ACRX (Mkap $98 M) (Cash $72M) FDA Entscheid am 12 Okt & P3 Daten diesen Monat (Seite 14)

[iknowtheway]

Why AcelRx Pharmaceuticals Inc Got Cut in Half Today
https://finance.yahoo.com/news/why-acelrx-pharmaceuticals-in…

Gibt es überzeugende Gründe hier einzusteigen??

[wandstrasse-ch]

AcelRx Pharma shares sink as FDA rejects its opioid painkiller
http://www.nasdaq.com/article/acelrx-pharma-shares-sink-as-f…

[schnappi]

Antwort auf Beitrag Nr.: 55.866.529 von Biohero am 02.10.17 18:22:32

Schaut gut aus hier hat sich der Mut zum nachkaufen bei ca 2$ auch rentiert, die Spannung steigt wie der Kurs

[Biohero]

Die 200% die ich im ersten Posting angegeben habe sind fast erreicht und es sind noch 8 handelstage bis zur FDA Entscheidung also noch Zeit um weiter steigen zu können .

[Biohero]

ACRX hat sich sehr gut erholt kein wunder in wenigen tagen ist die FDA Entscheidung aber es ist sehr schwierig zusagen wie sich die FDA entscheidet die chancen stehen 50/50 bei Zulassung gibts einen großen kurssprung aber wenn nicht dann könnte die Aktie bis auf $1 fallen was wieder eine gute Einstiegschanche bieten würde weil im 1H 2018 schon wieder eine FDA Entscheidung ansteht .

http://www.nasdaq.com/article/acrx-nearing-big-day-no-respit…

Near-term catalyst:

-- The FDA decision on the Company's investigational product Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting is expected to be announced on October 12, 2017.

Dsuvia, formerly known as ARX-04, consists of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator.

AcelRx estimates that the market potential of Dsuvia in the U.S. will be roughly $1.1 billion.

[wandstrasse-ch]

Irrational Opioid Crisis Volatility Nipping at AcelRx Pharmaceuticals Inc (ACRX) Presents Stellar Entry Point

https://www.smarteranalyst.com/2017/08/07/irrational-opioid-…

[manffreddoo]

....tja, wenn ich mir anschaue wie der Wert kursmässig filetiert wird, weiss ich schon was in dem Report steht, auch ohne Übersetzung.........bin draussen........
M.

[techxxnine]

Ouch. Wie gewonnen so zerronnen :O

[manffreddoo]

hi,
war mag das mal kurz auf deutsch zusammenfassen?
M.

[wandstrasse-ch]

AcelRx Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Corporate Update

REDWOOD CITY, Calif., Aug. 1, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, today provided a business update and reported financial results for the three and six months ended June 30, 2017.

Clinical Highlights

In the second quarter of 2017, AcelRx presented efficacy and integrated safety results from the DSUVIA™ (sufentanil sublingual tablet, 30 mcg) clinical program during the Annual Regional Anesthesiology and Acute Pain Medicine Meeting. DSUVIA is AcelRx's lead investigational candidate for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting. A New Drug Application (NDA) is currently under review at the U.S. Food and Drug Administration and a Marketing Authorisation Application (MAA) for ARX‑04 (known as DSUVIA in the U.S.) is being evaluated by the European Medicines Agency.

ZALVISO® (sufentanil sublingual tablet system), the company's patient-controlled analgesia system, was selected for a Red Dot Award in the category of Product Design – Life Sciences and Medicine in the second quarter of 2017. The Red Dot Award is organized by the Design Zentrum Nordrhein Westfalen in Essen, Germany, and is one of the largest design competitions in the world. ZALVISO is currently marketed in the EU through the company's licensee, Grunenthal, for the treatment of moderate to severe post-operative pain management in a hospital setting.

Today AcelRx reported top-line results from IAP312, a Phase 3 study that treated 320 hospitalized, post-operative patients who used ZALVISO to self-administer 15 mcg sublingual sufentanil tablets as often as once every 20 minutes for 24-to-72 hours to manage their moderate-to-severe acute pain. Throughout the study, 2.2% of patients experienced a ZALVISO device error, which was statistically less than the 5% limit specified in the study objectives. In addition, results of this study supported earlier clinical findings, with favorable tolerability and a significant majority of "good" or "excellent" ratings provided by both patients and healthcare providers when assessing the method of pain control. AcelRx remains on track to resubmit the NDA for ZALVISO by the end of the year.

"We are making solid progress on our path to commercializing our two late-stage product candidates, DSUVIA and ZALVISO," stated Vincent J. Angotti, AcelRx's chief executive officer. "We expect to receive a decision from the FDA on our marketing application for DSUVIA in the fourth quarter, and are on track to resubmit the NDA for ZALVISO to the FDA that same quarter. We also continue to manage our expenses and cash in line with our plan leading into these major company milestones."

Second Quarter 2017 Financial Results

Net loss for the second quarter of 2017 was $13.1 million, or $0.29 basic and diluted net loss per share, compared to $11.1 million, or $0.24 basic and diluted net loss per share for the second quarter of 2016. The net loss from operations in the second quarter of 2017 was $9.9 million, compared to $8.3 million during the second quarter last year.

During the second quarter of 2017, AcelRx recognized revenue of $2.2 million under the collaboration agreement with Grunenthal, mainly due to ZALVISO product shipments, and $0.5 million related to work performed under the Department of Defense (DoD) contract for DSUVIA. This compares to $1.3 million and $3.2 million in revenue recognized, respectively, from those two agreements in the second quarter of 2016.

Operating costs and expenses during the second quarter of 2017 included cost of goods sold of $3.5 million related to commercial production of ZALVISO in support of Grunenthal's European launch, as compared to $3.0 million during the three months ended June 30, 2016. Research and development expenses for the second quarter of 2017 and 2016 were $4.9 million and $6.3 million, respectively. The net decrease was due to the completion of the Phase 3 DSUVIA trials in June 2016, partially offset by an increase in R&D expenses in 2017 related to the IAP312 study for ZALVISO. General and administrative expenses for the second quarter of 2017 and 2016 were $4.2 million and $3.6 million, respectively, primarily due to increased pre-commercialization expenses in 2017. Total other expense for the second quarter of 2017 was $3.1 million as compared to $2.8 million in the second quarter of 2016, and consists mainly of non-cash interest expense on the liability related to the sale of future royalties.

Year-to-Date Financial Results

For the six months ended June 30, 2017, AcelRx reported a net loss of $28.6 million, or $0.63 basic and diluted net loss per share, compared to $22.1 million, or $0.49 basic and diluted net loss per share for the same period in 2016. The increased net loss in the first half of 2017 is primarily due to decreased DoD contract revenue, combined with increased costs of goods sold related to larger shipments of ZALVISO, and higher expenses related to the IAP312 study and pre-commercialization activities. In addition, total other expense increased in the six months ended June 30, 2017 primarily due to increased interest expense on the Hercules loan and other non-cash items, including interest expense on the liability related to the sale of future royalties.

During the six months ended June 30, 2017, AcelRx recognized revenue of $5.2 million under the collaboration agreement with Grunenthal and $0.6 million related to work performed under the DoD contract for ARX-04. This compares to $3.1 million and $4.4 million in revenue, respectively, related to these agreements in the six months ended June 30, 2016.

Operating costs and expenses during the six months ended June 30, 2017 included cost of goods sold of $7.7 million, as compared to $6.6 million in the comparable period last year. Research and development, and general and administrative expenses during the six months ended June 30, 2017 were $11.8 million and $8.3 million, respectively. These compare to $10.5 million in research and development expenses and $7.4 million in general and administrative expenses in the first half of last year.

Total other expense of $6.6 million during the six months ended June 30, 2017 compares to $5.2 million in other income during the six months ended June 30, 2016.

As of June 30, 2017, AcelRx had cash, cash equivalents and investments of $62.1 million, compared to $80.3 million at December 31, 2016. The decrease was primarily attributable to cash used in operating activities.

Conference Call

As previously announced, AcelRx will conduct an investment-community conference call on Tuesday, August 1, 2017 at 8:30 am Eastern Time (5:30 am Pacific Time) to discuss top-line results from the IAP312 study. IAP312 was a Phase 3 study in which hospitalized, post-operative patients self-administered 15 microgram sublingual sufentanil tablets using ZALVISO® (sufentanil sublingual tablet system) as often as once every 20 minutes to manage their moderate-to-severe acute pain. The company also plans to discuss its financial results for the three and six months ended June 30, 2017. Please note, this conference call and webcast will replace the previously announced financial results conference call that had been scheduled for August 2, 2017. A separate press release regarding the Phase 3 IAP312 study top-line results was issued today.

Investors who wish to participate in the conference call may do so by dialing [phone] for domestic callers, [phone] for Canadian callers or [phone] for international callers. Those interested in listening to a webcast of the conference call live via the Internet may do so by visiting the Investors page of the company's website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be archived on the AcelRx website for 90 days following the call.

http://ir.acelrx.com/phoenix.zhtml?c=241441&p=irol-newsArtic…