Catalyst Biosciences stock (CBIO) is rallying quite hard today. It appears to be on the back of no news for Catalyst Biosciences stock at this time, though there are whispers of positive data from some of its clinical development projects. What we do know is that there were some recent milestones for the company in the last few weeks. These milestones for Catalyst Biosciences stock include:
- Successfully completed dosing of the first and second cohorts of the Phase 1/2 clinical trial. The second cohort included the first subcutaneous dosing of individuals with hemophilia B;
- Demonstrated 22-fold higher potency and improved pharmacokinetics of CB 2679d compared with BeneFIX™ with intravenous dosing in the first patient cohort of the Phase 1/2 clinical trial in individuals with hemophilia B;
- Granted orphan drug designation for CB 2679d for the treatment of hemophilia B from the U.S. Food and Drug Administration; and
- Received patents covering both modified Factor IX polypeptides and uses thereof for CB 2679d in the People’s Republic of China, Singapore and Taiwan.
That said, there are a number of expectations for the name. It will hit several benchmarks this year and next:
- Present interim results from the subcutaneous Factor IX CB 2679d Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B in an oral presentation on Dec. 9, 2017 at the American Hematological Society Conference in Atlanta, GA;
- Initiate the Factor VIIa marzeptacog alfa (activated) Phase 2 part of a Phase 2/3 subcutaneous efficacy clinical trial in individuals with hemophilia A or B with an inhibitor by the end of 2017;
- Announce top-line multi-dose results from the subcutaneous Factor IX CB 2679d Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B by Q1 of 2018; and
- Announce interim results from the Factor VIIa marzeptacog alfa (activated) Phase 2 clinical trial in individuals with hemophilia A or B with an inhibitor in the first half 2018.
“We have made steady progress with the clinical development of our coagulation Factor IX hemophilia product candidate, and we look forward to presenting interim results from the ongoing Phase 1/2 subcutaneous dosing study in individuals with hemophilia B at the American Society of Hematology on Dec. 9, as we announced yesterday” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “This is an exciting time for the company as we continue towards near-term data milestones and longer-term program development for both our Factor IX and FVIIa programs.”
We believe Catalyst Biosciences stock is a hold at this time.
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