FDA Grants Orphan Drug Status to Cardiff's Onvansertib in Rare Leukemia
CRDF sits 26% above its 52-week low of $0.757.
Summary
The FDA granted orphan drug designation to onvansertib for chronic myelomonocytic leukemia, a rare blood cancer. The drug is in a Phase 1 study for relapsed/refractory CMML and showed preliminary efficacy in 40% of myeloproliferative CMML patients. Orphan status brings seven years of market exclusivity and development incentives, but this is a small early-stage program next to the company's main push in RAS-mutated colorectal cancer. Cardiff remains a microcap with a going concern warning and a recently settled Nerviano license dispute, so the designation is a modest positive rather than a thesis-changer. The special shareholder meeting on October 22 to approve doubling authorized shares is the nearer-term item.
At the time of this announcement, CRDF was trading at $0.95 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $73M. The 52-week trading range was $0.76 to $3.31. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Reuters.