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NEW HAVEN - Arvinas, Inc. (NASDAQ:ARVN), a biopharmaceutical company with a market capitalization of $705 million, announced positive results from two Phase 1 clinical trials evaluating ARV-102, its oral brain-penetrant PROTAC degrader targeting leucine-rich repeat kinase 2 (LRRK2), according to a press release statement. The company’s stock has shown strong momentum, gaining over 46% in the past six months, according to InvestingPro data.
The data, presented at the International Congress of Parkinson’s Disease and Movement Disorders in Honolulu, showed ARV-102 was well-tolerated in both healthy volunteers and patients with Parkinson’s disease. InvestingPro analysis indicates the company maintains a strong financial position with more cash than debt and a healthy current ratio of 5.64, providing runway for its clinical development programs.
In the healthy volunteer trial, ARV-102 demonstrated dose-dependent exposure in plasma and cerebrospinal fluid (CSF), indicating brain penetration. Daily doses of 20mg or higher resulted in over 90% reduction of LRRK2 protein in blood cells and more than 50% reduction in CSF.
After 14 days of treatment in healthy volunteers, ARV-102 decreased lysosomal and neuroinflammatory microglial pathway biomarkers that are typically elevated in Parkinson’s disease patients.
"To our knowledge, this is the first time an investigational LRRK2 therapy has shown effects on distal pathway biomarkers in CSF that are elevated in patients with LRRK2 Parkinson’s disease," said John Houston, CEO of Arvinas.
In the Parkinson’s disease patient trial, single doses of ARV-102 (50mg or 200mg) were well-tolerated with only mild treatment-related adverse events. The 200mg dose achieved 97% reduction of LRRK2 protein in blood cells.
Arvinas plans to present initial data from a multiple dose cohort of Parkinson’s patients in 2026. The company also intends to initiate a Phase 1b trial in progressive supranuclear palsy patients in the first half of 2026, pending data and regulatory clearance.
LRRK2 mutations are a frequent familial cause of Parkinson’s disease, and common LRRK2 variants have been linked with idiopathic Parkinson’s disease.
In other recent news, Arvinas Inc. announced a significant shift in its partnership with Pfizer regarding their drug candidate vepdegestrant. The companies plan to out-license the commercialization and development rights to a third party, a decision that has prompted varying responses from analysts. H.C. Wainwright reiterated its Buy rating with an $18 price target, viewing the move as beneficial for Arvinas by reducing financial risks. Conversely, BofA Securities downgraded Arvinas from Buy to Neutral, adjusting the price target to $10 due to the partnership change. Barclays also lowered its price target to $15 while maintaining an Overweight rating, highlighting the strategic licensing plans. Cantor Fitzgerald reaffirmed its Overweight rating, noting the potential impact on the company’s strategic direction. Stephens reduced its price target to $14 but maintained an Overweight rating, reflecting on the update about the Pfizer collaboration. These developments come as the drug approaches a potential FDA approval date in 2026.
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