Trevena

Trevena Reports First Quarter 2024 Results and Provides Business Update

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星期三, 五月 15, 2024
Epilepsy, Patient, Seizure, Sale, Trevena, Neuropathic pain, MOA, CNS, Panel, Appeal, Chronic pain, Central nervous system, Pain, NIH, Pharmaceutical industry

CHESTERBROOK, Pa., May 15, 2024 (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, 2024 and provided an overview of its recent operational highlights.

Key Points: 
  • TRV045 previously demonstrated positive results in two proof-of-concept studies, supporting further study in patients suffering from neuropathic pain and epilepsy.
  • Data from this clinical PK study, as well as the ongoing reproductive and sub-chronic toxicology studies are expected in 2H 2024.
  • For the first quarter of 2024, the Company reported a net loss attributable to common stockholders of $7.7 million, or $0.36 per share, compared to $7.8 million, or $0.81 per share in the first quarter of 2023.
  • Cash and cash equivalents were $23.6 million as of March 31, 2024.

Trevena Reports Fourth Quarter 2023 Results and Provides Corporate Update

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星期一, 四月 1, 2024
Blood pressure, EEG, Epilepsy, Bradycardia, Trevena, Rat, Neuropathic pain, Seizure, Central nervous system, Patient, CNS, TMS, Hospital, Sale, Chronic pain, NIH, IND, POC, Safety, Astrocyte, Status epilepticus, Neuroinflammation, Pharmaceutical industry

CHESTERBROOK, Pa., April 01, 2024 (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 fourth quarter ended December 31, 2023 and provided an overview of its recent operational highlights.

Key Points: 
  • Given performance to date, we are reducing commercial support and reviewing alternatives for OLINVYK to preserve capital,” said Carrie Bourdow, President and CEO of Trevena.
  • OLINVYK will remain available for purchase by customers, who can continue to order the product through their normal channels.
  • In a review of safety and tolerability across both studies, TRV045 was well tolerated with results generally consistent with prior first-in-human studies.
  • For the fourth quarter of 2023, the Company reported a net loss attributable to common stockholders of $16.5 million, or $1.06 per share, compared to $7.0 million, or $0.73 per share in the fourth quarter of 2022.

Trevena Announces TRV045 Presentation at the American College of Neuropsychopharmacology 62nd Annual Meeting

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星期一, 十二月 4, 2023
Epilepsy, Pain, Disease, Chemotherapy, Chemotherapy-induced peripheral neuropathy, CIPN, Trevena, Neuropathic pain, Central nervous system disease, CNS, Bangladesh Technical Education Board, Poster, American College, Single, NIH, Patient, Central nervous system, Senior, Vaccine

CHESTERBROOK, Pa., Dec. 04, 2023 (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 a poster presentation at the 62nd Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference is being held from December 3rd to 6th, 2023.

Key Points: 
  • CHESTERBROOK, Pa., Dec. 04, 2023 (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 a poster presentation at the 62nd Annual Meeting for the American College of Neuropsychopharmacology (ACNP).
  • The poster discussed the potential utility of TRV045 for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) using an established nonclinical model.
  • CIPN is a nerve-damaging side effect of antineoplastic agents and occurs in approximately 70% of oncology patients undergoing chemotherapy.
  • Oral administration of TRV045 reduced mechanical and cold stimulus-evoked nociception in a dose-related manner in a mouse model of CIPN.

Trevena Announces Acceptance of Abstract Examining the Use of OLINVYK in Patients with Acute Burn Injuries

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星期四, 十一月 30, 2023
Patient, Doctor of Pharmacy, IRB, ABA, Trevena, CNS, Burn, Severity, Prospective, Central nervous system, Safety, Oliceridine, Senior

Dr. Hill was independently responsible for the development and submission of the abstract.

Key Points: 
  • Dr. Hill was independently responsible for the development and submission of the abstract.
  • The single-center, prospective, case-controlled study was dual IRB approved and included 10 patients with burn injuries admitted between April and September 2023 and treated with OLINVYK.
  • Patients dosed with OLINVYK were compared to a matched historical control group (N=18) which included treatment across a range of other IV opioids.
  • “We look forward to the presentation of these data in the spring.”
    Financial support and study drug for the trial was provided by Trevena.

Trevena Reports Third Quarter 2023 Results and Provides Business Update

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星期二, 十一月 14, 2023
CNS, Sale, Webcast, TMS, POC, Senior, University, Pain, Plasma, Rheumatology, Cleveland Clinic, Patient, Transcranial magnetic stimulation, Psychiatry, Trevena, ARTEMIS, NIH, Epilepsy, Abstract, EEG, S1P, ASA, Central nervous system, Chronic pain, Alertness, Neuropathic pain, Pharmaceutical industry, Medicine, Anesthesiology

ET

Key Points: 
  • ET
    CHESTERBROOK, Pa., Nov. 14, 2023 (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 third quarter ended September 30, 2023 and provided an overview of its recent operational highlights.
  • “There is a significant need for safe and effective non-opioid therapies in pain, and for novel mechanisms for the treatment of epilepsy.
  • The Company previously announced preliminary topline data from two Phase 1 proof-of-concept studies evaluating S1PR mechanism of action and CNS target engagement.
  • As part of the R-Bridge Financing, Trevena may receive an additional $10 million upon achievement of either a commercial or financing milestone.

Trevena to Release Third Quarter 2023 Financial Results on November 14, 2023

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星期四, 十一月 9, 2023
Rheumatology, SVP, Chronic pain, Psychiatry, CNS, University, Trevena, Webcast, Patient, Central nervous system, Pharmaceutical industry, Management, Medicine, Anesthesiology

CHESTERBROOK, Pa., Nov. 09, 2023 (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 third quarter ended September 30, 2023, prior to the market open on Tuesday, November 14, 2023.

Key Points: 
  • CHESTERBROOK, Pa., Nov. 09, 2023 (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 third quarter ended September 30, 2023, prior to the market open on Tuesday, November 14, 2023.
  • The Company will host a conference call and webcast with the investment community at 8:00 a.m.
  • ET that same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, M.D., SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer.
  • In addition, Dan Clauw, M.D., Professor of Anesthesiology, Medicine (Rheumatology) and Psychiatry at the University of Michigan and Director of the Chronic Pain and Fatigue Research Center will join the call as well.

Trevena Reports Favorable TRV045 Topline Safety and Tolerability Data from Proof-of-Concept Studies

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星期一, 十月 16, 2023
TMS, ECG, Plasma, Headache, Central nervous system, Safety, Epilepsy, Trevena, Heart rate, Somnolence, EEG, POC, Lymphocytopenia, Fatigue, Dizziness, Blood pressure, Bradycardia, Neuropathic pain, S1P, QT interval, CNS, Patient, Pharmaceutical industry, Sewage treatment

CHESTERBROOK, Pa., Oct. 16, 2023 (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 topline safety and tolerability data for the two Phase 1 proof-of-concept (POC) studies of TRV045, a novel sphingosine-1 phosphate receptor modulator selective for the S1P receptor subtype 1.   

Key Points: 
  • Each subject received three different single doses of TRV045 (50mg, 150mg and 300mg) and placebo on four separate visits across the study duration.
  • Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.
  • This new safety and tolerability data in 50 subjects is generally consistent with, and further builds upon, the 89-subject data from the first-in-human study of TRV045 reported in November 2022.
  • “We are pleased to report additional safety and tolerability data which is consistent with what we have observed in prior datasets,” said Carrie Bourdow, President and CEO of Trevena.

Trevena Announces Completion of Initial Analysis of OLINVYK Continuous Respiratory Monitoring Data from VOLITION Study and Presentation at American Society of Anesthesiologists Conference

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星期一, 十月 2, 2023
Cognition, ASA, Abstract, Abstract (summary), BIO, Cleveland Clinic, Central nervous system, Atrium Health Wake Forest Baptist, Respiratory rate, Oxygen, Woman, Colectomy, Research, CNS, Șaeș, PCA, Patient, Hypoventilation, Disease, Heart rate, Cleveland, GI, Society, Morphine, Cryptocurrency, Pharmaceutical industry, Medical device, Trevena

CHESTERBROOK, Pa., Oct. 02, 2023 (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 completion of initial analysis of OLINVYK continuous respiratory monitoring data from the VOLITION study.

Key Points: 
  • The VOLITION study, a real-world, open-label, multi-site study, assessed the potential impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting.
  • “We are pleased to announce completion of the initial analysis of respiratory data from the ~200 patient VOLITION study generated at Cleveland Clinic and Wake Forest Baptist Health,“ said Carrie Bourdow, President and CEO of Trevena.
  • “We are excited to present these new results at the upcoming ASA meeting in October.”
    VOLITION Study Data, Including Continuous Respiratory Monitoring Analysis, to be Presented at ASA in San Francisco from October 13-17, 2023.
  • VOLITION is a real-world, open-label, multi-site, post-approval clinical outcomes study in 203 adult patients undergoing major non-cardiac surgery (197 patients with evaluable respiratory data).

Trevena Announces Receipt of $15 Million Non-Dilutive Tranche and Provides General Business Update

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星期三, 九月 6, 2023
Real-World Evidence, Seizure, ASA, Abstract (summary), Abstract, Cleveland Clinic, Central nervous system, Doctor of Pharmacy, Trevena Inc, Use, Senior, Delirium, Vomiting, TMS, Trevena, American Society of Anesthesiologists, Spasm, Research, CNS, Sale, Conference call, Patient, Webcast, Pain, Society, Conference, Receptor, Rare-earth element, Cryptocurrency, Pharmaceutical industry

This tranche of funding was triggered by the first commercial sale of OLINVYK in China by Jiangsu Nhwa, the Company’s licensee in China.

Key Points: 
  • This tranche of funding was triggered by the first commercial sale of OLINVYK in China by Jiangsu Nhwa, the Company’s licensee in China.
  • The $15 million tranche is in addition to the $28.1 million of cash and cash equivalents the Company previously reported as of June 30, 2023.
  • As part of the R-Bridge Financing, Trevena may receive an additional $10 million upon achievement of either a commercial or financing milestone.
  • Trevena expects to report new respiratory data from the study using continuous respiratory monitoring in 3Q 2023.

Trevena Reports Second Quarter 2023 Results and Provides Business Update

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星期一, 八月 14, 2023
Epilepsy, Male, Cleveland Clinic, Central nervous system, Delirium, ARTEMIS, TMS, Atrium Health Wake Forest Baptist, EMR, Trevena, EMG, Campbell R. Bridges, PACU, CNS, Electronic health record, Pain, Patient, EEG, Cleveland, IND, S1P, Transcranial magnetic stimulation, Cryptocurrency, Pharmaceutical industry, Q3

We look forward to updating you as these developments occur.”

Key Points: 
  • We look forward to updating you as these developments occur.”
    Two TRV045 proof-of-concept studies near completion, exploring the potential for use in epilepsy and pain.
  • New respiratory data from ~200 patient VOLITION real-world outcomes study using continuous respiratory monitoring expected 3Q 2023.
  • For the second quarter of 2023, the Company reported net revenue of $3.0 million, and a net loss attributable to common stockholders of $8.0 million, or $0.69 per share, compared to $15.0 million, or $2.26 per share in the second quarter of 2022.
  • This cash balance does not include a $15 million non-dilutive tranche from the R-Bridge Financing that the Company anticipates receiving in the third quarter of 2023.