Braveheart Bio study: No on-treatment serious adverse events
Treatment began at 40 mg twice daily, with titration to 60 mg or 80 mg based on Valsalva gradient and ejection-fraction criteria.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Braveheart Bio, Inc. (BRVE) and Hengrui Pharma reported 52-week open-label extension results for investigational HRS/BHB-1893 in obstructive hypertrophic cardiomyopathy. All 42 patients resumed treatment after the 12-week core study and washout. At Week 52, peak oxygen uptake rose a mean 2.7 mL/kg/min and KCCQ Clinical Summary Score rose 17.3 points from OLE baseline; 79% (33/42) had a Valsalva LVOT gradient below 30 mmHg.
57% (24/42) ended the study on the 40 mg twice-daily starting dose, and 90% reached the gradient threshold at one or more treatment visits. No on-treatment severe or serious adverse events were reported; two patients had transient site-measured LVEF reductions below 50% and resumed at a lower dose. A separate post hoc analysis of 84 non-obstructive HCM patients reported improvements across diastolic-function indices after 12 weeks. A fixed-dose Phase 2b oHCM study, TRUEHEART-HCM, was planned.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Mean increase in peak oxygen uptake: 2.7 mL/kg/min
Mean increase in KCCQ Clinical Summary Score: 17.3 points
Patients with Valsalva LVOT gradient below 30 mmHg: 79% (33/42)
+4 more
7 metrics
Mean increase in peak oxygen uptake
2.7 mL/kg/min
At Week 52 from OLE baseline
Mean increase in KCCQ Clinical Summary Score
17.3 points
At Week 52 from OLE baseline
Patients with Valsalva LVOT gradient below 30 mmHg
79% (33/42)
At Week 52
Patients with Valsalva gradient below 30 mmHg
90%
At one or more visits during the treatment period
Patients ending the study on the 40 mg twice-daily starting dose
57% (24/42)
At end of study
Patients in the non-obstructive HCM post hoc analysis
84 patients
Completed Phase 2 study
Transient site-measured LVEF reductions
48% and 49%
Two patients; both resumed treatment at a lower dose
Key Terms
open-label extension, Valsalva LVOT gradient, peak oxygen uptake (pVO2), Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), +2 more
6 terms
open-label extension medical
"52-week open-label extension results"
An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.
Valsalva LVOT gradient medical
"Valsalva LVOT gradient below 30 mmHg"
peak oxygen uptake (pVO2) medical
"Peak oxygen uptake (pVO2) increased"
Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) medical
"Kansas City Cardiomyopathy Questionnaire Clinical Summary Score"
left ventricular ejection fraction (LVEF) medical
"left ventricular ejection fraction (LVEF) criteria"
Left ventricular ejection fraction (LVEF) is the percentage of blood the heart’s main pumping chamber pushes out with each beat, a simple measure of how effectively the heart pumps like the efficiency rating on a water pump. Investors care because LVEF is a key clinical indicator used to diagnose and guide treatment for heart failure and other cardiac conditions, which affects demand for drugs, devices, reimbursement, trial outcomes, and company valuation.
post hoc pooled-dose analysis medical
"post hoc pooled-dose analysis showed"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What results did BRVE report from the 52-week HRS/BHB-1893 study?
At Week 52, mean peak oxygen uptake increased 2.7 mL/kg/min and KCCQ Clinical Summary Score increased 17.3 points from OLE baseline; 79% (33/42) had a Valsalva LVOT gradient below 30 mmHg.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
______________________
FORM 8-K
______________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2026
______________________
(Exact name of Registrant as Specified in Its Charter)
______________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: 415 -707-6312
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
______________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 7.01 Regulation FD Disclosure.
On November 6, 2026, Braveheart Bio, Inc. (the “Company”) issued a press release titled “Hengrui Pharma and Braveheart Bio Present Data from 52-Week Open-Label Extension of Phase 2 Study of HRS/BHB-1893 in Obstructive Hypertrophic Cardiomyopathy at American Heart Association Scientific Sessions 2026.” A copy of the press release in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in Item 7.01 of this Current Report on Form 8-K, including the accompanying Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| 99.1 | Press Release issued by Braveheart Bio, Inc. on November 6, 2026, furnished herewith. | ||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Braveheart Bio, Inc. | |||||||||||
| Date: | November 6, 2026 | By: | /s/ J. Paul Rickey | ||||||||
| Name: | J. Paul Rickey | ||||||||||
| Title: | Chief Financial Officer | ||||||||||
Hengrui Pharma and Braveheart Bio Present Data from
52-Week Open-Label Extension of Phase 2 Study
of HRS/BHB-1893 in Obstructive Hypertrophic Cardiomyopathy at American Heart Association Scientific Sessions 2026
52-Week Open-Label Extension of Phase 2 Study
of HRS/BHB-1893 in Obstructive Hypertrophic Cardiomyopathy at American Heart Association Scientific Sessions 2026
HRS/BHB-1893 demonstrated meaningful improvements in exercise capacity and patient-reported outcomes, with rapid, deep, and durable left ventricular outflow tract (LVOT) gradient reduction at 52 weeks
Data support a highly simplified dosing regimen, with a majority of patients potentially served by the starting dose
HRS/BHB-1893 data across both forms of hypertrophic cardiomyopathy (HCM) and preclinical models suggest potential to address underlying pathophysiology of disease, findings consistent with reverse-remodeling and diastolic benefits
Braveheart Bio to host Investor Event and Webcast today at 3:35 p.m. CT (4:35 p.m. ET), including discussion of a planned fixed-dose oHCM study, TRUEHEART-HCM
SHANGHAI and SAN FRANCISCO, November 6, 2026 — Hengrui Pharma (SSE: 600276; HKEX: 1276) and Braveheart Bio (NASDAQ: BRVE) today presented data from a 52-week open-label extension (OLE) of the Phase 2 study of the investigational, next-generation cardiac myosin inhibitor HRS/BHB-1893 in patients with obstructive hypertrophic cardiomyopathy (oHCM). The data were presented at the American Heart Association (AHA) Scientific Sessions 2026.
After the 12-week core period and a washout period, all 42 patients restarted HRS/BHB-1893 for an additional 52 weeks in the OLE. At Week 52, peak oxygen uptake (pVO2) increased by a mean of 2.7 mL/kg/min from OLE baseline; Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) increased by a mean of 17.3 points over the same period. At Week 52, 79% (33/42) of patients achieved a Valsalva LVOT gradient (LVOT-G) below 30 mmHg, with 90% of patients achieving a Valsalva gradient <30 mmHg at one or more visits during the treatment period. A majority (57%) of patients ended the study on the 40 mg twice-daily (BID) starting dose.
In a separate presentation, Braveheart Bio reported new preclinical mechanistic data and ad hoc analyses of the completed Phase 2 study in non-obstructive HCM (nHCM), suggesting HRS/BHB-1893 improves diastolic function while preserving systolic function.
“These 52-week data suggested the combination of clinical effect, tolerability, and simplicity in dosing of HRS/BHB-1893, which gives us growing confidence to proceed with our clinical development in China,” said Su Zhang, Vice President and Head of Non-Oncology Clinical Development, Hengrui Pharma. “We believe that it indicates HRS/BHB-1893 will be an effective and practical option for HCM patients.”
“These data reinforce the differentiated clinical profile of HRS/BHB-1893, suggesting encouraging efficacy, safety, and ease of use over a longer course of treatment,” said Travis Murdoch, M.D., President and Chief Executive Officer, Braveheart Bio. “The study data also suggest potential reverse-remodeling. Taken together with data presented today on the mechanistic differentiation of HRS/BHB-1893 from preclinical work and the completed nHCM Phase 2 study, we believe that HRS/BHB-1893 could fundamentally address the biology of HCM, including diastolic dysfunction, across both forms of the disease.”
“HCM has long been treated as a disease of obstruction, but the biology is more fundamental, and today's data begin to reflect that reality,” said Theodore Abraham, M.D., Co-director of UCSF HCM Center of Excellence. “These results suggest that it may be possible to engage that biology directly. The evidence of attenuated rebound after 52 weeks points to a treatment that is beginning to modify the structural and biological substrate of the disease. The diastolic findings in non-obstructive patients, consistent across preclinical models and the clinic, show that the same mechanism can improve ventricular relaxation and filling that have historically constrained this class. For patients living with HCM in all its forms, that could represent a meaningfully different kind of progress.”
Long-term efficacy and safety data of HRS/BHB-1893 in patients with obstructive hypertrophic cardiomyopathy: results from the 52-week extension period
The Phase 2 study of HRS/BHB-1893 (NCT06516068) enrolled 42 adults with symptomatic oHCM. During the 12-week core period, patients were randomized across three dosing cohorts. Following the core period and a washout phase, all 42 patients entered the OLE. Patients then resumed treatment with HRS/BHB-1893 at a starting dose of 40 mg BID with opportunity for titration to 60 mg or 80 mg BID based on Valsalva LVOT-G and left ventricular ejection fraction (LVEF) criteria.
Exercise capacity and symptoms improved with extended treatment. Peak oxygen uptake (pVO2) increased by a mean of 2.7 mL/kg/min at Week 52 from OLE baseline, with 70% of patients achieving a ≥1.5 mL/kg/min improvement and 50% achieving a ≥3.0 mL/kg/min improvement. KCCQ-CSS increased by a mean of 17.3 points at Week 52 from OLE baseline, with 45% of patients achieving a ≥20-point improvement. 60% of patients achieved New York Heart Association (NYHA) Class I after 52 weeks of treatment.
HRS/BHB-1893-treated patients showed rapid, deep, and durable reductions in LVOT-G. Responders were observed as early as Day 1. By Week 1 (before the first titration), 67% of patients achieved complete LVOT-G response (Valsalva gradient <30 mmHg). At Week 52, 79% of patients (33/42) achieved Valsalva LVOT-G <30 mmHg, and 90% of patients achieved a Valsalva gradient <30 mmHg at one or more visits during the treatment period. 57% of patients (24/42) were maintained on the 40 mg BID starting dose and an additional 19% (8/42) were maintained on 60 mg BID at end of study.
The OLE washout design enabled a post hoc analysis comparison of gradient and biomarker rebound following 12 weeks versus 52 weeks of treatment with matched drug exposure. Following the 12-week core period, LVOT-G and N-terminal pro-B-type natriuretic peptide (NT-proBNP) returned to or went above pre-treatment levels after washout. Following 52 weeks of OLE treatment, signs of reduced disease burden were observed with attenuated return of NT-proBNP and LVOT-G.
HRS/BHB-1893 was generally well tolerated across the 52-week OLE period, with no on-treatment severe or serious adverse events. All on-treatment treatment-emergent adverse events (TEAEs) were mild or moderate in severity and no adverse events led to permanent study drug discontinuation. Two patients had transient reductions in LVEF below 50% (48% and 49% site-measured) and both resumed treatment at a lower dose.
The data were presented in a late-breaking oral presentation, “Long-Term Efficacy and Safety of HRS/BHB-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy: Results From the 52-Week Extension Period,” by Xueyi Wu, M.D., Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, on Friday, November 6, 2026, at 2:15 p.m. CT.
HRS/BHB-1893 improved indices of diastolic function: evidence from in vitro studies and nHCM patients
In a second presentation, Braveheart Bio reported mechanistic and clinical evidence that HRS/BHB-1893 improves indices of diastolic function with minimal effect on systolic performance, suggesting potential to address a therapeutic gap that has limited existing therapies.
The post hoc pooled-dose analysis evaluated effects of HRS/BHB-1893 on cardiac function in HCM engineered heart tissues (EHTs) and echocardiographic parameters for 84 patients with nHCM from the completed, placebo-controlled Phase 2 HRS-1893-202 study (NCT06816251). In preclinical HCM EHTs carrying the R403Q pathogenic myosin mutation, HRS/BHB-1893 was observed to improve relaxation time well below concentrations required to meaningfully reduce systolic force.
In nHCM patients, post hoc pooled-dose analysis showed significant improvements across multiple established indices of diastolic function after 12 weeks of treatment. For septal e', 59% of treated patients exceeded the normal threshold of 7 cm/s, compared to 20% at baseline and 14% in the control group. For lateral e', 57% of treated patients exceeded the 10 cm/s threshold, compared to 21% at baseline and 18% in the control group. E/e' ratio decreased and left ventricular end-diastolic volume increased, which is consistent with a downward shift of the left ventricular pressure-volume relationship and a more compliant, distensible ventricle. Left atrial volume index decreased, reflecting the downstream benefit of improved diastolic filling. Left ventricular global longitudinal strain (LVGLS) was preserved across the treated group, with 39% of HRS/BHB-1893-treated patients versus 15% of placebo patients demonstrating an improvement in LVGLS by ≥10%.
Because patients with nHCM have no obstruction to relieve, these results point to the proposed mechanism of action of HRS/BHB-1893. Across laboratory models and patients, the molecule appears to act on the excess actomyosin cross-bridge activity that drives diastolic dysfunction in HCM, improving ventricular filling while preserving systolic function. Together, the data support the potential of HRS/BHB-1893 as a differentiated, next-generation cardiac myosin inhibitor.
The data were presented in a moderated poster session, “HRS/BHB-1893, a Next-Generation Cardiac Myosin Inhibitor, Improves Indices of Diastolic Function in Non-Obstructive Hypertrophic Cardiomyopathy: Evidence from In Vitro Studies and Patients,” by Carlos L. del Rio, Ph.D., Senior Vice President, Cardiovascular Research & Translational Science, Braveheart Bio, on Friday, November 6, 2026.
Investor Event and Webcast
Braveheart Bio will host an investor event and webcast today, November 6, 2026, at 3:35 p.m. CT (4:35 p.m. ET) to discuss these data and how they inform future clinical plans, including a planned fixed-dose Phase 2b study in oHCM (TRUEHEART-HCM). A live webcast will be available in the Investors section of the Braveheart Bio website at ir.braveheart.bio, and a replay will be archived following the event.
About Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a chronic disease estimated to affect more than 700,000 individuals in the United States, and remains an area of significant unmet medical need. HCM can lead to heart failure, stroke or sudden cardiac death, including in young adults and athletes who may often live with the disease undetected.
In HCM, overactive myosin can cause excessive contraction of the heart, resulting in the heart muscle becoming abnormally thick, particularly in the left ventricle, the heart's main pumping chamber. This can lead to symptoms like shortness of breath, chest pain, fatigue and fainting, which typically worsen with physical activity and can significantly limit patients' ability to exercise, work or perform routine tasks.
Approximately two-thirds of patients with HCM have oHCM, where the thickened muscle creates a blockage in the heart's main pumping chamber, making it harder for blood to flow out to the body with each heartbeat. Approximately one-third of patients with HCM have non-obstructive hypertrophic cardiomyopathy (nHCM), where there is no obstruction, but the muscle is thickened, limiting proper heart function.
About HRS/BHB-1893
HRS/BHB-1893 (designated HRS-1893 by Hengrui and BHB-1893 by Braveheart) is an investigational next-generation oral small-molecule cardiac myosin inhibitor engineered for rapid onset of action, minimal impact on left ventricular ejection fraction (LVEF) and ease of use. By modulating cardiac contractility, HRS/BHB-1893 aims to address the underlying pathophysiology of hypertrophic cardiomyopathy (HCM) while maintaining cardiac output.
HRS/BHB-1893 has undergone extensive clinical development, including dose-ranging Phase 2 studies in both symptomatic obstructive HCM (oHCM) and symptomatic non-obstructive HCM (nHCM), multiple clinical pharmacology studies including a bridging study in Australia, and an ongoing Phase 3 study in oHCM in China (NCT07021976). Braveheart Bio entered into an exclusive worldwide license agreement with Hengrui Pharma for the development, manufacture, and commercialization of HRS-1893 outside of Chinese mainland, the Hong Kong SAR, the Macao SAR and Taiwan Region.
About Hengrui Pharma
Hengrui Pharma is an innovation-driven, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology.
About Braveheart Bio
Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Its lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart's goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety and reversibility, and by reducing prescribing complexity. For more information, visit www.braveheart.bio.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding the therapeutic potential, safety, efficacy, tolerability, and dosing of HRS/BHB-1893, including its potential to support a low-monitoring dosing regime with a majority of patients served by the starting dose and potential reverse-remodeling; the potential of HRS/BHB-1893 to address the underlying biology of HCM, to improve diastolic function or to be a differentiated, next-generation cardiac myosin inhibitor across both forms of HCM; the beneficial characteristics, and the potential therapeutic effects of HRS/BHB-1893; the potential of HRS/BHB-1893 to reach a broad population of patients; and the clinical development of HRS/BHB-1893, including the ongoing Phase 3 study. Words such as “aim,” “anticipate,” “believe,” “expect,” “may,” “potential,” “suggest,” “will” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including that results of earlier-stage, open-label or nonclinical studies may not be predictive of results of later or controlled clinical trials; risks related to the design, conduct and outcomes of clinical trials; the regulatory review and approval process; dependence on the license arrangement between the companies; and the other risks described in Braveheart’s filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q and Hengrui’s public disclosures. Forward-looking statements speak only as of the date of this press release, and, except as required by law, Braveheart and Hengrui undertake no obligation to update them.
Contacts
Contact Information for Hengrui
Media
Jill Liu
Jill Liu
Associate Branding & PR Manager
jie.liu.jl391@hengrui.com
Investor Relations
Lina Zhang
Head of Capital Markets and Securities Affairs
lina.zhang.lz511@hengrui.com
Lina Zhang
Head of Capital Markets and Securities Affairs
lina.zhang.lz511@hengrui.com
Contact Information for Braveheart Bio
Media
FGS Global
Braveheart-bio@fgsglobal.com
FGS Global
Braveheart-bio@fgsglobal.com
Investors
Alexander Sharif
New Street Investor Relations
Alexander@NewStreetIR.com
Alexander Sharif
New Street Investor Relations
Alexander@NewStreetIR.com