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Fractyl Health introduces Revita: focus on weight maintenance after GLP‑1 therapy

Fractyl Health presented data at the H.C. Wainwright conference showing that the endoscopic Revita procedure substantially reduces weight regain after stopping GLP‑1 medications and has a favorable safety profile. The company expects pivotal top-line data in early Q4 2026 and plans a De Novo submission in late Q4 2026, with FDA feedback indicating a possible class II designation. Fractyl reports $47 million in cash, sees significant commercial potential, but remains dependent on approval, reimbursement and market acceptance. » Mere på de.investing.com
H.C. Wainwright puts Fractyl Health in focus and sees Revita approval in 2027

H.C. Wainwright identifies Fractyl Health as a promising biotech opportunity and sees potential approval of the Revita treatment in 2027 with market launch in early 2028. The investment firm praises the commercial strategy of centers of excellence and existing infrastructure, which could enable a capital-efficient model and cash profitability within five to eight quarters after market entry. Analysts expect interim data from a 45‑patient cohort to support the design of a pivotal study of about 315 patients, as well as a possible de novo submission in Q4 2026. Fractyl recently reported Q2 results that beat analyst expectations and showed a smaller loss per share due to reduced R&D spending. » Mere på de.investing.com
Fractyl Health bets on one-time therapies to maintain weight after GLP‑1

Fractyl Health presented at the Canaccord growth conference its strategy to develop one-time metabolic treatments that address weight and root causes of diabetes. Lead program Revita showed sustained weight maintenance after GLP‑1 therapy in pilot studies and is now running a 300‑patient, approval‑relevant trial with initial 6‑month data due in early Q4; a regulatory submission based on those data is planned by year‑end. Rejuva, a gene‑therapy candidate for endogenous GLP‑1 production, received IND clearance and is approaching first-in-human use. Fractyl plans to commercialize through roughly 200–400 centers of excellence rather than a broad rollout; success depends on clinical and regulatory milestones. » Mere på de.investing.com

Virksomhedstal

I det seneste kvartal havde FRACTYL HEALTH INC. O.N. Aktie en omsætning på 0 € og et nettoresultat på -22,38 mio. €

(EUR)	juni 2026	YoY
Omsætning	0	-
Bruttofortjeneste	0	-
Nettoresultat	-22,38 mio.	5,43 %
EBITDA	-21,89 mio.	6,60 %

Fundamentale data

Nøgletal	Værdi
Markedsværdi	87,63 mio. €
Antal aktier	158,65 mio.
Højeste/laveste i 52 uger	2,11 € - 0,33 €
Udbytte	Nej
Beta	2,33
P/E (PE Ratio)	-0,58
PEG (PEG Ratio)	-0,01
K/I (PB Ratio)	-60,98
P/S (PS Ratio)	0,00

Virksomhedsprofil

Fractyl Health, Inc. ist ein Unternehmen für Stoffwechseltherapeutika und entwickelt Therapien zur Behandlung von Typ-2-Diabetes (T2D) und Adipositas. Das Unternehmen entwickelt das Revita DMR System (Revita), ein ambulantes Therapieverfahren zur dauerhaften Veränderung der Duodenaldysfunktion, einer pathologischen Folge einer fett- und zuckerreichen Ernährung, die beim Menschen T2D und Fettleibigkeit auslösen kann. Darüber hinaus entwickelt das Unternehmen Rejuva, eine neuartige Gentherapieplattform für die Bauchspeicheldrüse, die eine langfristige Remission von T2D und Fettleibigkeit ermöglichen soll, indem sie die Funktion von Stoffwechselhormonen in den Inselzellen der Bauchspeicheldrüse von Patienten dauerhaft verändert. Fractyl Health, Inc. war früher als Fractyl Laboratories Inc. bekannt und änderte am 09. Juni 2021 seinen Namen in Fractyl Health, Inc. Das Unternehmen wurde im Jahr 2010 gegründet und hat seinen Sitz in Lexington, Massachusetts.