What Newron Pharmaceuticals does

Newron Pharmaceuticals S.p.A. is a biopharmaceutical company founded in 1999 and headquartered in Bresso, near Milan, Italy, with a US subsidiary in Morristown, New Jersey. The company focuses on developing novel therapies for diseases of the central and peripheral nervous system (CNS), operating a concentrated team of approximately 30 scientists, researchers, and clinicians with more than 25 years of proprietary research heritage. Newron is publicly listed on the SIX Swiss Exchange (ticker: NWRN) and additionally on the primary market of the Düsseldorf Stock Exchange and XETRA (trading symbol NP5).

The company's pipeline is anchored by evenamide, a first-in-class oral glutamate modulator being evaluated as an add-on therapy for treatment-resistant schizophrenia (TRS). Evenamide selectively inhibits voltage-gated sodium channels in hyper-active neurons to normalize glutamatergic dysfunction without interfering with over 150 CNS receptors, enzymes, or transporters. It is being assessed in two global pivotal Phase III trials — ENIGMA-TRS 1 (52-week, 600+ patients, initiated August 2025) and ENIGMA-TRS 2 (12-week, 400+ patients, initiated December 2025) — with pivotal results expected in Q4 2026 and a regulatory approval target of 2027. Newron's commercial asset is Xadago (safinamide), a once-daily selective MAO-B inhibitor approved for Parkinson's disease. Earlier-stage pipeline includes ralfinamide, a sodium/calcium/NMDA channel modulator for rare neuropathic pain, for which Newron is seeking a development partner. The company holds a registered patent on crystalline forms of evenamide.

Newron operates primarily through a licensing and partnership business model rather than direct sales. Revenue is generated via upfront payments, milestones, and royalties from regional commercialization partners, including EA Pharma (an Eisai subsidiary) for evenamide in Japan and other Asian territories — which generated a $46.1 million upfront in late 2024 — and Myung In Pharm for South Korea. The company supplements partner capital with equity raises, most recently a February 2026 share subscription of up to EUR 38 million structured in tranches tied to Phase III progress, and debt financing from the European Investment Bank, whose 2018 loan repayment dates were extended to June 2028.

Name

Newron Pharmaceuticals

Legal name

Newron Pharmaceuticals S.p.A.

Website

https://newron.com

Company type

Public

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

Newron Pharmaceuticals is a biopharmaceutical company developing novel CNS therapies, including evenamide (Phase III for treatment-resistant schizophrenia) and the approved Parkinson's drug Xadago/safinamide, monetizing its pipeline through regional licensing partnerships in Europe, Asia, and the US.

Ownership category

akta.pro rank

Product category

Central Nervous System (CNS) Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Pain Management & Anesthesiology Pharmaceuticals (HLAIAAAN)

Keywords

• CNS drug development
• Central nervous system therapeutics
• Treatment-resistant schizophrenia
• Parkinson's disease therapy
• Neuropathic pain treatment

Headquarters

HQ city

Bresso

HQ country

Italy

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Licensing and Commercialization Agreements: Newron generates revenue through licensing deals for its drug candidates. Received $46.1 million upfront payment from EA Pharma for evenamide rights in Japan and Asian territories, with potential additional milestone payments.
2. Drug Development and Commercialization: Pre-revenue pharmaceutical company focused on developing novel CNS therapies from discovery through commercialization.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Newron Pharmaceuticals is a biopharmaceutical company that develops proprietary new chemical entities for diseases of the central and peripheral nervous system, with its lead asset evenamide in pivotal Phase III for treatment-resistant schizophrenia, Xadago (safinamide) approved for Parkinson's disease, and ralfinamide in development for rare neuropathic pain. The company monetizes these assets primarily through regional licensing and commercialization partnerships with established pharmaceutical companies rather than through its own sales force.

Product overview

Newron Pharmaceuticals is a biopharmaceutical company focused on novel therapies for diseases of the central and peripheral nervous system. The company operates as a single-product portfolio company with multiple drug candidates in its pipeline. Its core products include Evenamide (Phase III, novel glutamate modulator for treatment-resistant schizophrenia), Xadago (safinamide, an approved MAO-B inhibitor for Parkinson's Disease), and Ralfinamide (preclinical/early development for neuropathic pain). The pipeline includes ENIGMA-TRS 1 (52-week study, 600+ patients, initiated August 2025) and ENIGMA-TRS 2 (12-week study, 400+ patients, initiated December 2025) as pivotal Phase III studies for evenamide. The company has development and commercialization agreements with EA Pharma for Japan and Asian territories, and with Myung In Pharm for South Korea.

Differentiator

Problem solved

Functional benefit

Brands

• Xadago (safinamide): A New Chemical Entity for the treatment of Parkinson's Disease with a mode of action characterized by selective MAO-B-inhibition.
• Evenamide
• Ralfinamide

Products and services

• Evenamide Evenamide is a novel oral new chemical entity and first-in-class glutamate modulator being developed by Newron as an add-on therapy to existing antipsychotics for treatment-resistant schizophrenia (TRS) and chronic schizophrenia with poor response to standard treatment. It selectively inhibits voltage-gated sodium channels in hyper-active neurons, normalizing hippocampal and cortical glutamatergic dysfunction without interfering with over 150 receptors, enzymes, or transporters involved in CNS activity. In Phase II studies, over 70% of TRS patients showed reduced disease severity, 25% achieved remission, and nearly 50% were no longer considered to have TRS after one year of treatment, with no patient relapsing.
• Xadago (safinamide) Xadago (safinamide) is a New Chemical Entity developed by Newron for the treatment of Parkinson's Disease, with a mode of action characterized by selective MAO-B inhibition. It provides statistically significant increases in ON-time without troublesome dyskinesia, decreases OFF-time, requires once-daily dosing, and has no diet restrictions due to its high MAO-B versus MAO-A selectivity. Commercialized globally through Newron's regional licensing partners.
• Ralfinamide Ralfinamide is a unique, well-tolerated New Chemical Entity originating from Newron's ion channel program, specifically targeting voltage-gated sodium channels (Nav 1.7), N-type Calcium channels, and the NMDA receptor. It is being developed for a rare neuropathic pain indication, and Newron is seeking partners to advance the program into potentially pivotal studies in orphan indications.

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Intra-Cellular Therapies: CNS-focused biopharma whose lead product Caplyta (lumateperone) is approved for schizophrenia and adjunctive treatment of major depressive disorder. Most directly comparable to Newron as a small/mid-cap CNS innovator competing in the same psychiatry prescriber audience.
• Karuna Therapeutics: Developed xanomeline-trospium (Cobenfy), the first muscarinic agonist approved for schizophrenia — a novel-mechanism antipsychotic competing for the same TRS-adjacent prescriber base and demonstrating the commercial appetite for mechanistically differentiated schizophrenia therapies.
• Axsome Therapeutics: Mid-cap CNS innovator with Auvelity (dextromethorphan/bupropion) approved for MDD and other CNS pipeline assets; comparable business model of developing novel-mechanism CNS therapies and competing for the same neurology/psychiatry specialty audience.
• Sage Therapeutics: CNS-focused innovator developing novel mechanisms for depression and neurology; was acquired by Biogen. Representative of the strategic-exit pathway available to late-stage CNS biotechs and a relevant comparable on pipeline economics and partnership dynamics.

Broad incumbents

• ACADIA Pharmaceuticals: Established CNS specialist with Nuplazid (pimavanserin) approved for Parkinson's disease psychosis; comparable commercial footprint in Parkinson's-adjacent indications and similar small-cap CNS commercialization dynamics.
• Alkermes: CNS-focused specialty pharma with approved schizophrenia and depression products (ARISTADA, LYBALVI). Operates at larger scale but shares Newron's strategic positioning around CNS innovation and licensing-driven growth.
• Supernus Pharmaceuticals: Specialty pharma focused on CNS disorders including Parkinson's disease (Apokyn, Onapgo) and epilepsy; comparable strategic emphasis on differentiated CNS therapies with similar commercial-stage dynamics.
• Lundbeck: Global CNS-focused pharmaceutical company with deep schizophrenia franchise (Rexulti) and Parkinson's assets; serves as both a competitive incumbent and a potential strategic-partner archetype for late-stage CNS assets like evenamide.
• Otsuka Pharmaceutical: Major CNS player with Abilify/Abilify Maintena (aripiprazole) franchise in schizophrenia; relevant comparable for evenamide's commercial and competitive positioning and a likely strategic-partner candidate for ex-Asia rights.

Emerging players

• BioXcel Therapeutics: Smaller CNS-focused biopharma with approved acute agitation therapies (IGALMI) and an early commercial CNS footprint; comparable in scale and strategic posture to Newron as it transitions from clinical to early commercial CNS stage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/newron-pharmaceuticals-spa

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors5 records

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

M&A2 records

Investments

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

Frequently asked questions about Newron Pharmaceuticals