PDS Biotechnology announces Q3 earnings per share of 19 cents, below consensus estimate of 20 cents.
FDA Meeting Request: PDS Biotech has requested a meeting with the FDA to propose an amendment to their VERSATILE-003 Phase 3 trial based on positive data from the completed VERSATILE-002 trial.
Positive Data Impact: The encouraging progression-free survival (PFS) data from VERSATILE-002 may allow for a shorter trial duration and quicker regulatory submission while keeping median overall survival (mOS) as the endpoint for full FDA approval.
Accelerated Treatment Availability: The proposed changes aim to expedite the availability of the promising treatment to patients in need.
Leadership Statement: Frank Bedu-Addo, CEO of PDS Biotech, emphasized the significance of the positive data in enhancing the trial's efficiency and regulatory process.
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Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer during the GOBLET Cohort 4, significantly exceeding the historical benchmark of 10%, indicating its crucial clinical value in a setting with no FDA-approved treatment options.
- Duration of Response: Among 14 evaluable patients, the median duration of response for pelareorep reached approximately 17 months, far surpassing the standard treatment's 9.5 months, showcasing the drug's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for potential accelerated approval if the data is validated.
- Strategic Investment and Expert Support: The company expanded its Scientific Advisory Board by adding three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, further strengthening its strategic positioning in the gastrointestinal oncology field.

Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer patients during the GOBLET Cohort 4 study, significantly surpassing the historical benchmark of 10%, indicating the therapy's substantial potential in a patient population with no FDA-approved options.
- Duration of Response: The study also revealed a median duration of response of approximately 17 months, far exceeding the standard treatment's 9.5 months, suggesting that pelareorep offers durable efficacy in heavily pretreated patients, addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for accelerated approval if the observed data can be replicated.
- Strategic Investment and Expansion: The company is enhancing its strategic positioning in gastrointestinal oncology by expanding its Scientific Advisory Board, further solidifying its market presence in anal cancer and other indications.






