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[8-K] Perspective Therapeutics, Inc. Reports Material Event

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(Moderate)
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(Neutral)
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8-K
Rhea-AI Filing Summary

Perspective Therapeutics (NYSE: CATX) announced significant developments in its clinical trials program on June 21, 2025. The company has received FDA alignment to open the third dosing cohort of its Phase 1/2a clinical trial for 212ʲճղѰ-α-, targeting patients with unresectable or metastatic somatostatin receptor 2-positive neuroendocrine tumors who haven't received prior radiopharmaceutical therapies.

Additionally, the company presented findings from a dosimetry sub-study using 202ʲճղѰ-α- as an imaging agent at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting in New Orleans. This presentation demonstrates the company's progress in developing innovative imaging solutions for neuroendocrine tumor treatment.

The 8-K filing also notes that Perspective Therapeutics has updated its corporate presentation on June 23, 2025, suggesting potential strategic or operational updates to its business model and development pipeline.

Perspective Therapeutics (NYSE: CATX) ha annunciato importanti sviluppi nel suo programma di studi clinici il 21 giugno 2025. L'azienda ha ricevuto l'approvazione della FDA per aprire la terza coorte di dosaggio del suo trial clinico di Fase 1/2a per 212ʲճղѰ-α-, rivolto a pazienti con tumori neuroendocrini positivi al recettore della somatostatina 2, non resecabili o metastatici, che non hanno ricevuto precedenti terapie radiopharmaceuticali.

Inoltre, la società ha presentato i risultati di un sottostudio di dosimetria utilizzando 202ʲճղѰ-α- come agente di imaging durante il Congresso Annuale 2025 della Society of Nuclear Medicine & Molecular Imaging a New Orleans. Questa presentazione evidenzia i progressi dell'azienda nello sviluppo di soluzioni innovative di imaging per il trattamento dei tumori neuroendocrini.

Il documento 8-K segnala anche che Perspective Therapeutics ha aggiornato la sua presentazione aziendale il 23 giugno 2025, suggerendo possibili aggiornamenti strategici o operativi al modello di business e alla pipeline di sviluppo.

Perspective Therapeutics (NYSE: CATX) anunció avances significativos en su programa de ensayos clínicos el 21 de junio de 2025. La compañía recibió la aprobación de la FDA para abrir la tercera cohorte de dosificación de su ensayo clínico de Fase 1/2a para 212ʲճղѰ-α-, dirigido a pacientes con tumores neuroendocrinos positivos al receptor de somatostatina 2, irresecables o metastásicos que no han recibido terapias radiopharmacéuticas previas.

Además, la empresa presentó resultados de un subestudio de dosimetría usando 202ʲճղѰ-α- como agente de imagen en la Reunión Anual 2025 de la Society of Nuclear Medicine & Molecular Imaging en Nueva Orleans. Esta presentación muestra el progreso de la compañía en el desarrollo de soluciones innovadoras de imagen para el tratamiento de tumores neuroendocrinos.

El informe 8-K también indica que Perspective Therapeutics ha actualizado su presentación corporativa el 23 de junio de 2025, lo que sugiere posibles actualizaciones estratégicas u operativas en su modelo de negocio y pipeline de desarrollo.

Perspective Therapeutics(NYSE: CATX)� 2025� 6� 21� 임상 시험 프로그램에서 중요� 발전� 발표했습니다. 회사� FDA로부� 3번째 투여 코호� 개시 승인� 받았으며, 이는 이전� 방사� 의약� 치료� 받지 않은 절제 불가능하거나 전이� 소마토스타� 수용� 2 양성 신경내분비종� 환자� 대상으� 하는 1/2a� 임상시험 212ʲճղѰ-α-� 해당합니�.

또한 회사� 2025� 뉴올리언스에� 열린 핵의� � 분자영상학회 연례회의에서 202ʲճղѰ-α-� 영상 촬영제로 사용� 선량측정 부연구 결과� 발표했습니다. � 발표� 신경내분비종� 치료� 위한 혁신적인 영상 솔루� 개발에서 회사� 진전� 보여줍니�.

8-K 보고서에� Perspective Therapeutics가 2025� 6� 23� 기업 프레젠테이션� 업데이트했다고도 명시되어 있으�, 이는 비즈니스 모델� 개발 파이프라인에 대� 전략� 또는 운영상의 변화를 시사합니�.

Perspective Therapeutics (NYSE : CATX) a annoncé des avancées significatives dans son programme d'essais cliniques le 21 juin 2025. La société a obtenu l'accord de la FDA pour ouvrir la troisième cohorte de dosage de son essai clinique de phase 1/2a pour 212ʲճղѰ-α-, ciblant des patients atteints de tumeurs neuroendocrines positives au récepteur de la somatostatine 2, non résécables ou métastatiques n'ayant pas reçu de traitements radiopharmaceutiques antérieurs.

Par ailleurs, l'entreprise a présenté les résultats d'une sous-étude de dosimétrie utilisant 202ʲճղѰ-α- comme agent d'imagerie lors de la réunion annuelle 2025 de la Society of Nuclear Medicine & Molecular Imaging à la Nouvelle-Orléans. Cette présentation illustre les progrès réalisés dans le développement de solutions d'imagerie innovantes pour le traitement des tumeurs neuroendocrines.

Le dépôt 8-K indique également que Perspective Therapeutics a mis à jour sa présentation d'entreprise le 23 juin 2025, suggérant des mises à jour stratégiques ou opérationnelles potentielles de son modèle commercial et de sa pipeline de développement.

Perspective Therapeutics (NYSE: CATX) gab am 21. Juni 2025 bedeutende Fortschritte in seinem klinischen Studienprogramm bekannt. Das Unternehmen erhielt die FDA-Zustimmung zur Eröffnung der dritten Dosiskoorte seiner Phase 1/2a-Studie für 212ʲճղѰ-α-, die sich an Patienten mit nicht resezierbaren oder metastasierten neuroendokrinen Tumoren mit Somatostatin-Rezeptor 2-Positivität richtet, die zuvor keine radiopharmazeutischen Therapien erhalten hatten.

Zusätzlich präsentierte das Unternehmen Ergebnisse einer Dosimetrie-Substudie mit 202ʲճղѰ-α- als Bildgebungsagent auf der Jahresversammlung 2025 der Society of Nuclear Medicine & Molecular Imaging in New Orleans. Diese Präsentation zeigt den Fortschritt des Unternehmens bei der Entwicklung innovativer Bildgebungslösungen für die Behandlung neuroendokriner Tumoren.

Die 8-K-Meldung weist zudem darauf hin, dass Perspective Therapeutics am 23. Juni 2025 seine Unternehmenspräsentation aktualisiert hat, was auf mögliche strategische oder operative Anpassungen im Geschäftsmodell und der Entwicklungspipeline hindeutet.

Positive
  • FDA approval to open third dosing cohort in Phase 1/2a trial for 212ʲճղѰ-α-, indicating trial progression and regulatory alignment
  • Acceptance of dosimetry sub-study data for presentation at major industry conference (Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting), suggesting positive clinical development progress
Negative
  • None.

Insights

Perspective Therapeutics advances its lead radiopharmaceutical to third dosing cohort with FDA alignment, while presenting imaging data at major industry conference.

The FDA alignment to proceed to the third dosing cohort represents a significant milestone in Perspective Therapeutics' clinical development program. In Phase 1/2a trials, dose escalation typically proceeds only when safety parameters at lower doses are deemed acceptable, suggesting the treatment has demonstrated a satisfactory safety profile thus far.

The trial focuses on 212ʲճղѰ-α- for patients with neuroendocrine tumors expressing somatostatin receptor 2 who haven't received prior radiopharmaceutical therapies. This patient selection criteria indicates the company is positioning their therapy potentially as an earlier line of treatment rather than only for previously treated patients.

Simultaneously, the company is conducting a dosimetry sub-study using 202ʲճղѰ-α- as an imaging agent, which was presented at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting. Dosimetry studies are crucial in radiopharmaceutical development as they help optimize the therapeutic dose by measuring radiation distribution and absorption in the body.

The updated corporate presentation filed immediately following these developments suggests the company views these advancements as material to their overall strategic positioning and timeline.

For a clinical-stage biopharmaceutical company, these developments represent concrete progress in their clinical program, particularly the advancement to higher dosing levels with regulatory alignment. The presentation at a major scientific conference also provides visibility among key opinion leaders in nuclear medicine.

Perspective Therapeutics (NYSE: CATX) ha annunciato importanti sviluppi nel suo programma di studi clinici il 21 giugno 2025. L'azienda ha ricevuto l'approvazione della FDA per aprire la terza coorte di dosaggio del suo trial clinico di Fase 1/2a per 212ʲճղѰ-α-, rivolto a pazienti con tumori neuroendocrini positivi al recettore della somatostatina 2, non resecabili o metastatici, che non hanno ricevuto precedenti terapie radiopharmaceuticali.

Inoltre, la società ha presentato i risultati di un sottostudio di dosimetria utilizzando 202ʲճղѰ-α- come agente di imaging durante il Congresso Annuale 2025 della Society of Nuclear Medicine & Molecular Imaging a New Orleans. Questa presentazione evidenzia i progressi dell'azienda nello sviluppo di soluzioni innovative di imaging per il trattamento dei tumori neuroendocrini.

Il documento 8-K segnala anche che Perspective Therapeutics ha aggiornato la sua presentazione aziendale il 23 giugno 2025, suggerendo possibili aggiornamenti strategici o operativi al modello di business e alla pipeline di sviluppo.

Perspective Therapeutics (NYSE: CATX) anunció avances significativos en su programa de ensayos clínicos el 21 de junio de 2025. La compañía recibió la aprobación de la FDA para abrir la tercera cohorte de dosificación de su ensayo clínico de Fase 1/2a para 212ʲճղѰ-α-, dirigido a pacientes con tumores neuroendocrinos positivos al receptor de somatostatina 2, irresecables o metastásicos que no han recibido terapias radiopharmacéuticas previas.

Además, la empresa presentó resultados de un subestudio de dosimetría usando 202ʲճղѰ-α- como agente de imagen en la Reunión Anual 2025 de la Society of Nuclear Medicine & Molecular Imaging en Nueva Orleans. Esta presentación muestra el progreso de la compañía en el desarrollo de soluciones innovadoras de imagen para el tratamiento de tumores neuroendocrinos.

El informe 8-K también indica que Perspective Therapeutics ha actualizado su presentación corporativa el 23 de junio de 2025, lo que sugiere posibles actualizaciones estratégicas u operativas en su modelo de negocio y pipeline de desarrollo.

Perspective Therapeutics(NYSE: CATX)� 2025� 6� 21� 임상 시험 프로그램에서 중요� 발전� 발표했습니다. 회사� FDA로부� 3번째 투여 코호� 개시 승인� 받았으며, 이는 이전� 방사� 의약� 치료� 받지 않은 절제 불가능하거나 전이� 소마토스타� 수용� 2 양성 신경내분비종� 환자� 대상으� 하는 1/2a� 임상시험 212ʲճղѰ-α-� 해당합니�.

또한 회사� 2025� 뉴올리언스에� 열린 핵의� � 분자영상학회 연례회의에서 202ʲճղѰ-α-� 영상 촬영제로 사용� 선량측정 부연구 결과� 발표했습니다. � 발표� 신경내분비종� 치료� 위한 혁신적인 영상 솔루� 개발에서 회사� 진전� 보여줍니�.

8-K 보고서에� Perspective Therapeutics가 2025� 6� 23� 기업 프레젠테이션� 업데이트했다고도 명시되어 있으�, 이는 비즈니스 모델� 개발 파이프라인에 대� 전략� 또는 운영상의 변화를 시사합니�.

Perspective Therapeutics (NYSE : CATX) a annoncé des avancées significatives dans son programme d'essais cliniques le 21 juin 2025. La société a obtenu l'accord de la FDA pour ouvrir la troisième cohorte de dosage de son essai clinique de phase 1/2a pour 212ʲճղѰ-α-, ciblant des patients atteints de tumeurs neuroendocrines positives au récepteur de la somatostatine 2, non résécables ou métastatiques n'ayant pas reçu de traitements radiopharmaceutiques antérieurs.

Par ailleurs, l'entreprise a présenté les résultats d'une sous-étude de dosimétrie utilisant 202ʲճղѰ-α- comme agent d'imagerie lors de la réunion annuelle 2025 de la Society of Nuclear Medicine & Molecular Imaging à la Nouvelle-Orléans. Cette présentation illustre les progrès réalisés dans le développement de solutions d'imagerie innovantes pour le traitement des tumeurs neuroendocrines.

Le dépôt 8-K indique également que Perspective Therapeutics a mis à jour sa présentation d'entreprise le 23 juin 2025, suggérant des mises à jour stratégiques ou opérationnelles potentielles de son modèle commercial et de sa pipeline de développement.

Perspective Therapeutics (NYSE: CATX) gab am 21. Juni 2025 bedeutende Fortschritte in seinem klinischen Studienprogramm bekannt. Das Unternehmen erhielt die FDA-Zustimmung zur Eröffnung der dritten Dosiskoorte seiner Phase 1/2a-Studie für 212ʲճղѰ-α-, die sich an Patienten mit nicht resezierbaren oder metastasierten neuroendokrinen Tumoren mit Somatostatin-Rezeptor 2-Positivität richtet, die zuvor keine radiopharmazeutischen Therapien erhalten hatten.

Zusätzlich präsentierte das Unternehmen Ergebnisse einer Dosimetrie-Substudie mit 202ʲճղѰ-α- als Bildgebungsagent auf der Jahresversammlung 2025 der Society of Nuclear Medicine & Molecular Imaging in New Orleans. Diese Präsentation zeigt den Fortschritt des Unternehmens bei der Entwicklung innovativer Bildgebungslösungen für die Behandlung neuroendokriner Tumoren.

Die 8-K-Meldung weist zudem darauf hin, dass Perspective Therapeutics am 23. Juni 2025 seine Unternehmenspräsentation aktualisiert hat, was auf mögliche strategische oder operative Anpassungen im Geschäftsmodell und der Entwicklungspipeline hindeutet.

0000728387false00007283872025-06-212025-06-21

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 21, 2025

 

 

Perspective Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-33407

41-1458152

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

c/o Perspective Therapeutics, Inc.

2401 Elliott Avenue

Suite 320

 

Seattle, Washington

 

98121

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (206) 676-0900

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 par value

 

CATX

 

NYSE American LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 8.01 Other Events.

On June 21, 2025, Perspective Therapeutics, Inc. (the “Company”) issued a press release announcing that alignment was reached with the U.S. Food and Drug Administration to open the third dosing cohort of its ongoing Phase 1/2a clinical trial for [212Pb]VMT‑α‑NET in patients with unresectable or metastatic somatostatin receptor 2‑positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

 

Additionally, on June 21, 2025, the Company issued a press release and posted to its website a presentation regarding a dosimetry sub-study using [202Pb]VMT‑α‑NET as an imaging agent in the Company’s ongoing Phase 1/2a clinical trial of [212Pb]VMT‑α‑NET that was accepted for presentation at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting, which is taking place from June 21-24, 2025 in New Orleans, Louisiana. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01. A copy of the presentation is filed as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

 

On June 23, 2025, the Company updated its corporate presentation. A copy of the presentation is filed as Exhibit 99.4 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press release #1 issued by Perspective Therapeutics, Inc., dated June 21, 2025.

99.2

 

Press release #2 issued by Perspective Therapeutics, Inc., dated June 21, 2025.

99.3

 

Presentation regarding data presented at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting.

99.4

 

Corporate Presentation.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

PERSPECTIVE THERAPEUTICS, INC.

 

 

 

 

Date:

June 23, 2025

By:

/s/ Johan (Thijs) Spoor

 

 

 

Johan (Thijs) Spoor
Chief Executive Officer

 


FAQ

What did CATX announce in their June 21, 2025 8-K filing?

CATX announced two key developments: 1) FDA alignment to open the third dosing cohort of their Phase 1/2a clinical trial for 212ʲճղѰ-α- in patients with neuroendocrine tumors, and 2) acceptance of a dosimetry sub-study presentation using 202ʲճղѰ-α- at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting.

What type of patients are eligible for CATX's Phase 1/2a clinical trial?

The clinical trial is for patients with unresectable or metastatic somatostatin receptor 2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies.

Where and when will CATX present their dosimetry sub-study results?

CATX will present their dosimetry sub-study results at the Society of Nuclear Medicine & Molecular Imaging 2025 Annual Meeting, taking place from June 21-24, 2025 in New Orleans, Louisiana.

What exhibits were included in CATX's June 2025 8-K filing?

The filing included 5 exhibits: two press releases dated June 21, 2025, a presentation of data for the SNMMI 2025 Annual Meeting, an updated corporate presentation, and a Cover Page Interactive Data File (embedded within the Inline XBRL document).

Who is the current CEO of CATX as of June 2025?

Johan (Thijs) Spoor is the Chief Executive Officer of Perspective Therapeutics, Inc. (CATX), as evidenced by his signature on the 8-K filing dated June 23, 2025.
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