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Durect

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uuid00035mr

Namestring
Durect
Legal namestring
DURECT Corporation
Websiteurl
durect.com
Company typeenum
Private
Founded yearint
1998
Descriptiontext

DURECT Corporation was a specialty biopharmaceutical company founded in 1998 and headquartered in Cupertino, California, focused on developing innovative therapeutics for acute organ injuries and chronic diseases. The company's lead asset was larsucosterol (DUR-928), an investigational drug candidate for the treatment of alcohol-associated hepatitis — a serious acute liver condition with high mortality and no FDA-approved pharmacological treatment prior to larsucosterol's development. Larsucosterol received FDA Breakthrough Therapy Designation, recognizing its potential as a first-in-class treatment, and the company served hepatology and gastroenterology patient populations through clinical-stage development rather than commercial channels.

DURECT's underlying technology platform centered on proprietary bioresorbable polymer-based drug delivery systems, including epichlorohydrin-based polymer systems and lipid-based formulations, used in controlled drug release, medical implant matrices, and tissue engineering scaffolds. The company had built this technology base over approximately 25 years, supplemented by historical acquisitions such as Southern Biosystems (2001) and IntraEAR (1999). Pre-commercial throughout its independent operating life, DURECT had no established commercial distribution, no publicly listed product pricing, and no recurring product revenue; its activities were limited to scientific communications, investor relations, and clinical development.

The company's business model was pre-commercial R&D funded by capital markets rather than product sales. DURECT financed operations through multiple equity and debt rounds, including a $20 million Oxford Finance-led financing in 2014, a $42.5 million round in February 2021, and a $15 million registered direct offering in July 2023. In September 2025, Bausch Health Companies Inc. completed the acquisition of DURECT for approximately $63 million ($1.75 per share), with potential additional milestone payments of up to $350 million tied to larsucosterol development and commercialization, converting DURECT into a wholly-owned subsidiary within Bausch Health's Salix gastrointestinal segment.

Short descriptiontext

DURECT Corporation was a pre-commercial specialty biopharmaceutical company developing larsucosterol, a Breakthrough Therapy-designated drug candidate for alcohol-associated hepatitis, using its proprietary bioresorbable polymer-based drug delivery platform. The company was acquired by Bausch Health in September 2025.

Operating statusenum
Acquired
Ownership categoryenum
Headcount rangeband
51–100
akta.pro rankint
HeadquartersCupertino, United States
HQ citystring
Cupertino
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
specialty pharmaceuticals, drug delivery technology, bioresorbable polymers, alcohol-associated hepatitis, clinical-stage therapeutics
Industry1 code
1Biodegradable Polymers & Resins (PLA, PHA, PBS, PBAT)
CodeIMAEAOAAPrimaryYes
NAICS code1 code
  • Pharmaceutical Preparation Manufacturing325412
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
Specialty Pharmaceuticals
Marketing channels1 record

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components3 values
Technology or R&D, Personnel, Operations
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

DURECT Corporation is a specialty biopharmaceutical company developing innovative therapeutics based on proprietary bioresorbable and lipid-based polymer drug delivery technologies. Its lead product candidate is larsucosterol (DUR-928), which received FDA Breakthrough Therapy Designation for the treatment of alcohol-associated hepatitis, a severe acute liver condition with no approved pharmacological therapy. The company historically generated no commercial product revenue, operating as a clinical-stage R&D organization prior to its September 2025 acquisition by Bausch Health Companies Inc.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • FDA Breakthrough Therapy Designation granted for larsucosterol in alcohol-associated hepatitis
Product overview1 text field

DURECT Corporation was a biopharmaceutical company focused on the development and commercialization of novel therapeutics based on its lipid-based drug delivery technology. The company's primary focus was on larsucosterol, a drug candidate for alcohol-associated hepatitis that received FDA Breakthrough Therapy Designation. DURECT's technology platform centered on lipid-based formulations for drug delivery applications. The company was acquired by Bausch Health Companies Inc. in September 2025 for approximately $63 million, with potential additional milestone payments of up to $350 million.

Product and service1 record
1Larsucosterol (DUR-928)
CategorySpecialty Pharmaceuticals
Description

Larsucosterol is DURECT's lead investigational drug candidate (also known as DUR-928) being developed for the treatment of alcohol-associated hepatitis, a severe acute liver condition with high mortality and no FDA-approved pharmacological therapy. The asset has received FDA Breakthrough Therapy Designation, signaling potential substantial improvement over existing treatments, and is intended for hepatologists and hospital-based liver specialists managing severe AH patients.

Scale indicator2 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-09-11
Description

Bausch Health Companies Inc. completed its acquisition of DURECT Corporation in September 2025. DURECT became a wholly-owned subsidiary of Bausch Health, which acquired all outstanding shares for $1.75 per share, totaling approximately $63 million, with potential additional milestone payments of up to $350 million tied to the development and commercialization of larsucosterol for alcohol-associated hepatitis. The acquisition was intended to expand Bausch Health's hepatology portfolio and strengthen its growth platform within the Salix segment.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight4 records

Each record includes

Type, Description

Peers10 records
TypeEmerging player
Description

Clinical-stage biopharma with TERN-501 (THR-β agonist) for MASH and other liver disease candidates. Comparable in liver disease focus at an earlier development stage.

TypeDirect peer
Description

Clinical-stage biopharma with pipeline candidates for metabolic and liver diseases, including VK2809 for MASH. Comparable in clinical-stage development profile and small-cap specialty positioning.

TypeDirect peer
Description

Clinical-stage company developing belapectin for liver fibrosis and NASH cirrhosis. Comparable in liver disease focus, pre-commercial development stage, and small-cap specialty positioning.

TypeDirect peer
Description

French biotech developing elafibranor (approved as Iqirvo for PBC) and other candidates for liver diseases including MASH. Comparable in liver disease specialty focus and small-to-mid-cap scale.

TypeDirect peer
Description

Specialty biopharma focused on liver diseases, with FDA-approved Rezdiffra (resmetirom) for MASH. Most directly comparable in liver disease therapeutic focus and specialty pharma positioning.

TypeDirect peer
Description

Clinical-stage biopharma developing efruxifermin (FGF21 analog) for compensated cirrhosis due to MASH. Comparable in therapeutic focus on advanced liver disease and similar late-stage clinical positioning.

TypeDirect peer
Description

Was a specialty pharma focused on liver diseases (seladelpar for PBC), acquired by Gilead Sciences in 2024. Comparable in liver disease focus and being absorbed by a larger pharma acquirer.

TypeDirect peer
Description

Was a specialty liver disease company (Bylvay/odevixibat for PFIC and Alagille syndrome), acquired by Ipsen in 2023. Comparable in rare/specialty liver disease focus and acquisition by larger pharma.

TypeDirect peer
Description

Was a specialty liver disease company developing obeticholic acid for NASH and other liver conditions, ultimately acquired by Alfasigma. Comparable in liver disease focus and acquisition outcome for a single-asset narrative.

TypeBroad incumbent
Description

Large biopharmaceutical company with a significant liver disease franchise including the recently acquired CymaBay for PBC. Provides broad market context for liver disease therapeutics and represents the strategic-acquirer archetype for DURECT's buyer.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat2 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights5 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature1 record

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles5 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds3 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors1 record

Each record includes

Name, Type, Date of entry, Rounds participated, Website

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

M&A2 records

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

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

Durect

Specialty Pharmaceuticalsdurect.com

DURECT Corporation was a pre-commercial specialty biopharmaceutical company developing larsucosterol, a Breakthrough Therapy-designated drug candidate for alcohol-associated hepatitis, using its proprietary bioresorbable polymer-based drug delivery platform. The company was acquired by Bausch Health in September 2025.

What Durect does

DURECT Corporation was a specialty biopharmaceutical company founded in 1998 and headquartered in Cupertino, California, focused on developing innovative therapeutics for acute organ injuries and chronic diseases. The company's lead asset was larsucosterol (DUR-928), an investigational drug candidate for the treatment of alcohol-associated hepatitis — a serious acute liver condition with high mortality and no FDA-approved pharmacological treatment prior to larsucosterol's development. Larsucosterol received FDA Breakthrough Therapy Designation, recognizing its potential as a first-in-class treatment, and the company served hepatology and gastroenterology patient populations through clinical-stage development rather than commercial channels.

DURECT's underlying technology platform centered on proprietary bioresorbable polymer-based drug delivery systems, including epichlorohydrin-based polymer systems and lipid-based formulations, used in controlled drug release, medical implant matrices, and tissue engineering scaffolds. The company had built this technology base over approximately 25 years, supplemented by historical acquisitions such as Southern Biosystems (2001) and IntraEAR (1999). Pre-commercial throughout its independent operating life, DURECT had no established commercial distribution, no publicly listed product pricing, and no recurring product revenue; its activities were limited to scientific communications, investor relations, and clinical development.

The company's business model was pre-commercial R&D funded by capital markets rather than product sales. DURECT financed operations through multiple equity and debt rounds, including a $20 million Oxford Finance-led financing in 2014, a $42.5 million round in February 2021, and a $15 million registered direct offering in July 2023. In September 2025, Bausch Health Companies Inc. completed the acquisition of DURECT for approximately $63 million ($1.75 per share), with potential additional milestone payments of up to $350 million tied to larsucosterol development and commercialization, converting DURECT into a wholly-owned subsidiary within Bausch Health's Salix gastrointestinal segment.

Durect firmographics

Firmographics
Name
Durect
Legal name
DURECT Corporation
Website
https://durect.com
Company type
Private
Founded year
1998
Operating status
Acquired
Headcount range
51–100 employees
Short description
DURECT Corporation was a pre-commercial specialty biopharmaceutical company developing larsucosterol, a Breakthrough Therapy-designated drug candidate for alcohol-associated hepatitis, using its proprietary bioresorbable polymer-based drug delivery platform. The company was acquired by Bausch Health in September 2025.
Ownership category
akta.pro rank

Durect industry classification

Industry
Product category
Specialty Pharmaceuticals
NAICS
Pharmaceutical Preparation Manufacturing (325412)
SIC
Pharmaceutical Preparations (2834)
akta.pro primary industry
Biodegradable Polymers & Resins (PLA, PHA, PBS, PBAT) (IMAEAOAA)

Keywords

  • Specialty pharmaceuticals
  • Drug delivery technology
  • Bioresorbable polymers
  • Alcohol-associated hepatitis
  • Clinical-stage therapeutics

Where Durect is headquartered

Location

Headquarters

HQ city
Cupertino
HQ country
United States
HQ region
North America

Markets served

Durect business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations

Distribution channels1 record

Marketing channels1 record

Durect product offering

Product offering

Core offering

DURECT Corporation is a specialty biopharmaceutical company developing innovative therapeutics based on proprietary bioresorbable and lipid-based polymer drug delivery technologies. Its lead product candidate is larsucosterol (DUR-928), which received FDA Breakthrough Therapy Designation for the treatment of alcohol-associated hepatitis, a severe acute liver condition with no approved pharmacological therapy. The company historically generated no commercial product revenue, operating as a clinical-stage R&D organization prior to its September 2025 acquisition by Bausch Health Companies Inc.

Product overview

DURECT Corporation was a biopharmaceutical company focused on the development and commercialization of novel therapeutics based on its lipid-based drug delivery technology. The company's primary focus was on larsucosterol, a drug candidate for alcohol-associated hepatitis that received FDA Breakthrough Therapy Designation. DURECT's technology platform centered on lipid-based formulations for drug delivery applications. The company was acquired by Bausch Health Companies Inc. in September 2025 for approximately $63 million, with potential additional milestone payments of up to $350 million.

Differentiator

Problem solved

Functional benefit

Products and services

  • Larsucosterol (DUR-928) Larsucosterol is DURECT's lead investigational drug candidate (also known as DUR-928) being developed for the treatment of alcohol-associated hepatitis, a severe acute liver condition with high mortality and no FDA-approved pharmacological therapy. The asset has received FDA Breakthrough Therapy Designation, signaling potential substantial improvement over existing treatments, and is intended for hepatologists and hospital-based liver specialists managing severe AH patients.

Quantifiable outcome

  • FDA Breakthrough Therapy Designation granted for larsucosterol in alcohol-associated hepatitis

Companies that use Durect

Customer profile

Segments1 record

Ideal customer profiles1 record

Durect technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

Durect partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • Bausch Health Companies Inc.coreStrategic or Co-development Partner · 11 September 2025Bausch Health Companies Inc. completed its acquisition of DURECT Corporation in September 2025. DURECT became a wholly-owned subsidiary of Bausch Health, which acquired all outstanding shares for $1.75 per share, totaling approximately $63 million, with potential additional milestone payments of up to $350 million tied to the development and commercialization of larsucosterol for alcohol-associated hepatitis. The acquisition was intended to expand Bausch Health's hepatology portfolio and strengthen its growth platform within the Salix segment.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Durect competitors and assessment

Company assessment

Emerging players

  • Terns Pharmaceuticals: Clinical-stage biopharma with TERN-501 (THR-β agonist) for MASH and other liver disease candidates. Comparable in liver disease focus at an earlier development stage.

Direct peers

  • Viking Therapeutics: Clinical-stage biopharma with pipeline candidates for metabolic and liver diseases, including VK2809 for MASH. Comparable in clinical-stage development profile and small-cap specialty positioning.
  • Galectin Therapeutics: Clinical-stage company developing belapectin for liver fibrosis and NASH cirrhosis. Comparable in liver disease focus, pre-commercial development stage, and small-cap specialty positioning.
  • Genfit: French biotech developing elafibranor (approved as Iqirvo for PBC) and other candidates for liver diseases including MASH. Comparable in liver disease specialty focus and small-to-mid-cap scale.
  • Madrigal Pharmaceuticals: Specialty biopharma focused on liver diseases, with FDA-approved Rezdiffra (resmetirom) for MASH. Most directly comparable in liver disease therapeutic focus and specialty pharma positioning.
  • Akero Therapeutics: Clinical-stage biopharma developing efruxifermin (FGF21 analog) for compensated cirrhosis due to MASH. Comparable in therapeutic focus on advanced liver disease and similar late-stage clinical positioning.
  • CymaBay Therapeutics: Was a specialty pharma focused on liver diseases (seladelpar for PBC), acquired by Gilead Sciences in 2024. Comparable in liver disease focus and being absorbed by a larger pharma acquirer.
  • Albireo Pharma: Was a specialty liver disease company (Bylvay/odevixibat for PFIC and Alagille syndrome), acquired by Ipsen in 2023. Comparable in rare/specialty liver disease focus and acquisition by larger pharma.
  • Intercept Pharmaceuticals: Was a specialty liver disease company developing obeticholic acid for NASH and other liver conditions, ultimately acquired by Alfasigma. Comparable in liver disease focus and acquisition outcome for a single-asset narrative.

Broad incumbents

  • Gilead Sciences: Large biopharmaceutical company with a significant liver disease franchise including the recently acquired CymaBay for PBC. Provides broad market context for liver disease therapeutics and represents the strategic-acquirer archetype for DURECT's buyer.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat2 records

Key risks5 records

Key highlights5 records

Customer concentration

Durect social profiles

Digital presence

Durect financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Durect leadership team

Management profile

Number of profiles

Profiles5 records

Durect funding detail

Funding detail

Funding overview

Funding rounds3 records

Investors1 record

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

Durect M&A and investment

M&A and investment

M&A2 records

Investments

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

Frequently asked questions about Durect

What does Durect do?

DURECT Corporation is a specialty biopharmaceutical company developing innovative therapeutics based on proprietary bioresorbable and lipid-based polymer drug delivery technologies. Its lead product candidate is larsucosterol (DUR-928), which received FDA Breakthrough Therapy Designation for the treatment of alcohol-associated hepatitis, a severe acute liver condition with no approved pharmacological therapy. The company historically generated no commercial product revenue, operating as a clinical-stage R&D organization prior to its September 2025 acquisition by Bausch Health Companies Inc.

Is Durect a public or private company?

Durect is a private company. It is classified as corporate owned and is currently acquired.

When was Durect founded?

Durect was founded in 1998. It employs 51 to 100 people.

Where is Durect based?

Durect is headquartered in Cupertino, United States, in the North America region.

Who are Durect's main competitors?

Terns Pharmaceuticals is listed as an emerging player. Direct peers are Viking Therapeutics, Galectin Therapeutics, Genfit, Madrigal Pharmaceuticals, Akero Therapeutics, CymaBay Therapeutics, Albireo Pharma and Intercept Pharmaceuticals. Gilead Sciences is listed as a broad incumbent.

Does Durect have an API?

No public API is recorded for Durect.

What industry is Durect in?

Durect's product category is Specialty Pharmaceuticals. Its primary akta.pro industry code is IMAEAOAA, Biodegradable Polymers & Resins (PLA, PHA, PBS, PBAT). Its NAICS code is 325412 and its SIC code is 2834.

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Live signals
PR NewswireAlcohol-associated Liver Disease Market Gearing Up for Outstanding Expansion at a CAGR of 31.1% During the Forecast Period (2026-2036) | DelveInsightThe alcohol-associated liver disease market is projected to grow at a CAGR of 31.1% from 2026 to 2036, with the 7MM market size at USD 145 million in 2025. The US accounted for 59% of the market, and emerging therapies like Larsuscosterol and GSK4532990 are expected to reshape the landscape.BioSpaceBausch Health Announces Third Quarter 2025 ResultsBausch Health reported third quarter 2025 consolidated revenues of $2.68 billion, up 7% on a reported basis and 5% on an organic basis, with GAAP net income of $181 million compared to a net loss in the prior year period. The company completed its acquisition of DURECT Corporation during the quarter, expanding its hepatology portfolio with larsucosterol, an epigenetic modulator with FDA Breakthrough Therapy Designation for alcohol-associated hepatitis treatment. Bausch Health raised its full-year 2025 revenue and Adjusted EBITDA guidance, with the company (excluding Bausch + Lomb) achieving its tenth consecutive quarter of year-over-year revenue and Adjusted EBITDA growth.Castle PlacementTop 10 Pharma Drug Discovery and Delivery Capital Raises in the U.S.This article reports on ten capital raising and M&A transactions in the U.S. pharmaceutical sector between September 1st and 15th, 2025. Key events include Bausch Health Companies' acquisition of Durect for $56.072 million and AlthaThera Pharmaceuticals receiving development capital to serve pediatric cardiac patients.PR NewswireBausch Health Completes Acquisition of DURECT Corporation, Expanding Late-stage Liver Disease PortfolioBausch Health completed its acquisition of DURECT Corporation, paying $1.75 per share for approximately $63 million upfront. The deal adds larsucosterol, an FDA Breakthrough Therapy for alcohol-associated hepatitis, to Bausch Health's pipeline, with potential milestone payments up to $350 million.PR NewswireSHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates VBTX, PVBC, DRRX on Behalf of ShareholdersHalper Sadeh LLC, an investor rights law firm, announced investigations into three proposed acquisitions for potential violations of federal securities laws and/or breaches of fiduciary duties to shareholders. The transactions under scrutiny are Veritex Holdings' sale to Huntington Bancshares (1.95 share exchange ratio), Provident Bancorp's sale to NB Bancorp (0.691 shares or $13 cash per share), and DURECT Corporation's sale to Bausch Health Companies Inc. for $1.75 per share. The law firm indicated it may seek increased consideration, additional disclosures, or other relief on behalf of shareholders on a contingency fee basis.PR NewswireDURECT Corporation Reports Second Quarter 2025 Financial Results and Provides Update on Proposed Acquisition by Bausch HealthDURECT reported Q2 2025 net loss of $2.265 million on revenues of $447,000, and announced Bausch Health's acquisition at $1.75 per share plus up to $350 million in milestones. The merger is expected to close in Q3 2025.YahooBausch Health to Acquire DURECT Corporation in $63M Deal to Advance Liver Disease TreatmentBausch Health announced a definitive agreement to acquire DURECT Corporation for approximately $63 million upfront, with potential $350 million in sales milestone payments. The deal targets larsucosterol, an epigenetic modulator with FDA Breakthrough Therapy Designation for alcoholic hepatitis, which had about 164,000 US hospital admissions in 2021. Bausch Health plans to advance the drug through a planned Phase 3 program.BenzingaUS Stocks Mixed; Procter & Gamble Posts Upbeat Earnings - AIM ImmunoTech (AMEX:AIM)U.S. stock markets showed mixed performance on Tuesday, with the Nasdaq Composite rising 0.4% and the S&P 500 gaining 0.18% while the Dow edged slightly lower. Procter & Gamble reported second-quarter earnings of $1.48 per share, beating analyst consensus estimates of $1.42, with quarterly sales of $20.889 billion exceeding expectations of $20.765 billion. Among notable movers, DURECT Corporation shares surged 360% following Bausch Health's announcement of plans to acquire the company, while AIM ImmunoTech shares dropped 56% after launching an $8 million public offering.PR NewswireBausch Health to Acquire DURECT Corporation, Strengthening Commitment to Developing Innovative Solutions for Patients with Liver DiseaseBausch Health Companies Inc. has announced a definitive agreement to acquire DURECT Corporation, aiming to enhance its portfolio in hepatology with the addition of DURECT's drug candidate larsucosterol, which has received FDA Breakthrough Therapy Designation. The acquisition involves an upfront cash payment of approximately $63 million, along with potential future milestone payments based on sales performance. This transaction underscores Bausch Health's focus on innovative treatments for liver disease, particularly given the significant unmet medical need in this area.PR NewswireDURECT Corporation Announces Publication of Larsucosterol Phase 2b Results in NEJM EvidenceDURECT Corporation announced the peer-reviewed publication of its AHFIRM Phase 2b trial results for larsucosterol in NEJM Evidence, showing clinically meaningful trends in reducing 90-day mortality in severe alcohol-associated hepatitis patients, with particularly pronounced results in U.S. patients (57-58% reduction, p<0.05). The trial enrolled 307 patients across three arms and while the primary endpoint of mortality or liver transplant at 90 days did not achieve statistical significance, the FDA has agreed that a single Phase 3 trial could be sufficient to support a New Drug Application. The company plans to initiate the Phase 3 trial in 2025, pending funding, building on the Fast Track and Breakthrough Therapy designations already granted by the FDA.