Case Study:
From Clinical Trials to FDA Approval
Shaping the Narrative Behind Iterum Therapeutics' Historic Milestone
Iterum Therapeutics (Nasdaq: ITRM) is a clinical-stage pharmaceutical company developing next-generation antibiotics for drug-resistant infections. As the company advanced ORLYNVAH™— the first FDA-approved oral therapy for uncomplicated urinary tract infections and the first U.S. approval for an oral penem—expectations were high. But recent FDA communications around potential off-label use introduced skepticism that threatened to overshadow what should have been a breakthrough moment.
Cogenta partnered with Iterum to guide its communications strategy from late-stage clinical trials through FDA decision. Ahead of approval, we pre-briefed select reporters to reset the narrative, pre-pitched embargoed stories to tier-one outlets, and built a launch-day plan to drive impactful coverage. Once FDA approval was secured, we expanded outreach across business, trade, and vertical media and issued targeted alerts to maximize attendance at Iterum’s investor call.
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The result: more than 70 articles across leading outlets including STAT, FiercePharma, Kaiser Health News, MedPage Today, WebMD, and BioSpace. Coverage was overwhelmingly positive, framing Iterum not around controversy but as an innovator meeting an urgent unmet need with a first-in-class therapy.
From our 2016 Series A through our 2024 FDA approval, Cogenta was a steady and strategic partner. They understood our goals, our urgency, and the environment we were operating in. What I valued most was that we didn’t have to reorient them — they stayed aligned with our mission and helped us communicate clearly so we could stay focused on moving the company forward sooner rather than later.
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Corey Fishman
Iterum Therapeutics, CEO
