Grifois, S.A. - GRFS STOCK NEWS

Grifols (NASDAQ:GRFS) has received FDA approval for its Fibrin Sealant (FS) to treat surgical bleeding in pediatric patients in the United States. The plasma-protein based solution, marketed as VISTASEAL™ in the U.S. and Canada and VERASEAL™ in Europe, combines fibrinogen and thrombin to promote hemostasis and tissue sealing during surgery.

The approval follows successful phase 3b study results showing >95% efficacy rate in achieving hemostasis within four minutes of application. The study involved 178 patients across 18 recruitment centers. The product is distributed through a strategic collaboration with Johnson & Johnson MedTech and is currently available in 18 countries.

Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) has partnered with BARDA to test ocular surface immunoglobulin (OSIG) eye drops for treating sulfur mustard-induced eye injury. This initiative aims to evaluate the nonclinical efficacy of OSIG in neutralizing symptoms from sulfur mustard exposure, a chemical warfare agent. If successful, it could lead to FDA approval for one of the first medical treatments for sulfur mustard ocular injury.

Grifols is repurposing an investigational OSIG therapeutic currently in development for dry eye disease (DED). The company plans to start a phase 2 clinical trial for DED in the first half of 2025. The research will investigate OSIG's anti-inflammatory properties and its ability to prevent the immune system from attacking self-antigens modified by sulfur mustard exposure.

This partnership follows Grifols' subsidiary GigaGen's recent contract with BARDA, worth up to $135 million, to develop recombinant polyclonal antibody therapies for biothreats including botulinum neurotoxins.

Grifols (GRFS) has received FDA approval for an expanded label for XEMBIFY®, its 20% subcutaneous immunoglobulin (SCIg) treatment. The new label includes treatment-naïve patients with primary humoral immunodeficiencies (PI), making XEMBIFY the first and only 20% SCIg with this extended label. This allows patients to start SCIg therapy without initial intravenous administration.

The approval also includes biweekly dosing, supported by phase 4 clinical trial data showing non-inferiority in total Ig levels compared to weekly administration. The expanded label aims to provide greater flexibility and convenience for patients. Grifols plans to launch the new label in the U.S. in Q3 2024, aligning with its strategy to increase XEMBIFY adoption and strengthen its position in the growing Ig market for immunodeficiencies.

Biotest, a Grifols Group company, has projected USD 1 billion in U.S. sales of its FDA-approved intravenous immunoglobulin, Yimmugo®, over the next seven years. Expected to launch in Q1 2025, Yimmugo will be distributed by Kedrion in the U.S. This marks Grifols' expansion in the U.S. market for immunodeficiency treatments, leveraging its existing portfolio and new proteins like fibrinogen and trimodulin, both in late-stage development. Yimmugo is the first Biotest product from their new FDA-certified facility in Germany, enhancing Grifols' strategy to meet rising demand for immunoglobulins.

Grifols has completed the sale of a 20% equity stake in Shanghai RAAS (SRAAS) to Haier Group for RMB 12.5 billion (EUR 1.6 billion). The strategic alliance aims to enhance China's healthcare system through synergies between Grifols' plasma and diagnostic expertise and Haier's healthcare solutions portfolio. Grifols retains a 6.58% stake in SRAAS and a seat on the Board of Directors. The exclusive albumin distribution agreement between Grifols and SRAAS is extended for 10 years, with an option to prolong it to 2044. Proceeds from the sale will be used by Grifols to reduce debt. The collaboration seeks to capitalize on China's growing demand for albumin and expand their footprint in life sciences, clinical medicine, and biotechnology.

The transaction has received regulatory approvals and compliance confirmation from the Shenzhen Stock Exchange. Grifols and SRAAS have worked together for four years, during which the Chinese hemoderivatives market has seen double-digit growth.

Grifols announced that its subsidiary Biotest has received FDA approval for Yimmugo®, an innovative intravenous immunoglobulin (Ig) to treat primary immunodeficiencies (PID). This approval marks Yimmugo as the first U.S.-approved medicine in Biotest’s portfolio, produced at their FDA-certified facility in Germany. Already approved in Europe, Yimmugo’s U.S. launch is expected in the latter half of 2024. The approval is anticipated to bolster Grifols' revenue and support its growth strategy. Additionally, Biotest has two more plasma proteins in late-stage development aimed at U.S. and other markets.

Grifols, S.A. has filed its 2023 Annual Report on Form 20-F with the SEC, offering insights into its governance practices and financial performance. The company, a prominent player in the healthcare sector specializing in plasma-derived medicines, aims to provide transparency to investors through this filing.

Grifols commemorates five decades of producing life-altering plasma-derived medications for patients at its primary facility in Clayton, North Carolina. The establishment of the Clayton site in 2011 propelled Grifols to become a prominent player in the plasma industry, fostering continuous business expansion. The flagship Grifols campus epitomizes the company's dominance in plasma therapeutics, generating significant positive impact on patient care and medical advancements.

Grifols announces CE mark for Procleix ArboPlex Assay, a test to detect major arboviruses in blood donors, enhancing transfusion safety. The test addresses a significant public health concern due to the spread of arboviruses like dengue and Zika. Grifols aims to improve donor screening efficiency and safety with this innovative solution.