Antidepressants

DGAP-News: PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Retrieved on: 
Tuesday, October 6, 2020

PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.

Key Points: 
  • PAION REPORTS PROGRESS WITH BYFAVO (REMIMAZOLAM) BY ITS LICENSEE ACACIA IN THE U.S.
  • Scheduling by DEA represents the final requirement for BYFAVO(TM) to be marketed in the U.S., with launch expected by the end of 2020.
  • Our first product, BARHEMSYS(R) (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales.
  • The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

FDA Grants Organicell Expanded Access to Treat COVID-19 Patients with Zofin™

Retrieved on: 
Tuesday, September 29, 2020

Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDAs approved expanded access program.

Key Points: 
  • Aside from Convalescent Plasma, Zofin, is the first reported acellular therapy which can be accessed under FDAs approved expanded access program.
  • Zofin is manufactured to retain naturally occurring microRNAs, without the addition of any other substance or diluent.
  • This recent FDA approval follows the treatment of six outpatients treated under emergency INDs, who have reported significant improvement after being treated with Zofin.
  • Organicell is currently in the process of enrolling moderate to severe COVID-19 patients for a Phase I/II placebo controlled clinical trial (NCT04384445) to evaluate the safety and potential efficacy of Zofin.

Concert Pharmaceuticals Completes Enrollment in CTP-692 Phase 2 Trial in Patients with Schizophrenia

Retrieved on: 
Tuesday, September 29, 2020

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has completed patient enrollment of its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia.

Key Points: 
  • Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that it has completed patient enrollment of its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia.
  • Maintaining the integrity of our trial has been a top priority, and were grateful to the study sites and patients for enabling us to complete enrollment and keep the study progressing forward despite the impact of COVID19.
  • The double-blind, randomized, placebo-controlled Phase 2 trial is designed to evaluate the safety and efficacy of CTP-692 as an adjunctive treatment in adult patients with schizophrenia.
  • However, deficient glutamatergic neurotransmission mediated by the NMDA receptor is believed to be another underlying cause of schizophrenia.

LB Pharmaceuticals Inc Secures $10.0 Million in Additional Financing

Retrieved on: 
Friday, September 25, 2020

LB Pharmaceuticals Inc, a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the closing of a $10.0 million convertible note offering through a private placement to existing and new investors.

Key Points: 
  • LB Pharmaceuticals Inc, a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the closing of a $10.0 million convertible note offering through a private placement to existing and new investors.
  • The notes are structured to convert into equity as part of the Companys Series B financing.
  • Proceeds from this convertible note financing will support continued clinical development of the Companys lead asset, LB-102.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.

LB Pharmaceuticals Inc Announces Results of LB-102 Phase 1 First-in-Human Clinical Study

Retrieved on: 
Monday, September 14, 2020

LB Pharmaceuticals Inc, (LB, or the Company), a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the results of a Phase 1 clinical study of LB-102 ( NCT04187560 ), a novel derivative of amisulpride designed to treat schizophrenia.

Key Points: 
  • LB Pharmaceuticals Inc, (LB, or the Company), a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, today announced the results of a Phase 1 clinical study of LB-102 ( NCT04187560 ), a novel derivative of amisulpride designed to treat schizophrenia.
  • The data from our Phase 1 study suggest that we are on the right track.
  • Were looking forward to following up with a PET study later this year to directly measure dopamine receptor occupancy in a clinical study.
  • Data from this study that will help us determine dose levels for the Phase 2 clinical study in schizophrenia patients that were planning for 2021.

Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress

Retrieved on: 
Thursday, September 10, 2020

AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist.

Key Points: 
  • AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist and sigma-1 receptor agonist.
  • AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder, Alzheimers disease agitation, and other central nervous system (CNS) disorders.
  • For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as a treatment for smoking cessation.

Prevail Therapeutics Announces Appointment of William H. Carson, M.D., to Board of Directors

Retrieved on: 
Thursday, September 10, 2020

Dr. Carson joined Otsuka as Vice President of the Princeton Aripiprazole Unit in 2002, establishing the companys presence there.

Key Points: 
  • Dr. Carson joined Otsuka as Vice President of the Princeton Aripiprazole Unit in 2002, establishing the companys presence there.
  • Before joining Otsuka, he rose through the ranks in the CNS Research and Development department at Bristol-Myers Squibb.
  • He is Board Chair Emeritus of the Sphinx Organization, which advocates for parity and inclusion in the arts.
  • Dr. Carson is an outstanding and important addition to our Board of Directors, said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail.

Minerva Neurosciences to Present at H.C. Wainwright 22nd Annual Global Investment Conference

Retrieved on: 
Wednesday, September 9, 2020

WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 at 10:00 a.m. Eastern Time.

Key Points: 
  • WALTHAM, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system (CNS) disorders, today announced that it will participate in the virtual H.C. Wainwright 22nd Annual Global Investment Conference on September 16, 2020 at 10:00 a.m. Eastern Time.
  • The presentation will be webcast and accessible on a live and archived basis through the investor relations section of the Companys web site, http://ir.minervaneurosciences.com .
  • Minervas portfolio of compounds includes: roluperidone (MIN-101), in clinical development for schizophrenia; a potential royalty stream from seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinsons disease.
  • Minervas common stock is listed on the NASDAQ Global Market under the symbol NERV.For more information, please visit www.minervaneurosciences.com .

Axsome Therapeutics to Present at the Morgan Stanley 18th Annual Global Healthcare Conference

Retrieved on: 
Tuesday, September 8, 2020

Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options.

Key Points: 
  • Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options.
  • For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines.
  • Axsomes core CNS product candidate portfolio includes five clinical-stage candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as a treatment for smoking cessation.

Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting

Retrieved on: 
Monday, August 31, 2020

In June 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-05 for the treatment of AD agitation, the second Breakthrough Therapy designation received by Axsome for AXS-05.

Key Points: 
  • In June 2020, Axsome received Breakthrough Therapy designation from the FDA for AXS-05 for the treatment of AD agitation, the second Breakthrough Therapy designation received by Axsome for AXS-05.
  • Breakthrough Therapy designation is granted by the FDA in order to expedite the development and review of drugs for serious or life-threatening conditions.
  • Alzheimers disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline, and behavioral and psychological symptoms including agitation.
  • AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimers disease (AD) agitation, and as treatment for smoking cessation.