Biotech Values

[DewDiligence]

The FDA moved BMY’s PDUFA date for subcutaneous Opdivo two months earlier in what is apparently a correction of a clerical error by the FDA. The new PDUFA date is 12/29/24 rather than 2/28/25.

Explanation: By treating BMY’s filing as an sBLA rather than an original BLA, an FDA standard review is 10 months rather than 12 months. In an sBLA—but not an original BLA—the approximately 2 months from the applicant’s submission to the FDA’s acceptance of the submission is counted as part of the total 10-month review period. The rationale for this review being an sBLA (rather than an original BLA) is that the FDA previously approved both Opdivo and HALO’s hyaluronidase excipient.

https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Announces-Updated-Action-Date-by-the-U.S.-Food-and-Drug-Administration-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx (5/21/24 PR)

https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx (5/6/24 PR)