ANVS

Phase 3 AD trial: 85% of patients enrolled; full enrollment on track in summer 2026 PD open-label extension (OLE) study: 40% of patients enrolled; full enrollment on track in fourth quarter 2026 New Drug Application (NDA) for buntanetap as a symptomatic treatment for AD is expected in early 2027 and as a potential disease-modifying treatment in early 2028 MALVERN, Pa., May 15, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided business updates and reported financial results for the first quarter ended March 31, 2026. "We saw strong momentum across both our AD and PD programs in the first quarter," said Maria Maccecchini, Ph.D., President and CEO of Annovis. “Our Phase 3 AD clinical trial achieved significant enrollment growth, keeping us firmly on track to complete randomization of patients in summer 2026 and deliver first top-line results in early 2027. Simultaneously, we launched a PD OLE study and have been encouraged by the robust interest from both returning and new patients. This year is pivotal: we expect to generate substantive clinical data across both indications that will anchor our regulatory path toward an NDA submission for buntanetap." Clinical highlights Alzheimer’s disease – pivotal Phase 3 trial (NCT06709014) Enrollment: 85% of patients enrolled. Screening: On May 15, 2026, Annovis closed enrollment to new participants after reaching a sufficient number of patients in screening to meet the trial's enrollment goal. Safety: Annovis received a positive recommendation from the Data and Safety Monitoring Board (DSMB) regarding the drug’s safety at 6 months, supporting seamless continuation of the study. Study design: The pivotal Phase 3 AD trial is recruiting early AD patients positive for pTau217 plasma biomarker. The study is designed to evaluate buntanetap's symptomatic effect at 6 months and its potential disease-modifying effect at 18 months. Parkinson’s disease – OLE study (NCT07284784) Enrollment: 40% of patients enrolled. Skin biomarker: The PD OLE study is implementing a biomarker test measuring levels of phosphorylated alpha-synuclein and nerve cell fiber density via skin biopsy. Digital biom...

Buntanetap improved cognition in pTau217-positive early AD patients The drug reduced neurotoxic proteins as well as biomarkers of neuroinflammation and neurodegeneration Buntanetap was safe and well-tolerated, including in ApoE4 carriers Phase 2/3 findings support ongoing pivotal Phase 3 study in early AD, with 80% patients enrolled to date MALVERN, Pa., April 28, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced a new publication titled “Buntanetap treatment in mild to moderate Alzheimer’s disease: phase 2/3 study” in a peer-reviewed journal Nature NPJ Dementia. The Phase 2/3 study (NCT05686044) was a randomized, double-blinded, placebo-controlled trial evaluating three doses of buntanetap (7.5 mg, 15 mg, and 30 mg) over 12 weeks in 351 patients with mild to moderate AD. The study demonstrated that buntanetap was safe and well-tolerated across all disease stages and dose levels. Notably, safety was also assessed in ApoE4 carriers, the most genetically at-risk population for AD, with no increase in adverse events compared to non-carriers and to placebo. Given buntanetap's distinct mechanism of action, the drug was also well-tolerated when taken alongside approved symptomatic therapies, allowing patients to maintain their existing medication regimens without the need for discontinuation. Study analyses revealed statistically significant, dose-dependent improvements in cognition, as measured by ADAS-Cog11, in pTau217 biomarker-positive patients with mild AD (MMSE 21–24). Moreover, at the 30 mg dose, buntanetap demonstrated a consistent treatment effect across all analyzed patient groups when stratified by age, body mass index, sex, ethnicity, ApoE4 carrier status, and concomitant medication use, with favorable effects versus placebo observed across each of these groups. Biomarker analyses further revealed reductions in neurotoxic proteins TDP-43 and tau, in the markers of neuroinflammation, including IL-5, IL-6, S100A12, IFN-γ, and IGF1R, as well as in the marker of neurodegeneration, neurofilament light chain (NfL), pointing to potential disease-modifying activity. Importantly, the same trends were observed in pla...

MALVERN, Pa., March 16, 2026 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a Phase 3 clinical-stage biotechnology company developing the investigational oral therapy, buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced business updates and reported financial results for the fiscal year 2025. In 2025, Annovis achieved a significant milestone in its clinical development program with the initiation of a pivotal Phase 3 clinical trial in early AD. The year was largely dedicated to the activation of clinical sites and the enrollment of participants across the United States. The Company also reported encouraging data from both its previous Alzheimer's and Parkinson's programs, demonstrating a potential disease-modifying signal for buntanetap through reductions in biomarkers of amyloid and tau pathology, neuroinflammation, and neurodegeneration. Building on this momentum, Annovis recently initiated an open-label extension (OLE) study in PD. "The year 2025 was a landmark period for Annovis, one in which we took decisive steps toward bringing buntanetap to patients," said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. "We initiated our pivotal Phase 3 AD study and later launched an OLE PD study, both critical milestones on the path to an NDA submission. Throughout the year, we remained focused on designing, preparing, and executing these studies with the highest standards of rigor while maintaining our scientific presence through key conferences, meetings, and publications. Equally important, we also revealed new biomarker data on buntanetap from our ongoing analysis of the completed studies, reinforcing the drug’s therapeutic potential." Clinical progress Alzheimer’s disease In February 2025, Annovis launched a pivotal Phase 3 study (NCT06709014) evaluating buntanetap over a period of 18 months as both a symptomatic (6 months) and a potential disease-modifying (18 months) treatment in early AD patients. In October 2025, Annovis announced that the first participants reached the 6-month milestone aimed at measuring the symptomatic effect of buntanetap. In October 2025, the Company also reported new biomarker data from its Phase 2/3 AD trial, demonstrating potential disease-modifying activity of buntanetap as measured by reductions in biomarkers of neurotoxic...

MALVERN, Pa., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and third quarter 2025 financial results. "The past quarter delivered breakthrough progress on every front," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our pivotal Phase 3 Alzheimer's study has achieved full activation across all clinical sites, with enrollment momentum advancing every day. We have fortified our intellectual property position by transferring all patents to our new crystal form of buntanetap while publishing compelling pharmacokinetic data that validates this milestone. The addition of a seasoned CFO strengthens our executive team precisely when it matters most. Adding to all this, we are particularly encouraged by the new biomarker findings from our Phase 2/3 study showing meaningful reductions in inflammation and neurodegeneration—powerful evidence of buntanetap's disease-modifying potential. Every element is now aligned as we move toward our data readouts—the final step before an NDA submission." Clinical highlights – pivotal Phase 3 AD study Annovis’ pivotal Phase 3 study in early AD (NCT06709014) remains on track, with all 84 clinical sites fully activated, recruiting, and treating participants across the U.S. The trial has generated robust participation, reflecting growing enthusiasm from the patient community. The screen failure rate remains within expected projections. The first patients have successfully completed the 6-month treatment period, a key milestone for the upcoming symptomatic readout, reinforcing steady progress toward trial completion. Business highlights In October, Annovis announced encouraging biomarker results from its Phase 2/3 AD trial, showing profound reductions in key markers of neuroinflammation and neurodegeneration after treatment with buntanetap compared to placebo. The effect was observed in patients with mild and moderate stages of the disease. These findings further validate the drug’s ability to halt the toxic cascade and reinforce its potential as a potential disease-modifying therapy. In September, Annovis published a new peer-reviewed article highlighting the pharmacokinet...

MALVERN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and second quarter 2025 financial results. “In the past quarter, our efforts were centered on driving enrollment for the pivotal Phase 3 trial in early AD, which now includes 76 secured clinical sites across the U.S. and over 400 patients screened to date,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “At the same time, we reached other notable milestones, including presenting our latest scientific findings at AAIC 2025 with the largest attendance ever from Annovis team and strengthening our global intellectual property protection by completing the transfer of all patent families to crystal buntanetap. As we move forward, our focus stays firmly on completing enrollment as planned to produce strong and trustworthy results, while also advancing our Parkinson’s program, with more updates coming as we progress.” Clinical highlights Annovis’ pivotal Phase 3 study in early AD (NCT06709014) is advancing rapidly, with 76 U.S. sites secured and 46 currently enrolling patients. The remaining sites are expected to begin enrollment shortly. The pivotal Phase 3 trial has attracted strong participation, with 38 patients already receiving buntanetap or placebo and nearly 200 more in screening – a number that continues to grow each day – with screen failure rate being as expected at 50%. Business highlights In April, Annovis welcomed Hui Liu as Director of Biostatistics, who is responsible for maintaining statistical integrity of the data generated by the Company’s clinical trials. In June, Annovis hosted a webcast to provide updates on its Phase 3 trial, engaging directly with the audience through a live Q&A session. The recording is available in the Video Library on the Company’s website. In July, senior members of Annovis attended AAIC 2025 in Toronto, presenting four scientific posters highlighting advancements in the Alzheimer’s Phase 3 study and the pharmacokinetic profile of its lead drug candidate, buntanetap. All posters are available in the Media Library on the Company’s website. In August, Annovis announced the successful transfer of all...

Malvern, Pa., May 13, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and first quarter 2025 financial results. The first quarter was largely dedicated to the initiation of a pivotal Phase 3 clinical trial in early AD, with the first participants entering the study on February 5, 2025. The trial is currently in the process of activating clinical sites across the U.S. and enrolling patients with the goal of treating an estimated 760 participants with either buntanetap or placebo. This dual 6/18-month pivotal Phase 3 study will evaluate the symptomatic benefits of buntanetap during the first 6 months and its potential disease-modifying effects over the subsequent 12 months. In addition, the first quarter was marked by active conference participation from Annovis senior management. “We are advancing as planned with our pivotal Phase 3 Alzheimer’s study, making steady progress every day,” said Melissa Gaines, SVP, Clinical Operations. “Our team is grateful to all collaborators for helping make this process efficient and to our community for their ongoing support. We look forward to providing continued updates on the current trial and other initiatives we have planned for this year.” “In these times of great uncertainty, we are choosing resilience and discipline, putting one foot in front of the other as we stay focused on advancing the Phase 3 AD study,” added Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “Our mission remains clear: to deliver a potentially life-changing treatment to patients as soon as possible.” Business highlights In January, Annovis was granted a U.S. patent covering methods for the treatment and prevention of acute brain and nerve injuries using buntanetap. In February, Annovis participated in Oppenheimer’s 35th Annual Healthcare Life Sciences Conference, which brought together leading innovators and investors in the healthcare sector. In February and March, Annovis’ management team participated in several key scientific conferences focused on neurodegenerative diseases. At AD/PDTM 2025 in Vienna, Annovis gave two presentations, showcasing findings from its Phase 3 PD trial and data on buntane...

MALVERN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and fourth quarter/full year 2024 financial results. In 2024, Annovis made significant progress by advancing the buntanetap program, successfully completing two clinical trials—Phase 2/3 AD and Phase 3 PD. Both studies yielded promising results, reinforcing buntanetap’s ability to improve cognition in AD and PD patients, as well as motor function in PD patients. Building on this success, the FDA cleared Annovis to proceed with a pivotal Phase 3 trial in early AD, which was launched at the start of 2025. The Company also participated in multiple scientific and investor conferences, announced new publications in peer-reviewed journals, expanded its patent portfolio, and added accomplished professionals to its growing team. “The last year was filled with extraordinary achievements for our company, and we are pleased with our continued momentum into 2025,” said Maria Maccecchini, Ph.D., Founder and CEO of Annovis. “We are deeply grateful to everyone who has supported and believed in our mission. As we move ahead, our focus remains on generating robust data for buntanetap and advancing its path to the patients who need it most.” Clinical progress In October 2024, the FDA granted clearance to proceed with a pivotal Phase 3 study for early AD, based on Phase 2/3 clinical data demonstrating symptomatic improvement in the subgroup of early AD patients. In February 2025, Annovis launched the pivotal Phase 3 AD study, which includes a 6-month data readout focused on buntanetap’s symptomatic effects followed by an additional 12-month assessment to evaluate its potential disease-modifying response. The symptomatic data is anticipated in mid-2026, followed by the disease-modifying data in mid-2027, with both expected to support their respective New Drug Applications (NDAs). Business highlights In October 2024, Annovis appointed Matthew Peterson, Ph.D., as Senior Clinical Scientist. In this role, Dr. Peterson ensures the medical, ethical, and scientific integrity of Annovis’ clinical trials, overseeing their initiation, execution, reporting, and successful comple...