Grifols Launches FESILTY™ (fibrinogen, human-chmt) in the U.S.

Rhea-AI Summary

Grifols (NASDAQ:GRFS) has launched FESILTY™ (fibrinogen, human-chmt) in the U.S., following FDA approval for treating acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

FESILTY offers a room-temperature, rapid-reconstitution fibrinogen concentrate with clinical data supporting its pharmacokinetics, hemostatic efficacy, and safety; it is not indicated for dysfibrinogenemia.

Positive

• FDA approval for FESILTY in congenital fibrinogen deficiency acute bleeding
• U.S. commercial launch of FESILTY expands bleeding management portfolio
• Room-temperature storage and approximately three-minute reconstitution at point of care
• Clinical study supports pharmacokinetics, hemostatic efficacy, and safety in adults and children

Negative

• Serious thrombotic events observed, including portal and deep vein thrombosis
• One patient death reported due to extradural hematoma after FESILTY administration
• Potential risk of transmitting infectious agents from pooled human plasma
• Hypersensitivity reactions, including anaphylaxis, reported and listed as contraindication

News Market Reaction – GRFS

-0.26%

-0.26% Session close to close

In the Jun 15 session, GRFS declined 0.26%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details the U.S. launch of FESILTY for acute bleeding in patients with congenital ...

Analysis

This announcement details the U.S. launch of FESILTY for acute bleeding in patients with congenital fibrinogen deficiency, following FDA approval supported by a Phase I/III study (NCT02065882). It broadens Grifols’ bleeding management portfolio in line with earlier regulatory disclosures that targeted a U.S. fibrinogen launch in H1-26. Investors may focus on uptake versus existing options like cryoprecipitate, safety signals such as thrombotic events, and how this product complements the company’s recent revenue and deleveraging progress.

Key Figures

H1-25 revenue: EUR 3.68 bn Revenue growth: 7.0% cc Adjusted EBITDA: EUR 876 m +5 more

8 metrics

H1-25 revenue EUR 3.68 bn H1-25 results 6-K

Revenue growth 7.0% cc H1-25 vs prior period

Adjusted EBITDA EUR 876 m H1-25 results 6-K

EBITDA margin 23.8% H1-25 results 6-K

Net profit EUR 177 m H1-25 results 6-K

Leverage 4.2× H1-25 net leverage ratio

Dividend per share EUR 0.15/share Interim cash dividend against FY-2025 earnings

Dividend cash outlay EUR 102.1 m Total dividend payment excluding treasury shares

Historical Context

1 past event · Latest: Mar 17 (Positive)

Pattern 1 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 17	Research data update	Positive	-0.4%	Chronos-PD data showing molecular Parkinson’s signals years before diagnosis.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Limited history: the prior positive research update saw a slight negative price reaction, while today’s positive launch news coincides with a modest gain.

Recent Company History

Over recent months, GRFS highlighted its Chronos platform with proof-of-concept data on early molecular changes in Parkinson’s disease, yet shares dipped 0.37% after that update. Regulatory filings later detailed solid H1-25 revenue of EUR 3.68 bn, margin expansion, deleveraging to 4.2×, and reinstatement of a EUR 0.15/share dividend. Today’s U.S. launch of FESILTY fits the strategy described in those filings of expanding the plasma-derived portfolio, including a targeted U.S. fibrinogen launch in H1-26.

Key Terms

congenital fibrinogen deficiency, cryoprecipitate, fresh frozen plasma, thrombotic events, +4 more

8 terms

congenital fibrinogen deficiency medical

"acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency"

Congenital fibrinogen deficiency is a rare inherited bleeding disorder in which the blood lacks enough fibrinogen, a key protein that acts like glue to form clots and stop bleeding. For investors, it matters because it creates ongoing need for specialized therapies, blood products, and diagnostic tests, and can influence the commercial potential and regulatory importance of drugs or devices aimed at treating or managing rare bleeding conditions.

cryoprecipitate medical

"alternate treatment options such as cryoprecipitate and fresh frozen plasma"

Cryoprecipitate is a concentrated portion of blood plasma that contains high levels of clotting proteins, produced by thawing frozen plasma and collecting the dense, protein‑rich fraction. Investors watch it because it is a critical, short‑shelf‑life medical product used to stop severe bleeding in surgery, trauma and certain disorders; its supply, manufacturing capacity, regulation and shortages can directly affect hospitals and blood‑product suppliers much like fuel availability affects airlines.

fresh frozen plasma medical

"alternate treatment options such as cryoprecipitate and fresh frozen plasma"

Fresh frozen plasma is the liquid portion of donated blood that is frozen soon after collection to preserve clotting proteins and other important factors used to stop severe bleeding, treat certain liver problems, or reverse blood-thinning drugs. Investors care because it is a regulated, perishable medical product that drives demand for blood banks, cold‑chain storage, medical suppliers and hospitals—shortages, regulatory changes, or shifts in clinical practice can affect revenues and costs for companies involved in its collection, processing and delivery.

thrombotic events medical

"Thrombotic events have occurred in patients receiving FESILTY."

Thrombotic events are episodes where blood clots form inside vessels and block blood flow, like a sudden traffic jam in a body’s circulation. For investors, these events matter because they affect a drug or device’s safety profile, can trigger regulatory scrutiny, lead to costly liability or recalls, and influence sales and stock value if treatments are delayed, restricted, or require additional warnings.

variant Creutzfeldt-Jakob disease (vCJD) medical

"may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD)"

Variant Creutzfeldt-Jakob disease (vCJD) is a rare, fatal brain disorder caused by abnormal infectious proteins called prions that gradually destroy brain tissue; it is similar to a computer corrupted by a tiny, self-spreading file that slowly breaks the system. Investors care because vCJD can trigger strict public-health rules, product recalls, testing or bans on biological materials and food products, and long-term liability or treatment costs that can affect companies across healthcare, agriculture and supply chains.

Creutzfeldt-Jakob disease (CJD) medical

"and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent."

A rare, rapidly progressive brain disease caused by misfolded proteins that destroy brain tissue, leading to dementia, coordination loss, and death. It matters to investors because even though cases are uncommon, CJD can drive urgent demand for diagnostics, therapeutics, or biosecurity measures, affect regulatory scrutiny and liability for healthcare or biotech firms, and influence market perception of companies working on related tests or treatments—much like a sudden quality crisis can reshape a supplier’s business prospects.

hypersensitivity reactions medical

"Hypersensitivity reactions have occurred in patients receiving FESILTY."

Hypersensitivity reactions are unwanted immune system overreactions to a drug, vaccine, medical device, or other substance that can range from mild rashes and itching to severe, potentially life-threatening allergic responses. Investors care because these reactions can change a product’s safety label, delay approvals, trigger additional testing or warnings, reduce market use, or lead to recalls and legal exposure—similar to a false alarm that forces costly changes to a building’s safety plan.

pyrexia medical

"most common adverse reactions ... were pain in extremity, back pain, hypersensitivity reactions, pyrexia"

Pyrexia is the medical term for a fever—an elevated body temperature that signals the body is fighting infection, inflammation, or reacting to a medication. For investors, pyrexia matters because it is a common safety signal in clinical trials and product use that can delay approvals, trigger additional testing, or affect workforce health and production; think of it as a warning light that prompts further investigation into a drug or operation.

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• The new fibrinogen concentrate, approved in the U.S. for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, is now available in the U.S.
  
  
• FESILTY complements Grifols’ bleeding management portfolio, expanding therapeutic options for patients.
  

BARCELONA, Spain, June 15, 2026 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced the U.S. launch of its new fibrinogen concentrate. Approved by the U.S. Food and Drug Administration in December for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia, FESILTY™ (fibrinogen, human-chmt) is now available in the U.S. FESILTY is not indicated for dysfibrinogenemia.

FESILTY provides health care professionals a new treatment option for acute bleeding in patients with CFD, a rare inherited condition caused by genetic mutations that impair the production or function of fibrinogen. Produced in the liver, fibrinogen is a plasma protein essential for blood clotting and wound healing. When fibrinogen levels are insufficient, the body’s ability to effectively control bleeding is compromised, particularly during acute bleeding episodes.

A highly purified product with a precisely defined amount of fibrinogen, FESILTY enables rapid and predictable restoration of fibrinogen levels – which is critical during bleeding events in patients with CFD. In contrast, alternate treatment options such as cryoprecipitate and fresh frozen plasma include additional proteins, often require infusions of large volumes to achieve adequate fibrinogen levels, and take longer to prepare and administer. FESILTY can be stored at room temperature at the point of care and is supplied as a complete kit, allowing for rapid reconstitution in approximately three minutes.

“The availability of an additional fibrinogen concentrate in the U.S. is a meaningful development for clinicians caring for patients with congenital fibrinogen deficiency during acute bleeding events," said Guy Young, MD, Director, Hemostasis and Thrombosis Center at University of Southern California's Keck School of Medicine. "Targeted fibrinogen replacement is becoming increasingly well supported, and purified concentrates can be especially useful because they allow for predictable dosing, can be administered quickly and do not require crossmatching."

The launch of FESILTY enhances Grifols’ bleeding management offering and further expands its portfolio of plasma-derived medicines to benefit patients and healthcare professionals.

“With FESILTY now available in the U.S., health care providers have a safe, effective and reliable treatment for acute bleeding episodes in patients with CFD – when every minute counts,” said Roland Wandeler, President of Grifols Biopharma. “This milestone reflects our continued commitment to bringing more medicines to more patients around the world.”

Clinical evidence supporting approval

FDA approval of FESILTY was based on evidence from the clinical study “A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency” (NCT02065882).

Two medical journals recently published results from this study. The findings, published in Thrombosis and Haemostasis (October 2025)¹ and Thrombosis Research (March 2026)² confirmed the therapy's pharmacokinetics, hemostatic efficacy, and safety for treatment of acute bleeding episodes in both adults and children with CFD.

Important Safety Information

Indications and Usage
FESILTY (fibrinogen, human-chmt) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

Limitations of Use:
FESILTY is not indicated for dysfibrinogenemia.

Contraindications
FESILTY is contraindicated in patients who have severe hypersensitivity reactions, including anaphylaxis, to FESILTY or its components (arginine hydrochloride, polysorbate 80, sodium citrate dihydrate, trehalose dihydrate).

Warnings and Precautions
Hypersensitivity reactions have occurred in patients receiving FESILTY. Should symptoms occur, discontinue FESILTY and administer appropriate treatment.

Thrombotic events have occurred in patients receiving FESILTY. Weigh the benefits of administration versus the risks of thrombosis.

FESILTY is made from pooled human plasma and may carry the risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Adverse Reactions
The most serious adverse reactions observed with FESILTY were thrombotic events, including portal vein thrombosis, deep vein thrombosis, and pain in extremity with clinically suspected thrombosis. One patient had an episode of epilepsy and died due to extradural hematoma 4 weeks after administration of FESILTY.

In a clinical study, the most common adverse reactions that occurred in >2% of patients receiving FESILTY were pain in extremity, back pain, hypersensitivity reactions, pyrexia, thrombosis, fibrin D dimer increased, headache, and vomiting.

Please see full Prescribing Information for FESILTY.

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries.

Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols focuses on treating conditions centered on six core therapeutic areas: immunology, neurology, pulmonology, hematology, hepatology and intensive care.

A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s most diversified with more than 400 across North America, Europe, Africa and the Middle East, and China.

As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 25,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the IBEX-35 (MCE:GRF). Grifols non- voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

For more information about Grifols, please visit www.grifols.com

MEDIA CONTACTS:

Grifols Press Office
media@grifols.com
Phone: +34 93 571 00 02

INVESTORS:

Investor Relations & Sustainability
investors@grifols.com – inversores@grifols.com
sustainability@grifols.com – sostenibilidad@grifols.com
Phone: +34 93 571 02 21

LEGAL DISCLAIMER

The facts and figures contained in this report that do not refer to historical data are ‘projections and future hypotheses’. Words and expressions such as ‘believe’, ‘expect’, ‘anticipate’, ‘predict’, ‘hope’, ‘intend’, ‘should’, ‘will try to achieve’, ‘is estimated’, ‘future’ and similar expressions, insofar as they refer to the Grifols group, are used to identify future projections and hypotheses. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a series of factors that mean that the real results may be materially different. The future results of the Grifols group could be affected by events related to its own activities, such as shortages of supplies of raw materials for the manufacture of its products, the appearance on the market of competing products, or changes in the regulatory framework of the markets in which it operates, among others. At the date of preparation of this report, the Grifols group has adopted the necessary measures to mitigate the foreseeable impact of these events. Grifols, S.A. assumes no obligation to publicly report, revise or update the projections or future hypotheses to adapt them to facts or circumstances after the date of writing of this report, except when expressly required by applicable legislation. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Law 6/2023, of 17 March, on the Securities Markets and Investment Services, and any regulations implementing said legislation. Furthermore, this document does not constitute an offer to purchase, sell or exchange, or a solicitation of an offer to purchase, sell or exchange any securities, or a solicitation of any vote or approval in any other jurisdiction. The information contained in this document has not been verified or revised by the external auditors of the Grifols group.

_______________________

_{¹ Djambas Khayat C, El-Beshlawy A, Meddeb B, et al. Pharmacokinetics, hemostatic efficacy, and safety of a new human fibrinogen concentrate in adult and pediatric patients with congenital fibrinogen deficiency. Thromb Haemost. 2025. https://doi.org/10.1055/a-2715-2994.}

_{² Khayat, Claudia Djambas, et al. Efficacy and safety of prophylaxis and treatment of bleeding events with a novel fibrinogen concentrate from human plasma in patients with congenital fibrinogen deficiency. Thrombosis Research. 2026.   https://www.thrombosisresearch.com/article/S0049-3848(26)00035-6/fulltext}

FAQ

What did Grifols (NASDAQ:GRFS) announce about FESILTY on June 15, 2026?

Grifols announced the U.S. launch of FESILTY, a fibrinogen concentrate for congenital fibrinogen deficiency. According to Grifols, FESILTY is now available for treating acute bleeding episodes in pediatric and adult CFD patients, following FDA approval granted in December.

For which patients is FESILTY (fibrinogen, human-chmt) from GRFS FDA-approved in the U.S.?

FESILTY is indicated for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency. According to Grifols, this includes hypo- or afibrinogenemia, while FESILTY is specifically not indicated for dysfibrinogenemia, defining its approved U.S. patient population and use.

Which clinical study supported FDA approval of FESILTY for congenital fibrinogen deficiency?

FDA approval was based on a prospective, open-label Phase I/III study of BT524 in CFD patients. According to Grifols, results published in Thrombosis and Haemostasis and Thrombosis Research confirmed pharmacokinetics, hemostatic efficacy, and safety for treating acute bleeding in adults and children.

How does FESILTY compare with cryoprecipitate and fresh frozen plasma for CFD bleeding treatment?

FESILTY provides a highly purified, precisely dosed fibrinogen concentrate for rapid, predictable level restoration. According to Grifols, alternatives like cryoprecipitate and fresh frozen plasma include additional proteins, often need larger infusion volumes, and take longer to prepare and administer during acute bleeding episodes.

What are the main safety warnings and adverse reactions for FESILTY reported by Grifols?

Key safety concerns include hypersensitivity reactions and thrombotic events such as portal and deep vein thrombosis. According to Grifols, one patient died from extradural hematoma, and common reactions included extremity pain, back pain, pyrexia, thrombosis, increased fibrin D dimer, headache, and vomiting.

How is FESILTY supplied and stored for treating congenital fibrinogen deficiency in the U.S.?

FESILTY is supplied as a complete kit that can be stored at room temperature at the point of care. According to Grifols, it allows rapid reconstitution in approximately three minutes, supporting quick administration during acute bleeding episodes in patients with congenital fibrinogen deficiency.