Onvansertib Phase 2 Trial Shows 72.2% ORR in mCRC, FDA Aligns on Phase 3 Design
CRDF is trading near its 52-week low of $1.4 (9.3% above the low) on elevated volume (6.9× avg).
Summary
Cardiff Oncology announced strong positive Phase 2 results for its lead drug, Onvansertib, in first-line RAS-mutated metastatic colorectal cancer, achieving a 72.2% objective response rate versus 42.1% for standard-of-care. The drug was well-tolerated, and the company has aligned with the FDA on the design for a registrational Phase 3 trial. This significant clinical de-risking for Onvansertib follows the May 15th news of FDA agreement on the Phase 3 design. However, this positive data is overshadowed by the May 29th 8-K, which revealed the termination of the license agreement for Onvansertib by its licensor, creating a major hurdle for the drug's commercial future despite its clinical promise.
At the time of this announcement, CRDF was trading at $1.53 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $101.2M. The 52-week trading range was $1.40 to $4.56. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.