The New York-headquartered firm, which recently decided to focus on gene therapy, has to decide whether to partner Zimura or go it alone.
Shares in Iveric Bio are continuing to soar after the small US biotech said its lead asset Zimura slowed eyesight deterioration in patients with dry age-related macular degeneration (AMD).
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Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.
The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.
But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
Abeona plans to offer an outcomes-based payment model for Zevaskyn, which likely will see complementary use with Krystal’s Vyjuvek in recessive dystrophic epidermolysis bullosa patients.
The AKT inhibitor proves ineffective for metastatic castration-resistant disease in a Phase III trial.
