IDEAYA Announces Webcast to Report Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma on Monday, September 23, 2024
IDEAYA Biosciences (Nasdaq:IDYA) has announced a webcast on September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from an FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is a protein kinase C (PKC) inhibitor being developed for primary and metastatic UM. The presentation will cover:
- Market introduction and UM incidence
- Registrational trial design based on FDA guidance
- Phase 2 clinical data update, including baseline characteristics, adverse event profile, and clinical efficacy
The webcast will feature a key opinion leader and IDEAYA management. Updated presentations will be available on the company's website at approximately 8:00 am ET on the day of the event.
IDEAYA Biosciences (Nasdaq:IDYA) ha annunciato un webcast per il 23 settembre 2024, alle 8:00 ET, per riportare i dati provvisori della fase 2 per darovasertib e fornire un aggiornamento normativo da un incontro FDA di tipo C nel trattamento del melanoma uveale neoadiuvante (UM). Darovasertib è un inibitore della proteina chinasi C (PKC) in fase di sviluppo per il melanoma uveale primario e metastatico. La presentazione coprirà:
- Introduzione al mercato e incidenza dell'UM
- Progettazione dello studio registrativo basato sulle linee guida FDA
- Aggiornamento dei dati clinici della fase 2, comprese le caratteristiche di base, il profilo degli eventi avversi e l'efficacia clinica
Il webcast presenterà un leader di opinione chiave e il management di IDEAYA. Le presentazioni aggiornate saranno disponibili sul sito web della società intorno alle 8:00 ET nel giorno dell'evento.
IDEAYA Biosciences (Nasdaq:IDYA) ha anunciado un webcast para el 23 de septiembre de 2024, a las 8:00 a.m. ET, para informar sobre los datos interinos de la fase 2 para darovasertib y proporcionar una actualización regulatoria de una reunión de tipo C de la FDA en melanoma uveal neoadyuvante (UM). Darovasertib es un inhibidor de la quinasa de proteínas C (PKC) que se está desarrollando para el melanoma uveal primario y metastásico. La presentación abarcará:
- Introducción al mercado y la incidencia de UM
- Diseño del ensayo registrativo basado en las directrices de la FDA
- Actualización de datos clínicos de la fase 2, incluyendo características basales, perfil de eventos adversos y eficacia clínica
El webcast contará con un líder de opinión clave y la dirección de IDEAYA. Las presentaciones actualizadas estarán disponibles en el sitio web de la empresa aproximadamente a las 8:00 a.m. ET el día del evento.
IDEAYA 바이오사이언스(Nasdaq:IDYA)는 2024년 9월 23일 오전 8시(ET)에 다로바세르티브에 대한 2상 중간 데이터를 보고하고 FDA 타입 C 회의에서의 규제 업데이트를 제공하는 웹캐스트를 발표했습니다. 다로바세르티브는 원발 생검 및 전이성 유베말라노마(UM)를 위해 개발되고 있는 단백질 키나제 C(PKC) 억제제입니다. 발표 내용은 다음과 같습니다:
- 시장 소개와 UM 발생률
- FDA 지침에 따른 등록 시험 설계
- 기초 특성, 부작용 프로필 및 임상 효능을 포함한 2상 임상 데이터 업데이트
웹캐스트에는 주요 의견 리더와 IDEAYA 경영진이 참여할 것입니다. 업데이트된 발표 자료는 이벤트 당일 오전 8시(ET)경에 회사 웹사이트에서 확인할 수 있습니다.
IDEAYA Biosciences (Nasdaq:IDYA) a annoncé un webinaire pour le 23 septembre 2024, à 8h00 ET, afin de présenter les données intermédiaires de la phase 2 pour darovasertib et fournir une mise à jour réglementaire à l'issue d'une réunion de type C avec la FDA concernant le mélanome uvéal néoadjuvant (UM). Darovasertib est un inhibiteur de la protéine kinase C (PKC) en cours de développement pour le mélanome uvéal primitif et métastatique. La présentation couvrira :
- Introduction au marché et incidence de l'UM
- Conception de l'essai d'enregistrement basée sur les recommandations de la FDA
- Mise à jour des données cliniques de la phase 2, y compris les caractéristiques de base, le profil des effets indésirables et l'efficacité clinique
Le webinaire mettra en avant un leader d'opinion clé et la direction d'IDEAYA. Les présentations actualisées seront disponibles sur le site Web de l'entreprise vers 8h00 ET le jour de l'événement.
IDEAYA Biosciences (Nasdaq:IDYA) hat ein Webcast für den 23. September 2024, um 8:00 Uhr ET angekündigt, um über die Zwischendaten der Phase 2 für Darovasertib zu berichten und ein regulatorisches Update aus einem FDA-Type-C-Meeting zur neoadjuvanten uvealen Melanome (UM) zu geben. Darovasertib ist ein Protein-Kinase-C (PKC) Hemmer, der für primäre und metastatische UM entwickelt wird. Die Präsentation wird Folgendes umfassen:
- Markteinführung und Inzidenz von UM
- Registrierungsstudien-Design basierend auf FDA-Richtlinien
- Aktualisierung der klinischen Daten der Phase 2, einschließlich Basismerkmale, Nebenwirkungsprofil und klinische Wirksamkeit
Das Webcast wird einen wichtigsten Meinungsführer und das Management von IDEAYA vorstellen. Aktualisierte Präsentationen werden am Tag der Veranstaltung gegen 8:00 Uhr ET auf der Website des Unternehmens verfügbar sein.
- Announcement of interim Phase 2 data for darovasertib in uveal melanoma
- Regulatory update from FDA Type C meeting to be presented
- Potential progress towards a registrational trial design
- None.
The investor webcast presentation agenda to review the interim Phase 2 clinical data and regulatory update for darovasertib in neoadjuvant UM will be the following:
- Market introduction: annual incidence of UM
- Registrational trial design based on FDA Type C meeting guidance
- Phase 2 clinical data update
- Baseline characteristics
- AE profile
- Clinical efficacy from Phase 2 company-sponsored and IST
The investor webcast and conference call will include participation from a key opinion leader. IDEAYA management, Yujiro S. Hata, Chief Executive Officer and President of IDEAYA Biosciences, and Darrin Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences, will also serve as presenters. The link to the investor webcast will be available on the Investor Relations Events section of the Company's website at: https://ir.ideayabio.com/events. Registration is available at https://ir.ideayabio.com/events or https://lifescievents.com/event/ideaya-3/ in advance of the event.
IDEAYA's darovasertib investor webcast presentation, as well as an updated corporate presentation, which will incorporate the updated darovasertib clinical data and regulatory update, will be available on the company's website, at its Investor Relations portal (https://ir.ideayabio.com/) at approximately 8:00 am ET on Monday, September 23, 2024.
About IDEAYA Biosciences
IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of the darovasertib clinical data update press release, investor webcast and investor presentations, (ii) the timing of FDA regulatory guidance and (iii) the timing of clinical trials evaluating darovasertib as a treatment for primary and metastatic UM. IDEAYA undertakes no obligation to update or revise any forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. For a further description of the risks and uncertainties that could cause actual events and results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K filed on February 20, 2024 and any current and periodic reports filed with the
Investor and Media Contact
IDEAYA Biosciences
Andres Ruiz Briseno
SVP, Head of Finance and Investor Relations
investor@ideayabio.com
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SOURCE IDEAYA Biosciences, Inc.
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