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Why Replimune Stock Crashed Nearly 40% Today - What Investors Need to Know

Why Replimune Stock Crashed Nearly 40% Today - What Investors Need to Know

Author:
foolstock
Published:
2025-09-18 10:59:13
10
3

Replimune shares just got absolutely hammered—plunging almost 40% in a single trading session. Here's what triggered the bloodbath.

Clinical Trial Shocker

The biotech firm dropped a bombshell update on their lead candidate—turns out the data didn't exactly scream 'blockbuster.' Investors bolted for the exits faster than a leveraged crypto trader spotting a -10% dip.

Market Punishment Mode

When you miss key endpoints in this sector, the market doesn't just frown—it executes. No grace periods, no second chances. Just a straight -40% haircut by lunchtime.

Biotech's Brutal Reality

One bad data readout and suddenly your market cap looks like it got rugged. At least in crypto when a project tanks you can blame anonymous devs—here you have to face the FDA.

A fateful meeting?

The meeting was conducted with U.S. Food and Drug Administration (FDA) officials, and it took place on Tuesday. The subject of discussion was Replimune's RP1, a cancer drug being trialed as a combination therapy with pharmaceutical sector mainstay's Opdivo to treat advanced melanoma.

Healthcare professional inspecting charts.

Image source: Getty Images.

In June, the regulator sent Replimune a complete response letter regarding RP1, a type of missive informing a drug developer that a given product will not be approved. That caught the company and many of its shareholders by surprise, as the drug had shown notable promise in clinical testing.

The Replimune/FDA summit took the FORM of a Type A meeting, described by the health agency as one that's "needed to help an otherwise stalled product development program proceed."

"The company is evaluating the feedback from the FDA provided during the meeting to determine next steps," Replimune wrote in its press release on the matter. "At this time, a path forward under the accelerated approval pathway has not been determined."

Uncertain fate

Clearly, investors took this to mean that the RP1 program will be discontinued. While we shouldn't necessarily jump to conclusions, Replimune's rather tepid and neutral statement on the future of the drug didn't strike a note of confidence.

|Square

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