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Tag: TRVN Stock

  • Trevena Inc. (TRVN) Stock Bullish in Pre Market Following an Upbeat News

    Trevena Inc. (TRVN) Stock Bullish in Pre Market Following an Upbeat News

    On January 27, Trevena Inc. (TRVN) declared the acceptance of NDA submission for oliceridine injection by China NMPA. Following the announcement, the stock became bullish in the premarket trading on Friday.

    During regular trading, the stock fluctuated between a high of $0.5600 and a low of $0.4630. TRVN closed the session at $0.4800, with a loss of 5.40% on Thursday. Consequent to the announcement, the stock rebounded to gain 10.38% in the pre-market. Hence, TRVN was trading at $0.5298 per share at the last check on Friday.

    Founded in 2009, Trevena Inc. works on novel medicines for central nervous system disorders. Currently, its 164.52 million outstanding shares trade at a market capitalization of $83.48 million.

    NDA Application

    Recently, TRVN’s partner Jiangsu Nhwa Pharmaceutical submitted New Drug Application for OLINVYK (oliceridine) injection with China NMPA. As per Thursday’s announcement, China’s National Medical Products Administrations (NMPA) has accepted the NDA submission.

    Oliceridine is a novel IV analgesic approved by the U.S. FDA for acute pain management in adults.

    Moreover, the NDA submission was based on data from two clinical bridging trials of OLINVYK in Chinese patients. The trials were designed to evaluate the safety profile, pharmacokinetics, and analgesic efficacy of OLINVYK.

    In 2018, the company entered into an exclusive license with Nhwa for the development and commercialization of OLINVYK in China.

    TRVN’s 2022 Participations

    So far in 2022, the company’s President & CEO, Carrie Bourdow, and CFO, Barry Shin have participated in three conferences.

    Firstly, LifeSci Partners 11th Annual Corporate Access Event & Panel Discussion from January 5-7, 2022.

    Secondly, H.C. Wainwright BioConnect Virtual Conference from January 10-12, 2022.

    Finally, BIO Partnering at JPM from January 10 to January 13, 2022.

    TRV045 Clinical Development

    On December 13, the TRVN announced the commencement of clinical development of TRV045. Following the FDA’s green signal, the company plans to commence A THREE-APRT Phase 1 MAD, food effect, and MAD trial. Furthermore, the study will evaluate the safety and tolerability of TRV045 along with its pharmacokinetics.

    TRV045 is under development as a potential treatment for diabetic neuropathic pain (DNP).

    In addition, the company is also assessing TRV045 for epilepsy under collaboration with the National Institute of Health.

    TRVN’s Financials

    In Q3 2021, the company incurred a net loss of $13.9 million ($0.08/share) against $5.6 million ($0.04/share) in Q3 of 2020.

    Additionally, TRVN ended the third quarter of 2021, with cash and cash equivalents of $78.6 million on September 30, 2021.

  • Travena, Inc. (TRVN) Stock Exhibits Minor Volatility Following First Patient Enrolment in ACTIV-4 Host Tissue Trial

    Travena, Inc. (TRVN) Stock Exhibits Minor Volatility Following First Patient Enrolment in ACTIV-4 Host Tissue Trial

    Travena, Inc. (TRVN) stock prices were down 3.24% shortly after market trading commenced on July 27th, 2021, bringing the price per share down to USD$1.3464.

    First Patient Enrolment

    July 26th, 2021 saw TRVN stock announce the enrollment of its first patient in the ACTIV-4 Host Tissue (Accelerating Covid-19 Therapeutic Interventions and Vaccines) trial. With the end of Covid-19 requiring a multi-pronged solution, TRVN stock is excited to be developing TRV027 as a pioneering active treatment arm available for patient randomization.

    ACTIV-4 Host Tissue Trial

    The ACTIV-4 Host Tissue trial serves to evaluate four investigational agents that fight dysregulation of the renin-angiotensin-aldosterone system (RAAS) and immune system irregularities caused by Covid-19 infections. The treatment is a novel AT1 receptor selective agonist that targets the AT1 receptor to bind to within the RAAS, thereby obstructing the damaging pathway that results in acute lung damage and abnormal blood clotting. TRVN stock’s treatment activates the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.

    TRVN Stock’s Efforts Against Pandemic

    More than 1600 patients will be enrolled across 50 sites spanning the United States for the TRVN stock’s trial. TRV027 is part of the initial trial launch, with additional study arms being added to the trial over time. The study will serve to evaluate the impact of each intervention on recovery, supplemental oxygen use, need for mechanical ventilation, organ failure, and mortality. As the global Covid-19 pandemic continues to devastate the globe, the development of interventions remains a top priority, aiming to combat the vascular, fibrotic, and inflammatory damage done by the virus.

    About the Trial

    The ACTIV-4 Host Tissue is a multi-site, randomized, placebo-controlled clinical trial with multiple treatment arms. Each arm is expected to enroll roughly 300-400 Covid-19 patients that are 18 years of age or older. The four trial arms will test investigational agents that target the RAAS or immune system through distinct mechanisms of action. The trial is designed for TRVN stock to determine whether modulation of these systems is a viable solution to preventing progression to critical illness in hospitalized Covid-19 patients.

    Future Outlook for TRVN Stock

    Armed with the initiation of patient testing in its ACTIV-4 Host Tissue trial, TRVN stock is poised to capitalize on the opportunities afforded to it. The company is keen to leverage the resources at its disposal to usher in significant long-term growth, which investors hope will translate into gains in shareholder value.

  • How Has The Trevena (TRVN) Stock Declined 13% In Extended Trades?

    How Has The Trevena (TRVN) Stock Declined 13% In Extended Trades?

    In after-hours trading, shares of Trevena Inc. (TRVN) were down -12.76% on Friday. The stock closed the previous trading session up 2.62% or $0.05 at $1.96. The stock fluctuated between $1.93 and $2.00 throughout the day. A total of 22.49 million shares were exchanged, more than TRVN’s 50-day volume of 3.41 million as well as its year-to-date volume of 3.46 million.

    The TRVN stock has lost 13.95 percent in the past 12 months, and in the last week the stock has gained 2.62%. A total of -20.33 % has been lost by TRVN stock over the last six months, and 7.10 % has been gained over the last three months. The TRVN stock price is down by 8.41% this year. In response to the reinstatement of patient recruitment for one of its studies, TRVN stock rose.

    In what study did TRVN take part?

    Trevena specializes in developing and commercializing treatments for patients with disorders of the central nervous system. A TRVN product, OLINVYK (oliceridine) injection, is approved in the United States for the treatment of adults who have acute pain severe enough to require intravenous opioid analgesic therapy and for whom alternative treatments are ineffective.

    TRRVN’s novel pipeline includes four investigational drug candidates that are the result of Nobel Prize-winning research. TRV027 is used to treat acute respiratory distress syndrome, abnormal blood clotting, and COVID-19-related symptoms; TRV734 treats opioid use disorder; TRV250 treats migraines and TRV045 treats epilepsy.

    Trevena announced recently that NIDA has reopened enrollment for its TRV734 prospective patient study, which tests the new mu opioid receptor selective agonist.

    • As part of TRVN’s ongoing collaboration with NIDA, TRV734 is being evaluated as potential maintenance therapy for opioid use disorder (OUD).
    • As a result of the global COVID-19 pandemic in March 2020, TRVN has paused its study.
    • In spite of COVID-19, opioid use disorder (OUD) is still a public health emergency.
    • TRVN believes it is important to continue developing effective treatments for patients suffering from opioid addiction.
    • By resuming their TRV734 study, NIDA emphasizes the unmet need for treatments for OUD, as TRV734 may be an effective treatment option with improved tolerability.
    • NIH and TRVN will join forces to explore a number of its pipeline assets as part of this collaboration.
    • This study aims to enroll approximately 50 opioid-dependent people undergoing stable methadone maintenance therapy in a double-blind, placebo- and positive-controlled study.
    • Using the Clinical Opioid Withdrawal Scale, this study will also evaluate whether TRVN’s TRV734 suppresses withdrawal symptoms.

    How the TRVN candidate will be evaluated?

    TRV734 will be the third Trevena (TRVN) investigational drug product being studied by NIDA. According to the Subjective Opioid Withdrawal Scale, the primary outcome is a reduction in withdrawal symptoms through TRVN drug. Additionally, secondary outcomes will include an assessment of safety, tolerability, and measure of changes in neurocognitive function of TRVN candidate.

  • Why Is Trevena (TRVN) Stock Up in Pre-Hour Trades?

    Why Is Trevena (TRVN) Stock Up in Pre-Hour Trades?

    The shares of Trevena Inc. (TRVN) were up 6.44% in premarket trading at $2.15. TRVN stock closed at $2.02 yesterday, down -8.18% or $0.18. TRVN stock fluctuated between $2.01 and $2.18 on the day.

    TRVN stock traded at 2.63 million shares, less than the company’s average daily volume of 3.22 million during its 50-day period. On the resumption of patient recruitment by the NIH, TRVN stock jumped.

    Why were patients recruited?

    Trevena focuses on the development and commercialization of innovative drugs for patients with diseases related to the central nervous system (CNS). OLINVYK (oliceridine) injection is TRVN’s only U.S.-approved product. As an opioid analgesic, OLINVYK has been indicated in the treatment of acute pain in adults who are unable to be managed using alternative treatments.

    As announced by Trevena today, NIDA is once again recruiting patients for TRV734, the Company’s novel mu-opioid receptor selective agonist.

    • TRVN has been collaborating with NIDA to evaluate TRV734 as a potential treatment for opioid use disorder (OUD).
    • The TRVN study was halted in March 2020 due to the global COVID-19 pandemic.
    • Despite COVID-19, opioid use disorder is an urgent public health issue that must be addressed.
    • In order to meet the needs of opioid addicted individuals, it is important to continue to develop effective treatments.

    TRN plans to go further:

    NIDA’s willingness to re-open the TRV734 study, which may present a treatment option that is effective and more tolerable than the current recommendations, demonstrates the unmet need for OUD medicines. Trevena (TRVN) will leverage this collaboration to explore several pipeline assets in the NIH.