Corbus Pharmaceuticals Announces Positive Topline Data from CANYON-1 Study of Daily Oral CRB-913 for the Treatment of Obesity

Q: What was the design of the CANYON-1 Phase 1b trial for CRB-913?

CANYON-1 was a 16-week, double-blind, placebo-controlled, dose-ranging Phase 1b trial in 254 obese, non-diabetic adults at 15 U.S. sites. Participants were randomized 1:1:1:1 to placebo or oral CRB-913 at 20, 40, or 60 mg once daily. All CRB-913 participants started at 20 mg/day and were titrated every two weeks to their assigned dose. The active treatment period lasted 12 weeks, followed by 4 weeks of follow-up.

Q: How robust was the weight-loss effect across CRB-913 doses compared with placebo?

At week 12, least-squares mean percent weight change from baseline (efficacy estimand) was 0.0% for placebo, 2.8% for 20 mg, 3.3% for 40 mg, and 5.0% for 60 mg. All CRB-913 doses showed placebo-adjusted reductions with p-values <0.0001, and no dose exhibited a plateau in weight loss by 12 weeks.

Q: What psychiatric adverse events were observed with CRB-913?

Treatment-emergent psychiatric adverse events were infrequent, mild to moderate, and transient. There were no serious or severe psychiatric events, no cases of suicidality, and one case of transient moderate depressive symptoms among 188 participants who received CRB-913. The most common psychiatric event was mild irritability, and events occurred across all cohorts, including placebo, without clear dose-related patterns.

Q: What gastrointestinal side effects were reported with CRB-913, and how common were they?

Gastrointestinal adverse events with CRB-913 were mild or moderate at all doses, with no serious or severe cases and generally no dose dependence. In the 20, 40, and 60 mg groups, vomiting occurred in 4.6%, 8.2%, and 1.6% of participants, nausea in 15.4%, 26.2%, and 22.6%, constipation in 4.6%, 1.6%, and 4.8%, and diarrhea in 21.5%, 26.2%, and 22.6%, respectively.

Q: What are Corbus Pharmaceuticals’ next steps for developing CRB-913?

Corbus plans to present detailed CANYON-1 data in a late-breaking session at ObesityWeek® 2026, scheduled for November 14–17, 2026. The company intends to engage with the FDA on the clinical development plan and expects to initiate a Phase 2 monotherapy study of CRB-913 in the first half of 2027. Corbus is also evaluating the potential to combine CRB-913 with GLP-1 therapy.

Q: How is CRB-913 described in terms of its mechanism and potential role in obesity treatment?

CRB-913 is described as an orally delivered, highly peripherally restricted CB1 inverse agonist. The company states that CANYON-1 data support its potential to establish a new class of oral, non-incretin obesity medicines and to offer a therapeutic alternative for patients who cannot tolerate or do not respond adequately to GLP-1 receptor agonists.

Early data suggest oral CB1 inverse agonist CRB-913 may offer meaningful weight loss with a differentiated tolerability profile, supporting progression to Phase 2 in 2027.

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Rhea-AI Summary

Corbus Pharmaceuticals (CRBP) reported positive topline Phase 1b data showing 5% mean weight loss with oral CRB-913 after 12 weeks.

The 16-week double-blind, placebo-controlled CANYON-1 trial enrolled 254 obese, non-diabetic adults across three once-daily dose cohorts (20, 40, 60 mg) and placebo. At week 12, least-squares mean percent weight change was 0.0% for placebo and 2.8%, 3.3% and 5.0% for the 20, 40 and 60 mg groups, all placebo-adjusted and statistically significant (p<0.0001). Among participants receiving 60 mg who completed treatment, 44.4% lost at least 5% of baseline weight, 6.7% lost more than 7.5%, and the maximum loss was 13.4%, with no plateau observed.

CRB-913 was generally well tolerated, with discontinuations due to adverse events of 3.1%-13.1%, no serious or severe psychiatric events, one transient moderate depressive symptom among 188 treated participants, and mostly mild, non–dose-dependent gastrointestinal events. Corbus plans a Phase 2 monotherapy study in the first half of 2027 and will present detailed data at ObesityWeek® 2026.

Positive

5.0% mean weight loss at 12 weeks with 60 mg CRB-913 vs 0.0% placebo (p<0.0001)
All 60 mg completers lost weight; 44.4% lost ≥5% and 6.7% lost >7.5% from baseline
Maximum individual weight loss of 13.4% from baseline in the 60 mg cohort
Psychiatric AEs had no serious or severe cases and only one transient moderate depressive symptom among 188 CRB-913–treated participants
GI adverse events were mild or moderate at all doses, with no serious or severe cases reported
AE-related discontinuations of 3.1%-13.1% were reported and described as in line with approved oral GLP-1 drugs

Negative

Adverse event–related discontinuations reached up to 13.1% in CRB-913 cohorts
Treatment duration was 12 weeks, shorter than the 36-72 week durations of comparator GLP-1 studies cited in cross-trial safety comparisons

News Explained

The release’s claim that CRB-913 has a more tolerable gastrointestinal profile than oral GLP-1 drugs is based on separate studies, not a head-to-head trial, so it supports a limited cross-trial comparison rather than a direct treatment comparison.

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+15.76% vs previous close $9.40 last price 2.0x rel. volume Open Argus

Details

Market reaction after Phase 1b clinical data: CRBP +15.76%

+9.2% Peak Tracked

-35.0% Trough Tracked

$6.00 $10.17 Day Range

$181.81M Market Cap

Following this news, CRBP has gained 15.76%, reflecting a significant positive market reaction. Argus tracked a peak move of +9.2% during the session. Argus tracked a trough of -35.0% from its starting point during tracking. Our momentum scanner has triggered 38 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $9.40. Trading volume is elevated at 2.0x the average, suggesting notable buying interest.

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Market Context

CRBP's pre-headline price change was -1.46%; the current positive CANYON-1 readout followed earlier ...

Analysis

CRBP's pre-headline price change was -1.46%; the current positive CANYON-1 readout followed earlier CRB-913 Phase 1 milestones whose 24-hour reactions were negative on Mar 28 and Jun 30.

Key Figures

Mean weight loss: 5% P-value: <0.0001 Study enrollment: 254 participants +5 more

Mean weight loss: 5%; 60 mg dose at week 12
P-value: <0.0001; 60 mg dose versus placebo at week 12
Study enrollment: 254 participants; CANYON-1 Phase 1b trial
At least 5% weight loss: 44.4%; Participants receiving 60 mg who completed the study
Highest weight loss: 13.4%; 60 mg cohort from baseline
Treatment discontinuations due to adverse events: 3.1%-13.1%; CRB-913 cohorts; compared with 6.9%-20.7% for approved oral GLP-1s
Study duration: 16 weeks; Double-blind, placebo-controlled, dose-ranging trial
Phase 2 initiation: First half of 2027; Expected monotherapy study

Previous Clinical trial Reports

2 past events · Latest: Mar 28

Same Type 2 events

Mar 28
Phase 1 initiation

24h Move

-4.7%

First patient dosed in Phase 1 CRB-913 obesity study
Jun 30
Phase 1 advancement

24h Move

-6.8%

Initiated multiple ascending dose portion of Phase 1 CRB-913 study

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

Key Terms

cb1 inverse agonist, double-blind, placebo-controlled, mmrm, +1 more

5 terms

cb1 inverse agonist medical

"peripherally restricted CB1 inverse agonist"

A CB1 inverse agonist is a drug that binds to the brain and nervous system’s CB1 cannabinoid receptor and pushes its activity below its normal resting level, producing effects opposite to those of cannabis-like stimulation. For investors, these drugs matter because altering appetite, mood, pain or addiction pathways can create significant market opportunities or regulatory risks—think of it as turning a dimmer switch lower than the factory setting to achieve a different therapeutic outcome.

double-blind medical

"a 16-week double-blind, placebo-controlled, dose-ranging study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"double-blind, placebo-controlled, dose-ranging study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

mmrm technical

"The LS means, and p-values are the Mixed Model for Repeated Measures (MMRM)"

MMRM is a statistical method used in clinical trials to analyze repeated measurements from the same patients over time, accounting for natural differences between individuals and for missing visits without simply guessing missing values. Think of it like comparing students’ test-score trends across semesters while recognizing each student’s pattern rather than averaging everyone together; for investors, MMRM matters because it influences how robust and reliable reported treatment effects appear, which can affect regulatory interpretation and market reaction.

efficacy estimand technical

"1 Efficacy estimand."

An efficacy estimand is the precise definition of the treatment effect a clinical trial aims to measure — who is being measured, what outcome counts, and how events like missed doses or additional medicines are handled. Think of it as the exact recipe and rules for measuring a cake’s taste so different tasters and interruptions don’t muddy the result. Investors care because the estimand determines how convincing and comparable trial results are, which directly affects regulatory decisions, market expectations, and valuation risk.

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

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09/14/2026 - 07:00 AM

CRB-913 demonstrated statistically significant and clinically meaningful mean weight loss of 5% at 60 mg after 12 weeks with no plateau observed
CRB-913 was generally well tolerated with psychiatric adverse events broadly in line with GLP-1 drugs and a favorable emerging GI tolerability profile
Data support CRB-913’s potential to establish a new class of oral non-incretin obesity medicines
Data selected for late-breaking presentation at ObesityWeek® 2026
Company will hold an investor call at 8:00am EDT today

NORWOOD, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced positive topline data from the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The data demonstrated statistically significant and clinically meaningful weight loss at all three doses with the 60 mg dose achieving a mean weight loss of 5% at 12 weeks. CRB-913 was associated with a favorable safety profile and fewer gastrointestinal (GI) adverse events based on cross-trial comparison with published data of currently marketed oral GLP-1 drugs. These data support CRB-913’s potential to establish a new class of oral, non-incretin obesity medicines.

“From a clinical practice perspective, a substantial number of patients with obesity either cannot tolerate GLP-1 receptor agonists or do not achieve an adequate therapeutic response,” said Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center/Monroe Biomedical Research, Clinical Associate Professor at the University of Louisville School of Medicine, and an investigator on the CANYON-1 trial. “In addition, more than 60% discontinue treatment within the first year. What I find particularly encouraging about the CANYON-1 study results is that weight reduction had not yet plateaued by the end of the 12-week treatment period, and that CRB-913 appears to have avoided the depressive effects associated with earlier central nervous system-acting cannabinoid receptor agonists. These findings support the potential emergence of the first agent in a new class of obesity medications, offering a novel mechanism of action to help treat the global epidemic of obesity.”

Yuval Cohen, Ph.D., CEO of Corbus Pharmaceuticals, added, “We set out to test a key hypothesis: by successfully designing a peripherally restricted CB1 inverse agonist, can we deliver a safe and tolerable therapeutic alternative with competitive weight loss to oral GLP-1s? The CANYON-1 data provide an important confirmatory milestone of this hypothesis. We are excited about these results and look forward to the Phase 2 study of CRB-913.”

Study Design
The CANYON-1 Phase 1b clinical trial was a 16-week double-blind, placebo-controlled, dose-ranging study that enrolled 254 obese, non-diabetic adult participants at 15 investigational sites in the United States (NCT07310901). The trial included three CRB-913 cohorts of 20 mg, 40 mg, and 60 mg dosed orally once-daily as well as a placebo cohort (randomization of 1:1:1:1). A dose titration regimen was used with all participants receiving CRB-913 commencing at 20 mg/day and then titrating up every two weeks to either 40 mg/day or 60 mg/day depending on their assigned cohort. Participants were dosed for 12 weeks and followed for an additional 4 weeks.

Topline Efficacy
CRB-913 demonstrated rapid, statistically significant and clinically meaningful weight loss at all dose levels, with no evidence of plateauing at any of the doses.

Cohort	Placebo (n=66)		CRB-913
			20 mg (n=65)		40 mg (n=61)		60 mg (n=62)
LS Mean % change in weight loss from baseline at week 12¹	0.0	%	2.8	%	3.3	%	5.0	%
LS Mean % change in weight loss at week 12¹ (placebo adjusted)	NA		2.8	%	3.3	%	5.0	%
p-value vs. placebo	NA		<0.0001		<0.0001		<0.0001

_{¹Efficacy estimand. The LS means, and p-values are the Mixed Model for Repeated Measures (MMRM) with percent change from baseline as the dependent variable; sex, treatment group, visit and treatment group-by-visit interaction as categorical fixed effects, and the baseline weight as a covariate. An unstructured covariate matrix is used.}

Weight loss response rates were significantly higher across all three CRB-913 cohorts compared to the placebo cohort. All participants who completed the study and received CRB-913 at the 60 mg dose lost weight, with 44.4% losing at least 5.0% from baseline. Similarly, 6.7% of the participants in that cohort lost more than 7.5% of their weight from baseline. The highest recorded weight loss for this cohort was 13.4% from baseline.

Topline Safety and Tolerability²
CRB-913 was generally safe and well tolerated. Treatment discontinuations due to AEs with CRB-913 (3.1%-13.1%) were in line with those recorded with approved oral GLP-1s (6.9%-20.7%) and markedly less than the 13%-42% study discontinuation rate reported with monlunabant.

Psychiatric AEs of Special Interest:
Treatment emergent psychiatric AEs were infrequent, mild to moderate, and transient. There were no serious or severe psychiatric AEs reported in the study. There were no cases of suicidality and only one case of transient depressive symptom (moderate) out of a total of 188 participants dosed with CRB-913. Psychiatric AEs were noted across all cohorts, including placebo, and generally showed no dose-related patterns. The most common psychiatric AE was irritability, and all cases were mild.

Psychiatric AEs were broadly in line with those reported for clinical studies for liraglutide, semaglutide and tirzepatide. The psychiatric AEs were lower than those seen with monlunabant, a recently studied but subsequently discontinued CB1 inverse agonist with significantly higher brain penetration than CRB-913.

Psychiatric Treatment Emergent Adverse Events

	Placebo (n=66)	CRB-913 20 mg (n=65)	CRB-913 40 mg (n=61)	CRB-913 60 mg (n=62)	Published data for liraglutide³, semaglutide⁴ and tirzepatide⁵	Monlunabant⁶ Phase 2 (n=180)
Depression	0%	0%	0%	1.6%	2%-4.6%	3%-8%
Anxiety	4.5%	3.1%	8.2%	4.8%	1.9%-7.2%	10%-27%
Irritability	0%	6.2%	8.2%	9.7%	Not reported	10%-17%
Insomnia	3.0%	1.5%	4.9%	0%	2.9%-3.9%	7%-17%

_{²These limited observations are cross trial comparison derived from separate clinical settings and do not represent head-to-head comparisons. Published safety data reflect adverse events reported over study durations longer than the 12-week CANYON-1 treatment period: 56-week study (liraglutide, Diabetes Obes Metab. 2017), 68-week study (semaglutide, JAMA Intern Med. 2024), and 72-week study (tirzepatide, Obesity 2026).}

_{³O'Neil et al. “Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 (link)}

_{⁴Wadden et al. Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials. JAMA Intern Med. 2024 (link)}

_{⁵Wadden et al, “Psychiatric Safety of Tirzepatide in People With Obesity and No Known Major Psychopathology: A Post Hoc Analysis of SURMOUNT,” Obesity 2026 (link)}

_{⁶Knop, F.K. et al. Efficacy and safety of monlunabant in adults with obesity and metabolic syndrome: a double-blind, randomised, placebo-controlled, phase 2a trial. The Lancet 2025 (link)}

Gastrointestinal AEs of Special Interest:
GI AEs were mild or moderate across all CRB-913 doses, with no serious or severe cases reported and were generally not dose-dependent. The emerging GI profile appears more tolerable than the oral GLP-1 class with markedly less vomiting, constipation, and nausea.

Gastrointestinal Treatment Emergent Adverse Events

	CRB-913 (20 mg) (n=65)		CRB-913 (40 mg) (n=61)		CRB-913 (60 mg) (n=62)		Oral semaglutide (25 mg)⁷		Orforglipron (36 mg capsule)⁸
Vomiting	4.6	%	8.2	%	1.6	%	31	%	14% – 28%
Nausea	15.4	%	26.2	%	22.6	%	47	%	41% – 48%
Constipation	4.6	%	1.6	%	4.8	%	20	%	24% – 28%
Diarrhea	21.5	%	26.2	%	22.6	%	18	%	3% –14%

_{Note: These limited observations are cross trial comparison derived from separate clinical settings and do not represent head-to-head comparisons. Published safety data reflect adverse events reported over study durations longer than the 12-week CANYON-1 treatment period: 68-week study (oral semaglutide 25 mg, N Engl J Med 2025) and 36-week study (orforglipron, N Engl J Med 2023).}

_{⁷Wharton, S. et al. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity; N Engl J Med 2025 (Link)}

_{⁸Wharton S, et al. Daily oral GLP-1 receptor agonist orforglipron for adults with obesity. N Engl J Med. 2023 (Link). Note: Early clinical development evaluated a 36mg capsule formulation; subsequent bridging established pharmacokinetic bioequivalence to the 17.2mg tablet commercial formulation.}

Next Steps
The data from the CANYON-1 Phase 1b trial will be detailed in a late-breaking presentation at ObesityWeek® 2026, to be held November 14 – 17, 2026. The Company plans to engage with the FDA on the clinical development plan and expects to initiate a Phase 2 monotherapy study in the first half of 2027. In addition, the Company is evaluating the potential to combine CRB-913 with GLP-1 therapy.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, anticipated timing for initiation of clinical trials, anticipated regulatory interactions and outcomes, including alignment with FDA on trial design, potential accelerated approval, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission including those described in our Annual Report on Form 10-K for the year ended December 31, 2025, and other filings we make with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.

INVESTOR CONTACTS:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com

MEDIA CONTACT:
Liz Melone
Founder & Principal
Melone Communications, LLC
liz@melonecomm.com

FAQ

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

What was the design of the CANYON-1 Phase 1b trial for CRB-913?

CANYON-1 was a 16-week, double-blind, placebo-controlled, dose-ranging Phase 1b trial in 254 obese, non-diabetic adults at 15 U.S. sites. Participants were randomized 1:1:1:1 to placebo or oral CRB-913 at 20, 40, or 60 mg once daily. All CRB-913 participants started at 20 mg/day and were titrated every two weeks to their assigned dose. The active treatment period lasted 12 weeks, followed by 4 weeks of follow-up.

How robust was the weight-loss effect across CRB-913 doses compared with placebo?

At week 12, least-squares mean percent weight change from baseline (efficacy estimand) was 0.0% for placebo, 2.8% for 20 mg, 3.3% for 40 mg, and 5.0% for 60 mg. All CRB-913 doses showed placebo-adjusted reductions with p-values <0.0001, and no dose exhibited a plateau in weight loss by 12 weeks.

What psychiatric adverse events were observed with CRB-913?

Treatment-emergent psychiatric adverse events were infrequent, mild to moderate, and transient. There were no serious or severe psychiatric events, no cases of suicidality, and one case of transient moderate depressive symptoms among 188 participants who received CRB-913. The most common psychiatric event was mild irritability, and events occurred across all cohorts, including placebo, without clear dose-related patterns.

What gastrointestinal side effects were reported with CRB-913, and how common were they?

Gastrointestinal adverse events with CRB-913 were mild or moderate at all doses, with no serious or severe cases and generally no dose dependence. In the 20, 40, and 60 mg groups, vomiting occurred in 4.6%, 8.2%, and 1.6% of participants, nausea in 15.4%, 26.2%, and 22.6%, constipation in 4.6%, 1.6%, and 4.8%, and diarrhea in 21.5%, 26.2%, and 22.6%, respectively.

What are Corbus Pharmaceuticals’ next steps for developing CRB-913?

Corbus plans to present detailed CANYON-1 data in a late-breaking session at ObesityWeek® 2026, scheduled for November 14–17, 2026. The company intends to engage with the FDA on the clinical development plan and expects to initiate a Phase 2 monotherapy study of CRB-913 in the first half of 2027. Corbus is also evaluating the potential to combine CRB-913 with GLP-1 therapy.

How is CRB-913 described in terms of its mechanism and potential role in obesity treatment?

CRB-913 is described as an orally delivered, highly peripherally restricted CB1 inverse agonist. The company states that CANYON-1 data support its potential to establish a new class of oral, non-incretin obesity medicines and to offer a therapeutic alternative for patients who cannot tolerate or do not respond adequately to GLP-1 receptor agonists.

Corbus Pharmaceuticals Announces Positive Topline Data from CANYON-1 Study of Daily Oral CRB-913 for the Treatment of Obesity