Rapastinel

Gate Neurosciences Publishes Data Highlighting Novel Mechanism of Lead Rapid-Acting Oral Antidepressant and Provides Business Update

Retrieved on: 
Thursday, September 29, 2022

Publication highlights robust preclinical profile and novel mechanism for lead Phase 2 clinical program, Zelquistinel

Key Points: 
  • Publication highlights robust preclinical profile and novel mechanism for lead Phase 2 clinical program, Zelquistinel
    The peer-reviewed manuscript spotlights Zelquistinels novel mechanism and pharmacology by which it elicits rapid and long-lasting antidepressant effects.
  • These data highlight Zelquistinels novel, potent, and highly differentiated mechanism of action with potential for a significantly improved safety profile compared to other NMDAR-targeted antidepressants in development for depressive disorders.
  • Published in several peer-reviewed journals highlighting novel NMDAR mechanism and antidepressant activity of lead programs.
  • Gate Neurosciences lead programs are highly differentiated from other NMDAR-targeted antidepressants by acting through positive modulation instead of antagonism.

Gate Neurosciences Emerges from Stealth with a Portfolio of Next-Generation Therapies for Central Nervous System Diseases

Retrieved on: 
Tuesday, August 23, 2022

Gate Neurosciences today announced it has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.

Key Points: 
  • Gate Neurosciences today announced it has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.
  • The company is focused on developing novel mechanisms that address synaptic dysfunction underlying neuropsychiatric and cognitive disorders, including major depressive disorder (MDD).
  • Gate will provide a strategic business update in the coming weeks that will provide additional information on its diverse development portfolio and major recent and upcoming milestones.
  • The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder (MDD).

Appaloosa Issues Statement Regarding Allergan’s Failed Anti-Depression Study

Retrieved on: 
Thursday, March 7, 2019

Appaloosa LP today issued a statement in response to Allergan plcs (NYSE: AGN) (Allergan) March 6, 2019 announcement that its drug, Rapastinel, failed a late stage study for treatment of major depressive disorder:

Key Points: 
  • Appaloosa LP today issued a statement in response to Allergan plcs (NYSE: AGN) (Allergan) March 6, 2019 announcement that its drug, Rapastinel, failed a late stage study for treatment of major depressive disorder:
    Yesterdays announcement that Allergans marquee pipeline drug, Rapastinel, had spectacularly failed its Phase III trials should make apparent to all that the Companys Open Science business model is broken.
  • The Boards misplaced fear of "disrupting" Allergan is wearing thin as an excuse for inaction and can only perpetuate further erosion in the shareholders investment.
  • Funds advised by Appaloosa LP (Appaloosa) have submitted to Allergan plc (Allergan) a shareholder proposal to separate the roles of Chairman and Chief Executive Officer to be considered at Allergans 2019 annual general meeting of shareholders.
  • This communication is not a solicitation of proxies and Appaloosa is not seeking authority to vote any proxy in connection with Allergans annual general meeting.

Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)

Retrieved on: 
Monday, July 23, 2018

DUBLIN, July 23, 2018 /PRNewswire/ --Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD).

Key Points: 
  • DUBLIN, July 23, 2018 /PRNewswire/ --Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD).
  • The Fast Track designation will allow Allergan to work more closely with the FDA to bring AGN-241751 to patients as soon as possible."
  • Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • Allergan acquired AGN-241751 as part of its ongoing research effort with Aptinyx, Inc.
    AGN-241751 development follows Rapastinel, which received FDA Fast Track Designation in 2014 and Breakthrough Designation from the FDA in 2016.