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European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025 EU approval is based on the complete data set from the phase-III PROTECT study ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. Continue Reading "The decision by the European Commission is an important advancement for people living with IgAN in the EU", said Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor. "The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe." The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe," said Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics. "This decision not only validates the strength of the phase-III PROTECT study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN." The European Commission's decision follows CHMP's recommendation to convert the CMA to standard MA from February 2025. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal phase-III PROTECT study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in Europe and is currently available in Germany, Austria and Switzerland, following the European Commission's conditional marketing authorization in April 2024 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, cslvifor.com. About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com. About IgA Nephropathy (IgAN) IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (Europe, Australia and New Zealand). About the PROTECT study The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head vs. comparator trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. eGFR is a blood test that measure how well kidneys filter waste products from blood. Treatment emergent adverse events were well-balanced between sparsentan and irbesartan, except for dizziness and hypotension. About FILSPARI (sparsentan) FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. FILSPARI is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. For more information, please refer to the Summary of Product Characteristics (SmPC). CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] Travere Therapeutics: Investors 888-969-7879 [email protected] Media 888-969-7879 [email protected] Logo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The deal expands Epsilogen’s pipeline with TigaTx’s TIGA-001—to be renamed EPS 401—an anti-EGFR IgA antibody that is expected to enter the clinic next year.\n U.K.-based Epsilogen has bought Boston biotech TigaTx with the aim of creating “the world’s leading pan-isotype cancer antibody company.”Both companies are focused on immunoglobulin antibodies, with Epsilogen’s work orienting around IgE, while TigaTX has been hard at work developing IgA therapies.The deal, for which Epsilogen is not disclosing the financial details, will see TigaTx become a subsidiary of the London-based company.“We are excited to create the world’s leading pan-isotype antibody company with the goal of bringing improved therapeutics to cancer patients,” Epsilogen CEO Tim Wilson said in the April 7 release.“Combining the capabilities of Epsilogen with those of TigaTx gives us the ability to choose the most relevant isotype for a given cancer, whether a cold tumour environment we want to drive multiple immune effector cells into or leverage neutrophils,” Wilson added. “The transaction also facilitates the combination of different isotype functions into a single antibody molecule.”The deal expands Epsilogen’s pipeline with TigaTx’s TIGA-001—to be renamed EPS 401—an anti-EGFR IgA antibody that is expected to enter the clinic next year.Epsilogen already has a candidate in the clinic in the form of MOv18 IgE, which targets the folate receptor alpha antigen. While researchers discovered IgE antibodies all the way back in 1966, and biologics pioneers considered them at the birth of the biotech industry, Epsilogen claims its candidate is the world’s first IgE antibody to enter human trials. Data from a phase 1 trial of MOv18 IgE have produced early signs of clinical activity, according to Epsilogen, leading the biotech to move the asset into a phase 1b trial in patients with platinum-resistant ovarian cancer.Looking ahead, Epsilogen sees the deal as giving it the option to “mix and match IgE, IgA and IgG functionality into a single antibody molecule.”“Such hybrid antibodies have the potential to activate multiple compartments of the immune system as well as possessing improved PK/PD profiles,” the company explained in the release. “This is especially powerful in the light of the importance of the epitope in determining the clinical performance of antibodies.”In September, Epsilogen completed a 12.5 million pound sterling ($16 million) series B top-up to help fund the phase 1b study of MOv18 IgE. Previous backers Novartis Venture Fund, British Patient Capital, Epidarex Capital, 3B Future Health Fund and ALSA Ventures all returned for the latest raise.Meanwhile, TigaTx—with tech based on work by Professor Jeanette Leusen at the Utrecht Medical Center in The Netherlands—secured $33.5 million in funding last December from the U.S. Department of Health and Human Services’ Advanced Research Projects Agency for Health, along with a $2 million business grant from the National Cancer Institute.

LONDON & BOSTON--([BUSINESS WIRE](https://www.businesswire.com/))--**Highlights** * The acquisition combines IgA antibody assets and expertise of Boston-based TigaTx with Epsilogen’s assets and expertise in IgE to create the world’s leading pan-isotype cancer antibody company * Allows selection of the most appropriate antibody isotype for a given cancer, applying the unique mechanisms of action for each: * IgA activates neutrophils, a potent and highly abundant immune effector cell * IgE activates T cells and macrophages to warm up the tumour microenvironment (TME) * Facilitates combination of different isotype functions into single antibody molecules with enhanced potency and performance * Combined clinical-stage company benefits from a strong pipeline: * MOv18 IgE, an anti-Folate Receptorα IgE antibody, currently in a Phase Ib Proof of Concept trial in platinum-resistant ovarian cancer. Data from a Phase I trial found it to be safe and well tolerated with early signs of clinical activity * EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody with IND-enabling studies underway * Further IgE and IgA antibodies targeted to other validated cancer antigens * In addition to IgE, the combined company has three proprietary antibody platforms: * IgEG antibodies which combine IgE and IgG functionality into a single antibody molecule * Bispecific IgEs and IgEGs which can bind two different antigens simultaneously * IgA 3.0, an engineered derivative of wild type IgA with improved manufacturing profile * US based TigaTx becomes a wholly owned subsidiary of Epsilogen * Sonia Gulati of Global BioAccess Fund has joined Epsilogen’s board of directors * Financial terms of the transaction have not been released Epsilogen, the global leader in the development of immunoglobulin E (IgE) antibody therapeutics, today announces that it has completed the acquisition of TigaTx, Inc., a biotechnology company developing engineered immunoglobulin A (IgA) antibodies, to create the world’s leading pan-isotype cancer antibody company. As a result of the combination of these two privately held companies, US-based TigaTx becomes a wholly owned subsidiary of Epsilogen. Financial terms of the transaction have not been disclosed. Additionally, Dr Sonia Gulati, a Principal at Global BioAccess Fund has joined the Epsilogen Board of Directors. Commenting on the acquisition, **Epsilogen CEO Tim Wilson said:** _“We are excited to create the world’s leading pan-isotype antibody company with the goal of bringing improved therapeutics to cancer patients. Combining the capabilities of Epsilogen with those of TigaTx gives us the ability to choose the most relevant isotype for a given cancer, whether a cold tumour environment we want to drive multiple immune effector cells into or leverage neutrophils. The transaction also facilitates the combination of different isotype functions into a single antibody molecule. We are looking forward to working with our new colleagues in Boston and creating additional opportunities in our pipeline.”_ **Sonia Gulati PhD, a Principal at the Global BioAccess Fund said:** _“We are thrilled about the merger with Epsilogen and believe deeply in the potential of IgA and IgE-based therapies to transform cancer treatment. Together, we are advancing a new frontier in immunotherapy to bring innovative solutions to patients in need.”_ **Pete Finan, Epsilogen’s Non-Executive Chairman and a General Partner at Epidarex Capital commented:** _“Nature has evolved five different antibody isotypes to perform specific biologic functions. Following the acquisition, Epsilogen is in a unique position with in-house deep expertise in three of these, IgE, IgA and IgG. We very much look forward to the company turning this potential into innovative new medicines for cancer patients.”_ **Rationale: Creating the world’s leading pan-isotype cancer antibody company** The primary purpose of this transaction is to create the world’s leading pan-isotype antibody company with the goal of pioneering radically new antibody therapeutics in oncology. The acquisition not only gives Epsilogen the capability of selecting the appropriate antibody isotype for a given cancer, given the differentiated therapeutic mechanisms of each, but also allows it to mix and match IgE, IgA and IgG functionality into a single antibody molecule. Such hybrid antibodies have the potential to activate multiple compartments of the immune system as well as possessing improved PK/PD profiles. This is especially powerful in the light of the importance of the epitope in determining the clinical performance of antibodies. The human immune system has evolved five main antibody isotypes (IgG, IgM, IgE, IgA and IgD) which it can call upon depending upon the challenge faced. All cancer antibodies and antibody derivatives to date, and virtually all in clinical development, are based on the IgG isotype. IgG utilises the gamma chain constant region whereas antibodies of the IgE and IgA isotypes use the epsilon and alpha chain constant regions respectively; the variable regions of all wild type antibodies are structurally the same. IgE and IgA antibodies have distinct and potent immunological effector functions predominantly working through myeloid cells and neutrophils respectively. Each of these broad classes can bring about solid tumour destruction in a variety of preclinical models. The acquisition bolsters Epsilogen’s pipeline by adding EPS 401 (formerly TIGA-001), an anti-EGFR IgA antibody, scheduled to enter the clinic in 2026. MOv18 IgE is currently in a Phase Ib trial for treatment of platinum-resistant ovarian cancer (PROC). Phase I trial data previously showed the antibody to be safe and well tolerated with preliminary signs of anti-cancer activity. Epsilogen’s earlier stage pipeline also features a number of other IgE antibody candidates targeting a variety of tumour antigens. **About TigaTx** TigaTx is a biotechnology company developing engineered monomeric IgA neutrophil engagers to unleash the tumour killing power of neutrophils for cancer. The company's cutting-edge approach in engineered therapeutic IgA is based on pioneering work by Professor Jeanette Leusen conducted at the Utrecht Medical Center (Utrecht, The Netherlands). Based in Boston, MA, TigaTx is developing a pipeline of therapies to treat different cancer types. **About Epsilogen Ltd** Epsilogen is the world’s leading pan-isotype antibody therapeutic company for the treatment of cancer. It has unique and proprietary expertise in the discovery and development of IgE, IgA and IgG-based therapeutics with each isotype possessing differentiated immune effector function. IgE has significant activity against various tumour types by activating myeloid cells and T cells thereby warming up the tumour micro-environment (TME). IgA’s anti-cancer potential is mediated by the activation of neutrophils, highly abundant effector cells which drive innate and adaptive immunity. The distinct activity profiles of each isotype allow Epsilogen to select the most appropriate isotype for a given cancer. The company has also combined different isotypes into a single antibody molecule with enhanced functionality. Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial found it to be safe and well tolerated with early signs of clinical activity. Epsilogen has initiated a Phase Ib trial in platinum-resistant ovarian cancer patients. Find out more at [Epsilogen.com](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fepsilogen.com%2F&esheet=54234498&newsitemid=20250406268542&lan=en-US&anchor=Epsilogen.com&index=1&md5=c1726cf4016165ecf5206d3fd9853bfb).