RegulatoryCompany release

Perspective Therapeutics wins FDA Fast Track for PSV359 and signs Merck Keytruda deal

🇺🇸 Perspective Therapeutics, Inc. (CATX) · Mon 09 Nov 2026

The alpha-emitting radiopharmaceutical developer also reported EU orphan status for bamzireotide navoxetan, about $202 million in cash and a Q3 net loss of $32.4 million.

Perspective Therapeutics reported third-quarter 2026 results and a business update on 9 November 2026, highlighting regulatory and partnering progress across its pipeline of alpha-emitting radiopharmaceuticals.

The US Food and Drug Administration granted Fast Track Designation to PSV359 for FAP-positive solitary fibrous tumours. Fast Track is an FDA programme intended to speed the development and review of medicines for serious conditions with unmet need, and it allows more frequent contact with the agency.

The company also signed a supply and collaboration agreement with Merck to explore a possible combination of PSV359 with pembrolizumab, Merck's anti-PD-1 therapy marketed as Keytruda. The summary available to VigiEye does not give financial terms or the design of any planned study.

For bamzireotide navoxetan in neuroendocrine tumours, the product received European orphan designation in July 2026. Perspective is targeting an end-of-Phase 2 meeting with the FDA in the first quarter of 2027.

On finances, the company reported about $202 million in cash, which it expects to fund operations into 2028. The net loss for the third quarter was $32.4 million.

What it means for your team

  • Fast Track for PSV359 gives the sponsor scope for more frequent FDA interaction, a relevant signal for teams tracking radiopharmaceutical development in rare sarcomas.
  • The Merck supply and collaboration agreement points to a potential PSV359 and pembrolizumab combination; any trial would need to address safety and dosing of both agents together.
  • The Q1 2027 end-of-Phase 2 FDA meeting for bamzireotide navoxetan is the next regulatory milestone to watch, alongside its EU orphan status.
  • Cash runway into 2028 suggests the company expects to fund these programmes without near-term financing, according to its own guidance.

Company's press release (SEC filing): Perspective Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Perspective Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →