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Recommendations
H.C. Wainwright sees Avenue's tramadol getting FDA approval by PDUFA date » 11:20
02/13/20
02/13
11:20
02/13/20
11:20
ATXI

Avenue Therapeutics

$10.85 /

-0.08 (-0.73%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Ed Arce affirmed a Buy rating and $12 price target on Avenue Therapeutics (ATXI) following the company's announcement that its New Drug Application, or NDA, of IV tramadol 50 mg for the management of moderate to moderately severe pain in adults has been formally accepted by the FDA, with a PDUFA date of October 10, 2020. The analyst continues to expect the drug's approval based on positive data from two Phase 3 trials, and sees it occuring ahead of the PDUFA date.

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Avenue Therapeutics announces acceptance of NDA for IV Tramadol » 08:07
02/13/20
02/13
08:07
02/13/20
08:07
ATXI

Avenue Therapeutics

$10.93 /

+0.18 (+1.67%)

Avenue Therapeutics…

Avenue Therapeutics announced that the U.S. Food and Drug Administration has accepted for review Avenue's New Drug Application for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. The FDA set a Prescription Drug User Fee Act goal action date of October 10, 2020.

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Over a month ago
Recommendations
H.C. Wainwright sees PDUFA date for Avenue Therapeutics' IV tramadol in 4Q20 » 12:14
12/11/19
12/11
12:14
12/11/19
12:14
ATXI

Avenue Therapeutics

$6.58 /

+0.13 (+2.02%)

H.C. Wainwright analyst…

H.C. Wainwright analyst Ed Arce reaffirmed a Buy rating and $12 price target on Avenue Therapeutics after the company announced the NDA submission of IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting, as expected by year-end 2019. Arce said he expects the U.S. Food and Drug Administration to assign a PDUFA date in the fourth quarter of 2020 based on the filing and continues to see IV tramadol's approval based on the safety and efficacy data collected to date. The analyst added that Avenue is now "one step closer" to completing its InvaGen Pharmaceuticals acquisition.

Hot Stocks
Avenue Therapeutics announces NDA submission for IV tramadol » 08:34
12/11/19
12/11
08:34
12/11/19
08:34
ATXI

Avenue Therapeutics

$6.45 /

+0.34 (+5.56%)

Avenue Therapeutics…

Avenue Therapeutics announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen. In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available.

Over a quarter ago
Earnings
Avenue Therapeutics reports Q3 EPS (14c), consensus (28c) » 07:34
11/04/19
11/04
07:34
11/04/19
07:34
ATXI

Avenue Therapeutics

$5.42 /

+ (+0.00%)

"We are pleased with…

"We are pleased with the progress made during the third quarter of 2019, especially with the fact that our partner company, Cipla Limited, brought on Ms. Garrett Ingram as head of their U.S. specialty hospital business to lead the potential commercialization of IV tramadol," said Lucy Lu, M.D., Avenue's President and Chief Executive Officer. "Looking ahead, we are on track to submit a New Drug Application for IV tramadol to the U.S. Food and Drug Administration by year-end 2019."

Hot Stocks
Avenue Therapeutics announces publication of IV tramadol Phase 1 clinical data » 08:39
10/28/19
10/28
08:39
10/28/19
08:39
ATXI

Avenue Therapeutics

$5.98 /

+0.61 (+11.36%)

Avenue Therapeutics…

Avenue Therapeutics announced that its Phase 1 data on intravenous tramadol has been published in the peer-reviewed journal Clinical Pharmacology in Drug Development. Based on the results of the study, Avenue chose the IV tramadol 50 mg dosing regimen for Phase 3 development. The objective of this Phase 1, open-label, single investigational center, three-treatment, three-period, multidose crossover study was to compare the pharmacokinetics of two novel IV tramadol dosing regimens to oral tramadol 100 mg given every six hours, the highest approved oral dosage in the United States. Compared to the oral regimen, IV tramadol 50 mg administered at hours 0, 2, and 4 and every 4 hours thereafter reached initial tramadol peak serum concentration (Cmax) more rapidly, while resulting in similar overall steady-state Cmax and area under the plasma concentration-time curve, and that the primary metabolite, M1, had lower area under the plasma concentration-time curve and Cmax than for the oral regimen. The IV tramadol 50 mg dosing regimen was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol.

Hot Stocks
Avenue Therapeutics to present Phase 3 bunionectomy study of IV Tramadol » 08:36
10/18/19
10/18
08:36
10/18/19
08:36
ATXI

Avenue Therapeutics

$5.30 /

+0.05 (+0.95%)

Avenue Therapeutics…

Avenue Therapeutics announced an eAbstract presentation at ANESTHESIOLOGY 2019, the Annual Meeting of the American Society of Anesthesiologists in Orlando, FL. The eAbstract entitled "Tramadol Hydrochloride Injection: Effective Relief of Postsurgical Pain in Patients Undergoing Bunionectomy Surgery", is scheduled to be presented on Sunday, October 20th. The eAbstract will highlight the Phase 3 data for IV tramadol in the management of post-surgical pain in patients undergoing bunionectomy, an orthopedic model. This Phase 3, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 409 patients following bunionectomy surgery. Patients were randomized in a 1:1:1 ratio to a postoperative regimen of 50 mg of IV tramadol, 25 mg of IV tramadol or placebo administered over 15 minutes at hours 0, 2, 4 and once every 4 hours thereafter, for up to 13 doses. The primary endpoint of the bunionectomy study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID48. The key secondary endpoints included SPID24, total consumption of rescue medicine and Patient Global Assessment, which captures the patient's perception of the treatment. As previously announced, IV tramadol 50 mg met the primary as well as all of the key secondary endpoints.

Hot Stocks
Avenue Therapeutics expects cash to fund operations into Second Stage Closing » 07:48
08/14/19
08/14
07:48
08/14/19
07:48
ATXI

Avenue Therapeutics

$6.08 /

+0.08 (+1.33%)

As of June 30, 2019,…

As of June 30, 2019, Avenue's cash and cash equivalents and short-term investments totaled $15.5 million, compared to $29.4 million at March 31, 2019. This decrease reflects the completion of the abdominoplasty and safety studies in the second quarter of 2019. Based on its current development plans, Avenue expects that its existing cash and cash equivalents and short-term investments and line of credit related to the InvaGen agreement, will enable it to fund its operations into the Second Stage Closing with InvaGen.

Earnings
Avenue Therapeutics reports Q2 EPS (43c), consensus (48c) » 07:33
08/14/19
08/14
07:33
08/14/19
07:33
ATXI

Avenue Therapeutics

$6.08 /

+0.08 (+1.33%)

"We recently…

"We recently reported positive data from our second pivotal Phase 3 trial of IV tramadol for the management of postoperative pain in patients following abdominoplasty surgery, which compared IV tramadol to placebo and an active-comparator arm of IV morphine," said Lucy Lu, M.D., Avenue's President and Chief Executive Officer. "We have successfully completed our Phase 3 program of IV tramadol for the management of postoperative pain and we are on track to submit a New Drug Application to the U.S. Food and Drug Administration by year-end."

Conference/Events
Avenue Therapeutics to hold a pharmaceutical update conference call » 07:53
06/03/19
06/03
07:53
06/03/19
07:53
ATXI

Avenue Therapeutics

$4.95 /

+ (+0.00%)

Management discusses the…

Management discusses the positive top line data from the second pivotal Phase 3 study of intravenous tramadol in the management of postoperative pain in a conference call to be held on June 3 at 9 am. Webcast Link

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