Vtv Therapeutics (VTVT) Stock News

vTv Therapeutics (Nasdaq: VTVT) has announced the randomization of its first participant in the CATT1 Phase 3 trial for cadisegliatin, a potential first-in-class oral treatment for Type 1 Diabetes (T1D). The trial will evaluate cadisegliatin as an adjunctive treatment to insulin in adults with T1D.

The study will enroll approximately 150 participants across 25 U.S. sites, testing two dose regimens (800 mg once or twice daily) against placebo. The drug, which has received FDA Breakthrough Therapy designation, has shown good tolerability in over 500 subjects. The trial's primary endpoint focuses on hypoglycemic events, with topline results expected in second half of 2026.

vTv Therapeutics (VTVT) announced its participation in the virtual H.C. Wainwright 'HCW@Home' Series on June 12, 2025. The company, which focuses on developing cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes treatment, will participate in a fireside chat at 10:00 AM ET. Key company executives including Paul Sekhri (Chairman, President & CEO), Thomas Strack (CMO), Carmen Valcarce (CSO), and Michael Tung (CFO) will engage in the discussion moderated by Emily Bodnar from H.C. Wainwright. The event will be accessible via webcast on the company's website.

vTv Therapeutics (VTVT) has appointed Michael Tung, M.D., MBA as Executive Vice President and Chief Financial Officer. Dr. Tung brings 20 years of experience in finance, corporate strategy, and business development in the biopharmaceutical industry. The appointment coincides with the company's reinitiation of the CATT1 Phase 3 trial for cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin for type 1 diabetes (T1D) treatment.

Prior to joining vTv, Dr. Tung served as CFO of AdvanCell Pty Limited and held senior positions at FibroGen Inc. and Aclaris Therapeutics. He holds B.A. and B.S. degrees in economics and biology from The George Washington University and a combined M.D./M.B.A. from Tufts University School of Medicine.

vTv Therapeutics (VTVT) reported its Q1 2025 financial results and provided updates on its lead drug candidate cadisegliatin. The company has reinitiated screening for its CATT1 Phase 3 trial evaluating cadisegliatin as an adjunctive therapy to insulin for type 1 diabetes treatment. A protocol amendment reduced the trial duration from 12 to 6 months, with topline data expected in 2H 2026. Financially, VTVT reported a cash position of $31.1 million as of March 31, 2025, down from $36.7 million at year-end 2024. The company posted a net loss of $5.1 million ($0.77 per share) compared to $4.9 million ($1.17 per share) in Q1 2024. R&D expenses increased to $2.8 million while G&A expenses decreased to $3.7 million.

vTv Therapeutics has reinitiated screening in its CATT1 Phase 3 trial for cadisegliatin, a potential first-in-class, oral, liver-selective glucokinase activator for Type 1 Diabetes. The company has implemented a protocol amendment that reduces the trial duration from 12 to 6 months, accelerating the timeline to topline data expected in 2H 2026. The study will evaluate approximately 150 patients across 20-25 U.S. sites, with continuous glucose monitors provided to all participants. The trial will assess two doses of cadisegliatin versus placebo, focusing on the primary endpoint of measuring level 2 and level 3 hypoglycemic events. Notably, cadisegliatin has received FDA Breakthrough Therapy designation, positioning it as a promising adjunctive treatment for Type 1 Diabetes.

vTv Therapeutics (VTVT) reported its Q4 and full-year 2024 financial results, highlighting the FDA's lifting of the clinical hold on its cadisegliatin program in March 2025. The company plans to resume its Phase 3 CATT1 trial for type 1 diabetes in Q2 2025, with a protocol amendment reducing trial duration from 12 to 6 months.

Financial highlights include a cash position of $36.7 million as of December 31, 2024, up from $9.4 million year-over-year. Q4 2024 net loss was $3.6 million ($0.55 per share), compared to $3.5 million ($1.67 per share) in Q4 2023. Full-year 2024 net loss decreased to $18.5 million ($3.20 per share) from $20.3 million in 2023.

The company strengthened its commercial leadership by appointing Martin Lafontaine as Chief Commercial Officer, bringing 27 years of pharmaceutical and medical device industry experience.

vTv Therapeutics (VTVT) announced that the FDA has lifted the clinical hold on its cadisegliatin program, including the CATT1 Phase 3 trial for type 1 diabetes (T1D). The company plans to amend the protocol to reduce the trial duration from 12 to 6 months, expediting the path to larger pivotal studies needed for NDA submission.

Cadisegliatin, an oral liver-selective glucokinase activator, aims to be the first oral adjunctive therapy to insulin for T1D. The drug has shown good tolerability in over 500 subjects with up to six months of treatment. The primary endpoint of measuring level 2 and 3 hypoglycemia rates at 6 months remains unchanged.

The clinical hold, initially placed on July 26, 2024, was due to an unresolved chromatographic signal in a human ADME study. The hold was lifted on March 14, 2025, after vTv demonstrated the signal was an experimental artifact. No patients had been dosed in the CATT1 trial during the hold period, and previous studies showed no concerning safety issues.

Cantex Pharmaceuticals has received FDA Orphan Drug Designation for azeliragon to treat brain metastasis from breast cancer. This is the third such designation for azeliragon, following previous designations for pancreatic cancer and glioblastoma in mid-2024 and early 2023.

Azeliragon is an oral, once-daily compound that inhibits the RAGE receptor. The drug's interaction with RAGE on cancer cells has been linked to radiation resistance, disease progression, and metastasis development in breast cancer. This designation provides Cantex with seven years of marketing exclusivity upon product launch, along with development assistance, tax credits, and FDA fee exemptions.

vTv Therapeutics (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on novel small molecules and diabetes treatments, has announced its participation in the 7th Annual Evercore HealthCONx Conference in Coral Gables, Florida. The company's management will engage in a fireside chat and one-on-one meetings during the event, scheduled for December 3-5, 2024.

The presentation is set for December 4, 2024, from 7:55 to 8:15 AM ET. Interested parties can access a live webcast through the Events section of vTv's investor relations website. Meeting requests can be made through institutional contacts.