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CDTX Stock Up on FDA's Breakthrough Therapy Tag for CD388 in Influenza
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Key Takeaways
CDTX secured FDA Breakthrough Therapy designation for CD388 to prevent seasonal influenza.
The FDA decision follows phase IIb data showing CD388's significant prevention of seasonal influenza.
CDTX's ANCHOR phase III study began ahead of schedule and may support regulatory filing if successful.
Cidara Therapeutics (CDTX - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to its lead pipeline candidate, CD388, for the prevention of seasonal influenza.
Shares of the company were up 12.4% following the announcement yesterday.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests that a drug may significantly improve over existing treatments on one or more important clinical measures.
CD388, developed using CDTX’s proprietary Cloudbreak platform, is an investigational drug-Fc conjugate designed as a long-acting small molecule inhibitor targeting influenza.
The FDA’s latest decision was based on positive data from the phase IIb NAVIGATE study. Data from the same showed that treatment with CD388 demonstrated statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.
CDTX’s Price Performance
Year to date, shares of Cidara Therapeutics have skyrocketed 312% compared with the industry’s rise of 8.7%.
Image Source: Zacks Investment Research
CDTX’s Recent Development Activities With CD388
The FDA had previously granted a Fast Track designation to CD388 for the prevention of seasonal influenza.
The regulatory body has now granted the Breakthrough Therapy tag to CD388 for the prevention of influenza A and B in adults and adolescents who face a higher risk of influenza complications due to underlying immunodeficiency, have an elevated risk of severe influenza despite vaccination, or for whom vaccines are contraindicated.
Last month, the company initiated dosing in the phase III ANCHOR study, six months earlier than originally planned, in patients who stand at a high risk for complications of influenza. 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.
Unlike vaccines or monoclonal antibodies, CD388 works through a novel mechanism that offers broad protection against both seasonal and pandemic flu strains. It has the potential to protect for an entire flu season with a single injection, and its efficacy does not rely on the body’s immune response—making it a promising option for individuals with any immune status.
In the absence of an approved product, the successful development of CD388 remains in key focus for Cidara Therapeutics.
CDTX’s Zacks Rank & Stocks to Consider
Cidara Therapeutics currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.92 to $3.74. Loss per share estimates for 2026 have narrowed from $4.38 to $4.13 during the same period. AKRO stock has surged 94.3% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 96 cents. Loss per share estimates for 2026 have narrowed from 98 cents to 86 cents during the same period. ALLO stock has lost 29.1% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 53.5% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.
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CDTX Stock Up on FDA's Breakthrough Therapy Tag for CD388 in Influenza
Key Takeaways
Cidara Therapeutics (CDTX - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to its lead pipeline candidate, CD388, for the prevention of seasonal influenza.
Shares of the company were up 12.4% following the announcement yesterday.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests that a drug may significantly improve over existing treatments on one or more important clinical measures.
CD388, developed using CDTX’s proprietary Cloudbreak platform, is an investigational drug-Fc conjugate designed as a long-acting small molecule inhibitor targeting influenza.
The FDA’s latest decision was based on positive data from the phase IIb NAVIGATE study. Data from the same showed that treatment with CD388 demonstrated statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.
CDTX’s Price Performance
Year to date, shares of Cidara Therapeutics have skyrocketed 312% compared with the industry’s rise of 8.7%.
Image Source: Zacks Investment Research
CDTX’s Recent Development Activities With CD388
The FDA had previously granted a Fast Track designation to CD388 for the prevention of seasonal influenza.
The regulatory body has now granted the Breakthrough Therapy tag to CD388 for the prevention of influenza A and B in adults and adolescents who face a higher risk of influenza complications due to underlying immunodeficiency, have an elevated risk of severe influenza despite vaccination, or for whom vaccines are contraindicated.
Last month, the company initiated dosing in the phase III ANCHOR study, six months earlier than originally planned, in patients who stand at a high risk for complications of influenza. 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.
Unlike vaccines or monoclonal antibodies, CD388 works through a novel mechanism that offers broad protection against both seasonal and pandemic flu strains. It has the potential to protect for an entire flu season with a single injection, and its efficacy does not rely on the body’s immune response—making it a promising option for individuals with any immune status.
In the absence of an approved product, the successful development of CD388 remains in key focus for Cidara Therapeutics.
CDTX’s Zacks Rank & Stocks to Consider
Cidara Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Chemomab Therapeutics (CMMB - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.92 to $3.74. Loss per share estimates for 2026 have narrowed from $4.38 to $4.13 during the same period. AKRO stock has surged 94.3% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 96 cents. Loss per share estimates for 2026 have narrowed from 98 cents to 86 cents during the same period. ALLO stock has lost 29.1% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 53.5% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.