AISRS

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Central nervous system, Topiramate, Investigational New Drug, PD, Total, New Drug Application, FDA, Food, Growth, PDUFA, Safety, GAAP, CNS, Depreciation, IQVIA, Patient, AISRS, Attention deficit hyperactivity disorder, DSM-IV codes, ADHD, Phase, MDD, Prescription, MADRS, Pharmaceutical industry

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points: 
  • Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
  • Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
  • Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
  • ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Cingulate Inc. Reports Third Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Monday, November 13, 2023
WFIA, Safety, Exercise, Psych, Patient, ADHD, Series, Cingulata, Dietary supplement, Security (finance), Adult, AISRS

KANSAS CITY, Kan., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended September 30, 2023, as well as a clinical and business update.

Key Points: 
  • If results from this study are successful, pivotal Phase 3 clinical trials in all patient segments for CTx-1302 are expected to begin in 2025.
  • Cash Position: As of September 30, 2023, Cingulate had $2.0 million in cash and cash equivalents.
  • Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures through mid-November 2023.
  • Net loss was $16.6 million for the nine months ended September 30, 2023, compared to $13.0 million for the same period in 2022.

MindMed Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Neurology, Other Health, Health, Clinical Trials, Week, Spectrum, AISRS, Congress, Prevalence, G&A, Telephone, Finance, University Hospital of Basel, Volunteering, Research, Pharmacokinetics, Growth, Attention deficit hyperactivity disorder predominantly inattentive, Clinical trial, Medicine, ECNP, Webcast, Research and development, Anticipation, European College of Neuropsychopharmacology, USD, GAD, NEO, UHB, ASD, MindMed, Patient, Administration, ADHD, Pharmaceutical industry, Birth control, Dietary supplement, Vaccine, Cryptocurrency, R

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2023.

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2023.
  • Dosing is complete with topline results for the primary endpoint (Week 4) expected to be announced in Q4 2023.
  • R&D expenses were $13.2 million for the quarter ended September 30, 2023, compared to $7.8 million for the quarter ended September 30, 2022, an increase of $5.4 million.
  • MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s third quarter 2023 financial results.

MindMed Completes Enrollment of Phase 2a Trial of MM-120 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)

Retrieved on: 
Tuesday, October 24, 2023
Health, Neurology, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, AISRS, Safety, NEO, MindMed, Medicine, ADHD, Pharmaceutical industry, Dietary supplement

“We are pleased to announce the completion of enrollment of our Phase 2a study in adults with ADHD,” said Robert Barrow, Chief Executive Officer and Director of MindMed.

Key Points: 
  • “We are pleased to announce the completion of enrollment of our Phase 2a study in adults with ADHD,” said Robert Barrow, Chief Executive Officer and Director of MindMed.
  • “This proof-of-concept trial is designed to evaluate the clinical effects of a sub-perceptual dose of MM-120 administered in a repeated fashion.
  • The study's results will inform our ongoing work to establish new clinical paradigms for this promising drug candidate.
  • Key secondary objectives, measured up to 10 weeks after the initial dose, include assessments of ADHD symptom severity, as well as safety and tolerability.

Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms

Retrieved on: 
Sunday, September 10, 2023
Blood pressure, Psych, MAOI, Fatigue, Research and development, Central nervous system, Depression, Senior, AE, Mania, State University of New York Upstate Medical University, Xerostomia, Aes, ADHD, Trae tha Truth, Constipation, Medicine, Appetite, CNS, OLE, AISRS, Vomiting, Administration, Insomnia, Vital signs, Patient, Child, Boxed warning, Psychiatry, Theophylline, Nausea, Somnolence, Behavioral medicine, Heart rate, Upper respiratory tract infection, FDA, Headache, Function (mathematics), Irritability, Bipolar disorder, Food, Safety, Dietary supplement, Birth control, Pharmaceutical industry, Copper, Residential care, Viloxazine

Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.

Key Points: 
  • Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant.
  • “These data demonstrate Qelbree’s ability to enhance efficacy when co-administered with stimulants, including significant improvement during evening hours when the effects of stimulants often wear off following their morning dose.
  • Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54).
  • Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9 (13.48).

Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on: 
Tuesday, July 11, 2023
Meta-analysis, Cingulata, Doctor of Pharmacy, New Drug Application, ADHD, NDA, Clinical Global Impression, Faraone, AISRS, Attention deficit hyperactivity disorder predominantly inattentive, Patient, Physician, Behavioral medicine, Psychiatry, Clutch (eggs), Adolescence, CGI, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Precision Time Protocol Industry Profile, Food, Safety, Dietary supplement, Pharmaceutical industry

Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.

Key Points: 
  • Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.
  • After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo.
  • In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023.
  • Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.

Axsome Therapeutics Initiates FOCUS Phase 3 Trial of Solriamfetol for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Retrieved on: 
Friday, July 7, 2023
FOCUS, ADHD, Attention deficit hyperactivity disorder, Central nervous system, Therapy, Patient, Forward, Safety, CNS, AISRS, Pharmaceutical industry, Dietary supplement

NEW YORK, July 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has dosed the first patient in the FOCUS Phase 3 trial of solriamfetol, an investigational treatment for attention deficit hyperactivity disorder (ADHD) in adults.

Key Points: 
  • NEW YORK, July 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has dosed the first patient in the FOCUS Phase 3 trial of solriamfetol, an investigational treatment for attention deficit hyperactivity disorder (ADHD) in adults.
  • FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults.
  • Approximately 450 patients will be randomized in a 1:1:1 ratio to receive solriamfetol (150 mg or 300 mg) or placebo for 6 weeks.
  • The primary endpoint will be change in the Adult ADHD Investigator Symptom Report Scale (AISRS).