Lucid Diligence Brief: Braveheart Bio launches with $185M Series A

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Dive deeper

Seven questions, 60-second thesis frame.

What changed, and when

Braveheart Bio launches with a $185M Series A on 05 Nov 2025 to advance BHB-1893, a selective cardiac myosin inhibitor for hypertrophic cardiomyopathy, and named Biogen CEO Chris Viehbacher as board chair (Braveheart press release). Independent reports confirm financing, investor syndicate, and positioning versus Camzyos and aficamten (Fierce Biotech, BioPharma Dive).

60-second thesis frame

The launch packages late-stage readiness around a China-origin asset, HRS-1893, now BHB-1893, with Phase 3 oHCM already recruiting in China and Phase 2 nHCM underway, creating a time-to-market angle if global bridging is efficient (NCT07021976, NCT06816251). The core differentiation claim is faster LVOT gradient reduction with a simpler dosing paradigm, per early data presented at ESC 2025, though details remain limited outside company communications (ESC 2025 presentation listing, Braveheart press release). Competitive bar is rising, with Camzyos label updates and REMS still shaping adoption and aficamten’s U.S. PDUFA scheduled for 26 Dec 2025, which will reset expectations on efficacy, safety, and monitoring burden (BMS label update, FDA label PDF, Cytokinetics 8-K on PDUFA).

The seven diligence questions

Clinical

• Does BHB-1893 reproduce rapid LVOT gradient reduction and sustain it without EF dips or tight echo-monitoring needs, in head-to-head or bridged designs, versus Camzyos or aficamten? (ESC 2025 listing, BMS Camzyos label)
• Can BHB-1893 show clinically meaningful benefit in nHCM where mavacamten failed ODYSSEY-HCM’s dual primary endpoints, or is the effect limited to biomarker and echo signals? (ESC press note on ODYSSEY, ACC trial page)

Payer or Access

• If efficacy is comparable, can BHB-1893 reduce REMS-like burdens that constrain prescriber uptake and payer friction seen with Camzyos, such as echo monitoring cadence and prescriber certification? (Camzyos REMS overview, Camzyos HCP REMS site)
• Will major U.S. PBMs keep prior-auth step edits that require failure of beta-blocker or calcium-channel blocker, and how would that impact first-line positioning for a new myosin inhibitor? (CVS Caremark PA criteria example, OptumRx PA list)

Ops or Adoption

• Can Braveheart operationalize global “late-stage” by 2026 with U.S./EU regulatory alignment and China data bridging, including CMC and drug-drug interaction packages, to avoid timeline slippage? (Braveheart launch PR, NCT07021976)

Competitive

• If aficamten secures approval around 26 Dec 2025 with a lighter monitoring footprint, what is the credible “best-in-class” wedge for BHB-1893 on efficacy, safety, or dosing simplicity? (Cytokinetics 8-K on PDUFA, Cytokinetics ESC 2025 update)

Team or Cap table

• Does the license from Hengrui create dependency risks for ex-China development, IP control, tech transfer, or geopolitics, and are milestone waterfalls aligned to financing cadence? (Hengrui–Braveheart license PR, Cooley deal note with milestone cap, BioPharma Dive context)

Red flags

• Non-obstructive HCM risk: prior Phase 3 failure for mavacamten in nHCM raises bar for any class generalization, increasing read-through risk to BHB-1893’s nHCM program (ESC press note on ODYSSEY, NEJM abstract via PubMed)
• Monitoring burden: if BHB-1893 ultimately requires Camzyos-like REMS or frequent echocardiograms, payer friction and prescriber inertia could persist despite efficacy claims (Camzyos label, REMS program page)
• Geopolitics and data bridging: ex-China rights with Phase 3 starting in China demand clean cross-regional CMC, PK, and interaction bridging, plus resilience to policy scrutiny of U.S.–China biotech deals (Hengrui license PR, BioPharma Dive noting DC scrutiny)

Next catalyst

Aficamten U.S. FDA PDUFA for oHCM on 26 Dec 2025, a key external bar for efficacy, safety, and monitoring expectations in the class (Cytokinetics 8-K).

FAQ

• What exactly changed by Braveheart Bio’s news regarding its $185M Series A launch on 05 Nov 2025, and why does it matter for HCM?
  Braveheart unveiled late-stage plans for BHB-1893, a myosin inhibitor targeting obstructive and non-obstructive HCM, backed by a16z Bio + Health, Forbion, OrbiMed, Enavate Sciences, and Frazier, with Biogen’s Chris Viehbacher as chair (Braveheart press release, Fierce Biotech).
• What is the regulatory path after Braveheart’s launch and what are the next formal steps in the US, UK, and EU?
  Braveheart plans to initiate global late-stage development in 2026, likely after FDA and EMA late-stage design alignment, with China Phase 3 already recruiting for oHCM (Braveheart press release, NCT07021976).
• Which endpoints in Braveheart/Hengrui’s program drove the “best-in-class” thesis, and how meaningful was the effect size?
  Company-cited ESC 2025 early data highlight rapid LVOT gradient reductions and a shallow EF exposure-response, but independent granular results remain limited publicly; careful review on full publication will be needed (ESC presentation listing, Braveheart press release).
• What safety issues matter post-launch, and do they change real-world use?
  The class risk is EF reduction and potential heart failure, which drives REMS and echo monitoring for Camzyos; BHB-1893’s ability to avoid similar constraints is central to adoption (FDA Camzyos label, Camzyos REMS).
• How will major US payers treat access after launch, including prior auth or step edits, and are codes available?
  Today, PBMs commonly require prior authorization and prior therapy steps for Camzyos; absent clear advantages, analogous criteria would likely apply to a new myosin inhibitor until value is proven in outcomes (CVS Caremark PA criteria example, OptumRx PA list).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 05 Nov 2025, 13:30 London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

Braveheart Bio; BHB-1893; HRS-1893; hypertrophic cardiomyopathy; obstructive HCM; non-obstructive HCM; cardiac myosin inhibitor; LVOT gradient; ejection fraction; Camzyos; mavacamten; aficamten; Cytokinetics; Bristol Myers Squibb; Biogen; Chris Viehbacher; Travis Murdoch; a16z Bio + Health; Forbion; OrbiMed; Enavate Sciences; Frazier Life Sciences; Hengrui Pharma; NCT07021976; NCT06816251; FDA; EMA; MHRA; REMS; prior authorization; PBM; CVS Caremark; OptumRx; ESC 2025; China Phase 3; global late-stage 2026; U.S. PDUFA 26 Dec 2025.

 

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