tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Summit Therapeutics’ Ivonescimab BLA Accepted by FDA

Story Highlights
  • Summit’s BLA for ivonescimab in post-TKI EGFR-mutated NSCLC was accepted by FDA with a November 14, 2026 PDUFA date.
  • Ivonescimab’s extensive Phase III program and commercial use in China could strengthen Summit’s oncology positioning if U.S. approval follows.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Summit Therapeutics’ Ivonescimab BLA Accepted by FDA

Claim 50% Off TipRanks Premium

An update from Summit Therapeutics ( (SMMT) ) is now available.

On January 29, 2026, Summit Therapeutics announced that the U.S. Food & Drug Administration accepted for filing its Biologics License Application for ivonescimab in combination with chemotherapy for patients with EGFR‑mutated locally advanced or metastatic non-squamous non-small cell lung cancer who have progressed after third-generation tyrosine kinase inhibitor therapy. The application, supported by results from the global Phase III HARMONi trial, has been assigned a Prescription Drug User Fee Act goal action date of November 14, 2026, and targets a setting with a significant unmet need, with more than 14,000 eligible U.S. patients annually. Ivonescimab, a novel bispecific antibody that blocks PD‑1 and VEGF, has been tested in numerous Phase III studies worldwide, including multiple Summit-sponsored global trials in lung and colorectal cancers, and already has commercial experience in China through partner Akeso, positioning Summit as a potential new competitor in the U.S. oncology market if approval is granted.

The most recent analyst rating on (SMMT) stock is a Hold with a $16.50 price target. To see the full list of analyst forecasts on Summit Therapeutics stock, see the SMMT Stock Forecast page.

Spark’s Take on SMMT Stock

According to Spark, TipRanks’ AI Analyst, SMMT is a Neutral.

Score is weighed down primarily by weak financial performance (minimal revenue, sharply larger losses, and accelerating cash burn) and a downtrending technical setup (below major moving averages). Offsetting these is a strong earnings-call outlook driven by positive Phase III data, program expansion, and near-term regulatory steps (planned BLA), but higher spending and funding needs remain key risks.

To see Spark’s full report on SMMT stock, click here.

More about Summit Therapeutics

Summit Therapeutics Inc. is a Nasdaq-listed biopharmaceutical oncology company focused on discovering, developing, and commercializing therapies aimed at improving quality and duration of life and addressing serious unmet medical needs. Founded in 2003 and headquartered in Miami with additional offices in Menlo Park, California, and Oxford, UK, Summit’s pipeline centers on innovative cancer medicines, including the investigational bispecific antibody ivonescimab, for global markets across North America, South America, Europe, the Middle East, Africa, and Japan.

Average Trading Volume: 2,607,782

Technical Sentiment Signal: Hold

Current Market Cap: $11.84B

For a thorough assessment of SMMT stock, go to TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1