H.C. Wainwright reiterates Buy on PDS following positive FDA meeting

H.C. Wainwright analyst Joseph Pantginis notes that PDS Biotechnology has announced it successfully completed a Type B meeting with the FDA that should lead to a registrational study of the triple combo of PDS0101, PDS0301, and an FDA-approved checkpoint inhibitor for the treatment of recurrent/metastatic human papilloma virus-positive, CKI refractory head and neck cancer. The guidance by the FDA paints a clearer picture for PDS as it moves down the registrational path, providing key components needed to successfully progress its assets, the firm adds. H.C. Wainwright believes that the utilization of an FDA-approved commercially available CKI as an alternative to bintrafusp alfa offers a more simplified path down the regulatory roadway for the combination treatment. The firm reiterates a Buy rating on the shares with a price target of $21.