ARVN Stock Jumps 10% After FDA Approves Breast Cancer Drug A Month Ahead Of Schedule

• The decision also marks the FDA’s first approval of a PROTAC therapy, a type of targeted protein-degrading drug.
• The approval is based on a Phase 3 trial, in which Veppanu reduced the risk of disease progression or death by 43% compared with Fulvestrant.
• Arvinas and Pfizer plan to partner with a third party to support the drug’s commercial rollout.

Shares of Arvinas Inc. (ARVN) gained nearly 10% on Friday, after the company announced that the U.S. Food and Drug Administration approved its breast cancer drug to treat patients with ES1 mutations.

The drug, Vepdegestrant, which will be marketed as Veppanu, was jointly developed with Pfizer (PFE). The approval comes more than a month ahead of the Prescription Drug User Fee Act (PDUFA) action date.

The decision also marks the FDA’s first approval of a Proteolysis Targeting Chimera (PROTAC) therapy, a type of targeted protein-degrading drug.

Disease Progression Reduced By 43%

The approval is based on a Phase 3 trial, in which Veppanu reduced the risk of disease progression or death by 43% compared with Fulvestrant, an injection for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Median progression-free survival improved to five months versus 2.1 months.

Arvinas and Pfizer plan to partner with a third party to support the drug’s commercial rollout.

“We are especially encouraged by receiving FDA approval ahead of the June 5 PDUFA date, and together with Pfizer, we are on track to announce selection of a third party to bring this new treatment option to patients as soon as possible,” said Randy Teel, President and CEO at Arvinas.

The drug received Fast Track designation from the FDA in 2024, followed by the agency’s acceptance of its New Drug Application (NDA) for review last August.

How Did Retail Traders React?

Retail sentiment for ARVN on Stocktwits remained in the ‘bullish’ territory over the past 24 hours, amid ‘high’ message volumes.

One user sees the stock as a “long-term hold.”

The stock has declined 11% so far this year.

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