Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease

Annovis Bio (NYSE: ANVS) announced that an independent DSMB issued a positive safety recommendation for 6-month buntanetap data, allowing the pivotal Phase 3 Alzheimer's trial to continue without modification.

Rhea-AI Summary

Annovis Bio (NYSE: ANVS) announced that an independent DSMB issued a positive safety recommendation for 6-month buntanetap data, allowing the pivotal Phase 3 Alzheimer's trial to continue without modification.

The DSMB found no safety concerns, noted alignment with Parkinson's safety data, the trial is 40% enrolled, and key readouts are expected early 2027 (symptomatic) and early 2028 (disease‑modifying).

Positive

• DSMB positive safety recommendation at 6 months
• 6-month safety in AD consistent with Parkinson's data
• Trial 40% complete on enrollment
• First symptomatic readout expected early 2027
• Disease‑modifying readout expected early 2028
• FDA indicated it may accept combined safety data for NDA

Negative

• None.

Argus Feb 12 session

+2.53% close to close Open Argus

Details

News Market Reaction – ANVS

On Feb 12, the day this news came out, ANVS closed 2.53% above the previous close.

Data tracked by StockTitan Argus for the Feb 12 session.

Key Figures

6‑month safety review: 6 months Subsequent safety checks: 12 and 18 months Trial completion status: 40% complete +2 more

6‑month safety review

6 months

DSMB safety evaluation timepoint in the pivotal AD Phase 3 trial

Subsequent safety checks

12 and 18 months

Planned future DSMB safety evaluations in the AD program

Trial completion status

40% complete

Pivotal Phase 3 Alzheimer’s trial enrollment/progress at time of DSMB review

Symptomatic readout timing

Early 2027

First symptomatic efficacy readout for the Phase 3 AD trial

Disease‑modifying readout

Early 2028

Planned disease‑modifying efficacy readout for the AD Phase 3

Previous Clinical trial Reports

5 past events · Latest: Nov 18

Same Type 5 events

1. Nov 18

   FDA meeting alignment

   24h Move

   +11.2%

   FDA Type C meeting set for PDD and reaffirmed Phase 3 AD alignment.

2. Nov 06

   Phase 3 progress update

   24h Move

   -2.5%

   All 84 sites activated and study 25% complete toward 760-patient target.

3. Feb 05

   Phase 3 AD initiation

   24h Move

   +0.0%

   First patients enrolled in pivotal AD Phase 3 with 18‑month design and funding.

4. Jul 02

   PD Phase III data

   24h Move

   +76.1%

   Phase III Parkinson’s study showed significant MDS‑UPDRS and cognition gains.

5. May 09

   PD data unblinding update

   24h Move

   +25.1%

   Completion of data cleaning and plan to report topline PD efficacy data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

data and safety monitoring board, dsm b, alzheimer’s disease, parkinson’s disease, +1 more

5 terms

data and safety monitoring board regulatory

"an independent Data and Safety Monitoring Board (DSMB) has issued a positive"

An independent panel of experts that watches over a clinical trial to protect participants and ensure the data are reliable, acting like an impartial referee who can recommend pausing or stopping the study if safety problems or clear benefits emerge. Investors care because the board’s findings can change a drug or device’s timeline, cost, and odds of regulatory approval, directly affecting a company’s value and risk profile.

dsm b regulatory

"Data and Safety Monitoring Board (DSMB) has issued a positive recommendation"

An independent committee of medical and statistical experts that watches over a clinical trial’s safety and progress, similar to an impartial referee who can recommend pausing, changing or stopping the study if participants are at risk or if results are already clear. Investors care because the committee’s decisions can change a drug’s development timeline, affect regulatory chances and trigger sudden stock moves when trials are modified or halted.

alzheimer’s disease medical

"buntanetap, for neurodegenerative diseases such as Alzheimer's disease (AD)"

A progressive brain disorder that gradually erodes memory, thinking and the ability to perform everyday tasks, similar to a computer slowly losing files and processing speed. It matters to investors because its large and growing patient population drives demand for treatments, long-term care, diagnostics and related services, making clinical trial results, regulatory decisions and patent exclusivity major value drivers for healthcare and biotech companies.

parkinson’s disease medical

"diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD)"

A progressive brain disorder that gradually impairs movement, balance and certain mental functions by reducing the brain’s ability to produce a chemical important for controlling motion. Investors care because it creates a large, growing market for treatments, devices and care services; success or failure of drugs and clinical trials, regulatory approvals, and long-term care costs can materially affect pharmaceutical and medical-device company valuations.

nda submission regulatory

"the FDA indicated it may consider accepting combined safety data in a future NDA submission"

An NDA submission is the formal application a drug developer files with a medicines regulator seeking permission to market a new prescription drug. Think of it as the final product pitch that compiles all clinical trial results, safety data and manufacturing details so the regulator can decide whether the drug can be sold. For investors, an NDA submission is a major milestone because acceptance or approval can unlock sales and revenue, while delays or rejections create uncertainty and financial risk.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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MALVERN, Pa., Feb. 12, 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 that an independent Data and Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the safety of buntanetap at 6 months, supporting the continuation of the ongoing pivotal Phase 3 AD clinical trial without modification.

The DSMB is responsible for periodically reviewing accumulated safety data and providing independent recommendations on the conduct and progression of the study. During the open session, Annovis presented an overview of the trial status, including enrollment progress, adverse events, and study timelines. In the closed session, attended exclusively by DSMB voting members to ensure full objectivity and by an unblinded reporting statistician, unmasked safety data were reviewed.

Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. Moreover, the 6-month safety data in Alzheimer’s patients were consistent with those observed in Parkinson’s patients at the same time point. Subsequent safety evaluations are planned at 12 and 18 months.

“We are pleased to receive this positive recommendation from the DSMB,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “This response reinforces our confidence in the safety profile of buntanetap and allows the clinical program to proceed without interruption. Importantly, due to the alignment of safety outcomes across the Alzheimer’s and Parkinson’s studies, the FDA indicated it may consider accepting combined safety data in a future NDA submission.”

The pivotal Phase 3 AD clinical trial of buntanetap (NCT06709014) is currently recruiting patients across the United States and is now 40% complete. The first symptomatic efficacy readout is anticipated in early 2027, followed by a disease-modifying readout expected in early 2028.

About Annovis
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. (NYSE: ANVS) is a Phase 3 clinical-stage biotechnology company developing treatments for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD). The Company's lead drug candidate, buntanetap (formerly posiphen), is an investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta, tau, alpha-synuclein, and TDP-43, through a specific RNA-targeting mechanism of action. By addressing the underlying causes of neurodegeneration, Annovis aims to halt disease progression and improve cognitive and motor functions in patients. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.

Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.

Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.

Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com

Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com‍

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Annovis (ANVS) announce about the Phase 3 buntanetap trial on February 12, 2026?

Annovis received a positive DSMB recommendation allowing the Phase 3 AD trial to continue unchanged. According to the company, the DSMB found no safety concerns at 6 months and recommended continuation without protocol modification.

How far along is the Annovis (ANVS) pivotal Phase 3 Alzheimer's trial as of February 12, 2026?

The trial is 40% complete on patient enrollment as reported by the company. According to Annovis, recruitment continues across the United States with ongoing safety monitoring and planned future evaluations at 12 and 18 months.

What safety findings did the DSMB report for buntanetap in the ANVS Phase 3 trial?

The DSMB found no safety concerns at the 6-month review and recommended continuation as planned. According to Annovis, 6-month AD safety data were consistent with safety observed in Parkinson's patients at the same time point.

When does Annovis (ANVS) expect efficacy readouts from the buntanetap Phase 3 trial?

Annovis expects a symptomatic efficacy readout in early 2027 and a disease‑modifying readout in early 2028. According to the company, these timelines follow the current enrollment pace and planned follow-up assessments.

Could the FDA accept combined safety data for an Annovis (ANVS) NDA submission?

The FDA indicated it may consider accepting combined safety data from Alzheimer’s and Parkinson’s studies. According to Annovis, alignment of safety outcomes across studies prompted this regulatory feedback as a possible future pathway.

What are the next safety review milestones for the Annovis (ANVS) Phase 3 buntanetap trial?

Subsequent safety evaluations are planned at 12 and 18 months following the 6-month review. According to the company, these scheduled reviews will continue independent DSMB oversight and unblinded safety assessments where appropriate.