- Trevi Therapeutics Inc's 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.
- HC Wainwright initiated coverage on NRx Pharmaceuticals Inc with a Buying rating and a price target of $2.
- Earlier today, the FDA declined to issue an Emergency Use Authorization for NRx's Zyesami for a subgroup of patients who also received Gilead Sciences Inc's remdesivir in addition to Zyesami.
- The analyst is bullish on:
- Significant potential for NRX-101 for bipolar depressed patients that can rapidly stabilize patients with suicidal ideation and behavior. "We believe NRx's focus on treatments for bipolar depression with SIB makes NRx a leader in drug development in this field," HC Wainwright notes.
- Zyesami's nascent value as a novel potential therapy for acute and chronic lung disorders.
- "We believe uncertainty in the Zyesami clinical program has been priced into NRx stock, representing a value proposition ahead of key clinical milestones that could potentially lead to NRX-101 approval in 2024", the analysts added.
