TRVN Trevena Inc.

1.53
-0.05  -3%
Previous Close 1.58
Open 1.61
52 Week Low 0.46
52 Week High 1.905
Market Cap $163,986,893
Shares 107,180,976
Float 106,075,769
Enterprise Value $149,533,942
Volume 2,079,599
Av. Daily Volume 2,804,337
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Upcoming Catalysts

Drug Stage Catalyst Date
Oliceridine (TRV130)
Moderate to severe acute pain
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
TRV027
COVID-19
Phase 1b
Phase 1b
Phase 1b trial to be initiated.
TRV250
Acute migraine
Phase 1
Phase 1
Phase 1 enrolment has been paused due to COVID-19 - noted March 26. 2020.
TRV734
Opioid use disorder
Phase 2
Phase 2
Proof of concept trial initiation announced December 23, 2019.
TRV027 - BLAST-AHF
Acute heart failure
Phase 2a
Phase 2a
Phase 2b endpoints not met - May 2016

Latest News

  1. CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company's partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for IV oliceridine, Trevena's lead investigational asset for the management of moderate-to-severe acute pain. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.

    "I am pleased to have reached this important regulatory milestone for IV oliceridine ," said Carrie Bourdow, President and Chief Executive…

    CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company's partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for IV oliceridine, Trevena's lead investigational asset for the management of moderate-to-severe acute pain. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.

    "I am pleased to have reached this important regulatory milestone for IV oliceridine ," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "As we work towards our August 7th PDUFA date for potential approval in the U.S., we also continue to support our ex-U.S. partnerships, as part of our mission to deliver novel treatment options to patients with moderate-to-severe acute pain."

    The Company expects to receive future milestone payments, as well as a 10% royalty on net sales of oliceridine in China.

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has five novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

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  2. --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung injury and ARDS

    Robust clinical development history with well-characterized PK and demonstrated safety in ~700 individuals

    --

    CHESTERBROOK, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is a major complication leading…

    --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung injury and ARDS

    Robust clinical development history with well-characterized PK and demonstrated safety in ~700 individuals

    --

    CHESTERBROOK, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is a major complication leading to mortality associated with COVID-19. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

    "It is a great privilege to be working with Imperial College London, a global thought leader in this pandemic, as we join the urgent fight to deliver treatments to healthcare providers and COVID-19 patients in dire need," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "TRV027 may offer a new and innovative approach to treating acute lung injury, which poses a grave threat to patients' lives."

    "We are very pleased to be partnering with Trevena in our endeavor to combat the global threat posed by this pandemic," said David Owen, M.D., Ph.D., Faculty of Medicine, Imperial College London and Head of Clinical Studies, Imperial Clinical Research Facility. "I am excited for this opportunity to study the potential utility of TRV027 in treating COVID-19 patients."

    In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs, causing elevated levels of angiotensin II. This drives overactivation of the AT1 receptor, which results in downstream acute lung injury. This often develops into ARDS, which can ultimately lead to mortality. TRV027 potentially counteracts the disproportionate levels of angiotensin II, by competitively binding to and rebalancing AT1 receptor activation. Additionally, its unique mechanism of action preferentially engages the signaling pathway to promote reparative effects on lung tissue.

    TRV027 is an investigational new drug that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS in COVID-19 patients.

    About the Imperial College London COVID-19 Study
    This will be a randomized, double-blind, placebo-controlled Phase 1b proof-of-concept study in approximately 60 hospitalized, non-ventilated patients aged 65 or older with a confirmed or suspected COVID-19 infection. The study will determine whether TRV027, a novel AT1 receptor selective agonist, modulates pathways that contribute to COVID-19 pathology. The primary endpoint is a coagulation cascade biomarker, which serves as a surrogate for measuring the effect of TRV027 on adverse health outcomes associated with increased mortality in COVID-19 infections. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

    About TRV027
    TRV027 is a novel AT1 receptor selective agonist. It is an investigational new drug that was studied through a Phase 2b trial for acute heart failure. TRV027 is currently being investigated as a potential treatment for acute lung injury contributing to ARDS in COVID-19 patients. TRV027 may counteract overactivation of the AT1 receptor caused by SARS-coronavirus-2, while simultaneously promoting reparative effects on lung tissue. The use of TRV027 in COVID-19 patients has been proposed by Nobel Laureate Robert J. Lefkowitz, M.D., and Howard A. Rockman, M.D., both Professors of Medicine at Duke University and scientific co-founders of the Company, along with two of their colleagues, Laura M. Wingler, Ph.D., Duke University and Aashish Manglik, M.D., Ph.D., University of California San Francisco.
                 
    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has five novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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  3. Trevena Reports First Quarter 2020 Results

    FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020

    IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain

    --

    Company to host conference call today, May 7, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.

    "In the first quarter, we reached a significant milestone for the oliceridine…

    Trevena Reports First Quarter 2020 Results

    FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020

    IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain

    --

    Company to host conference call today, May 7, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.

    "In the first quarter, we reached a significant milestone for the oliceridine program, with our resubmission and FDA's acceptance of the NDA. I am very pleased with FDA's engagement in the review process, and we look forward to receiving their decision in August," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc.

    First Quarter 2020 and Recent Corporate Highlights:

    •  Resubmitted NDA for oliceridine, with FDA review ongoing. In March 2020, the Company announced that the U.S. Food and Drug Administration (FDA) had set a Prescription Drug User Fee Act (PDUFA) goal date of August 7, 2020 for oliceridine, and the Agency considered the resubmitted New Drug Application (NDA) to be a complete response to their 2018 action letter.

      FDA's review of the NDA resubmission is ongoing, and the Company continues to expect a decision from the Agency by August 7.             
    • Further expanded body of peer-reviewed literature. The Company recently announced the publication of a comprehensive review of the nonclinical and clinical data for oliceridine. The monograph provides an overview of the data the Company has published over the past 18 months, including head-to-head data versus IV morphine in hard- and soft-tissue surgical models and safety / tolerability data in high-risk patients from an open-label, "real world" safety study. These high-risk patients –  elderly, obese, renally impaired and / or co-morbid – make up the initial target market for oliceridine.
       
    • Initiated collaboration with NIH to evaluate TRV045 for epilepsy and non-addictive treatment for pain. In March 2020, the Company announced it had entered into a collaboration with NIH to evaluate the potential of TRV045, the lead candidate for its novel S1P receptor modulator program, as a treatment for epilepsy. NIH has initiated the first round of assays for TRV045 within its Epilepsy Treatment Screening Program.

      The Company today announced that NIH is also investigating TRV045 as a potential non-addictive treatment for various acute and chronic pain conditions, including inflammatory and neuropathic pain, within its Preclinical Screening Platform for Pain.
       
    • Advanced IND-enabling activities for TRV045. The Company today announced it plans to file an Investigational New Drug (IND) application for TRV045 in 1H 2021. IND-enabling activities are currently ongoing.             

    Financial Results for First Quarter 2020

    For the first quarter of 2020, the Company reported a net loss attributable to common stockholders of $5.7 million, or $0.06 per share, compared to $5.2 million, or $0.06 per share, for the first quarter of 2019. This increase in net loss is primarily due to higher research and development expenses associated with the TRV250 acute migraine proof-of-concept study and activities to support the NDA resubmission for oliceridine.

    Cash and cash equivalents were $28.1 million at March 31, 2020, which the Company believes to be sufficient to fund the Company's operating expenses and capital expenditure requirements into the first quarter of 2021.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on May 7, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Robert Yoder, Chief Business Officer, Mark Demitrack, M.D., Chief Medical Officer, and Barry Shin, Chief Financial Officer.

    Title: Trevena First Quarter 2020 Conference Call and Webcast
    Date: Thursday, May 7, 2020
    Time: 8:00 a.m. ET
    Conference
    Call Details:
    Toll-Free: 855-465-0180
    International: 484-756-4313
    Conference ID: 5469527
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

    TREVENA, INC.
    Condensed Statements of Operations
    (Unaudited, in thousands except share and per share data)
             
        Three Months Ended March 31,
          2020       2019  
             
    Revenue   $ -     $ -  
             
    Operating expenses:        
    General and administrative     3,632       3,060  
    Research and development     2,191       2,154  
    Total operating expenses     5,823       5,214  
    Loss from operations     (5,823 )     (5,214 )
    Other income     98       45  
    Loss before income tax expense     (5,725 )     (5,169 )
    Income tax expense     -       -  
    Net loss   $ (5,725 )   $ (5,169 )
             
    Per share information:        
    Net loss per share of common stock, basic and diluted   ($0.06 )   ($0.06 )
    Weighted average shares outstanding, basic and diluted   96,332,324       88,897,292  
             



    TREVENA, INC.      
    Condensed Balance Sheets      
    (Unaudited, in thousands)      
                   
        March 31, 2020   December 31, 2019  
    Assets              
    Current assets:              
    Cash and cash equivalents   $ 28,090     $ 32,305        
    Marketable securities     -       3,500        
    Prepaid expenses and other current assets     1,666       1,683        
    Total current assets     29,756       37,488        
    Restricted cash     1,310       1,309        
    Property and equipment, net     2,577       2,705        
    Right-of-use lease assets     5,389       5,472        
    Other assets     18       20.00        
    Total assets   $ 39,050     $ 46,994        
                   
    Liabilities and stockholders' equity              
    Current liabilities:              
    Accounts payable   $ 698     $ 1,047        
    Accrued expenses and other current liabilities     1,277       2,403        
    Current portion of loans payable, net     -       5,037        
    Current portion of lease liabilities     642       620        
    Total current liabilities     2,617       9,107        
    Leases, net of current portion     7,636       7,804        
    Warrant liability     2       5        
    Total liabilities     10,255       16,916        
                   
    Common stock     99       94        
    Additional paid-in capital     447,566       443,129        
    Accumulated deficit     (418,870 )     (413,145 )      
    Total stockholders' equity     28,795       30,078        
    Total liabilities and stockholders' equity   $ 39,050     $ 46,994        
                   

     


     

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  4. CHESTERBROOK, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the first quarter ended March 31, 2020, prior to the market open on Thursday, May 7, 2020.

    Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. (ET) on the same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, SVP and Chief Business Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief…

    CHESTERBROOK, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the first quarter ended March 31, 2020, prior to the market open on Thursday, May 7, 2020.

    Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. (ET) on the same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, SVP and Chief Business Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer.  

       
    Title: Trevena First Quarter 2020 Financial Results Conference Call & Webcast
       
    Date: Thursday, May 7, 2020
       
    Time: 8:00 a.m. ET
       
    Conference 
    Call Details:
    Toll-Free: 855-465-0180
    International: 484-756-4313
    Conference ID: 5469527
     
     
    The conference call will be webcast live from the company's website and will be available via the following links:
     
     
      https://www.trevena.com/investors/events-presentations/ir-calendar
    Webcast:  
      https://edge.media-server.com/mmc/p/r7x9zckv
       

    The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the company's website.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please contact:

    Investor Contact:
    Dan Ferry - Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840 

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  5. Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients

    CHESTERBROOK, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today.

    The publication is titled "Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain", with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony…

    Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients

    CHESTERBROOK, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today.

    The publication is titled "Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain", with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony Brook Medicine (DOI: 10.1358/dot.2020.56.4.3107707).

    "I am pleased to have the opportunity to provide a comprehensive overview of the data we have amassed over the entire oliceridine development program from over 1,800 individuals," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "This monograph is the latest addition to the compelling body of peer-reviewed published literature for oliceridine, and summarizes the novel characteristics that make it a potentially differentiated treatment option for moderate-to-severe acute pain in hospital settings."

    Monograph Key Points:

    • Novel, biased mechanism of action; robust efficacy in animal models with less associated constipation, gastrointestinal (GI) dysfunction, and respiratory depression.

    • Novel pharmacology with a half-life that allows for adequate drug concentrations to provide efficacy without drug accumulation or development of active metabolites. No dosage adjustments needed when administering oliceridine to patients with renal impairment, mild to moderate hepatic impairment, or the elderly.

    • Rapid analgesia in hard- and soft-tissue surgeries in patients with moderate-to-severe acute pain. Safe and well-tolerated in a large, open-label, "real world" safety study, including in high-risk patients with advanced age, obesity, and diabetes and across a variety of surgical procedures and settings of care.

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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