FDA Grants Full Approval To Lilly's Inluriyo Plus Verzenio For ESR1-Mutated Breast Cancer

Eli Lilly received FDA approval for Inluriyo with Verzenio in advanced breast cancer. Shares closed at $1,152.93, up 0.04%. The approval adds to Lilly's oncology portfolio but lacks sales forecasts. Verzenio generated $1.474B in Q2 2026, down 1% YoY. Next earnings report on Oct. 29 may provide more insights.

Twist Bioscience (TWST) stock rose 7.02% after announcing an AI drug discovery collaboration with Eli Lilly. The company reported $376.6M in trailing revenue, 52% gross margin, and -$35.1M net income. Analysts set price targets at $144-$160, with a bullish technical outlook. TWST trades at ~22x sales and ~21x book.

Eli Lilly (LLY) received full FDA approval for Inluriyo, an oral treatment for a specific breast cancer subtype. The company's stock is trading at $1,146.38, with a GF Value™ of $1,542.92, suggesting a 25.7% undervaluation. LLY's GF Score™ is 96 out of 100, indicating strong financial health and growth potential. Insiders have sold $3.56 billion in shares over the past year, while 25 premium gurus hold positions, with 13 adding and 10 trimming stakes.

Eli Lilly's Inluriyo (imlunestrant) received FDA approval in combination with Verzenio (abemaciclib) for ER+, HER2-, ESR1-mutated advanced/metastatic breast cancer. The approval follows Phase 3 EMBER-3 trial results showing the combination doubled median progression-free survival (11.1 months vs. 5.5 months) compared to Inluriyo alone. The treatment targets two key drivers of breast cancer growth, offering a new option for patients with disease progression.

The U.S. FDA approved Eli Lilly's Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer. The combination doubled median progression-free survival in the Phase 3 EMBER-3 trial. Inluriyo targets mutated estrogen receptors, while Verzenio slows cancer cell division. The treatment is now available in the U.S.

The Trump administration will expand its Medicaid most-favored-nation drug pricing model to all 50 states, D.C., and Puerto Rico. The plan aims to lower drug prices by offering rates comparable to other developed nations. Deals have been signed with major drugmakers like Pfizer, Eli Lilly, and Novo Nordisk, as well as smaller biotechs.