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SERB

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uuid0023npi

Namestring
SERB
Legal namestring
SERB S.à.r.l.
Websiteurl
serb.eu
Company typeenum
Private
Founded yearint
1950
Descriptiontext

SERB Pharmaceuticals is a Brussels-headquartered, Luxembourg-domiciled (SERB S.à.r.l.) global specialty pharmaceutical company founded in 1950 that has operated for over 30 years in the niche of rare diseases, emergency medicines, medical countermeasures, and antidotes. The company commercializes a portfolio of 70+ essential medicines through direct sales operations in 18 countries and distribution networks serving healthcare providers in over 100 countries. Its core product franchises include Idefirix (imlifidase) — an enzyme therapy licensed-in for €115M from Hansa Biopharma in May 2026 for highly sensitized kidney transplant patients across Europe and MENA; FIRDAPSE (amifampridine) — a Lambert-Eaton myasthenic syndrome treatment licensed to Catalyst Pharmaceuticals in the US (with patent exclusivity protected through January 2035); and ThyroSafe 130mg potassium iodide tablets, now commercially available in the US for thyroid protection during nuclear emergencies.

The company generates revenue primarily through pharmaceutical product sales across three channels: direct enterprise sales to healthcare systems and first responders, government emergency preparedness stockpiling contracts, and out-licensing arrangements such as the FIRDAPSE/Catalyst partnership. SERB's customer base spans hospitals, clinics, government health agencies, emergency medical services, and non-profit healthcare organizations. Key subsidiary brands include BTG and Veriton, retained from prior acquisitions (BTG Specialty Pharmaceuticals acquired 2020; Veriton Pharma acquired 2020). The company is privately held with no public ticker or identified parent organization, and reports 500+ dedicated employees worldwide.

SERB's competitive positioning relies on an integrated specialty pharma platform capable of acquiring, developing, manufacturing, and commercializing niche medicines that larger pharmaceutical companies typically deprioritize. Its value proposition centers on regulatory expertise in fragmented international markets, validated quality processes (accreditations documented separately), and decades-long relationships with government preparedness and healthcare system buyers. Recent strategic moves in 2026 — including the €115M Idefirix acquisition, the US ThyroSafe launch, and US Board expansion with Dr. Peter C. Adamson — signal an offensive push into US and broader European/MENA specialty pharma markets, supported by sustained M&A activity and licensing transactions.

Short descriptiontext

SERB Pharmaceuticals is a Brussels-based specialty pharmaceutical company (founded 1950) that commercializes 70+ rare disease, emergency medicine, and antidote products across 100+ countries through direct sales and distribution networks serving healthcare providers, first responders, and government preparedness agencies.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
251–500
akta.pro rankint
HeadquartersBrussels, Belgium
HQ citystring
Brussels
HQ countrystring
Belgium
HQ regionstring
Europe
Markets served

Serves global market

Offices1 record

Each record includes

City, Country, Type, Description, Source

Keyword5 values
specialty pharmaceuticals, emergency medicines, medical countermeasures, rare disease treatments, antidote portfolio
Industry2 codes
1Specialty Care Pharmaceuticals
CodeHLAIAAABPrimaryYes
2Infectious Disease & Antimicrobials Pharmaceuticals
CodeHLAIAAAGPrimaryNo
NAICS code2 codes
  • Pharmaceutical Preparation Manufacturing325412
  • Biological Product (except Diagnostic) Manufacturing325414
SIC code2 codes
  • Pharmaceutical Preparations2834
  • Biological Products, (No Disgnostic Substances)2836
Product category
Specialty Pharmaceuticals
GTM motion2 records

Each record includes

Type, Description, Source

Revenue model1 record
1Pharmaceutical Product Sales
TypeOne Time License
Description

SERB generates revenue through the sale of specialty pharmaceutical products including emergency medicines, medical countermeasures, and antidotes. The company commercializes a portfolio of 70+ medicines directly in 18 countries and supplies to over 100 countries globally.

serb.com
Marketing channels3 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels6 records

Each record includes

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

Cost components6 values
Personnel, Supply Chain, Operations, Technology or R&D, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 2 records shown
1BTG
Description

BTG® is a registered trademark of Protherics Medicines Development Ltd.

serb.com
+1 more record
Core offering1 text field

SERB Pharmaceuticals is a global specialty pharmaceutical company that develops, manufactures, and commercializes a portfolio of 70+ essential medicines, including emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes for rare diseases and medical emergencies. The company serves healthcare providers, first responders, emergency preparedness agencies, and non-profit organisations across more than 100 countries via direct sales in 18 countries and through licensing partnerships.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 3 values shown
  • Serving healthcare providers in over 100 countries
+2 more records
Product overview1 text field

SERB Pharmaceuticals is a global specialty pharmaceutical company offering a broad portfolio of 70+ medicines for rare diseases and medical emergencies. The company provides medical countermeasures, antidotes, and critical care medicines to healthcare providers in over 100 countries. Key products include Idefirix (imlifidase) for kidney transplant patients, FIRDAPSE (amifampridine) for rare neuromuscular conditions, and ThyroSafe potassium iodide tablets for nuclear emergency preparedness. The portfolio is delivered through healthcare systems, first responders, emergency preparedness agencies, and non-profit organisations.

Product and service4 records
1Idefirix (imlifidase)
CategorySpecialty Pharmaceuticals
Description

Enzyme therapy for highly sensitized kidney transplant patients that breaks down antibodies that would otherwise reject the donor organ, enabling kidney transplantation.

2FIRDAPSE (amifampridine) 10 mg tablets
CategorySpecialty Pharmaceuticals
Description

Medication for Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disease. Distributed by SERB S.A. and licensed to Catalyst Pharmaceuticals for US commercialization, with patent protection preventing generic launch before January 2035.

3ThyroSafe 130mg Potassium Iodide Tablets
CategorySpecialty Pharmaceuticals
Description

Potassium iodide tablets for thyroid protection during radiation/nuclear emergencies, available in a 130 mg dose in the US market.

4Emergency Medicines and Antidote Portfolio
CategorySpecialty Pharmaceuticals
Description

Portfolio of 70+ essential medicines including emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes, delivered via healthcare systems, first responders, emergency preparedness agencies, and non-profit organisations.

Scale indicator4 records

Each record includes

Type, Value, Description, Source

Partnership3 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-05-19
Description

SERB Pharmaceuticals entered into a €115 million exclusive licensing agreement with Hansa Biopharma for the development and commercialisation of Idefirix (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA regions. SERB will acquire exclusive rights, with Hansa receiving €110 million upfront payment and €5 million upon EMA filing acceptance. The transaction closed on July 1, 2026.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-05-07
Description

SERB S.A. serves as licensor to Catalyst Pharmaceuticals for FIRDAPSE (amifampridine) 10 mg tablets. Settled patent litigation with Hetero Labs ensuring generic version not marketed before January 2035. Catalyst was later acquired by Angelini Pharma for $4.1 billion in 2026.

Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2026-05-07
Description

Hetero Labs attempted to launch generic version of FIRDAPSE. Settlement agreement reached prohibiting Hetero from marketing generic version in US before January 2035, pending FDA approval. All ongoing patent litigation terminated.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeBroad incumbent
Description

US specialty pharma with branded specialty care, sterile injectables, and generic injectable portfolios; comparable in hospital-channel distribution and specialty therapeutics focus, although broader in scope.

TypeDirect peer
Description

US-listed specialty pharma focused on medical countermeasures, vaccines, and antidotes (including CBRN products) sold to governments and first responders — the closest publicly listed analog to SERB's antidote and emergency preparedness portfolio.

TypeDirect peer
Description

Specialty pharma with a portfolio in iron deficiency, nephrology, and rare conditions. Now part of CSL but historically comparable as a European specialty pharma with hospital-channel distribution.

TypeDirect peer
Description

European-headquartered rare-disease specialty pharma with a portfolio of niche, high-value therapeutics — comparable in scale, specialty distribution model, and focus on underserved patient populations.

TypeDirect peer
Description

Specialty pharma with established brands in antidotes, critical care, and rare diseases. Comparable in therapeutic focus on hospital-administered specialty medicines and niche emergency indications.

TypeBroad incumbent
Description

European specialty pharma with a portfolio of dermatology, neurology, and specialty care products — overlaps with SERB in specialty therapeutics distribution across European healthcare systems.

TypeDirect peer
Description

Biopharma developing Idefirix (imlifidase) for kidney transplantation — directly linked to SERB as the licensor of European and MENA rights in the €115M 2026 deal; comparable in rare/ultra-rare specialty biotech positioning.

TypeBroad incumbent
Description

Rare-disease specialty pharma now part of AstraZeneca. Overlaps with SERB in rare-disease commercialization (e.g., complement-mediated and neurologic conditions) and in delivering high-value therapies through specialty distribution.

TypeDirect peer
Description

US specialty pharma commercializing FIRDAPSE under license from SERB; an existing commercial counterparty whose rare-disease commercialization model for LEMS is closely aligned with SERB's specialty pharma approach.

TypeDirect peer
Description

European specialty pharma focused on rare diseases and specialty care products distributed through established healthcare networks — directly comparable in business model and geographic mix to SERB.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat5 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers4 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment3 records

Each record includes

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

Ideal customer profile3 records

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

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles4 records

Each record includes

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

Subsidiaries2 records

Each record includes

Name, Acquired on, Relationship type, Type, Business focus

Compliance1 record

Each record includes

Name, Class, Description

Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

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

Investors

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 →

SERB

Specialty Pharmaceuticalsserb.eu

SERB Pharmaceuticals is a Brussels-based specialty pharmaceutical company (founded 1950) that commercializes 70+ rare disease, emergency medicine, and antidote products across 100+ countries through direct sales and distribution networks serving healthcare providers, first responders, and government preparedness agencies.

What SERB does

SERB Pharmaceuticals is a Brussels-headquartered, Luxembourg-domiciled (SERB S.à.r.l.) global specialty pharmaceutical company founded in 1950 that has operated for over 30 years in the niche of rare diseases, emergency medicines, medical countermeasures, and antidotes. The company commercializes a portfolio of 70+ essential medicines through direct sales operations in 18 countries and distribution networks serving healthcare providers in over 100 countries. Its core product franchises include Idefirix (imlifidase) — an enzyme therapy licensed-in for €115M from Hansa Biopharma in May 2026 for highly sensitized kidney transplant patients across Europe and MENA; FIRDAPSE (amifampridine) — a Lambert-Eaton myasthenic syndrome treatment licensed to Catalyst Pharmaceuticals in the US (with patent exclusivity protected through January 2035); and ThyroSafe 130mg potassium iodide tablets, now commercially available in the US for thyroid protection during nuclear emergencies.

The company generates revenue primarily through pharmaceutical product sales across three channels: direct enterprise sales to healthcare systems and first responders, government emergency preparedness stockpiling contracts, and out-licensing arrangements such as the FIRDAPSE/Catalyst partnership. SERB's customer base spans hospitals, clinics, government health agencies, emergency medical services, and non-profit healthcare organizations. Key subsidiary brands include BTG and Veriton, retained from prior acquisitions (BTG Specialty Pharmaceuticals acquired 2020; Veriton Pharma acquired 2020). The company is privately held with no public ticker or identified parent organization, and reports 500+ dedicated employees worldwide.

SERB's competitive positioning relies on an integrated specialty pharma platform capable of acquiring, developing, manufacturing, and commercializing niche medicines that larger pharmaceutical companies typically deprioritize. Its value proposition centers on regulatory expertise in fragmented international markets, validated quality processes (accreditations documented separately), and decades-long relationships with government preparedness and healthcare system buyers. Recent strategic moves in 2026 — including the €115M Idefirix acquisition, the US ThyroSafe launch, and US Board expansion with Dr. Peter C. Adamson — signal an offensive push into US and broader European/MENA specialty pharma markets, supported by sustained M&A activity and licensing transactions.

SERB firmographics

Firmographics
Name
SERB
Legal name
SERB S.à.r.l.
Website
https://serb.eu
Company type
Private
Founded year
1950
Operating status
Operating
Headcount range
251–500 employees
Short description
SERB Pharmaceuticals is a Brussels-based specialty pharmaceutical company (founded 1950) that commercializes 70+ rare disease, emergency medicine, and antidote products across 100+ countries through direct sales and distribution networks serving healthcare providers, first responders, and government preparedness agencies.
Ownership category
akta.pro rank

SERB industry classification

Industry
Product category
Specialty Pharmaceuticals
NAICS
Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)
SIC
Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
akta.pro primary industry
Specialty Care Pharmaceuticals (HLAIAAAB)
akta.pro secondary industry
Infectious Disease & Antimicrobials Pharmaceuticals (HLAIAAAG)

Keywords

  • Specialty pharmaceuticals
  • Emergency medicines
  • Medical countermeasures
  • Rare disease treatments
  • Antidote portfolio

Where SERB is headquartered

Location

Headquarters

HQ city
Brussels
HQ country
Belgium
HQ region
Europe

Offices1 record

Markets served

SERB business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Personnel, Supply Chain, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

  1. Pharmaceutical Product Sales: SERB generates revenue through the sale of specialty pharmaceutical products including emergency medicines, medical countermeasures, and antidotes. The company commercializes a portfolio of 70+ medicines directly in 18 countries and supplies to over 100 countries globally.

Go-to-market motion2 records

Distribution channels6 records

Marketing channels3 records

SERB product offering

Product offering

Core offering

SERB Pharmaceuticals is a global specialty pharmaceutical company that develops, manufactures, and commercializes a portfolio of 70+ essential medicines, including emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes for rare diseases and medical emergencies. The company serves healthcare providers, first responders, emergency preparedness agencies, and non-profit organisations across more than 100 countries via direct sales in 18 countries and through licensing partnerships.

Product overview

SERB Pharmaceuticals is a global specialty pharmaceutical company offering a broad portfolio of 70+ medicines for rare diseases and medical emergencies. The company provides medical countermeasures, antidotes, and critical care medicines to healthcare providers in over 100 countries. Key products include Idefirix (imlifidase) for kidney transplant patients, FIRDAPSE (amifampridine) for rare neuromuscular conditions, and ThyroSafe potassium iodide tablets for nuclear emergency preparedness. The portfolio is delivered through healthcare systems, first responders, emergency preparedness agencies, and non-profit organisations.

Differentiator

Problem solved

Functional benefit

Brands

  • BTG: BTG® is a registered trademark of Protherics Medicines Development Ltd.
  • Veriton

Products and services

  • Idefirix (imlifidase) Enzyme therapy for highly sensitized kidney transplant patients that breaks down antibodies that would otherwise reject the donor organ, enabling kidney transplantation.
  • FIRDAPSE (amifampridine) 10 mg tablets Medication for Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disease. Distributed by SERB S.A. and licensed to Catalyst Pharmaceuticals for US commercialization, with patent protection preventing generic launch before January 2035.
  • ThyroSafe 130mg Potassium Iodide Tablets Potassium iodide tablets for thyroid protection during radiation/nuclear emergencies, available in a 130 mg dose in the US market.
  • Emergency Medicines and Antidote Portfolio Portfolio of 70+ essential medicines including emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes, delivered via healthcare systems, first responders, emergency preparedness agencies, and non-profit organisations.

Quantifiable outcome

  • Serving healthcare providers in over 100 countries
  • +2 more outcomes

Companies that use SERB

Customer profile

Named customers4 records

Segments3 records

Ideal customer profiles3 records

SERB technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

SERB partnerships and signals

Strategic signal

Partnerships

Three partnerships are on record, tiered core and minor.

  • Hansa Biopharma ABcoreStrategic or Co-development Partner · 19 May 2026SERB Pharmaceuticals entered into a €115 million exclusive licensing agreement with Hansa Biopharma for the development and commercialisation of Idefirix (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA regions. SERB will acquire exclusive rights, with Hansa receiving €110 million upfront payment and €5 million upon EMA filing acceptance. The transaction closed on July 1, 2026.
  • Catalyst PharmaceuticalscoreStrategic or Co-development Partner · 7 May 2026SERB S.A. serves as licensor to Catalyst Pharmaceuticals for FIRDAPSE (amifampridine) 10 mg tablets. Settled patent litigation with Hetero Labs ensuring generic version not marketed before January 2035. Catalyst was later acquired by Angelini Pharma for $4.1 billion in 2026.
  • Hetero Labs Ltd.minorStrategic or Co-development Partner · 7 May 2026Hetero Labs attempted to launch generic version of FIRDAPSE. Settlement agreement reached prohibiting Hetero from marketing generic version in US before January 2035, pending FDA approval. All ongoing patent litigation terminated.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

SERB competitors and assessment

Company assessment

Broad incumbents

  • Endo International: US specialty pharma with branded specialty care, sterile injectables, and generic injectable portfolios; comparable in hospital-channel distribution and specialty therapeutics focus, although broader in scope.
  • Almirall: European specialty pharma with a portfolio of dermatology, neurology, and specialty care products — overlaps with SERB in specialty therapeutics distribution across European healthcare systems.
  • Alexion Pharmaceuticals (AstraZeneca Rare Disease): Rare-disease specialty pharma now part of AstraZeneca. Overlaps with SERB in rare-disease commercialization (e.g., complement-mediated and neurologic conditions) and in delivering high-value therapies through specialty distribution.

Direct peers

  • Emergent BioSolutions: US-listed specialty pharma focused on medical countermeasures, vaccines, and antidotes (including CBRN products) sold to governments and first responders — the closest publicly listed analog to SERB's antidote and emergency preparedness portfolio.
  • Vifor Pharma: Specialty pharma with a portfolio in iron deficiency, nephrology, and rare conditions. Now part of CSL but historically comparable as a European specialty pharma with hospital-channel distribution.
  • Swedish Orphan Biovitrum (Sobi): European-headquartered rare-disease specialty pharma with a portfolio of niche, high-value therapeutics — comparable in scale, specialty distribution model, and focus on underserved patient populations.
  • Mallinckrodt Pharmaceuticals: Specialty pharma with established brands in antidotes, critical care, and rare diseases. Comparable in therapeutic focus on hospital-administered specialty medicines and niche emergency indications.
  • Hansa Biopharma: Biopharma developing Idefirix (imlifidase) for kidney transplantation — directly linked to SERB as the licensor of European and MENA rights in the €115M 2026 deal; comparable in rare/ultra-rare specialty biotech positioning.
  • Catalyst Pharmaceuticals: US specialty pharma commercializing FIRDAPSE under license from SERB; an existing commercial counterparty whose rare-disease commercialization model for LEMS is closely aligned with SERB's specialty pharma approach.
  • Recordati: European specialty pharma focused on rare diseases and specialty care products distributed through established healthcare networks — directly comparable in business model and geographic mix to SERB.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

SERB social profiles

Digital presence

SERB compliance and trust

Trust signal

Compliance1 record

SERB financial estimates

Financial estimate

Revenue estimate

Valuation estimate

SERB leadership team

Management profile

Number of profiles

Profiles4 records

SERB subsidiaries and ownership

Company hierarchy

Subsidiaries2 records

SERB funding detail

Funding detail

Funding overview

Funding rounds

Investors

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

SERB 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 SERB

What does SERB do?

SERB Pharmaceuticals is a global specialty pharmaceutical company that develops, manufactures, and commercializes a portfolio of 70+ essential medicines, including emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes for rare diseases and medical emergencies. The company serves healthcare providers, first responders, emergency preparedness agencies, and non-profit organisations across more than 100 countries via direct sales in 18 countries and through licensing partnerships.

Is SERB a public or private company?

SERB is a private company. It is classified as unknown and is currently operating.

When was SERB founded?

SERB was founded in 1950. It employs 251 to 500 people.

Where is SERB based?

SERB is headquartered in Brussels, Belgium, in the Europe region.

How does SERB make money?

One revenue line is on record: pharmaceutical Product Sales.

Who are SERB's main competitors?

Broad incumbents on record are Endo International, Almirall and Alexion Pharmaceuticals (AstraZeneca Rare Disease). Direct peers are Emergent BioSolutions, Vifor Pharma, Swedish Orphan Biovitrum (Sobi), Mallinckrodt Pharmaceuticals, Hansa Biopharma, Catalyst Pharmaceuticals and Recordati.

Does SERB have an API?

No public API is recorded for SERB.

What industry is SERB in?

SERB's product category is Specialty Pharmaceuticals. Its primary akta.pro industry code is HLAIAAAB, Specialty Care Pharmaceuticals, with a secondary code of HLAIAAAG, Infectious Disease & Antimicrobials Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.

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Live signals
PR NewswireHansa Biopharma announces closing of €115 million licensing transaction with SERB Pharmaceuticals for Idefirix in Europe and MENAHansa Biopharma AB and SERB Pharmaceuticals have closed an exclusive licensing transaction valued at €115 million for Idefirix, a treatment for highly sensitized kidney transplant patients, covering Europe, the UK, Switzerland, Norway, Liechtenstein, Iceland, and the MENA region. The deal comprises an €110 million upfront payment and a €5 million milestone upon EMA filing acceptance, with Hansa applying for transfer of market authorization to SERB. The transaction strengthens Hansa's financial position and supports preparation for a potential US launch of imlifidase, subject to FDA approval, which has a PDUFA action date of December 19, 2026.PR NewswireHansa Biopharma enters into €115 million licensing agreement with SERB Pharmaceuticals for IDEFIRIX in Europe and MENAHansa Biopharma AB entered into a €115 million exclusive licensing agreement with SERB Pharmaceuticals for the development and commercialization of IDEFIRIX in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and MENA regions. Hansa will receive an upfront payment of €110 million plus €5 million upon EMA filing acceptance, with the transaction expected to close within 60 days pending FDI regulatory approval. The agreement strengthens Hansa's financial position to support U.S. launch and path to profitability, subject to a 2026 FDA approval.European BiotechnologySERB to pay Hansa €110M upfront for EU rights to kidney transplant drugSERB will pay Hansa €110 million upfront plus €5 million if the EMA accepts a full approval filing for Idefirix, granting SERB exclusive rights in Europe, the Middle East, and North Africa. Hansa expects to report Phase 3 results in mid-2026 and win full EMA approval in 2027, while focusing on a US launch.Stock TitanCatalyst settles FIRDAPSE patent case; generic in 2035Catalyst Pharmaceuticals and its licensor SERB S.A. have settled patent litigation with Hetero Labs Ltd. and its affiliated entities, resolving Hetero's attempt to launch a generic version of FIRDAPSE (amifampridine) 10 mg tablets before patent expiration. Under the settlement, Hetero will not market its generic version in the United States any earlier than January 2035, pending FDA approval, and all ongoing patent litigation in the U.S. District Court for the District of New Jersey will be terminated. This settlement marks the final unresolved patent challenge for FIRDAPSE, following Catalyst's previous settlements with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited.GlobeNewswireThomas Kolaras Joins SERB and BTG Specialty PharmaceuticalsThomas Kolaras has been named Chief Commercial Officer for the US business of SERB and BTG Specialty Pharmaceuticals. He brings over 25 years of experience across biopharmaceutical companies, including roles at Endo Pharmaceuticals, Otsuka, and Eisai. The company aims to build a global specialty pharmaceutical platform.GlobeNewswireSERB receives EU approval for Voraxaze® (glucarpidase) as Rescue Therapy for High Dose Methotrexate ToxicityThe European Commission granted marketing authorization for Voraxaze (glucarpidase) to reduce toxic methotrexate levels in adults and children. The drug is authorized in all EU member states, Iceland, Liechtenstein, and Norway, with an estimated 2,867 patients treated in the US. Further studies are ongoing to explore its use with high-dose methotrexate.PR NewswireSERB receives positive CHMP opinion for Voraxaze® (glucarpidase) as Rescue Therapy for High Dose Methotrexate ToxicityThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending marketing authorization for SERB’s Voraxaze® in the European Union to treat high-dose methotrexate toxicity. This regulatory milestone precedes final approval by the European Commission and follows the drug's prior approvals in the United States and Japan. The decision allows SERB, which merged with BTG Specialty Pharmaceuticals, to commercialize the rescue therapy across EU member states as well as Iceland, Liechtenstein, and Norway.