Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF) shares rose as much as 8% on Wednesday after receipt of Clinical Trial Authorisation from the UK medicines regulator for its POLB 001 TOPICAL study.
Cavendish said the milestone represents a key de-risking event and clears the final hurdle ahead of patient screening.
The broker maintained its 'buy' rating and 19p target price, implying 313% upside from the current 4.6p share price, and described the interim data expected this summer as a near-term value inflexion point.
POLB 001 is being developed as a potential first-approved preventative therapy for cytokine release syndrome (CRS), an acute immune reaction triggered by bispecific antibody and CAR-T cancer treatments, for which no established preventative option currently exists.
The TOPICAL trial will enrol approximately 30 patients with relapsed or refractory multiple myeloma receiving teclistamab, a bispecific antibody supplied by Johnson & Johnson, across six UK sites, with patient screening set to commence shortly.
Cavendish noted that the acute onset of CRS following bispecific antibody treatment enables a rapid interim readout, making the summer data catalyst particularly significant.
The broker said positive trial results would be a key catalyst for securing a partnering deal with large pharmaceutical companies.
It described it as a prerequisite for commercial progression, and noted that a recently granted Australian patent, with further international grants anticipated, strengthens POLB 001's appeal to partners seeking to backfill revenues ahead of upcoming patent expiries.
On the commercial opportunity, Cavendish said new independent US payer research engaging insurers covering approximately 75 million lives corroborates multi-billion-dollar peak sales potential in the United States, driven by POLB 001's capacity to reduce CRS-related hospitalisation and shift care toward outpatient settings.