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Denali awaits an April 5, 2026 FDA decision after a BLA review extension for its Hunter syndrome therapy.
Nuvalent's zidesamtinib NDA was accepted, with a Sept. 18, 2026 FDA action date in ROS1-positive NSCLC.
VNDA seeks priority review for imsidolimab in GPP, which could allow FDA approval as early as mid-2026.
The biotech sector staged a robust comeback in 2025, with the Nasdaq Biotechnology Index climbing 33.8%. Although concerns about potential high tariffs initially hurt the industry, sentiment among investors rebounded sharply, powering a notable recovery.
The rally has been driven by a steady stream of new drug approvals, encouraging pipeline and regulatory updates, and a notable pickup in mergers and acquisitions (M&A) activity supported by a shifting industry landscape and growing enthusiasm around AI-enabled drug discovery.
The FDA has approved more than 44 drugs in 2025, underscoring renewed momentum across the industry. This momentum is expected to continue in 2026 as well on the back of investor optimism around key drug approvals, positive data readouts and further innovation.
The dynamic yet volatile biotech industry appears well-positioned to maintain investor interest, driven by consistent demand for innovative medical therapies regardless of economic cycles.
We have highlighted three biotech stocks poised for high-impact catalysts in 2026, including pivotal clinical and regulatory events that could unlock significant shareholder value: Denali Therapeutics (DNLI - Free Report) , Nuvalent, Inc. (NUVL - Free Report) and Vanda Pharmaceuticals (VNDA - Free Report) .
All three delivered strong performances in the second half of 2025, a trend that could continue into 2026, supported by favorable regulatory developments and promising pipeline updates.
Denali owns an impressive pipeline of targeted therapeutic candidates for neurodegenerative diseases, and the recent pipeline progress is encouraging. The company is developing DNL310 or tividenofuspalfa, an Enzyme Transport Vehicle (ETV)-enabled iduronate-2-sulfatase (IDS) replacement therapy, for the treatment of MPS II (Hunter syndrome). It is designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain.
Denali submitted a biologics license application (BLA) for tividenofuspalfa under the FDA’s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
However, in October 2025, the FDA has extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa. The target date has been extended to April 5, 2026, from Jan. 5, 2026. The extension follows the company’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers.
The regulatory had previously granted tividenofuspalfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali continues to engage constructively with the FDA on the review process while advancing preparations for a potential commercial launch. A potential approval will be a significant boost to the company’s growth prospects as there are very few effective therapeutic options available for patients with diseases such Hunter syndrome.
In addition, Denali has pipeline candidates targeting Sanfilippo syndrome, Parkinson’s disease and ulcerative colitis, among other indications.
Nuvalent
Nuvalent is a clinical-stage biopharmaceutical company focused on developing precisely targeted cancer therapies designed to address the limitations of existing treatments for clinically validated kinase targets.
The company’s first lead product candidate, zidesamtinib (NVL-520), is being developed for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). Zidesamtinib is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs).
The candidate has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have previously been treated with two or more prior ROS1 TKIs, and orphan drug designation for ROS1-positive NSCLC.
The FDA has accepted the company’s new drug application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and assigned a target action date of Sept. 18, 2026.
In addition, the company recently reported positive top-line pivotal data for its second lead candidate, neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive NSCLC, from the phase I/II ALKOVE-1 study.
Nuvalent looks forward to discussing these pivotal data with the FDA and aligning on a potential registration pathway for neladalkib in TKI-pretreated patients with advanced ALK-positive NSCLC.
Vanda Pharmaceuticals
Vanda is a leading global biopharmaceutical company dedicated to developing and commercializing innovative therapies that target significant unmet medical needs and improve patients’ lives.
Earlier in the month, VNDA submitted a BLA to the FDA for pipeline candidate imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations.
The company has requested priority review for the BLA, citing GPP’s designation as a rare orphan disease with a significant unmet medical need. A potential priority review would shorten the FDA review timeline to six months, tentatively enabling approval of imsidolimab for the treatment of GPP as early as mid-2026.
A potential approval of the candidate would expand VNDA’s expertise in rare and orphan diseases while strengthening its anti-inflammatory portfolio, which includes Ponvory — an approved therapy for relapsing forms of multiple sclerosis that is also in clinical development for psoriasis and ulcerative colitis.
The company has multiple regulatory catalysts ahead, including FDA reviews of Bysanti (milsaperidone) for bipolar I disorder and schizophrenia, with a Feb. 21, 2026 target action date, and tradipitant for motion sickness, with a Dec. 30, 2025 target date. Vanda is also advancing tradipitant into a phase III program for GLP-1–induced nausea and vomiting, expected to begin in the first half of 2026.
Vanda is also evaluating tradipitant for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy in overweight and obese adults. A phase III program is anticipated to begin in the first half of 2026.
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3 Biotech Stocks With Major 2026 Catalysts
Key Takeaways
The biotech sector staged a robust comeback in 2025, with the Nasdaq Biotechnology Index climbing 33.8%. Although concerns about potential high tariffs initially hurt the industry, sentiment among investors rebounded sharply, powering a notable recovery.
The rally has been driven by a steady stream of new drug approvals, encouraging pipeline and regulatory updates, and a notable pickup in mergers and acquisitions (M&A) activity supported by a shifting industry landscape and growing enthusiasm around AI-enabled drug discovery.
The FDA has approved more than 44 drugs in 2025, underscoring renewed momentum across the industry. This momentum is expected to continue in 2026 as well on the back of investor optimism around key drug approvals, positive data readouts and further innovation.
The dynamic yet volatile biotech industry appears well-positioned to maintain investor interest, driven by consistent demand for innovative medical therapies regardless of economic cycles.
We have highlighted three biotech stocks poised for high-impact catalysts in 2026, including pivotal clinical and regulatory events that could unlock significant shareholder value: Denali Therapeutics (DNLI - Free Report) , Nuvalent, Inc. (NUVL - Free Report) and Vanda Pharmaceuticals (VNDA - Free Report) .
All three delivered strong performances in the second half of 2025, a trend that could continue into 2026, supported by favorable regulatory developments and promising pipeline updates.
Image Source: Zacks Investment Research
All three stocks currently have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Denali
Denali owns an impressive pipeline of targeted therapeutic candidates for neurodegenerative diseases, and the recent pipeline progress is encouraging. The company is developing DNL310 or tividenofuspalfa, an Enzyme Transport Vehicle (ETV)-enabled iduronate-2-sulfatase (IDS) replacement therapy, for the treatment of MPS II (Hunter syndrome). It is designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain.
Denali submitted a biologics license application (BLA) for tividenofuspalfa under the FDA’s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
However, in October 2025, the FDA has extended its review timeline of the BLA seeking accelerated approval of tividenofusp alfa. The target date has been extended to April 5, 2026, from Jan. 5, 2026. The extension follows the company’s submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to efficacy, safety or biomarkers.
The regulatory had previously granted tividenofuspalfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali continues to engage constructively with the FDA on the review process while advancing preparations for a potential commercial launch. A potential approval will be a significant boost to the company’s growth prospects as there are very few effective therapeutic options available for patients with diseases such Hunter syndrome.
In addition, Denali has pipeline candidates targeting Sanfilippo syndrome, Parkinson’s disease and ulcerative colitis, among other indications.
Nuvalent
Nuvalent is a clinical-stage biopharmaceutical company focused on developing precisely targeted cancer therapies designed to address the limitations of existing treatments for clinically validated kinase targets.
The company’s first lead product candidate, zidesamtinib (NVL-520), is being developed for patients with ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC). Zidesamtinib is a novel ROS1-selective inhibitor designed with the aim to address the clinical challenges of emergent treatment resistance, central nervous system (CNS)-related adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs).
The candidate has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with ROS1-positive metastatic NSCLC who have previously been treated with two or more prior ROS1 TKIs, and orphan drug designation for ROS1-positive NSCLC.
The FDA has accepted the company’s new drug application (NDA) for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and assigned a target action date of Sept. 18, 2026.
In addition, the company recently reported positive top-line pivotal data for its second lead candidate, neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive NSCLC, from the phase I/II ALKOVE-1 study.
Nuvalent looks forward to discussing these pivotal data with the FDA and aligning on a potential registration pathway for neladalkib in TKI-pretreated patients with advanced ALK-positive NSCLC.
Vanda Pharmaceuticals
Vanda is a leading global biopharmaceutical company dedicated to developing and commercializing innovative therapies that target significant unmet medical needs and improve patients’ lives.
Earlier in the month, VNDA submitted a BLA to the FDA for pipeline candidate imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations.
The company has requested priority review for the BLA, citing GPP’s designation as a rare orphan disease with a significant unmet medical need. A potential priority review would shorten the FDA review timeline to six months, tentatively enabling approval of imsidolimab for the treatment of GPP as early as mid-2026.
A potential approval of the candidate would expand VNDA’s expertise in rare and orphan diseases while strengthening its anti-inflammatory portfolio, which includes Ponvory — an approved therapy for relapsing forms of multiple sclerosis that is also in clinical development for psoriasis and ulcerative colitis.
The company has multiple regulatory catalysts ahead, including FDA reviews of Bysanti (milsaperidone) for bipolar I disorder and schizophrenia, with a Feb. 21, 2026 target action date, and tradipitant for motion sickness, with a Dec. 30, 2025 target date. Vanda is also advancing tradipitant into a phase III program for GLP-1–induced nausea and vomiting, expected to begin in the first half of 2026.
Vanda is also evaluating tradipitant for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy in overweight and obese adults. A phase III program is anticipated to begin in the first half of 2026.