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CDTX Stock Soars 218% YTD on Positive Updates From Influenza Program
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Key Takeaways
Cidara shares have jumped 217.8% in 2025 so far on progress with its influenza drug candidate CD388.
The phase IIb NAVIGATE study met all primary and secondary endpoints across multiple dose levels.
The phase III ANCHOR study began ahead of schedule and could support regulatory filing if successful.
Shares of Cidara Therapeutics (CDTX - Free Report) have skyrocketed 217.8% in the year so far, driven by positive updates from the development program of its only clinical-stage pipeline candidate, CD388, for the prevention of seasonal influenza.
CD388, developed using CDTX’s proprietary Cloudbreak platform, is an investigational drug-Fc conjugate designed as a long-acting small molecule inhibitor targeting influenza. Unlike vaccines or monoclonal antibodies, it has a novel mechanism of action to deliver broad protection against both seasonal and pandemic flu strains. CD388 has the potential to provide season-long protection from a single injection and its efficacy is not dependent on an immune response, which makes the candidate a promising option for individuals across all immune statuses.
The stock price rally began in June 2025 after Cidara Therapeutics reported meeting key goals in its mid-stage study of CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64. Per the data readout, the phase IIb NAVIGATE study achieved its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups of CD388 (150 mg, 300 mg and 450 mg) given as a single dose at the start of flu season and were evaluated for laboratory and clinically confirmed influenza over 24 weeks.
The NAVIGATE study also met all secondary endpoints, demonstrating efficacy at both 37.8°C and 37.2°C fever thresholds, and sustained PE through 28 weeks with statistical significance. Importantly, the highest PE percentages, across all endpoints, were observed at the highest dose of CD388. During the study period, the candidate was well-tolerated across all dose levels, with no unexpected dose-limiting treatment-related adverse events reported.
In the past year, shares of Cidara Therapeutics have surged 695.5% against the industry’s 12% decline.
Image Source: Zacks Investment Research
CDTX’s Next Steps in the Development Process of CD388
Last week, Cidara Therapeutics announced an accelerated and expanded late-stage development plan for CD388 for the prevention of seasonal influenza, following a positive End-of-Phase II meeting with the FDA. The company recently initiated dosing in the pivotal phase III ANCHOR study, six months earlier than originally planned, to align with the Northern Hemisphere flu season. Importantly, the FDA indicated that this phase III study, if successful, may be sufficient to support a regulatory filing in the high-risk populations for this indication. This likely also contributed to the stock price rally.
The ANCHOR study will significantly broaden its enrollment criteria to include not only individuals aged 12 and older with high-risk comorbidities or immune-compromised status, but also adults over 65 years of age without specific comorbidities. Per Cidara Therapeutics, this expansion more than doubles the potential U.S. patient pool for CD388 from roughly 50 million to more than 100 million, highlighting the drug’s potential market impact.
The global phase III ANCHOR study is expected to enroll about 6,000 patients, randomized equally in two groups to receive either a single 450 mg subcutaneous injection of CD388 or placebo at the start of flu season. Enrollment will extend into the Southern Hemisphere in early 2026, with an interim analysis planned after the Northern Hemisphere flu season to review study size and powering assumptions.
The ANCHOR study’s primary endpoint will be defined as laboratory-confirmed influenza accompanied by a body temperature of at least 37.2°C (99°F) and new or worsening of either two respiratory symptoms (such as cough, sore throat, or nasal congestion) or one respiratory symptom plus one systemic symptom (such as headache, fatigue, feverish feeling, or body aches).
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 94 cents to $1.77 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.65 to $2.54. In the past year, shares of CRMD have surged 37.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 40 cents to 10 cents. For 2026, PHAR’s earnings per share estimate has improved from 7 cents to 27 cents. PHAR stock has soared 77.3% in the past year.
Pharming Group’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has rallied 42.1% in the past year.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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CDTX Stock Soars 218% YTD on Positive Updates From Influenza Program
Key Takeaways
Shares of Cidara Therapeutics (CDTX - Free Report) have skyrocketed 217.8% in the year so far, driven by positive updates from the development program of its only clinical-stage pipeline candidate, CD388, for the prevention of seasonal influenza.
CD388, developed using CDTX’s proprietary Cloudbreak platform, is an investigational drug-Fc conjugate designed as a long-acting small molecule inhibitor targeting influenza. Unlike vaccines or monoclonal antibodies, it has a novel mechanism of action to deliver broad protection against both seasonal and pandemic flu strains. CD388 has the potential to provide season-long protection from a single injection and its efficacy is not dependent on an immune response, which makes the candidate a promising option for individuals across all immune statuses.
The stock price rally began in June 2025 after Cidara Therapeutics reported meeting key goals in its mid-stage study of CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64. Per the data readout, the phase IIb NAVIGATE study achieved its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups of CD388 (150 mg, 300 mg and 450 mg) given as a single dose at the start of flu season and were evaluated for laboratory and clinically confirmed influenza over 24 weeks.
The NAVIGATE study also met all secondary endpoints, demonstrating efficacy at both 37.8°C and 37.2°C fever thresholds, and sustained PE through 28 weeks with statistical significance. Importantly, the highest PE percentages, across all endpoints, were observed at the highest dose of CD388. During the study period, the candidate was well-tolerated across all dose levels, with no unexpected dose-limiting treatment-related adverse events reported.
In the past year, shares of Cidara Therapeutics have surged 695.5% against the industry’s 12% decline.
Image Source: Zacks Investment Research
CDTX’s Next Steps in the Development Process of CD388
Last week, Cidara Therapeutics announced an accelerated and expanded late-stage development plan for CD388 for the prevention of seasonal influenza, following a positive End-of-Phase II meeting with the FDA. The company recently initiated dosing in the pivotal phase III ANCHOR study, six months earlier than originally planned, to align with the Northern Hemisphere flu season. Importantly, the FDA indicated that this phase III study, if successful, may be sufficient to support a regulatory filing in the high-risk populations for this indication. This likely also contributed to the stock price rally.
The ANCHOR study will significantly broaden its enrollment criteria to include not only individuals aged 12 and older with high-risk comorbidities or immune-compromised status, but also adults over 65 years of age without specific comorbidities. Per Cidara Therapeutics, this expansion more than doubles the potential U.S. patient pool for CD388 from roughly 50 million to more than 100 million, highlighting the drug’s potential market impact.
The global phase III ANCHOR study is expected to enroll about 6,000 patients, randomized equally in two groups to receive either a single 450 mg subcutaneous injection of CD388 or placebo at the start of flu season. Enrollment will extend into the Southern Hemisphere in early 2026, with an interim analysis planned after the Northern Hemisphere flu season to review study size and powering assumptions.
The ANCHOR study’s primary endpoint will be defined as laboratory-confirmed influenza accompanied by a body temperature of at least 37.2°C (99°F) and new or worsening of either two respiratory symptoms (such as cough, sore throat, or nasal congestion) or one respiratory symptom plus one systemic symptom (such as headache, fatigue, feverish feeling, or body aches).
Cidara Therapeutics, Inc. Price and Consensus
Cidara Therapeutics, Inc. price-consensus-chart | Cidara Therapeutics, Inc. Quote
CDTX’s Zacks Rank and Stocks to Consider
Cidara Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , Pharming Group (PHAR - Free Report) and Kiniksa Pharmaceuticals (KNSA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from 94 cents to $1.77 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.65 to $2.54. In the past year, shares of CRMD have surged 37.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 40 cents to 10 cents. For 2026, PHAR’s earnings per share estimate has improved from 7 cents to 27 cents. PHAR stock has soared 77.3% in the past year.
Pharming Group’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has rallied 42.1% in the past year.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.