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Neumora Therapeutics to Host Key Opinion Leader Roundtable to Discuss the Potential of Navacaprant in Neuropsychiatric Disorders

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Neumora Therapeutics (Nasdaq: NMRA) announced a roundtable discussion on the neuropsychiatric treatment landscape and the role of kappa opioid receptor antagonists (KORAs) in neuropsychiatry. The event, featuring leading experts, will take place on September 12, 2024, at 8:00 a.m. ET.

The discussion will focus on the potential of navacaprant, Neumora's KORA candidate, in treating neuropsychiatric disorders. The company is currently conducting a Phase 3 KOASTAL program for navacaprant in major depressive disorder (MDD) and a Phase 2 study in bipolar depression. Neumora expects to report topline data from the KOASTAL-1 Phase 3 study in Q4 2024.

The event will cover topics including Neumora's mission and pipeline, the role of kappa opioid receptors in MDD, navacaprant's Phase 2 data, and potential indications beyond MDD and bipolar depression.

Neumora Therapeutics (Nasdaq: NMRA) ha annunciato una tavola rotonda sulla panoramica del trattamento neuropsichiatrico e sul ruolo degli antagonisti del recettore degli oppioidi kappa (KORAs) nella neuropsichiatria. L'evento, che vedrà la partecipazione di esperti di fama, si svolgerà il 12 settembre 2024, alle 8:00 a.m. ET.

La discussione si concentrerà sul potenziale di navacaprant, il candidato KORA di Neumora, nel trattamento dei disturbi neuropsichiatrici. L'azienda sta attualmente conducendo un programma KOASTAL di Fase 3 per navacaprant nel disturbo depressivo maggiore (MDD) e uno studio di Fase 2 nella depressione bipolare. Neumora prevede di comunicare i dati preliminari dello studio di Fase 3 KOASTAL-1 nel Q4 2024.

L'evento tratterà argomenti come la missione e il pipeline di Neumora, il ruolo dei recettori degli oppioidi kappa nella MDD, i dati di Fase 2 di navacaprant e le potenziali indicazioni al di là della MDD e della depressione bipolare.

Neumora Therapeutics (Nasdaq: NMRA) anunció una mesa redonda sobre el panorama del tratamiento neuropsiquiátrico y el papel de los antagonistas del receptor de opioides kappa (KORAs) en la neuropsiquiatría. El evento, que contará con expertos destacados, se llevará a cabo el 12 de septiembre de 2024, a las 8:00 a.m. ET.

La discusión se centrará en el potencial de navacaprant, el candidato KORA de Neumora, para tratar trastornos neuropsiquiátricos. La compañía está llevando a cabo un programa KOASTAL de Fase 3 para navacaprant en trastorno depresivo mayor (MDD) y un estudio de Fase 2 en depresión bipolar. Neumora espera informar sobre los datos preliminares del estudio KOASTAL-1 de Fase 3 en el Q4 de 2024.

El evento abordará temas como la misión y pipeline de Neumora, el papel de los receptores de opioides kappa en MDD, los datos de Fase 2 de navacaprant y posibles indicaciones más allá de MDD y depresión bipolar.

Neumora Therapeutics (Nasdaq: NMRA)는 신경정신 치료 환경과 신경정신에서 카파 오피오이드 수용체 길항제 (KORAs)의 역할에 대한 원탁 토론회를 발표했습니다. 이 이벤트는 저명한 전문가들이 참여하며, 2024년 9월 12일 오전 8시 (ET)에 열릴 예정입니다.

토론은 신경정신 장애 치료에서 Neumora의 KORA 후보인 navacaprant의 잠재력에 초점을 맞출 것입니다. 회사는 현재 주우울증(MDD)에 대한 navacaprant의 3상 KOASTAL 프로그램을 진행 중이며, 양극성 우울증에 대한 2상 연구를 수행하고 있습니다. Neumora는 2024년 4분기 KOASTAL-1 3상 연구의 초기 데이터를 보고할 예정입니다.

이 이벤트는 Neumora의 미션 및 파이프라인, MDD에서 카파 오피오이드 수용체의 역할, navacaprant의 2상 데이터, MDD와 양극성 우울증을 넘어서는 잠재적 적응증 등을 다룰 것입니다.

Neumora Therapeutics (Nasdaq: NMRA) a annoncé une table ronde sur le paysage du traitement neuropsychiatrique et le rôle des antagonistes des récepteurs opioïdes kappa (KORAs) en neuropsychiatrie. L'événement, qui réunira des experts de premier plan, aura lieu le 12 septembre 2024 à 8h00 (ET).

La discussion portera sur le potentiel de navacaprant, le candidat KORA de Neumora, pour le traitement des troubles neuropsychiatriques. L'entreprise mène actuellement un programme KOASTAL de Phase 3 pour navacaprant dans le cas du trouble dépressif majeur (MDD) et une étude de Phase 2 dans la dépression bipolaire. Neumora s'attend à communiquer les données préliminaires de l'étude KOASTAL-1 de Phase 3 au T4 2024.

L'événement abordera des sujets tels que la mission et le pipeline de Neumora, le rôle des récepteurs opioïdes kappa dans la MDD, les données de Phase 2 de navacaprant et les indications potentielles au-delà de la MDD et de la dépression bipolaire.

Neumora Therapeutics (Nasdaq: NMRA) hat eine Diskussionsrunde über die Behandlungslage in der Neuropsychiatrie und die Rolle der kappa-Opioid-Rezeptor-Antagonisten (KORAs) in der Neuropsychiatrie angekündigt. Die Veranstaltung mit führenden Experten findet am 12. September 2024 um 8:00 Uhr ET statt.

Die Diskussion wird sich auf das Potenzial von navacaprant, Neumoras KORA-Kandidaten, zur Behandlung neuropsychiatrischer Störungen konzentrieren. Das Unternehmen führt derzeit ein Phase-3-KOASTAL-Programm für navacaprant bei schwerer depressiver Störung (MDD) und eine Phase-2-Studie bei bipolarer Depression durch. Neumora erwartet, im 4. Quartal 2024 erste Ergebnisse der KOASTAL-1-Phase-3-Studie zu veröffentlichen.

Die Veranstaltung wird Themen wie Neumoras Mission und Pipeline, die Rolle der kappa-Opioid-Rezeptoren bei MDD, die Phase-2-Daten von navacaprant sowie potenzielle Indikationen über MDD und bipolare Depression hinaus behandeln.

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Roundtable discussion to take place on Thursday, September 12 at 8:00 a.m. ET

WATERTOWN, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced that the Company will host a roundtable discussion on the neuropsychiatric treatment landscape and role of kappa opioid receptor antagonists (KORAs) in neuropsychiatry. The discussion will feature leading experts in neuropsychiatry and will take place on Thursday, September 12 at 8:00 a.m. ET.

“We look forward to an engaging discussion with our panel of distinguished medical experts and to providing an overview of the potential for navacaprant to make a difference for patients,” said Henry Gosebruch, chief executive officer, Neumora. “It is clear that there is significant excitement among the scientific community regarding the potential of KORAs across many neuropsychiatric indications. We share their enthusiasm and are pleased to be executing the comprehensive Phase 3 KOASTAL program with navacaprant in MDD in the monotherapy setting and a Phase 2 study in bipolar depression. We believe navacaprant has the potential to reshape the treatment of these serious brain disorders. We look forward to reporting topline data from our first Phase 3 study, KOASTAL-1, in the fourth quarter.”

The program agenda will feature the following topics and speakers:

  • Global Brain Disease: Neumora’s Mission and Pipeline
    • Josh Pinto, Ph.D., Chief Financial Officer
  • The Role of Kappa Opioid Receptors in MDD and Overview of Navacaprant Phase 2 Data
    • Bill Aurora, Pharm.D., Chief Strategy Officer
  • Indication Opportunities for Navacaprant: MDD, BPD, and Beyond
    • Rob Lenz, M.D., Ph.D., Head of Research and Development
  • Fireside Chat: A Discussion on the Neuropsychiatric Treatment Landscape and Opportunity for Navacaprant
    • Roger McIntyre, M.D., University of Toronto
    • Sanjay Mathew, M.D., Baylor College of Medicine
    • John Krystal, M.D., Yale University School of Medicine
  • Company Outlook: A Look Ahead
    • Henry Gosebruch, Chief Executive Officer

Webcast Information
The event will begin at 8:00 a.m. ET on Thursday, September 12, 2024. Participants can register for the live webcast here. In addition, the live webcast of the event will be available on the events and presentations section of the Company’s website at www.neumoratx.com. A replay of the webcasts will be available following the completion of the event and will be archived for up to 30 days.

About Navacaprant Clinical Development Program
Navacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for major depressive disorder (MDD) and other neuropsychiatric disorders. The KOR antagonist approach has been clinically validated in three independent studies.

Neumora is currently enrolling the registrational Phase 3 KOASTAL program, which is designed to evaluate the efficacy and safety of navacaprant monotherapy for the treatment of MDD. KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3, randomized, placebo-controlled, double-blind studies in adult patients with MDD. Neumora is also evaluating the potential of navacaprant for the treatment of bipolar depression (BPD) in a Phase 2 study initiated in May 2024.

Neumora expect to report data from KOASTAL-1 study in the fourth quarter of 2024, topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025 and topline data from the Phase 2 BPD study in the second half of 2025.

About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; Neumora’s goal to make navacaprant available for MDD patients; the timing, progress and plans for its therapeutic development programs, including the timing of patient enrollment, initiation and data read outs for its programs and studies, as well as its clinical trial and development plans and; other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results or to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 that was filed with the SEC on or about the date hereof. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements. Our results for the quarter ended June 30, 2024 are also not necessarily indicative of our operating results for any future periods.

Neumora Contact:
Helen Rubinstein
315-382-3979
Helen.Rubinstein@neumoratx.com


FAQ

When is Neumora Therapeutics hosting the Key Opinion Leader Roundtable on navacaprant?

Neumora Therapeutics (NMRA) is hosting the Key Opinion Leader Roundtable on navacaprant on Thursday, September 12, 2024, at 8:00 a.m. ET.

What is the focus of Neumora's KOASTAL program for navacaprant?

Neumora's KOASTAL program is a comprehensive Phase 3 study evaluating navacaprant for the treatment of major depressive disorder (MDD) in the monotherapy setting.

When does Neumora expect to report topline data from the KOASTAL-1 Phase 3 study?

Neumora (NMRA) expects to report topline data from the KOASTAL-1 Phase 3 study in the fourth quarter of 2024.

What other neuropsychiatric indication is Neumora studying for navacaprant besides MDD?

In addition to major depressive disorder, Neumora (NMRA) is conducting a Phase 2 study of navacaprant in bipolar depression.

How can investors access the Neumora Therapeutics roundtable discussion on September 12, 2024?

Investors can access the Neumora Therapeutics (NMRA) roundtable discussion via a live webcast. Registration is available on the company's website, and a replay will be archived for up to 30 days after the event.

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