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Zymeworks Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 6, 2024

Financial Results for the Year Ended December 31, 2023

Key Points: 
  • Financial Results for the Year Ended December 31, 2023
    Revenue was $76.0 million in 2023 compared to $412.5 million in 2022.
  • Higher interest income in 2023 was due to income earned on higher cash resources and at higher rates of return in 2023.
  • “We are happy to report a continued reduction of our operating cash burn and operating losses during 2023 compared to 2022,” said Chris Astle, Ph.D., Senior Vice President and Chief Financial Officer of Zymeworks.
  • Reconciliations between historical GAAP and non-GAAP information are contained at the end of this press release following the accompanying financial data.

Alumis Presents Preclinical Data for Allosteric TYK2 Inhibitor A-005 at ACTRIMS

Retrieved on: 
Friday, March 1, 2024

SOUTH SAN FRANCISCO, Calif., March 01, 2024 (GLOBE NEWSWIRE) -- Alumis Inc., a clinical-stage biopharmaceutical company developing oral therapies using a precision approach to transform the lives of patients with immune-mediated diseases, today announced preclinical data for A-005 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) forum. A-005 is a potential first-in-class, brain penetrant tyrosine kinase 2 (TYK2) inhibitor being developed for the treatment of multiple sclerosis (MS), Parkinson’s Disease and other neuroinflammatory and neurodegenerative diseases, with Phase I clinical trial initiation planned in the first half of 2024.

Key Points: 
  • “Therapeutic inhibition of TYK2 has been clinically validated to treat immune-mediated diseases, but there remains a medical need for the clinical development of an allosteric TYK2 inhibitor targeting the central nervous system,” said David Goldstein, Ph.D., Chief Scientific Officer, Alumis.
  • Presented as a poster, results demonstrated A-005 to be highly potent and inhibit TYK2 pathway activation in human whole blood, PBMCs and microglial cells.
  • The data also underscored the ability of A-005 to reduce EAE clinical scores when administered prophylactically or therapeutically.
  • Data are being presented during ACTRIMS 2024 Poster Session 2 on March 1, 2024, from 6:00-7:30 pm ET, Poster Number 400.

GH Research Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, February 29, 2024

DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.

Key Points: 
  • DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.
  • As announced in November 2023, both trials were recruiting slower than anticipated, in part due to the closure, for business reasons, of one of the two sites activated in each trial.
  • Subsequently, we have implemented measures to strengthen recruitment of both trials, including the addition of further clinical trial sites.
  • For the trial in patients with PPD (GH001-PPD-203), we now expect completion and availability of top-line data in the third quarter of 2024.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Avenue Therapeutics Announces Publication in Drug Development Research Highlighting First-In-Class Preclinical Data of BAER-101 in a Translational Model of Absence Epilepsy

Retrieved on: 
Thursday, February 22, 2024

MIAMI, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence Epilepsy Rats from Strasbourg (“GAERS”) model of absence epilepsy.

Key Points: 
  • MIAMI, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the publication of preclinical in vivo data in Drug Development Research highlighting BAER-101’s full suppression of seizure activity using the Genetic Absence Epilepsy Rats from Strasbourg (“GAERS”) model of absence epilepsy.
  • The publication describes the extent of anti-seizure activity of BAER-101 in the GAERS model, a widely used and translationally relevant animal model.
  • The study demonstrated full suppression of seizure activity with a minimal effective dose (MED) of 0.3 mg/kg.
  • “The preclinical data published in Drug Development Research demonstrate BAER-101’s ability to fully suppress seizures in the GAERS model, a translational animal model for anti-seizure drug development with a documented high predictability of response in humans.

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Retrieved on: 
Tuesday, March 12, 2024

Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Key Points: 


Herbal medicinal product: Foeniculi dulcis fructusArray, F: Assessment finalised

Herbal medicinal product: Avenae herbaArray, C: ongoing call for scientific data

Retrieved on: 
Tuesday, March 12, 2024

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of oat herb.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing oat herb.
  • Herbal medicines containing these oat herb preparations are usually available in solid or liquid forms to be taken by mouth or as herbal tea to be drunk.
  • Oat herb preparations may also be found in combination with other herbal substances in some herbal medicines.

Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic®/Wegovy® and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio

Retrieved on: 
Wednesday, February 28, 2024

NPM-119 has previously demonstrated pharmacokinetic data exhibiting continuous and therapeutic exenatide exposure levels over a six-month duration in healthy rats.

Key Points: 
  • NPM-119 has previously demonstrated pharmacokinetic data exhibiting continuous and therapeutic exenatide exposure levels over a six-month duration in healthy rats.
  • These preclinical data provide further evidence that the weight loss potential of exenatide treatment in humans may be comparable to other GLP-1 molecules such as semaglutide assuming adequate exposure levels are achieved and maintained.
  • NPM-115 is planned to maximize exenatide’s weight loss effect in humans, pending further development and regulatory clearance, by evaluating exenatide exposure levels higher than previously explored.
  • Dr. Mendelsohn will present study results on May 17 at the TIDES USA 2024 conference in Boston.

Gabather reports initial positive results from the EEG/fMRI target engagement study

Retrieved on: 
Thursday, March 7, 2024

STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

Key Points: 
  • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
  • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
  • The secondary objective to demonstrate target engagement in human brain was also met.
  • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

Gabather reports initial positive results from the EEG/fMRI target engagement study

Retrieved on: 
Thursday, March 7, 2024

STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

Key Points: 
  • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
  • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
  • The secondary objective to demonstrate target engagement in human brain was also met.
  • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.