Cingulate Appoints Downey as Chief Commercial Officer to Oversee CTx-1301 Launch Preparation
- New Appointment: Cingulate has appointed Bryan Downey as Chief Commercial Officer (CCO) following the FDA's acceptance of its New Drug Application for CTx-1301.
- FDA Timeline: The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, for CTx-1301.
- Financing Success: Cingulate has completed a $6 million financing transaction, enhancing its financial position.
- Commercialization Plans: The company is preparing for commercialization of CTx-1301, contingent on FDA approval, with extended cash runway into the second quarter of 2026.
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Biotech Stocks Surge: Coherus Up 9.09% in After-Hours Trading
- Coherus Performance: Coherus Oncology, Inc. (CHRS) rose 9.09% in after-hours trading, closing at $1.73 with a $0.14 gain, indicating strong investor confidence in its future prospects.
- Sensei Biotech Surge: Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% after hours, finishing at $12.47 with a $1.14 increase, reflecting positive market expectations for its products.
- uniQure Significant Jump: uniQure N.V. (QURE) posted a 9.96% rise in after-hours trading, closing at $24.95 with a $2.26 gain, suggesting investor optimism regarding its R&D progress.
- IO Biotech Strategic Exploration: Although IO Biotech, Inc. (IOBT) had no fresh news on Thursday, its stock still gained 4.19%, closing at $0.50, indicating market interest in its exploration of strategic alternatives, including potential mergers or asset sales.
Roth Capital Reaffirms Buy Rating on Cingulate, Reduces Price Target to $16
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing their trading strategies.
Market Winning Tools: Benzinga Pro is designed to help traders win in the markets every day with accurate stock market intelligence.
INBX Rises 81% Following Study Results; FEMY, CING, CYH Surge in After-Hours Trading
Inhibrx Biosciences Surge: Inhibrx Biosciences (INBX) shares soared over 81% after positive Phase 2 trial results for ozekibart in treating advanced chondrosarcoma, alongside updates on other cancer treatment studies.
Femasys Gains: Femasys Inc. (FEMY) saw an 18% increase following the launch of a post-market clinical study for its FemBloc Permanent Birth Control, complying with EU regulations.
Cingulate's Presentation: Cingulate Inc. (CING) rose over 6% after announcing that data from its ADHD treatment candidate, CTx-1301, will be presented at the AACAP Annual Meeting, highlighting its potential in ADHD management.
Community Health Systems Performance: Community Health Systems, Inc. (CYH) shares increased over 4% after reporting positive Q3 results, contributing to a generally favorable after-hours trading environment for biotech stocks.
Cingulate's Top ADHD Candidate CTx-1301 Chosen for Podium Presentation at AACAP Annual Meeting
CTx-1301 Presentation: Cingulate Inc. announced that data from its ADHD candidate CTx-1301 will be presented at the AACAP Annual Meeting, highlighting its once-daily, extended-release formulation aimed at improving treatment for ADHD patients.
Expert Presentation: Dr. Ann Childress, a leading ADHD specialist, will present the Phase 3 trial results, emphasizing CTx-1301's efficacy and safety in pediatric subjects with ADHD.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's Precision Timed Release™ platform to provide three timed releases of medication throughout the day, addressing limitations of current stimulant therapies.
Company Overview: Cingulate Inc. is focused on developing next-generation pharmaceutical products to enhance patient outcomes, with CTx-1301 in late-stage development for ADHD and other candidates targeting anxiety and neuropsychiatric conditions.
Roth Capital Reaffirms Buy Rating on Cingulate, Increases Price Target to $17
Real-time Intelligence: Benzinga Pro offers the fastest news alerts to help traders stay informed and make winning trades in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
Cingulate Forms Exclusive Manufacturing Alliance with Bend Bio Sciences for Upcoming ADHD Treatment Commercialization
Commercial Supply Agreement: Cingulate Inc. has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301, its lead ADHD treatment, ensuring exclusive manufacturing capabilities in the U.S. through 2028, pending FDA approval.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology to provide a novel, extended-release formulation of dexmethylphenidate, designed to improve ADHD treatment by delivering medication in a controlled manner throughout the day.
Biotech Stocks Surge: Coherus Up 9.09% in After-Hours Trading
- Coherus Performance: Coherus Oncology, Inc. (CHRS) rose 9.09% in after-hours trading, closing at $1.73 with a $0.14 gain, indicating strong investor confidence in its future prospects.
- Sensei Biotech Surge: Sensei Biotherapeutics, Inc. (SNSE) surged 10.06% after hours, finishing at $12.47 with a $1.14 increase, reflecting positive market expectations for its products.
- uniQure Significant Jump: uniQure N.V. (QURE) posted a 9.96% rise in after-hours trading, closing at $24.95 with a $2.26 gain, suggesting investor optimism regarding its R&D progress.
- IO Biotech Strategic Exploration: Although IO Biotech, Inc. (IOBT) had no fresh news on Thursday, its stock still gained 4.19%, closing at $0.50, indicating market interest in its exploration of strategic alternatives, including potential mergers or asset sales.
Roth Capital Reaffirms Buy Rating on Cingulate, Reduces Price Target to $16
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing their trading strategies.
Market Winning Tools: Benzinga Pro is designed to help traders win in the markets every day with accurate stock market intelligence.
INBX Rises 81% Following Study Results; FEMY, CING, CYH Surge in After-Hours Trading
Inhibrx Biosciences Surge: Inhibrx Biosciences (INBX) shares soared over 81% after positive Phase 2 trial results for ozekibart in treating advanced chondrosarcoma, alongside updates on other cancer treatment studies.
Femasys Gains: Femasys Inc. (FEMY) saw an 18% increase following the launch of a post-market clinical study for its FemBloc Permanent Birth Control, complying with EU regulations.
Cingulate's Presentation: Cingulate Inc. (CING) rose over 6% after announcing that data from its ADHD treatment candidate, CTx-1301, will be presented at the AACAP Annual Meeting, highlighting its potential in ADHD management.
Community Health Systems Performance: Community Health Systems, Inc. (CYH) shares increased over 4% after reporting positive Q3 results, contributing to a generally favorable after-hours trading environment for biotech stocks.
Cingulate's Top ADHD Candidate CTx-1301 Chosen for Podium Presentation at AACAP Annual Meeting
CTx-1301 Presentation: Cingulate Inc. announced that data from its ADHD candidate CTx-1301 will be presented at the AACAP Annual Meeting, highlighting its once-daily, extended-release formulation aimed at improving treatment for ADHD patients.
Expert Presentation: Dr. Ann Childress, a leading ADHD specialist, will present the Phase 3 trial results, emphasizing CTx-1301's efficacy and safety in pediatric subjects with ADHD.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's Precision Timed Release™ platform to provide three timed releases of medication throughout the day, addressing limitations of current stimulant therapies.
Company Overview: Cingulate Inc. is focused on developing next-generation pharmaceutical products to enhance patient outcomes, with CTx-1301 in late-stage development for ADHD and other candidates targeting anxiety and neuropsychiatric conditions.
Roth Capital Reaffirms Buy Rating on Cingulate, Increases Price Target to $17
Real-time Intelligence: Benzinga Pro offers the fastest news alerts to help traders stay informed and make winning trades in the stock market.
Exclusive Community: Joining Benzinga Pro connects users with over 10,000 serious traders and provides access to exclusive stories and insights from Benzinga reporters.
Cingulate Forms Exclusive Manufacturing Alliance with Bend Bio Sciences for Upcoming ADHD Treatment Commercialization
Commercial Supply Agreement: Cingulate Inc. has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301, its lead ADHD treatment, ensuring exclusive manufacturing capabilities in the U.S. through 2028, pending FDA approval.
Innovative Drug Delivery: CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology to provide a novel, extended-release formulation of dexmethylphenidate, designed to improve ADHD treatment by delivering medication in a controlled manner throughout the day.
