Numinus Wellness Comments on FDA Decision on New Drug Application for MDMA-Assisted Therapy for PTSD
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) comments on the FDA's decision to not approve Lykos Therapeutics' new drug application for MDMA-assisted therapy for PTSD. The FDA has requested an additional Phase 3 study to further examine safety and efficacy. Despite this setback, Numinus remains committed to advancing psychedelic therapies and continues to execute its plan for profitability with existing operations.
Numinus clinics have delivered over 43,600 Spravato® and ketamine treatments to patients. The company's Cedar Clinical Research has conducted studies involving four psychedelic medicines with over 50 subjects in the past 2.5 years. Numinus emphasizes its ongoing clinical trials work and commitment to research partnerships as more compounds advance through late-stage trials.
Additionally, Numinus has terminated its previously announced letter of intent to acquire MedBright AI Investments Inc.
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) commenta la decisione della FDA di non approvare la nuova richiesta di farmaco di Lykos Therapeutics per la terapia assistita da MDMA per il PTSD. La FDA ha richiesto uno studio di Fase 3 aggiuntivo per esaminare ulteriormente la sicurezza e l'efficacia. Nonostante questo ostacolo, Numinus rimane impegnata a promuovere le terapie psicoattive e continua a seguire il suo piano per raggiungere la redditività con le operazioni esistenti.
Le cliniche Numinus hanno somministrato oltre 43.600 trattamenti con Spravato® e ketamina ai pazienti. La Cedar Clinical Research dell'azienda ha condotto studi su quattro medicinali psicoattivi con oltre 50 soggetti negli ultimi 2,5 anni. Numinus enfatizza il suo continuo lavoro negli studi clinici e il suo impegno verso le partnership di ricerca man mano che più composti avanzano attraverso le fasi finali degli studi.
Inoltre, Numinus ha annullato la lettera di intenti precedentemente annunciata per acquisire MedBright AI Investments Inc.
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) comenta sobre la decisión de la FDA de no aprobar la nueva solicitud de medicamento de Lykos Therapeutics para terapia asistida con MDMA para el PTSD. La FDA ha solicitado un estudio adicional de Fase 3 para examinar más a fondo la seguridad y eficacia. A pesar de este contratiempo, Numinus sigue comprometida con el avance de las terapias psicodélicas y continúa ejecutando su plan de rentabilidad con las operaciones existentes.
Las clínicas Numinus han brindado más de 43,600 tratamientos con Spravato® y ketamina a pacientes. La Cedar Clinical Research de la compañía ha llevado a cabo estudios que han involucrado cuatro medicamentos psicodélicos con más de 50 sujetos en los últimos 2.5 años. Numinus enfatiza su trabajo continuo en ensayos clínicos y su compromiso con las asociaciones de investigación a medida que más compuestos avanzan en las fases finales de los ensayos.
Además, Numinus ha terminado su carta de intención previamente anunciada para adquirir MedBright AI Investments Inc.
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF)는 Lykos Therapeutics의 PTSD를 위한 MDMA 보조 치료제의 새로운 약물 신청을 FDA가 승인하지 않기로 한 결정에 대해 논평했습니다. FDA는 안전성과 효능을 더욱 검토하기 위해 추가적인 3상 연구를 요청한 상태입니다. 이러한 차질에도 불구하고 Numinus는 환각제 치료의 발전에 전념하고 있으며, 기존 운영을 통해 수익성 계획을 계속 실행하고 있습니다.
Numinus 클리닉은 환자에게 43,600건 이상의 Spravato® 및 케타민 치료를 제공했습니다. 회사의 Cedar Clinical Research는 지난 2.5년 동안 4가지 환각제에 대한 연구를 실시했으며, 50명 이상의 피험자가 참여했습니다. Numinus는 진행 중인 임상 시험 작업과 연구 파트너십에 대한 약속을 강조하며, 더 많은 화합물이 후기 단계에서 진행되고 있습니다.
추가로 Numinus는 MedBright AI Investments Inc. 인수에 대한 이전에 발표된 의향서의 종료를 발표했습니다.
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) commente la décision de la FDA de ne pas approuver la nouvelle demande de médicament de Lykos Therapeutics pour la thérapie assistée par MDMA pour le PTSD. La FDA a demandé une étude supplémentaire de phase 3 pour examiner plus en détail la sécurité et l'efficacité. Malgré ce revers, Numinus reste engagée à faire progresser les thérapies psychédéliques et continue d'exécuter son plan de rentabilité avec ses opérations existantes.
Les cliniques Numinus ont effectué plus de 43 600 traitements avec Spravato® et de la kétamine pour les patients. La Cedar Clinical Research de l'entreprise a réalisé des études impliquant quatre médicaments psychédéliques avec plus de 50 sujets au cours des 2,5 dernières années. Numinus souligne son travail continu sur les essais cliniques et son engagement envers les partenariats de recherche alors que davantage de composés avancent dans les essais de dernière phase.
De plus, Numinus a mis fin à sa lettre d'intention précédemment annoncée pour acquérir MedBright AI Investments Inc.
Numinus Wellness Inc. (TSX: NUMI) (OTCQX: NUMIF) kommentiert die Entscheidung der FDA, den neuen Zulassungsantrag von Lykos Therapeutics für MDMA-unterstützte Therapie bei PTSD nicht zu genehmigen. Die FDA hat eine zusätzliche Phase-3-Studie angefordert, um Sicherheit und Wirksamkeit weiter zu untersuchen. Trotz dieses Rückschlags bleibt Numinus entschlossen, psychedelische Therapien voranzutreiben und setzt seinen Plan zur Rentabilität mit den bestehenden Operationen um.
Die Numinus-Kliniken haben über 43.600 Spravato®- und Ketaminbehandlungen für Patienten durchgeführt. Die Cedar Clinical Research des Unternehmens hat in den letzten 2,5 Jahren Studien mit vier psychedelischen Medikamenten und über 50 Probanden durchgeführt. Numinus betont seine fortlaufende Arbeit an klinischen Studien und sein Engagement für Forschungspartnerschaften, da immer mehr Verbindungen in späten Testphasen vorankommen.
Darüber hinaus hat Numinus das zuvor angekündigte Absichtsschreiben zur Übernahme von MedBright AI Investments Inc. beendet.
- Numinus clinics have delivered over 43,600 Spravato® and ketamine treatments
- Cedar Clinical Research has conducted studies on four psychedelic medicines with over 50 subjects in 2.5 years
- Company's operations are not dependent on commercialization of new therapies
- Numinus continues to execute its plan to achieve profitability with existing operations
- FDA's decision to not approve MDMA-assisted therapy for PTSD may delay market entry
- Termination of letter of intent to acquire MedBright AI Investments Inc.
"While this is a blow to all the incredibly positive and encouraging work that has been done to advance safe access to psychedelic therapy, which MAPS and Lykos have led the charge for, we remain unwavering and committed to doing all we can to make these important therapies available for all those suffering who need it most," said Payton Nyquvest, Numinus Founder and CEO. "We're confident that further study will continue to show the efficacy of MDMA, and with many psychedelic compounds at the late stages of research, the pipeline of treatments to address severe conditions remains strong."
"For Numinus, we will continue to execute on our previously announced plan to achieve profitability with our existing operations, which were and continue not to be dependent on the commercialization of new therapies," Mr. Nyquvest added.
Spravato® (esketamine) and ketamine continue to be available to practitioners to treat mental health conditions, and Numinus Wellness clinics have delivered over 43,600 such treatments to patients. The clinics have built an optimized business model with best-in-class patient care, including a call center and expertise in reimbursed billing. The company is working to leverage its leadership into an offering available to mental health professionals across the
"The FDA decision demonstrates the high level of scrutiny that psychedelic compounds receive and the continuing requirement for comprehensive, rigorous research as some of these investigational products move through late-stage clinical trials," said Dr. Paul Theilking, Numinus Chief Science and Medical Officer. "We're proud of our clinical trials work with major psychedelic drug developers and will continue to be a committed research partner as more compounds are advanced."
Letter of intent with MedBright AI
Numinus also announces that it has terminated the letter of intent previously announced on June 20, 2024, to acquire MedBright AI Investments Inc.
About Numinus
Numinus Wellness Inc. (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms of depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.
Learn more at www.numinus.com and follow us on LinkedIn, Facebook, and Instagram.
Forward-looking statements
Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect", and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including the results of further research into MDMA, if any, the FDA and other regulators' decisions in respect of MDMA and other psychedelic medications, restrictions that may be placed on the use of psychedelic compounds by regulatory authorities; safety and efficacy of psychedelic-assisted therapy; acceptance, uptake and commercialization of psychedelic-assisted therapy, if any; dependence on obtaining regulatory approvals, and other risks that are set forth in our annual information form dated November 29, 2023, and available on SEDAR at www.sedarplus.ca. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
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