Amgen’s Bemarituzumab Receives Breakthrough Therapy Designation


Amgen’s investigational treatment bemarituzumab has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration based on results from the Phase 2 FIGHT trial.

The designation is for the treatment of gastric and gastroesophageal adenocarcinoma in combination with fluoropyrimidine, leucovorin, and oxaliplatin.

Amgen (AMGN) Executive Vice president of Research and Development, David M. Reese, M.D., said, “The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy.”

In the FIGHT trial, a combination of bemarituzumab and chemotherapy showed clinically significant and substantial improvements in progression-free survival and overall survival of patients as compared to treatment with chemotherapy alone.

Notably, this is the 2nd breakthrough therapy designation received by Amgen in the last six months after sotorasib . (See Amgen stock analysis on TipRanks)

On April 19, Mizuho Securities analyst Salim Syed reiterated a Hold rating on the stock with a price target of $200 implying 22% downside potential.

Commenting on Amgen’s upcoming 1Q results on April 27, Syed said, ”Investor focus will remain on sotorasib’s upcoming anticipated launch and combo data, Amgen’s BiTE  portfolio and where it stands, bema regulatory interactions and tezepelumab.”

Consensus among analysts is that Amgen is a Moderate Buy based on 8 Buys and 7 Holds. The average analyst price target of $261.08 implies that the stock is almost fully priced at current levels. Shares have gained about 10.7% over the past year.

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