacturing and supply of ZALVISO to Grunenthal for commercial sales and clinical trials.

Currently, there are 19 million surgical procedures with associated moderate-to-severe pain in the European Union on an annual basis for which the use of ZALVISO could be suitable. The regulatory review by EMA is expected to take twelve to sixteen months.

About ZALVISO

ZALVISO is an investigational pre-programmed, non-invasive, handheld system that allows hospital patients with moderate-to-severe acute pain to self-dose with sublingual sufentanil tablets to manage their pain. ZALVISO is designed to help address certain problems associated with post-operative intravenous patient-controlled analgesia, which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the complexity of infusion pumps.

AcelRx retains all rights to ZALVISO in North America, Asia, Latin America and Middle East/Africa.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx's lead product candidate, ZALVISO, is designed to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for ZALVISO, and has submitted an NDA to the FDA seeking approval for ZALVISO in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting. AcelRx plans to initiate a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting, during the second half of 2014. The company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx's clinical programs, please visit www.acelrx.com.

About Grunenthal

The Grunenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company in the field of pain and thus to be a leader in therapy innovation.

Grunenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 27 percent of revenues in 2013. Grunenthal's research and development strategy concentrates on selected fields of therapy and state-of-the-art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies.

Altogether, the Grunenthal Group has affiliates in 25 countries worldwide. Grunenthal products are sold in more than 155 countries and approx. 5,500 employees are working for the Grunenthal Group worldwide. In 2013, Grunenthal achieved revenues of ¬901 mn.

More information: www.grunenthal.com.
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Een pijnlijke tegenvaller vandaag met een CRL (Compete Response Letter).

FDA zoekt meer informatie rond wijze van gebruik door de patient en houdbaarheid van het middel.

acelRX denkt eind dit jaar opnieuw te kunnen indienen. Als de FDA van goede wil is, zou er in de eerste helft van 2015 een nieuwe beslissing kunnen vallen.

Uiteraard een vervelende ontwikkeling. Brengt mij ook tot een lastig punt, zitten blijven en misschien zelfs bijkopen, of elders proberen het nu virtuele verlies goed te maken?

Wat mij betreft is de uiteindelijke goedkeur een kwestie van tijd, maar hier heeft AcelRX natuurlijk qua beheersing van de procedure een lelijke beurt gemaakt.

news.acelrx.com/phoenix.zhtml?c=24144...
junkbond
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Targets van $15 en $16 ziet er goed uit :) Ik heb ook wat ACRX gekocht gisteren @6.39. Als het nog lager gaat koop ik bij. Dan is het een kwestie van geduld. Gaat wel weer omhoog
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Dat is lekker instappen...
Ik sta wel stevig onder water maar ik ben nog jong.
Dit product komt op de markt, daar ben ik wel zeker van. De Grunenthal deal in de EU zegt genoeg. Dat is een gerenommeerde speler in de pijnbestrijding.
www.grunenthal.nl
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Analisten van Mizuho houden het koop-advies overeind, prijsdoel 15 dollar.

overzicht

Date-Analyst-Latest Rating-Latest Target


07/28 JMP Securities outperform $12


07/28 Roth Capital buy $16


07/28 Mizuho buy $15


07/28 RBC Capital outperform $12


07/28 Canaccord Genuity hold $8
junkbond
0
junkbond
0
quote:

doewap schreef op 31 juli 2014 10:37:


Ik ben even met mijn centen naar Hydrogenics.

Tot later!
bad timing.
junkbond
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quote:

doewap schreef op 31 juli 2014 16:55:


Hij veert wat op. Het is nog vroeg.
het is meer dat je hier een 8% pop gemist heb
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