We are pleased that the FDA has accepted the re-submitted BLA of pegzilarginase and granted priority review. This is a significant step towards providing a much-needed treatment option for patients with ARG1-D in the U.S. For this rare and debilitating condition there are limited therapeutic options, and we are hopeful that pegzilarginase, if approved, could offer a valuable alternative for managing the disease. We look forward to continuing to work with the FDA to potentially bring this treatment to those in need.

This study provides crucial insights into the challenges faced by ARG1-D patients and their families, reaffirming the need for continued innovation. As we expand our health economic function, we are focused on generating and analyzing relevant data to support the value of our products. This growing capability allows us to translate these findings into actionable steps that inform better clinical practices, improve healthcare decisions, and ultimately enhance the lives of those impacted by rare diseases

"We are thrilled to have Joe on board. His vast industry knowledge and successful track record in strategic deal-making will be key as we continue to drive growth and expand Immedica’s footprint in the rare disease and specialty care sectors."

This collaboration with KKR and Impilo marks an exciting step forward in our mission to deliver innovative treatments to more patients with rare diseases. With their support, we are well-positioned to enhance our growth and continue addressing critical unmet medical needs across the globe

The approval of Loargys for patients with ARG1-D is addressing a high unmet medical need in this disease, providing the first disease-modifying treatment. However, Immedica is committed to serve all patients with the disease and to investigate the ability to treat patients as early as possible, before any effects of the disease in the crucial first years of life, a particularly important period of child development

I’m excited to join Immedica at this pivotal time and lead the development of a U.S. commercial organization. I look forward to working closely with our European colleagues and U.S. employees to develop Immedica into a global leader in rare disease

This expansion into the U.S. is a pivotal moment for Immedica as we continue our mission to deliver life-changing therapies to people living with rare diseases

These data are of high importance for Loargys as a new treatment option in arginase 1 deficiency providing long-term and real-world outcomes data

With exceptional entrepreneurship, solid functional skill sets and capabilities fostered by a strong ‘can-do’ attitude, the team have time after time proven that we can overcome any obstacle together and achieve great things.

The Immedica team is one of the best that we have encountered in a space that we have been following for some time. We are deeply impressed by the accomplishments of Immedica under Impilo’s ownership and the establishment of a rare disease player with a highly promising pipeline. We look forward to working with the management team alongside Impilo to accelerate growth further

KKR, with its experience in rare disease and specialty pharma in Europe and the U.S., as well as its global presence and network, is an ideal strategic partner for the next stage of Immedica’s evolution. We are excited to continue our engagement in Immedica, together with KKR, supporting management to realize our joint vision of becoming a leading ultra-rare disease platform and making medicines available to patients with high unmet medical needs

I am excited to continue our partnership with Impilo and welcome KKR as a new strategic partner for the next step in Immedica’s journey, Since our inception in 2018 backed by Impilo, Immedica has made significant strides towards becoming a leader in the rare disease sector, providing innovative therapies to patients with severe unmet medical needs. I look forward to working alongside both KKR and Impilo as we further our mission, continue to build our organisation, and expand our reach globally"

"We are extremely proud to be recognized as one of Sweden's Best Workplaces™ by Great Place to Work®. It is a testament to our commitment to creating an inclusive and enjoyable work environment for all our employees,"

We raise awareness for Rare Disease Day, since it’s crucial to address the widespread issue of underdiagnosis and misdiagnosis, notably in conditions like ARG1-D. These rare diseases often remain overlooked, leaving patients and families to confront their challenges alone.

"This is a very important approval for the people living with ARG1-D and their families across the whole of United Kingdom and proof of the huge unmet medical need in this ultra rare disease. We will now focus on getting Loargys available to patients in the UK as soon as possible."

Today’s approval marks a major milestone for Immedica, but an even greater one for the people living with ARG1-D and their families.

Today’s announcement demonstrates significant progress towards providing the first disease modifying treatment for ARG1-D. The unmet medical need in this vulnerable patient population is huge and we look forward to the decision by the European Commission

“This approval by ANMAT is an important milestone for the people living with UCDs in Argentina and addresses the significant unmet medical need in this patient population”

We are very pleased with this new agreement with Aeglea, giving us the global rights to pegzilarginase. People with arginase 1 deficiency lack sufficient treatment options today and we believe that pegzilarginase, where awarded marketing authorizations, has the potential to benefit these patients as the first disease modifying treatment