Raymond James initiates Trevi Therapeutics at Outperform, sees first-to-market opportunity for Haduvio

On Friday, Raymond James initiated coverage on Trevi Therapeutics (NASDAQ:TRVI), assigning an Outperform rating to the stock with a price target of $9.00. The focus of the coverage is on Trevi's development of Haduvio, an oral, extended-release formulation of nalbuphine.

This medication is an unscheduled opioid previously approved for pain indications and is now being evaluated for its efficacy in reducing cough frequency in patients with idiopathic pulmonary fibrosis-associated chronic cough (IPF-CC), an orphan disease with no approved treatments.

Trevi's Haduvio has demonstrated promising results in a Phase 2a study, showing statistically significant reductions in cough frequency—over 50% compared to placebo—during both daytime and over a 24-hour period.

The drug is currently undergoing the Phase 2b CORAL study, with data expected to be released in the first half of 2025. Additionally, Haduvio is being tested for refractory chronic cough (RCC), a condition affecting an estimated 3-5 million patients, with results from a Phase 2a study anticipated in the fourth quarter of 2024.

The analyst from Raymond James highlighted the significant unmet medical need in the treatment of chronic cough conditions, particularly in IPF-CC and RCC. With a history of failed drugs in these areas, Haduvio's positive Phase 2a outcomes may position Trevi Therapeutics as a potential first-to-market therapy for IPF-CC and a first or second-to-market option for RCC, should the drug's efficacy be confirmed in ongoing studies.

Trevi Therapeutics' progress with Haduvio comes at a critical time for patients suffering from these chronic cough conditions, for which there are currently no approved therapies. The company's approach could offer a new avenue of relief for patients, and the market is watching closely as Trevi advances through the clinical trial phases toward potential regulatory approval and market entry.

In other recent news, Trevi Therapeutics has been making noteworthy progress in its clinical trials for chronic cough and idiopathic pulmonary fibrosis (IPF) treatments. The company disclosed a net loss of $12.4 million during its Second Quarter 2024 Earnings Conference Call.

Despite this, with funding secured until 2026, Trevi continues to advance several trials. The RIVER trial for refractory chronic cough (RCC) is 80% enrolled, with essential data expected by the end of 2024. Also, the CORAL Phase 2b trial for IPF chronic cough is actively enrolling, with topline data anticipated in the first half of 2025.

Analyst firms H.C. Wainwright and EF Hutton have initiated coverage on Trevi Therapeutics with a Buy rating. H.C. Wainwright set a price target of $6.00, while EF Hutton set a 12-month price target at $21.00. The positive outlook from both firms is influenced by promising clinical data that suggests a reduced risk for the ongoing trials.

The development of Trevi's lead product, Haduvio, has been recognized for its potential to address significant unmet medical needs in the treatment of chronic cough.

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