Aspire Biopharma Holdings, Inc., to Present at the Emerging Growth Conference on Thursday, April 17
Aspire Biopharma Holdings (Nasdaq: ASBP) has announced its upcoming presentation at the Emerging Growth Conference on April 17, 2025, at 12:35 p.m. EDT. CEO Kraig Higginson will deliver a corporate presentation followed by Q&A.
The virtual event comes after the company's recent initiation of a Phase 1 single-center clinical study for their lead therapeutic candidate - an oral transmucosal fast-acting high-dose aspirin formulation. The study aims to determine optimal drug product formulation and guide potential subsequent clinical trials.
Following the trial completion, Aspire plans to schedule a pre-IND meeting with the FDA in Q2 2025. The company intends to pursue a section 505(b)(2) NDA approval for treating suspected acute myocardial infarction.
Aspire Biopharma Holdings (Nasdaq: ASBP) ha annunciato la sua prossima presentazione alla Emerging Growth Conference il 17 aprile 2025, alle 12:35 EDT. Il CEO Kraig Higginson terrà una presentazione aziendale seguita da una sessione di domande e risposte.
L'evento virtuale arriva dopo l'avvio da parte dell'azienda di uno studio clinico di fase 1 a centro singolo per il loro principale candidato terapeutico - una formulazione di aspirina ad alto dosaggio a rilascio rapido per via transmucosa. Lo studio mira a determinare la formulazione ottimale del prodotto farmaceutico e a guidare i potenziali successivi studi clinici.
Dopo il completamento della sperimentazione, Aspire prevede di programmare un incontro pre-IND con la FDA nel secondo trimestre del 2025. L'azienda intende richiedere l'approvazione NDA ai sensi della sezione 505(b)(2) per il trattamento dell'infarto miocardico acuto sospetto.
Aspire Biopharma Holdings (Nasdaq: ASBP) ha anunciado su próxima presentación en la Emerging Growth Conference el 17 de abril de 2025, a las 12:35 p.m. EDT. El CEO Kraig Higginson realizará una presentación corporativa seguida de una sesión de preguntas y respuestas.
El evento virtual se lleva a cabo después de que la compañía iniciara un estudio clínico de fase 1 en un solo centro para su principal candidato terapéutico: una formulación de aspirina de alta dosis de acción rápida por vía transmucosa. El estudio tiene como objetivo determinar la formulación óptima del producto farmacéutico y guiar posibles ensayos clínicos posteriores.
Tras la finalización del ensayo, Aspire planea programar una reunión pre-IND con la FDA en el segundo trimestre de 2025. La compañía tiene la intención de buscar la aprobación de la NDA bajo la sección 505(b)(2) para el tratamiento de infarto agudo de miocardio sospechoso.
아스파이어 바이오파마 홀딩스 (Nasdaq: ASBP)는 2025년 4월 17일 오후 12:35 EDT에 신흥 성장 컨퍼런스에서의 발표를 발표했습니다. CEO 크레이그 히긴슨이 기업 발표를 진행한 후 질의응답 시간을 가질 예정입니다.
이번 가상 이벤트는 회사가 주요 치료 후보인 고용량의 빠른 작용을 하는 경구용 점막 투여 아스피린 제형에 대한 1상 단일 센터 임상 연구를 최근 시작한 후 진행됩니다. 이 연구는 최적의 약물 제품 제형을 결정하고 잠재적인 후속 임상 시험을 안내하는 것을 목표로 합니다.
시험이 완료된 후, 아스파이어는 2025년 2분기에 FDA와의 사전 IND 회의를 계획하고 있습니다. 회사는 의심되는 급성 심근경색 치료를 위한 505(b)(2) NDA 승인을 추구할 계획입니다.
Aspire Biopharma Holdings (Nasdaq: ASBP) a annoncé sa prochaine présentation à la Emerging Growth Conference le 17 avril 2025 à 12h35 EDT. Le PDG Kraig Higginson fera une présentation de l'entreprise suivie d'une séance de questions-réponses.
Cet événement virtuel survient après le lancement récent par l'entreprise d'une étude clinique de phase 1 à centre unique pour son principal candidat thérapeutique - une formulation d'aspirine à forte dose à action rapide par voie transmucale. L'étude vise à déterminer la formulation optimale du produit médicamenteux et à guider les éventuels essais cliniques ultérieurs.
Après l'achèvement de l'essai, Aspire prévoit de programmer une réunion pré-IND avec la FDA au deuxième trimestre de 2025. L'entreprise a l'intention de demander une approbation NDA en vertu de la section 505(b)(2) pour traiter un infarctus du myocarde aigu suspecté.
Aspire Biopharma Holdings (Nasdaq: ASBP) hat seine bevorstehende Präsentation auf der Emerging Growth Conference am 17. April 2025 um 12:35 Uhr EDT angekündigt. CEO Kraig Higginson wird eine Unternehmenspräsentation halten, gefolgt von einer Frage-und-Antwort-Runde.
Die virtuelle Veranstaltung findet nach dem kürzlichen Beginn einer Phase-1-Einzelzentrum-Studie für ihren führenden therapeutischen Kandidaten statt - eine orale transmukosale hochdosierte Aspirin-Formulierung mit schneller Wirkung. Die Studie zielt darauf ab, die optimale Arzneimittelproduktformulierung zu bestimmen und mögliche nachfolgende klinische Studien zu leiten.
Nach Abschluss der Studie plant Aspire, im zweiten Quartal 2025 ein Pre-IND-Meeting mit der FDA anzusetzen. Das Unternehmen beabsichtigt, eine 505(b)(2) NDA-Zulassung zur Behandlung des Verdachts auf einen akuten Myokardinfarkt anzustreben.
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HUMACAO, PR AND NEW YORK, NY / ACCESS Newswire / April 14, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, today announced that Kraig Higginson, CEO of Aspire, will present at the Emerging Growth Conference.
Virtual Presentation Details
Date: April 17, 2025
Time of Presentation: 12:35 p.m. EDT
Format: Corporate presentation with Q&A
Participants can register for and view the webcast, along with accompanying slides, here: https://goto.webcasts.com/starthere.jsp?ei=1705403&tp_key=612b99c876&sti=asbp
If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, http://www.YouTube.com/EmergingGrowthConference.
This event follows the recently announced initiation of its Phase 1 single-center clinical study of its lead therapeutic candidate, an oral transmucosal fast-acting high-dose aspirin formulation. This Phase 1 trial is expected to provide information required to select the optimal drug product formulation and inform the design of a second clinical trial, if needed, to support FDA approval. Following completion of this trial, Aspire plans to request a pre-IND meeting with the FDA in the second quarter of 2025 to finalize plans for continued development of high-dose aspirin leading to submission of a section 505(b)(2) NDA seeking approval to market the product for treatment of suspected acute myocardial infarction.
About the Aspire Targeted Oral Delivery Platform
Aspire's technology delivers a soluble, fast acting granular or powder form drug formulation which has been developed by using our patent-pending methodology, and "trade secret" process. The technologies new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream. The benefits of "rapid absorption" are to provide nearly instant treatment impact and high dose absorption. The Company's patent-pending delivery system includes components specifically formulated to allow rapid sublingual absorption of drugs into the blood stream, thus by-passing the gastrointestinal tract, and potentially provide an improved treatment outcome.
About Aspire Biopharma, Inc.
Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which addresses emergencies, drug efficacy, dosage management, and response time. For more information, please visit www.aspirebiolabs.com.
Safe Harbor Statement
Certain statements made in this communication are "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as "estimate," "projects," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "would," "should," "future," "propose," "potential," "target," "goal," "objective," "outlook" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Aspire Biopharma Holdings, Inc.
Contact
TraDigital IR
Kevin McGrath
+1-646-418-7002
kevin@tradigitalir.com
SOURCE: Aspire Biopharma Holdings, Inc.
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