What changed, and when

BioMarin announced a definitive agreement on 19 Dec 2025 to acquire Amicus Therapeutics for $14.50 per share in cash, valuing Amicus at about $4.8B, with expected close in Q2 2026, subject to Amicus shareholder and antitrust approvals (Company press release). Independent outlets confirm the price, premium and timeline, and report financing as cash plus approximately $3.7B of new non-convertible debt (Reuters, Fierce Pharma, Barron’s).

60-second thesis frame

Strategically clean bolt-on that swaps BioMarin’s Roctavian uncertainty for durable, growing rare-disease cashflows, plus a Phase 3 renal asset option. The deal adds Galafold for Fabry and the two-component Pombiliti + Opfolda for Pompe, together $599M trailing four-quarter revenue, with BioMarin guiding to immediate revenue acceleration and EPS accretion within 12 months post-close and “substantial” accretion from 2027 (Company press release, Investor’s Business Daily). Galafold’s US exclusivity is expected through Jan 2037 following Aurobindo and Lupin settlements, reducing near-term generic overhang (BioMarin investors page). Operationally, BioMarin’s global ERT footprint should help scale Pompe and expand Fabry, while DMX-200 for FSGS provides a late-stage optionality kicker as ACTION3 recruitment has recently completed (ClinicalTrials.gov, Morningstar PR Newswire note).

The seven diligence questions

Clinical

• For Fabry, how differentiated is Galafold’s long-term organ protection versus ERTs and Elfabrio in amenable-variant populations, and how will confirmatory outcomes underpin continued US accelerated approval status (FDA Galafold label, FDA Elfabrio snapshot)?
• For Pompe, in ERT-experienced adults not improving on current therapy, what is the magnitude and durability of Pombiliti + Opfolda effects on respiratory and motor endpoints versus Nexviazyme and Lumizyme in head-to-head or real-world settings (FDA Pombiliti label, FDA Opfolda label, Sanofi Nexviazyme approval)?

Payer or Access

• In the US, how sticky are current coverage policies, including J-codes J1203 for Pombiliti and J1202 for Opfolda, and do major PBMs apply step edits against Nexviazyme or Lumizyme (CMS April 2024 OPPS update, G0138, UHC self-admin list noting J1202, Moda/Prime payer policy with J1203)?
• In the UK, how do NICE decisions frame access and budget impact for Galafold and for Pombiliti + Opfolda, and what is the implied price-volume trade-off under existing patient access schemes (NICE HST4, Galafold, NICE TA912, Pombiliti + Opfolda)?

Ops or Adoption

• Can BioMarin’s established enzyme-therapy commercial network and in-house manufacturing accelerate Pompe adoption and expand Fabry testing and amenability screening, particularly in under-penetrated markets (Company press release)?

Competitive

• How does the combined Fabry and Pompe franchise compete versus Sanofi’s Nexviazyme and Lumizyme and Chiesi’s Elfabrio across efficacy, infusion burden, and access over 2026–2030 (FDA labels for Nexviazyme, Lumizyme, FDA Elfabrio snapshot)?

Team or Cap table

• What leverage, integration and portfolio focus guardrails will the Hardy leadership team use post-Elliott settlement and Roctavian retrenchment, given new debt and deleveraging targets (<2.5x within two years) (BioMarin investors PR, Reuters on strategy shift)?

Red flags

• Antitrust or FTC scrutiny of Fabry and Pompe markets could delay or condition the close, and the Galafold patent settlements will be filed with FTC and DOJ for review (BioMarin investors page).
• Debt load introduces execution risk if Pompe uptake underperforms or Fabry volumes plateau despite exclusivity through Jan 2037 (Company press release, Reuters financing detail).
• DMX-200 outcome risk, single Phase 3 ACTION3 must show hard kidney outcomes beyond proteinuria to create real optionality in FSGS (ClinicalTrials.gov).

Next catalyst

Amicus Schedule 14A filing and shareholder vote window, plus HSR process milestones, with close targeted in Q2 2026; company has scheduled a same-day call on 19 Dec 2025 (BioMarin investors page).

FAQ

• What exactly changed by BioMarin’s acquisition of Amicus Therapeutics for $4.8B news on 19 Dec 2025, and why does it matter for Fabry and Pompe?
  BioMarin agreed to buy Amicus for $14.50 per share in cash, adding Galafold for Fabry and Pombiliti + Opfolda for Pompe to its portfolio, with guidance for immediate revenue acceleration post-close (Company press release). Independent reports confirm price, premium and strategic rationale to shore up BioMarin’s rare-disease franchise (Reuters, STAT).
• What is the regulatory path after BioMarin’s and Amicus’ 19 Dec 2025 announcement, and what are the next formal steps?
  The transaction is subject to approval by Amicus stockholders and customary regulatory clearances, including antitrust reviews (Kirkland & Ellis). The companies currently anticipate a formal closing in the second quarter of 2026 (Stock Titan).
• Which assets drove the value in the 19 Dec 2025 BioMarin/Amicus deal, and how meaningful is their performance?
  The deal is centered on two commercial assets, Galafold and Pombiliti + Opfolda, which generated $599 million in trailing twelve-month revenue (BioSpace). Additionally, the U.S. rights to DMX-200, a Phase 3 candidate for focal segmental glomerulosclerosis, provide future pipeline upside (BioMarin press release).
• What safety or legal issues were resolved alongside the acquisition announcement by BioMarin?
  Amicus concurrently resolved U.S. patent litigation for Galafold with Aurobindo and Lupin, securing exclusivity until 30 Jan 2037 (BioMarin press release). This removes immediate generic risk, which had been a significant overhang on Amicus’s long-term valuation (Zacks).
• How will BioMarin finance the $4.8 billion acquisition price?
  BioMarin intends to use cash on hand plus approximately $3.7 billion in new non-convertible debt financing (BioMarin press release). The company has committed to a deleveraging plan to bring its gross leverage below 2.5x within two years of the deal’s close (Market news).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 19 Dec 2025, 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

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