Biohaven Provides Update From Phase 2 Proof-of-Concept Study with BHV-7000 in Major Depressive Disorder

Biohaven (NYSE: BHVN) reported results from a Phase 2 proof-of-concept study of BHV-7000 in major depressive disorder (MDD) on Dec. 24, 2025.

Rhea-AI Summary

Biohaven (NYSE: BHVN) reported results from a Phase 2 proof-of-concept study of BHV-7000 in major depressive disorder (MDD) on Dec. 24, 2025. The study did not meet its primary endpoint (change in MADRS over six weeks versus placebo). Trends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline. Overall safety was acceptable: adverse events were mostly mild or moderate and largely resolved, with headache (10.7% vs 9.9%) and nausea (4.2% vs 5.6%) as the only events >5% in any arm. Additional analyses are ongoing and Biohaven will present updates at the J.P. Morgan Healthcare Conference in Jan 2026. The company does not plan additional psychiatric trials in 2026 to prioritize immunology, obesity, and epilepsy programs.

Positive

• Study showed trends favoring BHV-7000 in more severe depression subgroup
• Overall safety: adverse events mostly mild or moderate
• Low incidence of central nervous system adverse events consistent with no GABA activity

Negative

• Phase 2 study failed primary endpoint (MADRS change at six weeks)
• Company will not pursue additional psychiatric trials in 2026
• Only adverse event >5% was headache (10.7% vs 9.9%)

Argus Dec 24 session

+2.95% close to close Open Argus

Details

News Market Reaction – BHVN

On Dec 24, the day this news came out, BHVN closed 2.95% above the previous close.

Data tracked by StockTitan Argus for the Dec 24 session.

Key Figures

Study phase: Phase 2 Primary endpoint duration: 6 weeks Headache incidence BHV-7000: 10.7% +5 more

Study phase

Phase 2

Proof-of-concept trial of BHV-7000 in major depressive disorder

Primary endpoint duration

6 weeks

Change in MADRS vs placebo over treatment period

Headache incidence BHV-7000

10.7%

Adverse events occurring in >5% of BHV-7000-treated patients

Headache incidence placebo

9.9%

Adverse events occurring in >5% of placebo patients

Nausea incidence BHV-7000

4.2%

Reported nausea in BHV-7000 arm

Nausea incidence placebo

5.6%

Reported nausea in placebo arm

Central nervous system AEs

Low incidence

Consistent with lack of GABA activity and prior safety data

Priority year

2026

Resources focused on immunology, obesity and epilepsy in 2026

Historical Context

5 past events · Latest: Dec 11

5 events

1. Dec 11

   Oncology trial update

   24h Move

   +7.9%

   Promising Phase 1 BHV-1510 efficacy and safety data at ESMO IO.

2. Nov 13

   Equity offering close

   24h Move

   +2.7%

   Closing of upsized public share offering generating ~$200M gross proceeds.

3. Nov 12

   Equity offering pricing

   24h Move

   -6.7%

   Pricing of $175M common share offering at $7.50 per share.

4. Nov 11

   Equity offering launch

   24h Move

   +9.4%

   Announcement of proposed $150M public offering of common shares.

5. Nov 10

   Earnings and reprioritization

   24h Move

   -5.7%

   Q3 loss and R&D focus shift to three late-stage value-driving programs.

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

Key Terms

phase 2, proof-of-concept, montgomery åsberg depression rating scale (madrs), central nervous system, +4 more

8 terms

phase 2 medical

"reported results from a Phase 2 proof-of-concept study evaluating BHV-7000"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

proof-of-concept medical

"results from a Phase 2 proof-of-concept study evaluating BHV-7000"

A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

montgomery åsberg depression rating scale (madrs) medical

"measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS)"

A 10-question clinician-rated scale that measures the severity of depressive symptoms and change over time in patients, commonly used in clinical trials to evaluate how well an antidepressant or therapy works. Investors watch MADRS scores because they serve as a kind of report card for a treatment’s effectiveness — strong, consistent improvements can sway regulators, shape prescribing decisions and directly affect a drug’s commercial and market value.

central nervous system medical

"A low incidence of central nervous system adverse events was observed"

The central nervous system (CNS) is the body's main control center, made up of the brain and spinal cord, that processes information and directs movement, sensation and basic functions like breathing. For investors, CNS-related products and research matter because they face long development times, strict safety testing and regulatory hurdles; success or failure can dramatically affect a company’s costs, timelines and potential market value.

gaba activity medical

"consistent with BHV-7000's lack of GABA activity and with safety data"

GABA activity describes how a drug or substance affects the brain’s GABA system, which acts like a built‑in brake that slows overactive nerve signals. Measuring GABA activity tells investors whether a treatment is likely to calm anxiety, reduce seizures, cause drowsiness, or carry safety risks, so it helps predict clinical benefit, side effects, regulatory hurdles and commercial potential—similar to judging how well a dimmer switch controls a room’s lighting.

phase 1b medical

"from initial patient experience in the Phase 1b expansion cohorts BHV-1400"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

phase 2b medical

"recently initiated Phase 2b study with taldefgrobep alfa in obesity"

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

focal epilepsy medical

"emerging data from its ongoing clinical trial with BHV-7000 in adult focal epilepsy"

A neurological condition where seizures start in one specific area of the brain, causing symptoms that depend on which part is affected — like a short circuit in one room of a house rather than the whole building. It matters to investors because the location, frequency and severity of these seizures shape the need for targeted drugs, devices, surgical options and regulatory approvals, influencing market size, development risk and potential revenue for medical companies.

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

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NEW HAVEN, Conn., Dec. 24, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for the treatment of major depressive disorder (MDD). The study did not meet its primary endpoint, a reduction of depressive symptoms as measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS) over six weeks compared with placebo. Trends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline, on primary and secondary outcome measures (see Figures 1-3). Overall, BHV-7000 was safe and well-tolerated with adverse events mostly mild and moderate in intensity and largely resolved spontaneously. The only individual adverse events occurring with an incidence above 5% were headache (10.7% and 9.9% in BHV-7000 and placebo, respectively) and nausea (4.2% and 5.6% in BHV-7000 and placebo, respectively). A low incidence of central nervous system adverse events was observed, consistent with BHV-7000's lack of GABA activity and with safety data from previously reported studies. Additional analyses are ongoing and the company plans to present the results at an upcoming scientific meeting. The company considers the depression subgroup analyses as hypothesis generating but based upon strategic prioritization of its portfolio does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity and epilepsy in 2026.

Ahmed Tahseen, MD, Development Lead for Depression at Biohaven, commented, "There is an urgent need for novel therapies for depression that require the exploration of new mechanistic approaches to this common disorder. Although the results of this study do not support the efficacy of BHV-7000 in a broad population of depressed patients, we appreciate the commitment of the patients, investigators, and study teams who have advanced the field assessing new therapeutic approaches and made this important research possible."

Biohaven management will be presenting at the annual J.P. Morgan Healthcare Conference in San Francisco in January 2026 and intends to provide extensive updates across the breadth of its clinical programs, notably including:

• clinical data for two of its extracellular degrader programs from initial patient experience in the Phase 1b expansion cohorts BHV-1400 for IgAN and BHV-1300 for Graves' disease;
• expectations for the company's recently initiated Phase 2b study with taldefgrobep alfa in obesity
• oncology clinical stage assets;
• and emerging data from its ongoing clinical trial with BHV-7000 in adult focal epilepsy

About Biohaven 
Biohaven is a biopharmaceutical company focused on the discovery, development and commercialization of life-changing treatments in key therapeutic areas, including immunology, obesity, neuroscience and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's key clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degraders for immunological diseases; and myostatin-activin pathway targeting agents for neuromuscular and metabolic diseases, including SMA and obesity. For more information, visit www.biohaven.com.

Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of opakalim; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.

Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

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SOURCE Biohaven Ltd.

FAQ

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

What was the primary result of Biohaven's Dec. 24, 2025 BHV-7000 Phase 2 study (BHVN)?

The study did not meet its primary endpoint of MADRS change over six weeks versus placebo.

Did BHV-7000 show any positive signals in the BHVN Phase 2 depression study?

Yes; the company reported trends favoring BHV-7000 in subgroups with more severe depression at screening and baseline.

How was the safety profile of BHV-7000 in the Phase 2 trial (BHVN)?

BHV-7000 was reported as safe and well-tolerated, with mostly mild/moderate adverse events and low CNS events.

Which adverse events occurred above 5% in the BHV-7000 study (BHVN)?

Headache occurred in 10.7% of BHV-7000 patients vs 9.9% placebo; nausea rates were <5% in both arms.

Will Biohaven run more psychiatric trials of BHV-7000 in 2026 (BHVN)?

No; the company stated it does not plan additional psychiatric clinical trials in 2026 to focus resources on other priorities.

When will Biohaven (BHVN) present additional BHV-7000 data to investors?

Biohaven intends to present further analyses and program updates at the J.P. Morgan Healthcare Conference in January 2026.