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Egetis Therapeutics: approval decision for tiratricol draws nearer

Egetis Therapeutics said at the Cantor Health Conference that the FDA review for tiratricol to treat MCT8 deficiency is underway and the PDUFA date is set for September 28, 2024. The company points to a substantial evidence package and 60 patients in the US expanded-access program, as well as a full switch in Germany after market launch. A second growth path is RTH-beta, for which a registration-relevant study is planned in 2025. Egetis sees commercial potential with high expected treatment costs per patient and estimates the US market for MCT8 at about 1,000 patients. » Mais em de.investing.com
Egetis Therapeutics increases revenue and prepares US launch of Emcitate

Egetis Therapeutics reported a currency-adjusted revenue increase of 23% to SEK 17.4m in the second quarter and ended the quarter with SEK 378m in cash after a SEK 350m capital raise. Operating loss widened to SEK 109.3m as the company invested in the US approval process, building its sales organization and launch preparations. The FDA has accepted the approval application for Emcitate and set a PDUFA date of 28 September; if approved, a US launch is planned for Q4, prompting a positive reaction in the stock. » Mais em de.investing.com
Egetis Therapeutics could receive FDA priority review voucher if approved

Egetis Therapeutics would qualify for a Priority Review Voucher under the FDA’s Rare Pediatric Disease Priority Review Program if approved; the program has been extended through 2029. Such vouchers accelerate future approval processes or can be sold to other pharma companies, making them a valuable asset for the company. A voucher would strategically help Egetis in the development and commercialization of its therapies for rare pediatric diseases. » Mais em de.investing.com

Dados financeiros da empresa

No último trimestre, Egetis Therapeutics registou receitas de € 1,57 mi e um ganho líquido de -€ 9,83 mi

(EUR)	junho de 2026	YoY
Receitas	1,57 mi	20,66%
Ganho bruto	324,85 mil	141,31%
Ganho líquido	-9,83 mi	41,10%
EBITDA	-8,7 mi	30,10%

Dados fundamentais

Métrica	Valor
Capitalização bolsista	€ 325,33 mi
Número de ações	464,95 mi
Máximo/mínimo de 52 semanas	€ 0,73 - € 0,32
Dividendos	Não
Beta	0,81
PER (PE Ratio)	-7,81
PEG (PEG Ratio)	9,17
P/VC (PB Ratio)	7,36
P/V (PS Ratio)	55,50

Perfil da empresa

Egetis Therapeutics AB (publ), ein Unternehmen der pharmazeutischen Arzneimittelentwicklung, konzentriert sich auf Projekte in der späten Entwicklungsphase zur Behandlung schwerer seltener Nischenkrankheiten mit ungedecktem medizinischem Bedarf im Bereich der Orphan Drugs. Die Produktpipeline des Unternehmens umfasst Aladote, ein Medikament zur Verringerung des Risikos akuter Leberschäden im Zusammenhang mit Acetaminophen/Paracetamol-Vergiftungen, das sich in der klinischen Phase IIb/III befindet, sowie Emcitate, ein Medikament zur Behandlung des MCT8-Mangels, einer seltenen angeborenen Störung der Schilddrüsenhormon-Signalübertragung, das sich in der klinischen Phase IIb/III befindet. Das Unternehmen war früher als PledPharma AB (publ) bekannt und änderte im Dezember 2020 seinen Namen in Egetis Therapeutics AB (publ). Egetis Therapeutics AB (publ) wurde im Jahr 2006 gegründet und hat seinen Sitz in Stockholm, Schweden.