The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.
Apellis Pharmaceuticals, Inc. is looking at a three-month extension of the US Food and Drug Administration action date for its pegcetacoplan in geographic atrophy (GA), but that’s because it is choosing to submit additional data to the agency. The firm opted for the short delay in order to have a more compelling dataset to take to the market.
Apellis said 3 November that it would submit 24-month Phase III data from the 637-patient DERBY and 621-patient OAKS clinical...
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
The group has stopped further development of the IL-17A inhibitor in hidradenitis suppurativa and psoriatic arthritis, and intends to pivot to a thyroid eye disease therapy.
The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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