PharmaLogic Announces Successful Supply of First Cohort Dosing for Ratio Therapeutics' Phase 1/2 Study of a Novel FAP-Targeted Radiopharmaceutical in Late-Stage Aggressive Sarcomas

BRONX, N.Y., Dec. 16, 2025 /PRNewswire/ -- PharmaLogic Holdings Corp. ("PharmaLogic" or "the Company"), a leading contract development and manufacturing organization (CDMO) specialized in radiopharmaceuticals, announced today that it has successfully supplied the first cohort dosing of Ratio Therapeutics' investigational FAP-targeted radiopharmaceutical, [Ac-225]-RTX-2358, for the ATLAS trial. The dose was manufactured and delivered from PharmaLogic's radiopharmaceutical manufacturing facility in the Bronx, New York, which supports clinical and commercial supply for advanced radiopharmaceutical programs.

"PharmaLogic is proud of this collaboration with Ratio Therapeutics and the advancement of [Ac-225]-RTX-2358 into the clinic," said Etienne Montagut, President and CEO of PharmaLogic. "The supply of the first cohort doses from our Bronx facility underscores our commitment to supporting the development of and access to innovative radiopharmaceutical therapies around the globe."

About PharmaLogic Holdings Corp.
PharmaLogic is a leading global contract development and manufacturing organization (CDMO) specialized in diagnostic and therapeutic radiopharmaceuticals. With decades of industry expertise and a robust network of more than 45 facilities across the U.S., Puerto Rico, Canada, and Norway, PharmaLogic delivers comprehensive solutions spanning development, manufacturing, and distribution of both clinical and commercial-stage radiopharmaceutical products, all in accordance with the highest quality and regulatory standards.

Our rapidly expanding diagnostics business leverages advanced technologies to enhance patient access to novel diagnostics in oncology, cardiology, and neurology. In the therapeutic segment, PharmaLogic is the world's only cGMP-compliant CDMO currently manufacturing and distributing a commercial radiopharmaceutical therapeutic to more than 30 countries across the globe.

PharmaLogic is dedicated to enabling global patient access to radiopharmaceuticals through strategic development partnerships with industry innovators, advancing the future of the field and supporting our partners throughout the product lifecycle. For more information, visit radiopharmacy.com and follow us on LinkedIn.

About the ATLAS Trial 
The ATLAS trial is a Phase 1/2 open-label clinical trial (clinicaltrials.gov identifier, NCT07156565) designed to assess the safety, tolerability, dosimetry, biodistribution, pharmacokinetics, and preliminary anti-tumor activity of [Ac-225]-RTX-2358, a highly selective, FAP targeted radiotherapeutic labeled with Actinium 225, in patients with relapsed or refractory soft tissue sarcomas that express FAP.

The study consists of two phases: an ascending administered activity phase (Phase 1) and an expansion phase (Phase 2). For patients to be eligible to receive treatment, FAP expression will be assessed using a [Cu-64]-LNTH-1363S PET scan. In the Phase 1 portion, patients with FAP positive sarcomas will receive intravenous injections of [Ac-225]-RTX-2358 once every eight weeks, for up to six treatment cycles over a 12-month period. Using a standard 3+3 dose escalation design, participants will be assigned to one of three groups, each receiving an increasing dose level to determine the maximum tolerated dose and establish a recommended dose for the expansion phase. Cohort expansion will be allowed to a max of 10 patients per cohort, enabling up to 26 patients to be treated and evaluated during the Phase 1 portion of the trial. This will allow better characterization of safety and tolerability as well as the assessment of preliminary efficacy. Safety data from each group will be reviewed by an independent Safety Review Committee before dose escalation proceeds. The Phase 2 portion of the study will evaluate the efficacy and safety of [Ac-225]-RTX-2358 in up to 50 patients. [Ac-225]-RTX-2358 is being manufactured by Pharmalogic. [Cu-64]-LNTH-1363S is being provided by Lantheus and manufactured by PharmaLogic.

About Ratio Therapeutics
Ratio Therapeutics Inc. is a clinical-stage pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. With headquarters and laboratories in Boston, the company currently employs a growing team of multidisciplinary experts with backgrounds in radiopharmaceutical discovery and development. Ratio's proprietary R&D platforms, Trillium™ and Macropa™, enable the development of fit-for-purpose heterobifunctional radiopharmaceuticals for therapy and imaging that possess pharmacokinetic modulation, thereby improving drug availability, tumor delivery, and tumor loading. The company maintains a strong commitment to manufacturing through its collaboration with PharmaLogic and its own state-of-the-art facility located in Salt Lake City, Utah, ensuring reliable supply and quality in radiopharmaceutical production. Please visit http://www.ratiotx.com for more information and follow us on Twitter (X) and LinkedIn.

SOURCE PharmaLogic Holdings Corp