Regeneron Expands Into Pulmonary Hypertension With New Phase 2 Trial for REGN13335
Regeneron Pharmaceuticals (REGN) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals is running a mid-stage trial called “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension.” The goal is to test safety and benefit of REGN13335 in adults with pulmonary arterial hypertension who are already on standard drugs.
The study tests REGN13335, an antibody drug designed to block PDGF-B, a protein linked to vessel changes in the lungs. A placebo is used as a comparison to see how much extra gain REGN13335 may add on top of existing treatments.
The trial is interventional and randomized, so participants are put into groups by chance. It uses a parallel design with REGN13335 or placebo given under double-blind rules, meaning patients, doctors, and assessors do not know who gets what during the main treatment phase.
Masking is “quadruple,” covering participants, care teams, investigators, and outcome reviewers to reduce bias. The primary aim is treatment focused, with an open-label extension planned so participants can continue REGN13335 once the blinded period ends.
The study was first submitted on Jan. 2, 2026, marking the formal start of its clinical path for this use. The last update was logged on May 26, 2026, signaling recent changes to the protocol or site status.
Primary completion and final completion dates are not posted yet, so investors should view this as a multi-year readout story. Key value inflection points will likely come at interim data updates, which could appear before full completion if Regeneron chooses to share them.
For investors, this trial extends Regeneron’s reach beyond its core eye and immunology drugs into rare cardio-pulmonary disease. Success could open a niche but high-value market in pulmonary arterial hypertension, where branded therapies are expensive and payer uptake can be strong.
Competitors in PAH include Johnson & Johnson’s Janssen unit and United Therapeutics, which already market established drugs. A positive signal for REGN13335 could lift REGN’s multiple on future pipeline cash flows, while any safety or efficacy issues might be a modest overhang given earlier-stage risk.
In the near term, the update that the trial is recruiting and recently refreshed on the registry may support confidence in pipeline momentum but is unlikely to move REGN stock on its own. Investors may treat this as a long-dated call option on a new mechanism in PAH, with valuation impact tied to later Phase 2 data and any move into Phase 3.
The study of REGN13335 in pulmonary arterial hypertension is active and recruiting, with current details and future updates available on the ClinicalTrials portal.
To learn more about REGN’s potential, visit the Regeneron Pharmaceuticals drug pipeline page.
