Arcturus Announces Launch of 12-Week Cystic Fibrosis Study in 2026, Facing Cost Management and KOSTAIVE BLA Delays
Management Insights: CEO Joseph Payne reported positive interim Phase II data for ARCT-032, an mRNA therapeutic for cystic fibrosis, and ARCT-810 for OTC deficiency, while also noting the indefinite delay of the KOSTAIVE COVID-19 vaccine's US BLA filing due to regulatory changes.
Financial Performance: CFO Andrew Sassine highlighted a significant revenue decline for Q3 2025, with total revenues of $17.2 million, and a net loss of approximately $13.5 million, while emphasizing the company's strong financial position with a cash runway extended into 2028.
Future Outlook: The company plans to initiate a 12-week study for ARCT-032 in the first half of 2026 and is preparing for regulatory meetings regarding pivotal trials for both CF and OTC programs, focusing on safety and efficacy data.
Risks and Concerns: Management acknowledged challenges due to sudden FDA regulatory changes affecting KOSTAIVE, alongside the need for further regulatory alignment for both therapeutic programs, while maintaining a focus on cost control and resource allocation.
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Arcturus to Present mRNA Technologies at J.P. Morgan Healthcare Conference
- Leadership Presentation: Arcturus Therapeutics CEO Joseph Payne will present at the J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco, showcasing the company's latest advancements in mRNA therapeutics, which is expected to attract investor and industry attention.
- Technological Innovation: Arcturus developed KOSTAIVE®, the world's first approved self-amplifying mRNA COVID vaccine, demonstrating its leading position in vaccine development and potentially laying the groundwork for future market expansion.
- Global Collaboration: The company's global collaboration with CSL Seqirus and U.S. BARDA focuses on pandemic flu vaccine development, indicating Arcturus's strategic positioning in addressing public health crises, which may enhance its market competitiveness.
- Diverse Pipeline: Arcturus's pipeline includes RNA therapeutic candidates targeting cystic fibrosis and ornithine transcarbamylase deficiency, showcasing its potential in rare disease treatment, which could provide new revenue streams for the company.
Arcturus Announces Launch of 12-Week Cystic Fibrosis Study in 2026, Facing Cost Management and KOSTAIVE BLA Delays
Management Insights: CEO Joseph Payne reported positive interim Phase II data for ARCT-032, an mRNA therapeutic for cystic fibrosis, and ARCT-810 for OTC deficiency, while also noting the indefinite delay of the KOSTAIVE COVID-19 vaccine's US BLA filing due to regulatory changes.
Financial Performance: CFO Andrew Sassine highlighted a significant revenue decline for Q3 2025, with total revenues of $17.2 million, and a net loss of approximately $13.5 million, while emphasizing the company's strong financial position with a cash runway extended into 2028.
Future Outlook: The company plans to initiate a 12-week study for ARCT-032 in the first half of 2026 and is preparing for regulatory meetings regarding pivotal trials for both CF and OTC programs, focusing on safety and efficacy data.
Risks and Concerns: Management acknowledged challenges due to sudden FDA regulatory changes affecting KOSTAIVE, alongside the need for further regulatory alignment for both therapeutic programs, while maintaining a focus on cost control and resource allocation.
INVESTIGATION ALERT: Edelson Lechtzin LLP Announces Investigation of Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) and Encourages Investors with Substantial Losses to Contact the Firm
Investigation Announcement: Edelson Lechtzin LLP is investigating Arcturus Therapeutics for potential violations of federal securities laws due to allegations of misleading business information provided to investors.
Stock Impact: Following the release of disappointing Phase 2 trial results for its inhaled mRNA therapy ARCT-032, Arcturus's stock plummeted by over 50%, closing at $11.54 per share.
Company Overview: Arcturus Therapeutics focuses on developing mRNA vaccines and therapies, highlighting its role in the biotechnology sector.
Legal Representation: Investors affected by the stock drop or with relevant non-public information are encouraged to contact Edelson Lechtzin LLP for potential legal assistance.
Cathie Wood Reduces Holdings in AMD and Other U.S. Tech Stocks, Increases Investment in Baidu and Biotech Sectors
Portfolio Adjustments: ARK Invest's ETFs made significant changes on October 24, 2025, reducing holdings in high-valuation tech stocks like AMD, Shopify, and Palantir, while increasing positions in Baidu and biotech companies such as Pacific Biosciences and Arcturus Therapeutics.
Major Transactions: The ARK Innovation ETF (ARKK) sold large quantities of shares, including 23,717 shares of AMD and 39,077 shares of Shopify, indicating a strategy of profit-taking in the tech sector amid rising AI chip demand.
Focus on AI and Biotech: ARK's renewed interest in Baidu, with a purchase of over 51,000 shares, reflects confidence in the company's role in AI and autonomous driving, while continued investments in biotech firms highlight a commitment to genomic innovation.
Ongoing Trends: The ARK Genomic Revolution ETF (ARKG) also sold shares of Tempus AI, continuing a trend of reducing exposure in certain tech stocks while actively buying into next-generation sequencing technologies.
Molina Healthcare Analyst Adopts Bearish Stance; Check Out the Top 5 Downgrades for Friday
Analyst Downgrades: Jefferies downgraded Inspire Medical Systems from Buy to Hold, reducing the price target from $160 to $85, with shares closing at $80.17.
Healthcare Sector Changes: Barclays downgraded Molina Healthcare from Equal-Weight to Underweight, lowering the price target from $185 to $144, while shares closed at $161.00.
Biotech Adjustments: HC Wainwright downgraded Arcturus Therapeutics from Buy to Neutral, slashing the price target from $60 to $12, with shares closing at $12.00.
Other Notable Downgrades: Citigroup downgraded Integer Holdings from Buy to Neutral, cutting the price target from $140 to $77, and William Blair downgraded Torrid Holdings from Outperform to Market Perform, with shares closing at $1.47.
Citi Downgrades Arcturus to Neutral Following mRNA Candidate Data Release
Citi Downgrade: Arcturus Therapeutics' stock fell after Citi downgraded it from Buy to Neutral, citing disappointing mid-stage data for its cystic fibrosis treatment ARCT-032.
FEV1 Concerns: Analyst Yigal Nochomovitz noted that the interim results showed only a 5.1% increase in lung function, which fell within a "worst-case scenario" and raised concerns about the drug's efficacy.
Price Target Reduction: Following the downgrade, Nochomovitz reduced his price target for Arcturus from $49 to $12 per share, indicating challenges ahead for the drug's late-stage development.
Future Readouts: There is anticipation for more promising results from a 15 mg dosing group expected in H1 2026, but current data is not convincing according to the analyst.
Arcturus to Present mRNA Technologies at J.P. Morgan Healthcare Conference
- Leadership Presentation: Arcturus Therapeutics CEO Joseph Payne will present at the J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco, showcasing the company's latest advancements in mRNA therapeutics, which is expected to attract investor and industry attention.
- Technological Innovation: Arcturus developed KOSTAIVE®, the world's first approved self-amplifying mRNA COVID vaccine, demonstrating its leading position in vaccine development and potentially laying the groundwork for future market expansion.
- Global Collaboration: The company's global collaboration with CSL Seqirus and U.S. BARDA focuses on pandemic flu vaccine development, indicating Arcturus's strategic positioning in addressing public health crises, which may enhance its market competitiveness.
- Diverse Pipeline: Arcturus's pipeline includes RNA therapeutic candidates targeting cystic fibrosis and ornithine transcarbamylase deficiency, showcasing its potential in rare disease treatment, which could provide new revenue streams for the company.
Arcturus Announces Launch of 12-Week Cystic Fibrosis Study in 2026, Facing Cost Management and KOSTAIVE BLA Delays
Management Insights: CEO Joseph Payne reported positive interim Phase II data for ARCT-032, an mRNA therapeutic for cystic fibrosis, and ARCT-810 for OTC deficiency, while also noting the indefinite delay of the KOSTAIVE COVID-19 vaccine's US BLA filing due to regulatory changes.
Financial Performance: CFO Andrew Sassine highlighted a significant revenue decline for Q3 2025, with total revenues of $17.2 million, and a net loss of approximately $13.5 million, while emphasizing the company's strong financial position with a cash runway extended into 2028.
Future Outlook: The company plans to initiate a 12-week study for ARCT-032 in the first half of 2026 and is preparing for regulatory meetings regarding pivotal trials for both CF and OTC programs, focusing on safety and efficacy data.
Risks and Concerns: Management acknowledged challenges due to sudden FDA regulatory changes affecting KOSTAIVE, alongside the need for further regulatory alignment for both therapeutic programs, while maintaining a focus on cost control and resource allocation.
INVESTIGATION ALERT: Edelson Lechtzin LLP Announces Investigation of Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) and Encourages Investors with Substantial Losses to Contact the Firm
Investigation Announcement: Edelson Lechtzin LLP is investigating Arcturus Therapeutics for potential violations of federal securities laws due to allegations of misleading business information provided to investors.
Stock Impact: Following the release of disappointing Phase 2 trial results for its inhaled mRNA therapy ARCT-032, Arcturus's stock plummeted by over 50%, closing at $11.54 per share.
Company Overview: Arcturus Therapeutics focuses on developing mRNA vaccines and therapies, highlighting its role in the biotechnology sector.
Legal Representation: Investors affected by the stock drop or with relevant non-public information are encouraged to contact Edelson Lechtzin LLP for potential legal assistance.
Cathie Wood Reduces Holdings in AMD and Other U.S. Tech Stocks, Increases Investment in Baidu and Biotech Sectors
Portfolio Adjustments: ARK Invest's ETFs made significant changes on October 24, 2025, reducing holdings in high-valuation tech stocks like AMD, Shopify, and Palantir, while increasing positions in Baidu and biotech companies such as Pacific Biosciences and Arcturus Therapeutics.
Major Transactions: The ARK Innovation ETF (ARKK) sold large quantities of shares, including 23,717 shares of AMD and 39,077 shares of Shopify, indicating a strategy of profit-taking in the tech sector amid rising AI chip demand.
Focus on AI and Biotech: ARK's renewed interest in Baidu, with a purchase of over 51,000 shares, reflects confidence in the company's role in AI and autonomous driving, while continued investments in biotech firms highlight a commitment to genomic innovation.
Ongoing Trends: The ARK Genomic Revolution ETF (ARKG) also sold shares of Tempus AI, continuing a trend of reducing exposure in certain tech stocks while actively buying into next-generation sequencing technologies.
Molina Healthcare Analyst Adopts Bearish Stance; Check Out the Top 5 Downgrades for Friday
Analyst Downgrades: Jefferies downgraded Inspire Medical Systems from Buy to Hold, reducing the price target from $160 to $85, with shares closing at $80.17.
Healthcare Sector Changes: Barclays downgraded Molina Healthcare from Equal-Weight to Underweight, lowering the price target from $185 to $144, while shares closed at $161.00.
Biotech Adjustments: HC Wainwright downgraded Arcturus Therapeutics from Buy to Neutral, slashing the price target from $60 to $12, with shares closing at $12.00.
Other Notable Downgrades: Citigroup downgraded Integer Holdings from Buy to Neutral, cutting the price target from $140 to $77, and William Blair downgraded Torrid Holdings from Outperform to Market Perform, with shares closing at $1.47.
Citi Downgrades Arcturus to Neutral Following mRNA Candidate Data Release
Citi Downgrade: Arcturus Therapeutics' stock fell after Citi downgraded it from Buy to Neutral, citing disappointing mid-stage data for its cystic fibrosis treatment ARCT-032.
FEV1 Concerns: Analyst Yigal Nochomovitz noted that the interim results showed only a 5.1% increase in lung function, which fell within a "worst-case scenario" and raised concerns about the drug's efficacy.
Price Target Reduction: Following the downgrade, Nochomovitz reduced his price target for Arcturus from $49 to $12 per share, indicating challenges ahead for the drug's late-stage development.
Future Readouts: There is anticipation for more promising results from a 15 mg dosing group expected in H1 2026, but current data is not convincing according to the analyst.
