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- Yesterday Trevi Therapeutics Inc's (NASDAQ:TRVI) Phase 2b/3 trial (PRISM) evaluating Haduvio (nalbuphine ER) for prurigo nodularis (PN) successfully met the key primary and secondary endpoints.
- Needham writes that Haduvio had a quick onset of action, reaching stat sig at 6 weeks with efficacy that had yet to plateau at the wk-14 readout.
- Trevi will meet with FDA before initiating a Phase 3 trial that is likely to start in 1H23
- The analysts say that the second program de-risking trial readout for Haduvio in 1H22 and believe Trevi's valuation discounts Haduvio's potential in both IPF cough and PN.
- Needham maintains its Buy rating and adjusts the price target to $10 from $8 to reflect additional de-risking of the PN program.
- Next Steps. Patients that completed the PRISM trial were eligible to enroll in an OLE trial to receive an additional 38-wks of Haduvio treatment. Needham says these data will provide a better picture of Haduvio's long-term efficacy and tolerability.
- Price Action: TRVI shares are up 7.33% at $2.63 during the market session on the last check Thursday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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