Shares of Kodiak Sciences plunged by over 50% in premarket trading on Monday as the biopharmaceutical company announced the termination of its lead investigational medicine, tarcocimab tedromer. This decision comes after the failure of two Phase 3 studies focusing on the treatment of diabetic macular edema.
Disappointing Results in Phase 3 Studies
Kodiak Sciences, headquartered in Palo Alto, California, revealed that both studies failed to meet their primary efficacy endpoints, which aimed to demonstrate non-inferior visual acuity gains compared to aflibercept. The company attributes these failures to an unexpected rise in cataracts observed in the tarcocimab study groups over time.
The Impact on Regulatory and Clinical Development Strategy
While a separate Phase 3 study concerning wet age-related macular degeneration did achieve the primary endpoint of non-inferior visual acuity gains when compared with aflibercept, Kodiak emphasizes that successful outcomes in the diabetic macular edema studies were crucial for the regulatory and clinical development strategy of tarcocimab.
Financial Stability Amidst New Plans
Kodiak reassures stakeholders that it is financially stable as it adjusts its near-term business plan. The company reported approximately $379 million in cash and equivalents as of June 30.
As a result of this announcement, Kodiak shares experienced a significant decline, falling nearly 56% from $7.29 to $3.24 in premarket trading on the same day.
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