Grace Therapeutics (formerly Acasti Pharma)

What Grace Therapeutics (formerly Acasti Pharma) does

Grace Therapeutics, Inc. (NASDAQ: GRCE) is a late-stage clinical biopharmaceutical company developing drug candidates for rare and orphan diseases, with its headquarters in Princeton, New Jersey. The company's core technology is a proprietary nanoparticle platform that enables aqueous formulation of otherwise insoluble drugs for standard peripheral IV infusion. Its lead asset, GTx-104, is a novel IV formulation of nimodipine in development for aneurysmal subarachnoid hemorrhage (aSAH), a rare and life-threatening neurological emergency affecting approximately 50,000 patients per year in the United States. GTx-104 has received FDA Orphan Drug Designation, providing seven years of marketing exclusivity upon approval, and is protected by over 40 granted and pending patents worldwide.

The company targets acute care hospitals and neurocritical care centers as its primary customer segment, with specialist neurologists and neurosurgeons as key prescribing personas. Following the April 2026 FDA Complete Response Letter citing CMC concerns (leachables data, toxicology risk assessments, and manufacturing deficiencies at the contract manufacturer), the company plans to request a Type A meeting with the FDA. The pivotal STRIVE-ON Phase 3 trial met its primary endpoint with a 19% reduction in clinically significant hypotension versus oral nimodipine, supporting the clinical differentiation case for IV delivery in critically ill aSAH patients.

Grace Therapeutics is currently pre-revenue, with planned monetization through pharmaceutical product sales to hospital formularies and specialty healthcare providers post-approval, with potential premium pricing enabled by orphan drug status. The company was created through Acasti Pharma's August 2021 all-stock acquisition of Grace Therapeutics Inc. for approximately $138 million, after which the combined entity rebranded from Acasti Pharma back to the original Grace Therapeutics name. The pipeline also includes GTX-102 and GTX-101, both with Orphan Drug Designation. The company has funded operations through multiple private placements including $7.5M in September 2023, $10.46M in February 2025, and additional warrant exercises of approximately $4M and $2.86M in October 2025.

Name

Grace Therapeutics (formerly Acasti Pharma)

Legal name

Grace Therapeutics, Inc.

Website

https://gracetx.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Grace Therapeutics is a late-stage clinical biopharmaceutical company developing GTx-104, a novel IV nanoparticle formulation of nimodipine for aneurysmal subarachnoid hemorrhage, targeting acute care hospitals and neurocritical care specialists with FDA Orphan Drug Designation providing seven years of marketing exclusivity.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals (Neurocritical Care)

NAICS

Medicinal and Botanical Manufacturing (325411), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

akta.pro secondary industries

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF), Rare Cardiovascular & Vascular Disorder Therapies (HLAIAIAH)

Keywords

• Intravenous drug delivery
• Rare disease therapeutics
• Subarachnoid hemorrhage treatment
• Nanoparticle drug formulation
• Orphan drug development

Headquarters

HQ city

Laval

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales

Revenue model

1. Pharmaceutical Product Sales: Post FDA approval, Grace Therapeutics will generate revenue through sales of GTx-104 to hospitals and healthcare providers for treatment of aneurysmal subarachnoid hemorrhage. Revenue will come from product sales with potential for premium pricing due to orphan drug designation and competitive differentiation.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Grace Therapeutics develops and is preparing to commercialize GTx-104, a clinical-stage, novel injectable (IV) formulation of nimodipine enabled by proprietary nanoparticle technology that allows aqueous solubilization of the otherwise insoluble drug for peripheral IV infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients. The pipeline also includes additional rare/orphan neurology candidates (GTX-102, GTX-101) protected by a 40+ patent portfolio and FDA Orphan Drug Designation.

Product overview

Grace Therapeutics is a late-stage biopharma company developing drug candidates that target rare and orphan diseases. The company's lead clinical asset is GTx-104, an intravenous infusion formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH), a rare and life-threatening medical emergency. Grace Therapeutics' novel drug delivery technologies have the potential to improve the performance of currently marketed drugs through nanoparticle technology that enables improved bioavailability and patient management. The company also has additional pipeline candidates (GTX-102, GTX-101) and holds over 40 granted and pending patents with Orphan Drug Designation from the FDA providing seven years of marketing exclusivity.

Differentiator

Problem solved

Functional benefit

Products and services

• GTx-104 Clinical-stage, novel injectable (IV) formulation of nimodipine enabled by proprietary nanoparticle technology that solubilizes the otherwise insoluble dihydropyridine calcium channel blocker for standard peripheral IV infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients. Designed for neurocritical care specialists, ICU pharmacists, and hospital formularies treating aSAH patients, including those who are unconscious or dysphagic and cannot take oral medication.

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators8 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• Sage Therapeutics: Late-stage CNS-focused biopharma developing novel therapies for rare and serious neurological conditions. Comparable in focusing on CNS specialty indications with high unmet need and orphan drug positioning.
• Edge Therapeutics: Former direct peer developing EG-1962 (nimodipine microparticles) for aSAH; Grace's current CMO Dr. Macdonald was previously CSO there. Failed Phase 3 NEWTON trial but represents the closest historical comparable in the aSAH drug-delivery space.
• Azurity Pharmaceuticals: Specialty pharma focused on rare and orphan diseases with reformulated/improved versions of established molecules. Comparable business model of developing niche, differentiated formulations for underserved patient populations.
• BioXcel Therapeutics: Clinical-stage biopharma focused on immuno-neurology and rare neurological disorders with reformulated/innovative therapies. Comparable in CNS specialty pharma positioning, small-cap profile, and orphan/rare disease strategy.
• Assertio Therapeutics: Specialty pharma focused on neurology and rare disease products with reformulation/improved-delivery strategies. Comparable in targeting underserved specialty indications with differentiated drug-delivery approaches.

Broad incumbents

• Cerevel Therapeutics: Specialty neurology biopharma developing differentiated therapies for CNS disorders. Comparable in CNS-focused drug development with orphan and specialty positioning, though broader in scale.
• Mallinckrodt Pharmaceuticals: Markets generic nimodipine oral capsules in the US and is a major specialty pharma player. Directly competes with GTx-104 as a low-cost nimodipine supplier to hospitals treating aSAH patients.
• Amneal Pharmaceuticals: Generic and specialty pharmaceutical company with a portfolio including nimodipine products and broader neurology offerings. Comparable in providing nimodipine alternatives and competing in neurocritical care channels.
• Merz Therapeutics: Specialty pharma division with strong neurology portfolio. While broader than Grace, it competes in neurocritical care and rare CNS indications, making it a relevant incumbent comparable for hospital-channel specialty products.
• Pfizer (Nimotop): Markets Nimotop, the original oral nimodipine brand approved for aSAH. While a broad pharma incumbent, it competes head-to-head with GTx-104 in the same clinical indication and sets the existing standard-of-care benchmark.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/grace-tx

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Grace Therapeutics (formerly Acasti Pharma)