ZACKS·2025-12-29 16:15Industry Overview - The biotech and drug industry experienced a significant rebound in 2025 after a cautious start, driven by drug pricing agreements and increased M&A activity [1] - The FDA approved 44 novel therapies in 2025, with 26 approvals occurring in the second half of the year, indicating an acceleration in regulatory activity [1][2] Company Analysis: Altimmune (ALT) - Altimmune is focused on developing therapies for liver diseases, with its lead candidate pemvidutide currently in mid-stage studies for metabolic dysfunction-associated steatohepatitis (MASH) [4] - Shares of Altimmune have decreased over 46% year-to-date due to mixed results from the phase IIb IMPACT study, although it met one primary endpoint related to MASH resolution [5] - Recent 48-week results from the IMPACT study showed further improvements in non-invasive tests and significant reductions in liver health biomarkers [6] - Altimmune plans to initiate a late-stage study for pemvidutide in MASH in 2026 after aligning with the FDA on key parameters [7] - The company is also exploring pemvidutide for alcohol use disorder and alcohol-associated liver disease, with data expected next year [8] Company Analysis: ImmunityBio (IBRX) - ImmunityBio focuses on therapies for cancer and infectious diseases, with its marketed drug Anktiva approved for bladder cancer [11] - Shares of ImmunityBio have declined over 16% this year due to a regulatory setback from the FDA regarding a label expansion for Anktiva [12] - Despite the setback, Anktiva generated nearly $75 million in sales this year, a significant increase from $7 million in the previous year, and the company is seeking EU market expansion [13] - ImmunityBio is also developing Anktiva for other cancer indications, with promising data in non-small cell lung cancer and glioblastoma expected to be updated in 2026 [14] - Loss per share estimates for 2026 have improved from $0.37 to $0.33 in the past 60 days [15] Company Analysis: Seres Therapeutics (MCRB) - Seres Therapeutics is developing SER-155, an oral live biotherapeutic aimed at preventing bloodstream infections in patients undergoing stem cell transplantation [16] - Investor interest in SER-155 increased after a phase Ib study showed a 77% relative reduction in bacterial infections compared to placebo [17] - The FDA has provided positive feedback for SER-155's advancement to mid-stage development, with an interim update expected within 12 months of study initiation [18] - Shares of Seres Therapeutics have decreased nearly 12% year-to-date, but loss per share estimates for 2026 have improved from $10.66 to $7.67 in the past 60 days [18]