✎ Contributed by Ty Griffin
Biotech shares were under pressure Tuesday after FDA Commissioner Marty Makary defended the agency’s recent drug approval decisions following mounting criticism. Speaking to CNBC, Makary said he stands by FDA scientists amid backlash tied to high-profile rejections, including a melanoma treatment candidate from Replimune Group Inc.
Makary pushed back on claims of inconsistency or bias, stating that multiple independent review teams reached the same conclusions and emphasizing that commissioners overriding scientific staff has historically led to poor outcomes. The comments come as scrutiny intensifies over the agency’s decision-making process and its impact on smaller biotech firms reliant on regulatory approvals.
Market Reaction
- Replimune Group Inc. (NASDAQ: REPL): $2.66, down $0.36 (12.05%)
- Moderna Inc. (NASDAQ: MRNA): $46.40, down $0.90 (1.91%)
- Pfizer Inc. (NYSE: PFE): $26.08, down $0.22 (0.82%)
- Eli Lilly and Co. (NYSE: LLY): $980.82, up $12.89 (1.33%)
- Bristol-Myers Squibb Co. (NYSE: BMY): $56.82, down $0.56 (0.98%)
Investor Sentiment
The sharp decline in Replimune shares highlights how sensitive smaller biotech companies are to FDA decisions, particularly when clinical outcomes hinge on a single product candidate. Makary’s defense of the agency suggests a continued emphasis on strict scientific review, which may temper expectations for regulatory flexibility.
Meanwhile, larger pharmaceutical companies showed more muted reactions, reflecting diversified pipelines and lower reliance on any single approval. Investors appear to be factoring in sustained regulatory scrutiny, especially for novel therapies, while continuing to differentiate between early-stage biotech risk and established pharmaceutical stability.
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