MDD

Supernus Announces Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023
Adjustment, Topiramate, FDA, MADRS, New Drug Application, IND, PD, PDUFA, MDD, DSM-IV codes, Investigational New Drug, Research and development, GAAP, CNS, R, Phase, Prescription, Parkinson's disease, Depreciation, APOKYN, NDA, Safety, Psych, Patient, IQVIA, ADHD, Central nervous system, Attention deficit hyperactivity disorder predominantly inattentive, Video game, Medical device, Pharmaceutical industry, Cryptocurrency, Viloxazine

Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022

Key Points: 
  • Total revenues (GAAP) of $153.9 million in the third quarter of 2023; total revenues excluding Trokendi XR® net product sales (non-GAAP)(2), increased by 24% in the third quarter of 2023, compared to the same period in 2022
    Qelbree® net product sales of $37.1 million in the third quarter of 2023, a 103% increase compared to the third quarter of 2022 and a 20% increase compared to the second quarter of 2023
    GOCOVRI® net product sales of $32.9 million in the third quarter of 2023, an 18% increase compared to the third quarter of 2022 and a 14% increase compared to the second quarter of 2023
    Operating earnings (GAAP) of $8.1 million in the third quarter of 2023, compared to an operating loss (GAAP) of ($1.5) million in the third quarter of 2022
    Adjusted operating earnings (non-GAAP) of $37.3 million in the third quarter of 2023, an increase of 47% compared to the third quarter of 2022
    SPN-830 (apomorphine infusion device) NDA resubmission accepted for review by FDA; PDUFA date of April 5, 2024
    ROCKVILLE, Md., Nov. 08, 2023 (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 third quarter of 2023, and associated Company developments.
  • “Our third-quarter performance underscores the strength of our growth products, with combined Qelbree and GOCOVRI net product sales increasing 52% in the third quarter of 2023 compared to the same period last year,” said Jack Khattar, President and CEO of Supernus.
  • Qelbree continues to expand its base of prescribers, with approximately 24,189 prescribers in the third quarter of 2023, up from 21,291 prescribers in the second quarter of 2023.
  • A reconciliation of the full year 2023 financial guidance for Operating Loss (GAAP) to Adjusted Operating Earnings (non-GAAP) is included under the heading “Full Year 2023 Financial Guidance – GAAP to Non-GAAP Adjustments.”
    The Company hosted a successful Research & Development (R&D) Day in October 2023 highlighting clinical and R&D progress and its emerging pipeline of novel CNS product candidates.

Xenon Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
Research, MADRS, Ageing, MDD, DBP, DSM-IV codes, Icahn School of Medicine at Mount Sinai, Neurocrine, Neurocrine Biosciences, JAMA Neurology, OLE, MPC, Mount Sinai, SCN8A, Webcast, Seizure, FOS, Safety, Epilepsy, Generalized tonic–clonic seizure, Patient, Grammatical mood, Pharmaceutical industry, Cryptocurrency, Xenon

VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • VANCOUVER, British Columbia, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.
  • Xenon anticipates that patient enrollment in X-TOLE2 will be completed in the second half of 2024.
  • Other income for the quarter ended September 30, 2023 was $7.1 million, compared to $0.4 million for the same period in 2022.
  • Xenon will host a conference call and webcast today at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss its third quarter 2023 results.

Real-World Evidence Confirms IDgenetix®-Guided Medication Management Significantly Improves Response and Remission Rates in Patients with Major Depressive Disorder

Retrieved on: 
Wednesday, November 8, 2023
Other Health, Pharmaceutical, Optical, Oncology, General Health, Mental Health, Medical Devices, Neurology, Genetics, Clinical Trials, Biotechnology, Science, Other Science, Research, Health, Medical Supplies, Real-World Evidence, NEI, MDD, Congress, Medication, RWE, RCT, Bradley, Poster, Major depressive disorder, Depression, Patient, Randomized controlled trial, Grammatical mood, DDI, Medical device

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a single-site, open-label study demonstrating the consistent impact of IDgenetix® on medication response and remission rates in patients with major depressive disorder (MDD).

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a single-site, open-label study demonstrating the consistent impact of IDgenetix® on medication response and remission rates in patients with major depressive disorder (MDD).
  • Compared to patients in the unguided group, response rates for the IDgenetix-guided participants improved by 37% in the RCT vs. 32% in the RWE.
  • Overall, comparing the clinical outcome results from the RCT with RWE demonstrated the consistent impact of IDgenetix on patient response and remission rates.
  • This study provides evidence-based research that supports the clinical use of IDgenetix to guide medication management in patients with MDD.

Gate Neurosciences Announces Positive Topline Human EEG Biomarker Results Demonstrating Dose-Dependent Target Activation in Phase 1 Study of Apimostinel

Retrieved on: 
Tuesday, November 7, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Pharmacology, Trial of the century, Phase II, MDD, Biomarker, IV, CSF, DSM-IV codes, Gate, Zelquistinel, Neuroscience, Medicine, Safety, Quantitative electroencephalography, NMDA, Patient, POC, Pharmaceutical industry, Vaccine, Apimostinel

Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.

Key Points: 
  • Gate Neurosciences , a clinical-stage biotechnology company using precision medicine approaches to develop next-generation neuroscience therapies, today announced positive topline qEEG biomarker and safety results from its Phase 1 multiple ascending dose study of apimostinel in healthy volunteers.
  • Results demonstrated a dose-dependent increase in qEEG pharmacodynamic biomarkers of NMDA receptor target activation from baseline, compared with subjects who received placebo.
  • Apimostinel was also generally well-tolerated with no ketamine-like dissociative side effects, highlighting its novel mechanistic approach of enhancing synaptic function.
  • Gate plans to initiate a Phase 2 study of zelquistinel to confirm efficacy in MDD in Q1 2024.

Autobahn Therapeutics Announces Positive Topline Results from Phase 1 Study of ABX-002, its Lead Oral Treatment for Major Depressive Disorder

Retrieved on: 
Tuesday, November 7, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Trial of the century, IND, PD, MDD, Food, DSM-IV codes, CNS, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, Development, Pharmacokinetics, Autobahn, PK, Biology, Safety, Vital signs, Therapy, TSH, Central nervous system, Pharmaceutical industry, Vaccine

ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).

Key Points: 
  • ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).
  • Results from the Phase 1 study:
    Across the range of doses tested, ABX-002 was safe and well-tolerated.
  • There were no serious adverse events and no premature discontinuations related to safety, with all 48 subjects completing the study.
  • “The positive data from this Phase 1 study represent a major milestone for ABX-002 and support its advancement into Phase 2 development,” said Kevin Finney, President and Chief Executive Officer of Autobahn Therapeutics.

Sage Therapeutics Announces Third Quarter 2023 Financial Results and Highlights Pipeline and Business Progress

Retrieved on: 
Tuesday, November 7, 2023
Research, Mental Health, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, Woman, AD, PD, Food, MCI, DSM-IV codes, European Medicines Agency, Deficit spending, CIV, GABAA, Risk, Schedule, Sale, Essential tremor, MDD, HD, Workforce, DEA, Acquisition, Webcast, EMA, Safety, Therapy, Patient, D, PPD, Plasma, Tremor, ODD, Zuranolone, Education, Incidence, PAM, Anxiety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NMDA, Diagnosis, Grammatical mood, Nursing, Pharmaceutical industry, Dietary supplement, Surveying, Elevator mechanic, Biogen, Sage

Sage Therapeutics, Inc. (Nasdaq: SAGE) today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Sage Therapeutics, Inc. (Nasdaq: SAGE) today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • ZURZUVAE is being developed and commercialized in collaboration with Biogen Inc. Sage also commercializes ZULRESSO® (brexanolone) CIV injection in the treatment of PPD.
  • Restructuring Expenses: Restructuring expenses were $33.6 million in the third quarter of 2023 due to the August 2023 corporate reorganization.
  • ET to review its third quarter 2023 financial results and discuss recent corporate updates.

Myriad Genetics Reports Third Quarter 2023 Financial Results; Generates Double-Digit Revenue Growth; Raises 2023 Revenue Guidance and Introduces 2024 Revenue Guidance

Retrieved on: 
Monday, November 6, 2023
PRS, UnitedHealth Group, Memorial Sloan Kettering Cancer Center, Cancer, Policy, ARR, Genetic testing, Patent, MDD, CDX, Radiation, Myriad Genetics, Family, Physician, DSM-IV codes, Genetics, Prostate cancer, MSK, GAAP, Research, ADT, Circulating tumor DNA, Metabolism, Meta-analysis, Ravgen, MRD, Women's health, Biopsy, Breast cancer, Risk assessment, Breast, Woman, Depression, ABL, Anxiety, Google Images, Attention deficit hyperactivity disorder, Neoplasm, Metastasis, DNA, Video game, Medical imaging, Pharmaceutical industry, Vaccine, Dietary supplement, Birth control, Medical device, Bank, Risk, Patient, Oncology

SALT LAKE CITY, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced financial results for its third quarter ended September 30, 2023. The Company also provided an update on its business performance and 2023 financial guidance.

Key Points: 
  • GAAP gross margins of 70.0% in the third quarter of 2023; adjusted gross margins for the third quarter of 2023 was 70.4%, an increase of 140.0 basis points from the second quarter of 2023.
  • The Myriad Genetics Oncology business provides hereditary cancer testing, including the MyRisk® hereditary cancer test for patients who have cancer.
  • Prolaris continued to see healthy demand as third quarter testing revenue and volumes grew 18% and 9% year-over-year, respectively.
  • 16_suppl (June 01, 2023)5030
    Myriad Genetics updates its 2023 revenue and non-GAAP financial guidance, as stated in the table below.

Sunstone Therapies Announces Start of First Study of Multiple Doses of Psilocybin in Treatment of Depression in Patients with Cancer

Retrieved on: 
Monday, November 6, 2023
Niacin, MADRS, Principal investigator, MDD, Sunstone, Medicine, Psilocybin, JAMA Oncology, Oncology, Safety, Depression, Cancer, Pain, Patient, Pharmaceutical industry

Study participants are adults with cancer and major depressive disorder (MDD) who are receiving up to two doses of psilocybin with concurrent therapy.

Key Points: 
  • Study participants are adults with cancer and major depressive disorder (MDD) who are receiving up to two doses of psilocybin with concurrent therapy.
  • Sunstone aims to recruit 56 patients into this single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks (ClinicalTrials.gov ID NCT05947383).
  • This new study includes a placebo control arm, the use of group administration, and - for the first time - multiple doses.
  • We look forward to making a further contribution to the clinical development of this potentially vitally important treatment modality.”

Neumora Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, November 1, 2023
Research, MDD, DSM-IV codes, Myenteric plexus, Clinical trial, Safety, BPD, KOR, Therapy, Patient, Pharmaceutical industry, Cryptocurrency, Amgen

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced financial results for the third quarter ended September 30, 2023 and provided a general business update.

Key Points: 
  • Additionally, we are on track to achieve the anticipated milestones for NMRA-511 and NMRA-266,” said Henry Gosebruch, chief executive officer, Neumora.
  • The Company expects the following milestones for navacaprant in MDD:
    Initiate KOASTAL-3 study in the fourth quarter of 2023.
  • Announced key leadership appointments: In October 2023, Neumora announced that Robert Lenz, M.D., Ph.D., had joined Neumora as executive vice president, head of R&D.
  • As of September 30, 2023, Neumora had $519.5 million in cash, cash equivalents and marketable securities.

Tonix Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept Study of TNX-601 ER for the Treatment of Major Depressive Disorder

Retrieved on: 
Tuesday, October 31, 2023
SAE, Fibromyalgia, SL, NDA, Tonix Pharmaceuticals, Depression, MADRS, Patient, MDD, Major depressive disorder, Pharmaceutical industry

CHATHAM, N.J., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced topline results from the Phase 2 proof-of-concept double-blind, randomized, multi-center, placebo-controlled UPLIFT study of TNX-601 ER* (tianeptine hemioxalate extended-release tablets) in patients with major depressive disorder (MDD). The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.

Key Points: 
  • The primary efficacy endpoint of change from baseline in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, did not achieve clinical or statistical significance.
  • “Based on these efficacy results, we are discontinuing development of TNX-601 ER.
  • We look forward to topline results from our Phase 2 study of TNX-1900 in chronic migraine in early December and topline results from our Phase 3 potential NDA-enabling study of TNX-102 SL in fibromyalgia in late December,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals.
  • In the study, TNX-601 ER was generally well-tolerated with a favorable safety profile.