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ACRX

AcelRx

$3.95

(0.00%)

16:17
10/12/18
10/12
16:17
10/12/18
16:17

AcelRx says FDA advisory committee recommeds approval of Dsuvia

AcelRx Pharmaceuticals announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA voted 10-3 in favor of recommending the approval of Dsuvia for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. Developed to address challenges with existing treatment options and to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes, Dsuvia is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional. While the FDA is not bound by the committee's recommendation, it does take its advice into consideration. The Prescription Drug User Fee Act, or PDUFA, date for Dsuvia is November 3.

  • 12

    Oct

  • 03

    Nov

ACRX AcelRx
$3.95

(0.00%)

10/10/18
CANT
10/10/18
NO CHANGE
Target $6
CANT
Overweight
Positive vote on AcelRx's Dsuvia 'a real possibility,' says Cantor Fitzgerald
After the FDA released the briefing documents for this Friday's Advisory Committee meeting to review AcelRx's Dsuvia, Cantor Fitzgerald analyst Brandon Folkes said he expects "a robust discussion" and believes a positive vote on Dsuvia being used only in a medically supervised setting "is a real possibility." He attributes the initial negative reaction in the stock to extracts from the 2017 CRL, which was attached as an appendix, but he believes AcelRx has addressed these concerns and views the briefing documents as an incremental positive. Folkes keeps an Overweight rating and $6 price target on AcelRx shares.
10/10/18
LTCO
10/10/18
NO CHANGE
Target $10
LTCO
Buy
AcelRx price target raised to $10 from $7 at Ladenburg
10/10/18
LTCO
10/10/18
NO CHANGE
Target $10
LTCO
Buy
Ladenburg says briefing docs support Dsuvia approval, ups AcelRx target to $10
After the FDA released briefing documents ahead of Friday's Advisory Committee meeting for AcelRx, Ladenburg analyst Michael Higgins said the documents "could not be more supportive of Dsuvia." He believes pre-market weakness in the shares occurred as investors initially read the comments from the prior review, which had produced a CRL, but the documents are actually "very positive on Dsuvia," he contends. Higgins, who expects the committee to vote in support of Dsuvia's efficacy, safety, proposed REMS and overall approval, raised his price target on AcelRx shares to $10 from $7 and keeps a Buy rating on the shares.
10/10/18
HCWC
10/10/18
NO CHANGE
Target $7
HCWC
Buy
AcelRx briefing docs bode well for positive panel, says H.C. Wainwright
H.C. Wainwright analyst Ed Arce believes the briefing document released this morning for the October 12 FDA meeting to review the resubmitted new drug application of Dsuvia bode well for a positive panel vote. The statements and tone of the FDA reviewers are broadly supportive of approval, Arce tells investors in a research note. The analyst affirms a Buy rating on AcelRx Pharmaceuticals with a $7 price target.

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