Shares Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF), the clinical-stage biopharmaceutical company, were up 9% following the positive outcome of a pre-investigational new drug meeting with the US Food and Drug Administration (FDA) for lead asset POLB 001.
Cavendish reiterated its 'buy' rating and 19p target price, noting the FDA discussions de-risk the overall development programme by ensuring that the regulator agrees, at least in principle, that the data produced through the clinical programme could support approval.
Crucially, the broker expects the FDA feedback to strengthen Poolbeg's hand in partnering discussions by giving potential licensees greater confidence in the route to market.
POLB 001 is being developed as a preventative therapy for cytokine release syndrome (CRS), a serious side effect of cancer immunotherapy treatments, including bispecific antibodies.
Poolbeg is preparing to initiate the TOPICAL clinical trial, which will test the drug's effectiveness in preventing CRS in approximately 30 patients with relapsed or refractory multiple myeloma receiving an approved bispecific antibody, with interim data expected during the summer.
Cavendish highlights the scale of the commercial opportunity, noting that Poolbeg estimates peak sales potential for POLB 001 in the multi-billion-dollar range in the US alone, within a total addressable market of more than $10 billion.
That estimate accounts only for the potential in relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma, with recent payer research covering approximately 75 million lives validating both the unmet need and the appetite among insurers for an effective preventative approach.
Beyond POLB 001, Poolbeg is also expected to initiate a proof-of-concept study for an oral GLP-1 obesity treatment in the second half of 2026.
Cavendish's target price implies upside of 245% from the current share price of 5.5p, which values Poolbeg at a market capitalisation of £35.1 million.