67 results
8-K
EX-99.1
ATXI
Avenue Therapeutics Inc
25 May 18
Regulation FD Disclosure
8:30am
Unmet Need in Postoperative Pain Uniquely Positioned to Address a Clear Need for New Therapies Amidst Opioid Crisis Double MOA delivers opioid efficacy … intravenous Schedule IV opioid in the U.S. Broad Applicability Translates into Substantial Market Opportunity A new option for patients
8-K
EX-99.1
ATXI
Avenue Therapeutics Inc
14 Jul 17
Other Events
12:00am
intravenous Schedule IV opioid in the U.S. if approved Less addiction potential than widely prescribed narcotics in the hospital Oral tramadol has … & Contraindications IV Tramadol
What is Tramadol Not a typical opioid 7 Inhibitor of Re - uptake of Norepinephrine and Serotonin Weak Opioid Agonist Opioid Binding
8-K
EX-99.1
ATXI
Avenue Therapeutics Inc
17 Apr 23
Avenue Therapeutics Announces Regulatory Update Based on Type C Meeting with FDA and Next Steps in the Development of IV Tramadol
4:06pm
study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol compared to IV morphine … risks related to opioid stacking and the FDA stated that the proposed study design appeared reasonable and agreed on various study design aspects
8-K
EX-99.1
ATXI
Avenue Therapeutics Inc
3 Jun 19
Avenue Therapeutics Announces Positive Topline Data from Second Pivotal Phase 3 Study of Intravenous Tramadol in the Management of Postoperative Pain
8:45am
key secondary endpoints. The study also includes a standard-of-care IV opioid as an active comparator: IV morphine 4 mg. In this study, IV tramadol also … -end 2019.”
“IV tramadol may fill a gap between non-opioid medicine and Schedule II opioids in the post-surgical setting and has the potential
FWP
ATXI
Avenue Therapeutics Inc
3 Oct 23
Free writing prospectus
5:47pm
Disease) Epilepsy and acute anxiety Mechanism Opioid agonist & inhibitor of norepinephrine & serotonin re - uptake Activation of Nrf1 & Nrf2 and promotion … regarding opioid stacking Finalized trial design with FDA for final Phase 3 safety study Initiate Phase 3 safety study; topline data expected within 7 - 8
FWP
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5 Oct 23
Free writing prospectus
5:05pm
8-K
EX-99.1
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13 Oct 20
Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol
6:10am
8-K
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15 Jul 21
Other Events
12:00am
8-K
EX-99.1
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23 Apr 20
Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters
9:00am
FWP
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6 Oct 22
Free writing prospectus
4:05pm
8-K
EX-99.1
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30 Mar 23
Avenue Therapeutics Reports Full Year 2022 Financial Results and Recent Corporate Highlights
4:07pm
8-K
EX-99.1
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10 Aug 23
Avenue Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights
4:20pm
8-K
EX-99.1
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18 Mar 24
Avenue Therapeutics Reports Full Year 2023 Financial Results and Recent Corporate Highlights
4:10pm
8-K
EX-99.1
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22 Sep 22
Material Modifications to Rights of Security Holders
4:32pm
8-K
EX-99.1
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21 May 18
Avenue Therapeutics Announces Positive Topline Phase 3 Data for Intravenous Tramadol in the Management of Postoperative Pain
8:15am