Biohaven's Phase 2 Obesity Study with Taldefgrobep Alfa, a Novel Myostatin-Activin Pathway Inhibitor, Completes Enrollment

Biohaven (NYSE: BHVN) completed enrollment in a Phase 2 randomized, double-blind, placebo-controlled study of taldefgrobep alfa in adults with overweight and obesity, targeting ~150 randomized participants across 20 US sites.

Rhea-AI Summary

Biohaven (NYSE: BHVN) completed enrollment in a Phase 2 randomized, double-blind, placebo-controlled study of taldefgrobep alfa in adults with overweight and obesity, targeting ~150 randomized participants across 20 US sites. Topline data are expected in 2H 2026.

The 24-week double-blind period evaluates percent change in total body weight (primary) and body fat and lean mass (secondary); an additional 24-week open-label extension follows.

Positive

• Enrollment complete: ~150 participants randomized across 20 US sites
• Topline timing: results expected in 2H 2026
• Prior phase 1 body-composition: >6% reduction in total body fat mass and up to 4% lean mass increase after 29 days
• Phase 3 neuromuscular data: 9.7% reduction in total body fat (p<0.0003) and 2.1% muscle mass increase
• Safety exposure: evaluated in >700 participants with low rates of SAEs and discontinuations

Negative

• Comparator safety concerns: prior MAP inhibitor bimagrumab showed high GI- and muscle-related AEs that complicated development
• Topline pending: no efficacy data yet from this obesity Phase 2 study (results due 2H 2026)

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Key Figures

Phase 2 obesity sample: ≈150 participants Treatment duration: 24‑week double‑blind + 24‑week extension Sites: 20 clinical sites +5 more

Phase 2 obesity sample

≈150 participants

Target randomization size for taldefgrobep Phase 2 PoC obesity study

Treatment duration

24‑week double‑blind + 24‑week extension

Design of taldefgrobep Phase 2 obesity trial

Sites

20 clinical sites

US locations conducting Phase 2 obesity study

Fat mass reduction

>6% reduction

Phase 1 taldefgrobep total body fat mass change after 29 days

Lean mass increase

up to 4% increase

Phase 1 taldefgrobep total body lean muscle mass change

Phase 3 fat accumulation

9.7% reduction (p<0.0003)

BHV2000‑301 taldefgrobep trial total body fat accumulation vs placebo

Trial exposure

>700 participants

Total clinical trial participants exposed to taldefgrobep

BELIEVE fat loss

-25.3% vs -24.8%

One‑year total body fat mass change: bimagrumab vs semaglutide 2.4 mg

Previous Clinical trial Reports

5 past events · Latest: Dec 24

Same Type 5 events

1. Dec 24

   Phase 2 MDD results

   24h Move

   +3.0%

   Phase 2 BHV‑7000 in MDD failed primary endpoint but showed subgroup trends.

2. Dec 11

   Oncology Phase 1 data

   24h Move

   +7.9%

   BHV‑1510 Trop2 ADC plus cemiplimab showed high ORR and favorable safety.

3. Nov 04

   Troriluzole CRL

   24h Move

   -40.2%

   FDA Complete Response Letter for VYGLXIA NDA in spinocerebellar ataxia.

4. May 29

   PD trial initiation

   24h Move

   -2.1%

   First patient enrolled in global Phase 2/3 BHV‑8000 trial in early PD.

5. May 28

   Oncology ADC updates

   24h Move

   -1.8%

   Promising Trop2 and FGFR3 ADC clinical and pipeline updates at R&D day.

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

Key Terms

myostatin-activin signaling pathway, glp-1 agonist, randomized, double-blind, placebo-controlled, autoinjector, +4 more

8 terms

myostatin-activin signaling pathway medical

"Taldefgrobep is a novel inhibitor of the myostatin-activin signaling pathway..."

A biological signaling route in which proteins called myostatin and activin send messages to cells to limit muscle growth and influence metabolism and tissue repair. Investors care because this “brake system” for muscle is a common drug target: therapies that safely block or adjust the pathway can treat muscle-wasting and metabolic disorders, affecting clinical trial success, regulatory approval, and potential market size.

glp-1 agonist medical

"in combination with a GLP-1 agonist, generated significant reductions in fat mass..."

A GLP‑1 agonist is a drug that mimics a naturally occurring hormone involved in controlling blood sugar and appetite; think of it as a spare key that fits a body’s lock to trigger signals reducing blood sugar and slowing hunger. For investors, these medicines matter because they can treat common, long‑term conditions like diabetes and obesity, drive large prescription sales, and face close regulatory scrutiny and competitive innovation that affect company revenues and valuations.

randomized, double-blind, placebo-controlled technical

"is a randomized, double-blind, placebo-controlled, dose-ranging study..."

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

autoinjector technical

"as monotherapy, via self-administered autoinjector, in adults living with overweight..."

A prefilled, spring‑loaded medical device that automatically delivers a measured dose of medication beneath the skin when pressed against the body, like a self‑operating syringe packaged for quick use. Investors care because autoinjectors can increase patient safety, adherence and convenience — factors that drive demand, shape reimbursement and regulatory review, and affect a product’s market size, manufacturing complexity and competitive moat.

visceral adipose tissue medical

"greater reduction in metabolically active visceral adipose tissue (-40.2% vs. -29.5%)..."

Fat stored deep inside the belly around internal organs rather than under the skin; think of it as padding that surrounds the body’s “engine” rather than the outer insulation. It matters to investors because higher levels are linked to greater risk of chronic illness (like heart disease and diabetes), which can drive demand for medical tests, treatments, wellness programs, and affect healthcare costs, insurer risk, and workforce productivity.

activin receptors (actrii) medical

"by interrupting the signaling through activin receptors (ActRII) caused by transforming..."

Activin receptors are proteins on the surface of cells that act like locks for certain growth-factor “keys,” receiving signals that control cell growth, repair and function. They matter to investors because drugs that block or activate these receptors can change the course of diseases (for example muscle wasting, anemia, fibrosis or some cancers), so clinical trial results or regulatory news about such drugs can strongly affect a company’s value.

transforming growth factor-beta (tgf-ß) medical

"caused by transforming growth factor-beta (TGF-ß) ligands, such as myostatin..."

Transforming growth factor-beta (TGF-β) is a naturally occurring signaling protein that helps cells communicate to control growth, repair, scarring and immune responses; think of it as a cellular traffic cop or thermostat that tells tissues when to grow, slow down or lay down scar tissue. It matters to investors because drugs or diagnostics that alter TGF-β activity can treat cancer, fibrosis and other diseases, making it a high-impact drug target and biomarker with both therapeutic promise and safety risks.

proof-of-concept (poc) technical

"completion of enrollment in a Phase 2 proof-of-concept (PoC) study..."

Proof-of-concept (PoC) is an early test or demonstration that shows whether a new product, drug, technology, or idea can work in a basic, real-world way. For investors it signals the difference between a hopeful plan and something that has practical potential—like seeing a small model of a bridge hold weight before funding the full construction—and helps assess risk, timelines, and likely future funding needs.

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

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• Phase 2 study in obesity, evaluating treatment with once-weekly and once-monthly taldefgrobep alfa as monotherapy, is now fully enrolled; topline data expected in 2H 2026.
• Taldefgrobep is a novel inhibitor of the myostatin-activin signaling pathway, which directly targets both fat and muscle, offering the potential to achieve high-quality weight loss in people living with overweight and obesity.
• In previous clinical studies, taldefgrobep produced meaningful reductions in fat mass while increasing lean muscle mass in healthy adults and other non-obese populations; it has also demonstrated a highly favorable safety and tolerability profile in more than 700 trial participants.
• In nonclinical studies in obese mouse models, taldefgrobep, both as monotherapy and in combination with a GLP-1 agonist, generated significant reductions in fat mass and body weight, while increasing lean mass.

NEW HAVEN, Conn., March 19, 2026 /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 announced the completion of enrollment in a Phase 2 proof-of-concept (PoC) study with its myostatin-activin pathway inhibitor (MAPI), taldefgrobep alfa, which offers the potential to achieve high-quality weight loss in people living with obesity. Topline data from the study are expected in 2H 2026.

Frank Greenway, M.D., Professor, Chief Medical Officer of the Clinical Trials Unit at Pennington Biomedical Research Center, Baton Rouge, LA stated, "We are at a watershed moment in the treatment of obesity, brought on by the introduction of highly effective therapies like the GLP-1 agonists. To realize optimal long-term health outcomes, however, we will need to look beyond maximizing weight reduction and remain vigilant around the importance of muscle mass in overall health and wellness. Investigational medications, like taldefgrobep, with the potential to meaningfully reduce body weight and adipose tissue, while increasing muscle mass can be an important addition to the anti-obesity armamentarium."

The Phase 2 PoC study (NCT07281495) is a randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and tolerability of once-weekly and once-monthly taldefgrobep as monotherapy, via self-administered autoinjector, in adults living with overweight and obesity. It includes a 24-week double-blind treatment period followed by 24-week open-label extension period. The study is targeting approximately 150 participants for randomization. The primary outcome measure is percent change in total body weight from baseline to Week 24, and secondary outcome measures are percent change in total body fat mass and in total body lean mass. The study is being conducted at 20 clinical sites across the US.

Peter Ackerman, M.D., Senior Vice President of Clinical Development at Biohaven stated, "We are excited to evaluate taldefgrobep, as both a once-weekly and once-monthly dosing regimen, in an obese patient population. We believe taldefgrobep could represent an important new agent, as monotherapy and in combination with the current standard of care, that can help optimize high-quality weight loss in people living with obesity." Dr. Ackerman added, "New investigational therapies with novel modes of action are critical to maximizing long-term health benefits in people living with overweight and obesity. While there have been great recent advancements in the field of obesity medicine, there is still a lot of work to do in optimizing the management of a complex, heterogeneous condition that affects nearly half of the world's population. Our team is grateful to the investigators, their staff, and all participants involved in this important study."

In previous clinical studies, taldefgrobep demonstrated beneficial changes in fat mass and lean mass in non-obese populations. Participants in a Phase 1 trial who received taldefgrobep realized significant reductions in total body fat mass (>6%) with commensurate increases in lean muscle mass (up to 4%) after 29 days of dosing. In that study, taldefgrobep benefit in body composition change was not fully realized until four weeks beyond the final dose was administered, suggesting the drug may support extended dosing intervals. In the Phase 3 study BHV2000-301, examining patients with a neuromuscular disorder, taldefgrobep-treated participants achieved statistically significant reductions in total body fat accumulation (9.7%; p<0.0003) and numerically greater benefit in bone mineral density (1.2%) and muscle mass (2.1%) relative to placebo.

Taldefgrobep also has an established safety profile that is well-suited for an indication in chronic weight management. It has been evaluated in >700 clinical trial participants and has been well tolerated with low rates of serious adverse events (SAEs) and adverse events (AEs) leading to early discontinuation. Rates of muscle- and GI-related AEs have been generally comparable to placebo.

In nonclinical studies, taldefgrobep has demonstrated the ability to have direct beneficial effects on lean muscle mass and adipose tissue by interrupting the signaling through activin receptors (ActRII) caused by transforming growth factor-beta (TGF-ß) ligands, such as myostatin and multiple activins (A, E, etc.). In a diet-induced obese (DIO) mouse model, taldefgrobep monotherapy showed significant improvements in total body weight, fat mass, and lean mass relative to vehicle. In DIO mice, taldefgrobep in combination with a GLP-1 agonist showed additive benefit across these endpoints.

Data from multiple Phase 2 studies conducted with bimagrumab, a myostatin-activin pathway inhibitor, demonstrates a strong proof of concept for this therapeutic approach to obesity. In the BELIEVE study, participants dosed with bimagrumab as monotherapy, achieved reductions in total body fat mass comparable to high-dose semaglutide (2.4 mg) at one year (-25.3% vs. -24.8%, respectively). In the same study, bimagrumab-treated individuals saw a greater reduction in metabolically active visceral adipose tissue (-40.2% vs. -29.5%) and improvement in lean muscle mass compared semaglutide (+2.7% vs. -7.9%, respectively). Unfortunately, the safety profile of bimagrumab (high rates of GI- and muscle-related AEs and worsening of cholesterol levels) has complicated further development of this asset for an indication in chronic weight management.

 and worsening of cholesterol leves) has complicated further development of this asset for an indication in chronic weight management.

About Taldefgrobep Alfa

Taldefgrobep alfa is a novel fusion protein designed to inhibit signaling through activin transmembrane receptors (ActRII). Taldefgrobep targets free myostatin, forming stable complexes which bind to ActRII in a manner that prevents downstream signaling from transforming growth factor-beta (TGF-ß) ligands (including myostatin and activins) important in body composition change. Taldefgrobep's novel mechanism of action offers the potential for meaningful reductions in fat mass, increased lean mass, and improvements in multiple metabolic parameters.

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 clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; TYK2/JAK1 inhibition for neuroinflammatory disorders; myostatin-activin pathway inhibition for neuromuscular and metabolic diseases; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. 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, including statements regarding the expected timing and amounts of funding under the NPA. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate", "potential first-in-class" 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 Phase 2 taldefgrobep trial in people living with obesity (BHV2000-202); the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies, including the potential for taldefgrobep as a treatment for overweight and obesity; 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 did Biohaven (BHVN) announce about taldefgrobep alfa enrollment on March 19, 2026?

Biohaven announced completion of enrollment in a Phase 2 obesity study with taldefgrobep alfa, targeting about 150 randomized participants. According to the company, the trial enrolled across 20 US sites and will report topline data in 2H 2026.

When will topline results from Biohaven's BHVN Phase 2 taldefgrobep obesity study be available?

Topline data are expected in 2H 2026, according to the company. The study's 24-week double-blind period ends before an additional 24-week open-label extension, informing the timing.

What are the primary and secondary endpoints in Biohaven's BHVN Phase 2 taldefgrobep study?

The primary endpoint is percent change in total body weight at Week 24, with secondary endpoints of percent change in total body fat mass and total body lean mass. According to the company, these measures assess high-quality weight loss.

How has taldefgrobep performed in prior clinical studies noted by Biohaven?

In earlier studies, taldefgrobep produced >b>6% reductions in total body fat mass and up to 4% increases in lean mass after 29 days, per the company. The company also cites significant fat reductions in a Phase 3 neuromuscular study.

Does Biohaven report safety data for taldefgrobep ahead of the Phase 2 obesity topline readout?

Biohaven reports taldefgrobep has been evaluated in >700 clinical trial participants with low rates of serious adverse events and discontinuations. According to the company, muscle- and GI-related AEs were generally comparable to placebo.

What development risks does Biohaven highlight related to myostatin-activin pathway inhibitors for obesity?

The company notes that a prior MAP inhibitor, bimagrumab, had high GI- and muscle-related adverse events that complicated development. According to the company, safety profiles will be an important consideration for chronic weight management.