2025 was a catalyst yr for biotech and drug shares. Whereas the yr started on a cautious word for the sector as a consequence of issues over potential tariffs on pharmaceutical imports, the sector rebounded within the second half. Massive drugmakers’ drug pricing agreements with the Trump administration and a rise in M&A exercise fueled this rally. New drug approval and fast pipeline progress additionally contributed to the sector restoration. To date this yr, the FDA has authorized 44 novel therapies, out of which 26 have been authorized previously six months, highlighting an acceleration in regulatory exercise because the yr progressed.
The biotech and drug business continues to draw investor consideration no matter business dynamics, given the continued want for modern medical remedies.
Right here, we talk about three biotech/drug shares that took a beating in 2025 however are more likely to bounce again in 2026 based mostly on anticipated regulatory approvals and/or optimistic pipeline updates. These are Altimmune ALT, ImmunityBio IBRX and Seres Therapeutics MCRB. All three shares carry a Zacks Rank #2 (Purchase) and have seen optimistic estimate revisions for 2026.
Altimmune
ALT is a clinical-stage biotech targeted on creating therapies focusing on liver ailments. Its lead pipeline candidate is pemvidutide, a novel peptide-based GLP-1/glucagon twin receptor agonist presently being developed in a mid-stage research for a fatty liver illness referred to as metabolic dysfunction-associated steatohepatitis (MASH).
Shares of Altimmune have plummeted greater than 46% yr up to now, largely as a consequence of combined top-line outcomes from the section IIb IMPACT research reported in June, which evaluated pemvidutide in MASH sufferers over 24 weeks. Whereas this research met one in every of its major endpoints — MASH decision with out worsening fibrosis — it failed to attain statistical significance within the different co-primary endpoint of enhancing fibrosis with out MASH worsening. Regardless of this setback, the corporate nonetheless highlighted encouraging indicators of anti-fibrotic exercise, together with enhancements in non-invasive exams (NITs) of fibrosis and irritation.
Earlier this month, Altimmune reported 48-week top-line outcomes from the IMPACT research, which confirmed additional enhancements in NITs in comparison with the 24-week outcomes, together with statistically vital reductions throughout liver well being and hepatic irritation biomarkers. The outcomes additionally confirmed that extra weight reduction was noticed in sufferers handled on the greater drug dose in comparison with the 24-week knowledge, with none indicators of plateauing.
Alongside the 48-week outcomes, Altimmune additionally introduced that it held a gathering with the FDA the place it reached alignment on key parameters for a late-stage research on pemvidutide within the MASH indication. ALT plans to begin this research in 2026, probably clearing a path towards its first marketed drug.
Aside from MASH, Altimmune can also be evaluating the drug in separate mid-stage research for alcohol use dysfunction (AUD) and alcohol-associated liver illness (ALD). An information readout from the AUD research is predicted subsequent yr, which might function a catalyst for the inventory.
Loss per share estimates for 2026 have improved from $1.33 to $1.13 previously 60 days.
ImmunityBio
IBRX is a commercial-stage biotech targeted on creating novel therapies focusing on most cancers and infectious ailments. Anktiva, the sole-marketed drug in its portfolio, was authorized by the FDA final yr together with Bacillus Calmette-Guérin (BCG) to deal with adults with BCG-unresponsive non-muscle invasive bladder most cancers (NMIBC) with carcinoma in situ (CIS), with or with out papillary tumors.
But, shares of ImmunityBio have misplaced greater than 16% to this point this yr. This decline is primarily attributable to a regulatory setback earlier this yr, when the corporate acquired a refusal to file (RTF) letter from the FDA for a regulatory submitting looking for label enlargement for Anktiva plus BCG in BCG-unresponsive papillary-only NMIBC. IBRX is presently evaluating its subsequent steps to deal with this situation.
That stated, underlying fundamentals stay encouraging. To date this yr, the drug has generated practically $75 million in gross sales, a big improve from practically $7 million recorded within the year-ago interval, pushed by elevated demand developments. The corporate can also be looking for to broaden the drug’s market past america. A regulatory submitting is presently beneath evaluation within the European Union looking for conditional advertising and marketing authorization for the drug within the above indication. Earlier this month, an EMA advisory committee really helpful approving this submitting. A last determination is predicted quickly.
ImmunityBio can also be creating Anktiva, each as a monotherapy and together with different brokers, for expanded use in bladder most cancers in addition to for different most cancers indications like non-small cell lung most cancers (NSCLC), glioblastoma and non-Hodgkin lymphoma. In NSCLC research, the drug has proven potential to reverse lymphopenia and lengthen general survival, whereas in glioblastoma research, it confirmed robust knowledge in reaching illness management. We anticipate the corporate to supply an replace on these research in 2026.
Loss per share estimates for 2026 have improved from 37 cents to 33 cents previously 60 days.
Seres Therapeutics
A clinical-stage biotech, MCRB is concentrated on creating new therapies comprised of rationally chosen stay bacterial consortia. Its lead pipeline drug is SER-155, an investigational oral stay biotherapeutic designed to stop life-threatening bloodstream infections (BSIs) and associated issues in sufferers present process allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Investor consideration towards SER-155 elevated after Seres Therapeutics reported encouraging knowledge from a section Ib research, which confirmed that therapy with the drug achieved a 77% relative discount in bacterial BSIs in comparison with placebo in adults present process allo-HSCT. The outcomes additionally recommend the drug’s potential to deal with inflammatory and immune-mediated ailments.
Regulatory response has additionally been optimistic. Lately, the FDA issued constructive suggestions supporting SER-155’s development to mid-stage improvement. Whereas Seres Therapeutics is presently engaged in securing the mandatory funding for this research, it believes that it will likely be in a position to present an interim replace inside 12 months of research initiation.
Yr up to now, shares of Seres Therapeutics have misplaced practically 12%.
Loss per share estimates for 2026 have improved from $10.66 to $7.67 previously 60 days.
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Altimmune, Inc. (ALT) : Free Inventory Evaluation Report
Seres Therapeutics, Inc. (MCRB) : Free Inventory Evaluation Report
ImmunityBio, Inc. (IBRX) : Free Inventory Evaluation Report
This text initially printed on Zacks Funding Analysis (zacks.com).
The views and opinions expressed herein are the views and opinions of the writer and don’t essentially mirror these of Nasdaq, Inc.
