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MacroGenics (MGNX) reported that following the U.S. FDA's approval of Incyte's (INCY) Biologics License Application for ZYNYZ, the company will receive a $15M milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1, was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. "The FDA approval of ZYNYZ represents the third approval of a product originating from MacroGenics' pipeline of proprietary or partnered product candidates," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. Under the terms of the license agreement, beyond the $15M approval milestone, MacroGenics is also eligible to receive up to a total of $320M in potential remaining development and regulatory milestones and up to $330M in potential commercial milestones from Incyte. In addition, MacroGenics is eligible to receive tiered royalties of 15% to 24% on any global net sales of the product. Finally, MacroGenics has an agreement with Incyte under which it manufactures a portion of Incyte's global commercial supply of retifanlimab.

Incyte announced that the U.S. Food and Drug Administration has approved Zynyz, a humanized monoclonal antibody targeting programmed death receptor-1, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma, or MCC. The Biologics License Application, or BLA, for Zynyz for this indication has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response, or DOR, the company noted. "Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials," Incyte said. "Zynyz offers patients and healthcare professionals an additional first-line anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat. Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. We continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds," said Herve Hoppenot, Chief Executive Officer, Incyte.

Roche (RHHBY) announced that it has entered into a collaboration with Eli Lilly (LLY) to support the development of Roche's Elecsys Amyloid Plasma Panel, or EAPP, which it calls "an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer's disease." Roche said: "Today, barriers to early and accurate diagnosis of Alzheimer's exist across the globe with up to 75% of people living with the symptoms of Alzheimer's, but without a diagnosis. Those who have received a diagnosis waited, on average, 2.8 years after symptom onset. To address the growing strain that Alzheimer's is putting on healthcare systems, it will be essential to make a person's journey to diagnosis faster and more accessible. This will ultimately enable access to appropriate new therapies as they become available. This collaboration is aligned to both Roche and Lilly's shared objective to support patients by improving the journey to a timely and accurate diagnosis and treatment. If approved, the EAPP test would be an additional tool to identify low likelihood of amyloid pathology in symptomatic patients and determine whether they should proceed to further evaluation and testing that may confirm a diagnosis."