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Reviva Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on:

Monday, April 15, 2024

Molecule, BCPP, Safety, NDA, PANSS, WCG, CNS, KOL, Schizophrenia, OLE, MPH, Central nervous system, FCCP, Pharmaceutical industry

CUPERTINO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the full year ended December 31, 2023 and summarized recent business highlights.

Key Points:

“2023 was an exciting and productive year for Reviva that included significant progress in the late-stage development of our brilaroxazine program for schizophrenia.
As of December 31, 2023, the Company’s cash and cash equivalents totaled approximately $23.4 million compared to approximately $18.5 million as of December 31, 2022.
The financial and related data for 2022 included in this press release, including in this “Financial Results” section and in the attached tables, is reflective of the restatement adjustments to the Company’s previously issued financial statements for the year ended December 31, 2022.
The financial information in this press release has been updated to reflect the effects of the restatement adjustments.

Newron Announces Positive Top-line Results From Potentially Pivotal Phase II/III Study 008A With Evenamide in Schizophrenia Patients

Retrieved on:

Tuesday, April 30, 2024

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.

Key Points:

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America.
291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.
Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.
Ravi Anand, MD, Chief Medical Officer of Newron, stated: “The results seen in study 008A with evenamide are ground-breaking and unique from many perspectives.

EQS-News: Newron presents 2023 financial results and provides 2024 outlook

Retrieved on:

Wednesday, April 10, 2024

Psychosis, Schizophrenia, Clozapine, XETRA, Patient, CNS, Business development, Peripheral nervous system, Psychedelic literature, Safety, TRS, PANSS, EIB, Canadian International Council, Pharmaceutical industry

Milan, Italy, March 19, 2024, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

Key Points:

Milan, Italy, March 19, 2024, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.
Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint.
These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment.
Patient enrollment has completed and results from this study are expected in April 2024.

Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

Retrieved on:

Monday, March 18, 2024

NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative, neurodevelopmental, and psychiatric disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia has been screened ahead of schedule.

Key Points:

“Initiating our Phase 2 trial of ANAVEX®3-71 in schizophrenia ahead of schedule is a testament to the hard work and dedication of our clinical study team,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
“Schizophrenia is a challenging disorder that can impair social and occupational functions and overall quality of life for the nearly 24 million people affected worldwide.
The placebo-controlled Phase 2, two-part, in-patient trial, ANAVEX®3-71-SZ-001 ( NCT06245213 ), will investigate the effects of ANAVEX®3-71 in patients with schizophrenia.
In addition to the electrophysiological biomarkers, Anavex is applying novel neuroinflammatory, metabolomic, and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX®3-71’s novel, dual mechanism of action.

Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Retrieved on:

Saturday, April 6, 2024

Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points:

Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia.
Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
In the interim analysis, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.
In long-term trials, KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.

Newron Presents 2023 Financial Results and Provides 2024 Outlook

Retrieved on:

Tuesday, March 19, 2024

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

Key Points:

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.
Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint.
These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment.
Patient enrollment has completed and results from this study are expected in April 2024.

Karuna Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides General Business Update

Retrieved on:

Thursday, February 22, 2024

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a general business update.

Key Points:

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a general business update.
Results from the EMERGENT-2 trial published in The Lancet in December 2023.
Announced positive results from the Phase 1b Ambulatory Blood Pressure Monitoring trial in schizophrenia in the fourth quarter of 2023.
Presented additional data from the EMERGENT program at the 2023 Neuroscience Education Institute (NEI) Congress and the CNS Summit in the fourth quarter of 2023.

Reviva to Host KOL Event to Discuss Topline Data from Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia

Retrieved on:

Tuesday, February 6, 2024

Molecule, University, Schizophrenia, Retirement, Patient, Safety, BCPP, Pharmacology, Central nervous system, Doctor of Pharmacy, OLE, MPH, CNS, PANSS, RP5063, KOL, Pharmaceutical industry

CUPERTINO, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it will host a key opinion leader (KOL) event on Thursday, February 15, 2024 at 12:00 PM ET, featuring Larry Ereshefsky, PharmD, BCPP (Retired professor of Psychiatry, Pharmacology and Psychiatry, The University of Texas; Chief Scientific Officer, Owner, Follow the Molecule LLC) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute), who will discuss the unmet medical need and current treatment landscape for patients suffering from acute to chronic symptoms of schizophrenia, and brilaroxazine (RP5063), a next-generation serotonin/dopamine modulator, as a potential treatment.

Key Points:

CUPERTINO, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it will host a key opinion leader (KOL) event on Thursday, February 15, 2024 at 12:00 PM ET, featuring Larry Ereshefsky, PharmD, BCPP (Retired professor of Psychiatry, Pharmacology and Psychiatry, The University of Texas; Chief Scientific Officer, Owner, Follow the Molecule LLC) and Mark Opler, PhD, MPH (Chief Research Officer at WCG Inc., Executive Director of the PANSS Institute), who will discuss the unmet medical need and current treatment landscape for patients suffering from acute to chronic symptoms of schizophrenia, and brilaroxazine (RP5063), a next-generation serotonin/dopamine modulator, as a potential treatment.
To register, click here .
The event will focus on reviewing Reviva's positive topline results and successful completion of pivotal Phase 3 RECOVER trial evaluating the efficacy, safety, and tolerability of once-daily brilaroxazine in adults with acute schizophrenia, as well as the Company's ongoing enrollment in the one-year open label extension (OLE) trial and the initiation of registrational Phase 3 RECOVER-2 trial.
A live question and answer session will follow the formal presentations.

Anavex Life Sciences Announces U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

Retrieved on:

Tuesday, January 16, 2024

Schizophrenia, Patient, Weight gain, Dementia, Delusion, DSM-IV codes, Positive, SIGMAR1, Rett syndrome, Personalized medicine, Parkinson's disease, Alzheimer's disease, FDA, Therapy, Doctor of Philosophy, PANSS, Hallucination, Pharmaceutical industry

NEW YORK, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and schizophrenia, today announced the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX®3-71 for the treatment of schizophrenia, which is expected to begin in Q2 2024. ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1

Key Points:

ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1
ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects.
As currently approved treatments only control a subset of symptoms, patients continue to exhibit severe impairments in social and occupational functioning and poor quality of life.
The placebo-controlled Phase 2 ANAVEX®3-71-SZ-001 study, will consist of two-parts to explore multiple ascending doses in individuals with schizophrenia followed by a 28-day treatment period in a larger cohort.
While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties.

Reviva Provides Corporate and Program Updates and Highlights Key Upcoming Milestones

Retrieved on:

Thursday, January 4, 2024

Food, FDA, Idiopathic pulmonary fibrosis, IPF, NDA, New Drug Application, CNS, PANSS, Central nervous system, Safety, Psoriasis, OLE, Pharmaceutical industry

CUPERTINO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today provided program updates and announced upcoming key milestones.

Key Points:

– Schizophrenia late-stage clinical program advances with positive topline Phase 3 data, successful ongoing enrollment in open label extension (OLE) trial, and positive drug-drug interaction data supporting a differentiated profile for once-daily brilaroxazine –
CUPERTINO, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today provided program updates and announced upcoming key milestones.
“We also furthered foundational preclinical support for the therapeutic potential of brilaroxazine in other inflammatory conditions driven by underlying serotonin signaling dysfunction, including psoriasis and idiopathic pulmonary fibrosis (IPF).
We believe these advances reinforce the broad potential of brilaroxazine to be a safe and effective therapy for major neuropsychiatric and inflammatory indications caused by a dysfunctional serotonin-dopamine system.
Importantly, our recent progress brings us closer than ever to fulfilling our mission of reviving the full promise of patients’ lives with treatment paradigm changing drugs targeting neurotransmitter-driven diseases.