Asset profile

sirolimus · Orchestra BioMed (OBIO)

Indication: coronary in-stent restenosis
Also known as: Virtue SAB, Virtue Sirolimus AngioInfusion Balloon, SirolimusEFR

Company

Orchestra BioMed Holdings Inc is a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships with medical device companies. The company's flagship product candidates are Atrioventricular Interval Modulation T…

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Timeline

Newest first.

Sep 28, 2026

03:22 PM

OBIOOrchestra BioMed

sirolimus · NCT05103358 registry update

Trial registry changeClinicalTrials.gov Open record

Oct 28, 2025

12:12 PM

OBIOOrchestra BioMed

Orchestra BioMed enters $30M Terumo ROFR and investment deal for Virtue SAB

OtherSEC 8-K

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Sep 28, 2026

Primary endpoint metUnknown

Overall survival significant or trendingUnknown

US / Western patient shareFavourable

173 of 189 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

Terumo Corporation Not US-listedPartner

Terumo Medical Corporation Not US-listedPartner

OBIOOrchestra BioMedOwner

SEC 8-K Oct 28, 2025

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT05103358	Phase 2	Completed	Dec 23, 2024	128	159 of 166 sites in the United States
NCT02583893	Phase 2	Completed	Apr 17, 2023	39	1 of 1 sites in the United States
NCT01231412	Phase 3	Completed	Oct 8, 2016	174	6 of 11 sites in the United States
NCT00544115	Phase 2	Active, not recruiting	Mar 13, 2007	260
NCT00105001	Phase 2	Completed	May 1, 2011	210	7 of 11 sites in the United States

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