Several biotechnology companies reported their fourth quarter earnings this week, highlighting ongoing regulatory challenges and significant developments across the sector. The reports come after a turbulent 2025, which saw market instability due to regulatory uncertainty and policy debates over drug pricing. While some predicted a recovery early in the year, law firm Ropes & Grey described the first half of 2025 as a bear market.
The second half of the year brought renewed optimism as mergers and acquisitions activity increased, notably with Pfizer's successful bid for Metsera. This shift set up a more promising environment for smaller biotech firms now sharing their latest financial results.
Capricor Therapeutics faced setbacks when the Food and Drug Administration (FDA) rejected its Duchenne muscular dystrophy cardiomyopathy cell therapy in July 2025. The rejection was reportedly influenced by internal disagreements at the FDA between Nicole Verdun, then head regulator of cell and gene therapies, and her supervisor Vinay Prasad. Following Prasad’s recent departure, Capricor CEO Linda Marbán said during an earnings call that while it is unclear whether an advisory committee meeting will be required for their resubmitted therapy deramiocel, "Either way, we’ll be prepared." Marbán added that strong data from the Phase 3 HOPE-3 trial supports their case: "I really would be delighted, whether I present it in an AdComm or we proceed directly to PDUFA without it."
Legend Biotech reported $555 million in revenue for its CAR T cell therapy Carvykti in the fourth quarter—a nearly six percent increase from the previous period—though it still posted a net loss of $30.9 million. CEO Ying Huang said Legend aims to reach company-wide profitability this year with growing sales and $949 million cash on hand.
Allogene is anticipating critical results from its Phase 2 ALPHA3 study of CD19 CAR T cema-cel in large B cell lymphoma patients during the second quarter of 2026. William Blair wrote that they remain optimistic about cema-cel’s potential to outperform other therapies.
Inovio is awaiting an FDA decision by October on its biologics license application for INO-3107 after nearly three decades of development. CEO Jacqueline Shea said this was the first time Inovio had heard concerns about eligibility for accelerated approval but remains confident: “We strongly believe that INO-3107 does fulfill the criteria for review under the accelerated approval program.” Inovio has made staffing cuts to extend its cash runway into late 2026 but may need additional funding if approved.
These updates reflect both persistent hurdles and new opportunities as biotechs navigate evolving regulatory landscapes and pursue commercial success.
