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What Awaits These 4 Biotech Stocks That More Than Doubled in 2025
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Key Takeaways
Ionis Pharmaceuticals surged 127.6% in 2025 on progress across wholly-owned programs.
GPCR jumped on phase II data showing up to 15.3% placebo-adjusted weight loss for oral GLP-1 aleniglipron.
KOD rallied as late-stage tarcocimab and KSI-501 advance, with multiple phase III readouts slated for 2026.
After a weak first half, the drug and biotech sector regained momentum in the latter part of 2025, setting the stage for a strong year for select stocks. Improved policy clarity following most large drugmakers’ drug pricing agreements with the Trump administration reduced a key source of uncertainty, while a rebound in mergers and acquisitions helped revive investor appetite for risk across the biotech industry.
Fundamentals have also been supportive, with innovation accelerating across high-growth areas, such as obesity, gene therapy, inflammation, and neuroscience. Regulatory activity remained healthy, with the FDA approving 43 novel therapies as of Dec. 22, 2025.
As we approach the New Year, let us take a good look at some biotech companies like Ionis Pharmaceuticals (IONS - Free Report) , Structure Therapeutics (GPCR - Free Report) , Monopar Therapeutics (MNPR - Free Report) , and Kodiak Sciences (KOD - Free Report) , which provided more than double returns in 2025 as sentiment improved and company-specific catalysts emerged.
Looking forward to 2026, investors are likely to focus on whether these high-performing biotech stocks can sustain their momentum through clinical execution, regulatory milestones, commercialization progress, and potential strategic transactions.
In the past year, shares of Ionis Pharmaceuticals have soared 120.5% compared with the industry’s 5% growth.
Image Source: Zacks Investment Research
The stock’s rally reflects a combination of favorable regulatory developments and encouraging pipeline progress, which have strengthened confidence in the company’s ability to advance its wholly-owned programs and meaningfully expand future revenues beyond its existing partnered, marketed products portfolio.
In 2025, Ionis advanced its wholly-owned portfolio, highlighted by the late-2024 FDA approval of Tryngolza (olezarsen) for familial chylomicronemia syndrome (FCS), its first independently launched product. Sales of the drug generated $57.4 million in the first nine months of 2025. Encouraging commercial uptake has prompted sequential increases in revenue guidance, with the momentum expected to extend into 2026. The drug’s EU approval in October 2025 expanded its geographical presence.
Ionis Pharmaceuticals is evaluating Tryngolza in three late-stage studies (CORE, CORE2, and ESSENCE) for severe hypertriglyceridemia (sHTG), all of which met primary endpoints with significant triglyceride reductions and fewer acute pancreatitis events. Based on these results, IONS plans to file for an FDA label expansion soon. If approved, it will materially broaden the drug’s patient base in an indication that IONS views as having a substantially larger commercial opportunity, supporting meaningful incremental revenue growth. Like FCS, Ionis Pharmaceuticals also has a first-mover advantage in the sHTG indication.
In August 2025, the FDA approved the company’s second wholly-owned drug, Dawnzera (donidalorsen), for hereditary angioedema (HAE). A regulatory filing for this HAE drug is under review in the EU, with a final decision expected in the first quarter of 2026. Ionis Pharmaceuticals also remains on track for more wholly-owned product launches in the next one to two years. These include zilganersen in Alexander disease (regulatory filing expected in early 2026) and ION82 in Angelman Syndrome (ongoing phase III study). If approved, zilganersen will be the company’s first launch in the neurology space.
In the past 60 days, estimates for IONS’ 2026 loss per share have narrowed from $2.84 to $2.76.
Structure Therapeutics
In the past year, Structure Therapeutics' shares have surged 127.2% compared with the industry’s 15.6% growth.
Image Source: Zacks Investment Research
The stock price rally was primarily driven by positive top-line data from GPCR’s ACCESS clinical program of investigational GLP-1 candidate, aleniglipron, for the treatment of obesity, announced earlier in December.
In the core 36-week phase IIb ACCESS study, GPCR’s aleniglipron met its primary and all key secondary endpoints, with the 120 mg dose delivering an 11.3% placebo-adjusted weight loss. Higher doses drove deeper reductions, reaching 15.3% at 240 mg. Extension data showed continued weight loss through 44 weeks with no plateau. Based on the encouraging results across the ACCESS program, Structure Therapeutics is currently gearing up to advance aleniglipron into phase III development.
The company intends to meet with the FDA in the first half of 2026 to align on the impending phase III study design. Structure Therapeutics expects to initiate the late-stage program of aleniglipron to treat obesity and/or overweight patients around mid-2026.
Beyond aleniglipron, Structure Therapeutics is developing ANPA-0073, a phase II-ready candidate designed to enable selective, muscle-sparing weight loss. GPCR also recently initiated an early-stage first-in-human study of ACCG-2671 for the treatment of obesity. The obesity arena, currently dominated by Eli Lilly and Novo Nordisk, represents a sizeable and still underpenetrated market opportunity that is attracting several smaller biotech players to challenge the incumbents.
In the past 60 days, estimates for GPCR’s 2026 loss per share have narrowed from $1.72 to $1.20.
Monopar Therapeutics
In the past year, shares of Monopar Therapeutics have rallied 185.9% compared with the industry’s 15.6% growth.
Image Source: Zacks Investment Research
The phenomenal stock price rally was fueled by positive investor expectations regarding the potential of its lead investigational oral candidate, ALXN-1840 (bis-choline tetrathiomolybdate), for Wilson disease. Last year, Monopar Therapeutics signed a licensing agreement with AstraZeneca, which granted the former an exclusive worldwide license to ALXN-1840.
Following the licensing deal, MNPR has assumed responsibilities for all future global development and commercialization activities related to ALXN-1840 to treat Wilson disease. Management believes that the company’s expertise in rare disease drug development and commercialization will catapult ALXN-1840 into a successful product for the above indication. Per Monopar Therapeutics, ALXN-1840 has a significant market opportunity, as one in 30,000 live births in the United States is affected by Wilson disease.
AstraZeneca had earlier announced that a phase III study evaluating the candidate for the above indication had met its primary endpoint. In 2025, Monopar Therapeutics reported long-term data showing that ALXN1840 delivered sustained efficacy and a favorable safety profile as a potential treatment for Wilson disease.
Pooled results from three studies demonstrated durable neurological improvement and effective copper mobilization over a median treatment period of 2.63 years, alongside improvements in liver function measures, with a favorable safety profile. Patients also reported greater convenience versus standard therapies, supporting the company’s plan to submit a regulatory filing with the FDA in early 2026. Apart from ALXN-1840, MNPR is currently evaluating several other candidates for various oncology indications in separate early-stage studies.
In the past 60 days, estimates for Monopar Therapeutics’ 2026 loss per share have widened from $4.13 to $4.43.
Kodiak Sciences
In the past year, shares of Kodiak Sciences have rallied 181.1% against the industry’s 15.7% decline.
Image Source: Zacks Investment Research
Kodiak Sciences’ sharp share price rally in 2025 reflects growing investor confidence in the commercial and clinical potential of its late-stage pipeline assets, tarcocimab and KSI-501. KOD is evaluating the efficacy and safety of tarcocimab in treatment-naïve patients with diabetic retinopathy (DR) in the phase III GLOW2 study. Top-line data is expected in the first quarter of 2026.
Kodiak Sciences is also studying tarcocimab as a second investigational arm in the phase III DAYBREAK study to treat wet age-related macular degeneration (wet AMD), with KSI-501 being the first investigational arm. Top-line data from both arms of the DAYBREAK study are anticipated in the third quarter of 2026.
Based on the success of these two pivotal studies, Kodiak Sciences plans to submit a single regulatory filing, seeking the approval of tarcocimab for three large indications — DR, wet AMD and retinal vein occlusion.
Kodiak Sciences has also completed an early-stage study evaluating its third investigational candidate, KSI-101, for macular edema. Following its success, KOD has initiated two pivotal phase III studies (PEAK and PINNACLE) investigating two dose levels (5 mg and 10 mg) of KSI-101 for macular edema secondary to inflammation. Both studies are currently enrolling patients with top-line results expected in late 2026 and early 2027, respectively.
In the past 60 days, estimates for Kodiak Sciences’ 2026 loss per share have narrowed from $3.91 to $3.78.
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What Awaits These 4 Biotech Stocks That More Than Doubled in 2025
Key Takeaways
After a weak first half, the drug and biotech sector regained momentum in the latter part of 2025, setting the stage for a strong year for select stocks. Improved policy clarity following most large drugmakers’ drug pricing agreements with the Trump administration reduced a key source of uncertainty, while a rebound in mergers and acquisitions helped revive investor appetite for risk across the biotech industry.
Fundamentals have also been supportive, with innovation accelerating across high-growth areas, such as obesity, gene therapy, inflammation, and neuroscience. Regulatory activity remained healthy, with the FDA approving 43 novel therapies as of Dec. 22, 2025.
As we approach the New Year, let us take a good look at some biotech companies like Ionis Pharmaceuticals (IONS - Free Report) , Structure Therapeutics (GPCR - Free Report) , Monopar Therapeutics (MNPR - Free Report) , and Kodiak Sciences (KOD - Free Report) , which provided more than double returns in 2025 as sentiment improved and company-specific catalysts emerged.
Looking forward to 2026, investors are likely to focus on whether these high-performing biotech stocks can sustain their momentum through clinical execution, regulatory milestones, commercialization progress, and potential strategic transactions.
IONS, GPCR, MNPR, and KOD carry a Zacks Rank #3 (Hold) each at present. The stocks have been mostly witnessing favorable earnings estimate revisions as well. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Ionis Pharmaceuticals
In the past year, shares of Ionis Pharmaceuticals have soared 120.5% compared with the industry’s 5% growth.
The stock’s rally reflects a combination of favorable regulatory developments and encouraging pipeline progress, which have strengthened confidence in the company’s ability to advance its wholly-owned programs and meaningfully expand future revenues beyond its existing partnered, marketed products portfolio.
In 2025, Ionis advanced its wholly-owned portfolio, highlighted by the late-2024 FDA approval of Tryngolza (olezarsen) for familial chylomicronemia syndrome (FCS), its first independently launched product. Sales of the drug generated $57.4 million in the first nine months of 2025. Encouraging commercial uptake has prompted sequential increases in revenue guidance, with the momentum expected to extend into 2026. The drug’s EU approval in October 2025 expanded its geographical presence.
Ionis Pharmaceuticals is evaluating Tryngolza in three late-stage studies (CORE, CORE2, and ESSENCE) for severe hypertriglyceridemia (sHTG), all of which met primary endpoints with significant triglyceride reductions and fewer acute pancreatitis events. Based on these results, IONS plans to file for an FDA label expansion soon. If approved, it will materially broaden the drug’s patient base in an indication that IONS views as having a substantially larger commercial opportunity, supporting meaningful incremental revenue growth. Like FCS, Ionis Pharmaceuticals also has a first-mover advantage in the sHTG indication.
In August 2025, the FDA approved the company’s second wholly-owned drug, Dawnzera (donidalorsen), for hereditary angioedema (HAE). A regulatory filing for this HAE drug is under review in the EU, with a final decision expected in the first quarter of 2026. Ionis Pharmaceuticals also remains on track for more wholly-owned product launches in the next one to two years. These include zilganersen in Alexander disease (regulatory filing expected in early 2026) and ION82 in Angelman Syndrome (ongoing phase III study). If approved, zilganersen will be the company’s first launch in the neurology space.
In the past 60 days, estimates for IONS’ 2026 loss per share have narrowed from $2.84 to $2.76.
Structure Therapeutics
In the past year, Structure Therapeutics' shares have surged 127.2% compared with the industry’s 15.6% growth.
The stock price rally was primarily driven by positive top-line data from GPCR’s ACCESS clinical program of investigational GLP-1 candidate, aleniglipron, for the treatment of obesity, announced earlier in December.
In the core 36-week phase IIb ACCESS study, GPCR’s aleniglipron met its primary and all key secondary endpoints, with the 120 mg dose delivering an 11.3% placebo-adjusted weight loss. Higher doses drove deeper reductions, reaching 15.3% at 240 mg. Extension data showed continued weight loss through 44 weeks with no plateau. Based on the encouraging results across the ACCESS program, Structure Therapeutics is currently gearing up to advance aleniglipron into phase III development.
The company intends to meet with the FDA in the first half of 2026 to align on the impending phase III study design. Structure Therapeutics expects to initiate the late-stage program of aleniglipron to treat obesity and/or overweight patients around mid-2026.
Beyond aleniglipron, Structure Therapeutics is developing ANPA-0073, a phase II-ready candidate designed to enable selective, muscle-sparing weight loss. GPCR also recently initiated an early-stage first-in-human study of ACCG-2671 for the treatment of obesity. The obesity arena, currently dominated by Eli Lilly and Novo Nordisk, represents a sizeable and still underpenetrated market opportunity that is attracting several smaller biotech players to challenge the incumbents.
In the past 60 days, estimates for GPCR’s 2026 loss per share have narrowed from $1.72 to $1.20.
Monopar Therapeutics
In the past year, shares of Monopar Therapeutics have rallied 185.9% compared with the industry’s 15.6% growth.
The phenomenal stock price rally was fueled by positive investor expectations regarding the potential of its lead investigational oral candidate, ALXN-1840 (bis-choline tetrathiomolybdate), for Wilson disease. Last year, Monopar Therapeutics signed a licensing agreement with AstraZeneca, which granted the former an exclusive worldwide license to ALXN-1840.
Following the licensing deal, MNPR has assumed responsibilities for all future global development and commercialization activities related to ALXN-1840 to treat Wilson disease. Management believes that the company’s expertise in rare disease drug development and commercialization will catapult ALXN-1840 into a successful product for the above indication. Per Monopar Therapeutics, ALXN-1840 has a significant market opportunity, as one in 30,000 live births in the United States is affected by Wilson disease.
AstraZeneca had earlier announced that a phase III study evaluating the candidate for the above indication had met its primary endpoint. In 2025, Monopar Therapeutics reported long-term data showing that ALXN1840 delivered sustained efficacy and a favorable safety profile as a potential treatment for Wilson disease.
Pooled results from three studies demonstrated durable neurological improvement and effective copper mobilization over a median treatment period of 2.63 years, alongside improvements in liver function measures, with a favorable safety profile. Patients also reported greater convenience versus standard therapies, supporting the company’s plan to submit a regulatory filing with the FDA in early 2026. Apart from ALXN-1840, MNPR is currently evaluating several other candidates for various oncology indications in separate early-stage studies.
In the past 60 days, estimates for Monopar Therapeutics’ 2026 loss per share have widened from $4.13 to $4.43.
Kodiak Sciences
In the past year, shares of Kodiak Sciences have rallied 181.1% against the industry’s 15.7% decline.
Kodiak Sciences’ sharp share price rally in 2025 reflects growing investor confidence in the commercial and clinical potential of its late-stage pipeline assets, tarcocimab and KSI-501. KOD is evaluating the efficacy and safety of tarcocimab in treatment-naïve patients with diabetic retinopathy (DR) in the phase III GLOW2 study. Top-line data is expected in the first quarter of 2026.
Kodiak Sciences is also studying tarcocimab as a second investigational arm in the phase III DAYBREAK study to treat wet age-related macular degeneration (wet AMD), with KSI-501 being the first investigational arm. Top-line data from both arms of the DAYBREAK study are anticipated in the third quarter of 2026.
Based on the success of these two pivotal studies, Kodiak Sciences plans to submit a single regulatory filing, seeking the approval of tarcocimab for three large indications — DR, wet AMD and retinal vein occlusion.
Kodiak Sciences has also completed an early-stage study evaluating its third investigational candidate, KSI-101, for macular edema. Following its success, KOD has initiated two pivotal phase III studies (PEAK and PINNACLE) investigating two dose levels (5 mg and 10 mg) of KSI-101 for macular edema secondary to inflammation. Both studies are currently enrolling patients with top-line results expected in late 2026 and early 2027, respectively.
In the past 60 days, estimates for Kodiak Sciences’ 2026 loss per share have narrowed from $3.91 to $3.78.