Progress for the ReTRIACt trial, not much left

Egetis Q2: initial Germany launch, key catalysts still ahead

Egetis has reported Q2 results, marking the first commercial sales of Emcitate in Germany following its 1st May launch, and a cash position of SEK203m, providing an est. runway into Q1 2026. While exact German sales figures remain undisclosed, SEK14.5m in total revenues (vs SEK13.9m in Q2 2024) inc

Egetis: Submits pre-NDA meeting, positive recruitment update

Egetis posted a positive US development update on Emcitate with 15 evaluable patients in the US ReTRIACt phase 3 study (vs 12 at previous update) and has submitted a pre-NDA meeting (Type B) request to the FDA, with plans to initiate the submission of the NDA for tiratricol (Emcitate) this year. As

Egetis: additional insights into the BTD for Emcitate

Following a conversation with management, we come back on Egetis' announcement that the FDA has granted Breakthrough Therapy Designation (BTD) for Emcitate in the treatment of MCT8 deficiency, with some more flesh on the bone, as we believe key additional information might have been overlooked by i

Egetis: Distribution agreement signed for Emcitate in Turkey

Egetis has signed an exclusive distribution agreement with Er-Kim for Emcitate in Turkey. While financial terms were not disclosed, we do not believe the Turkish market opportunity is material enough at this stage to impact our near-term forecasts. This is primarily due to the ultra-rare patient po

ReTRIACt struggle continues

Egetis: US trial tracking slowly, Emcitate to be launched in Germany M...

Egetis reported Q1 with an operating loss of SEK 62.9m and a cash position of SEK273m. Regarding the US phase 3 trial, it is tracking slowly where 12 patients have now completed the randomization phase (vs 11 previously), 1 is currently in the randomization phase and 1 which is in the run-in period

Q1: ReTRIACt a constant headache

Egetis: Article highlights Emcitate's broad efficacy in MCT8 deficienc...

A recent publication in Nature Communications (Groeneweg, van Geest et al. 2025) highlights the broad therapeutic applicability of Emcitate across the heterogeneity of the MCT8 deficient target group and supporting its uniform treatment eligibility across a genetically diverse patient population. I

Egetis: KOL event takeaways

Egetis hosted a KOL event with Prof. Edward Visser, from the Erasmus MC, which focused on the advancements in MCT8 deficient patient identification in the past years largely due to increased disease awareness and the widespread availability of genetic panels — which have led to a greater number of

Egetis: model update

Following FY 2024 results published yesterday, we update our model taking into account the latest financials. We reiterate our Buy rating and SEK15 PT.

Q4 a mixed bag but Germany launch ahead

Egetis Therapeutics (Buy, TP: SEK11.00) - First launch coming up

In our view, the Q4 report was something of a non-event, but the company gained European approval for Emcitate on 13 February, and is planning launches in Germany in Q2 and in Spain, Italy and France in H2. Moreover, the pivotal US trial, ReTRIACt, is progressing, with the company planning to file for US approval in 2025. We reiterate our BUY and SEK11 target price.

Egetis: Making steady progress in the US trial

Egetis has reported FY 2024 results with a net loss for the period of SEK343.6m and a cash position standing at SEK351m. Importantly, the company provided an updated on the status of the US phase 3 trial, with now 19 patients included (up from 17 in December), of which 11 patients have completed th

Q4: ReTRIACt lagging, but GER launch coming

Egetis: Emcitate receives EU approval

Egetis announced yesterday during market hours the EU approval of Emcitate to treat MCT8 deficiency from birth, with a launch expected in Q2 2025. As communicated during the CMD in December (note here), the EU commercialisation will be phased, and most of the early focus will be on pricing and reim

Egetis: Takeaways from CMD

Egetis hosted its CMD yesterday featuring i) KOL presentations on MCT8 deficiency and RTH-beta, ii) Emcitate global commercialisation efforts, with a particular focus on the upcoming EU launch, iii) an update on the ReTRIACt pivotal trial, and iv) data on some phenotype manifestations in RTHb patie

Takeaways from Investor Day 2024

Egetis: Emcitate receives positive CHMP opinion

Yesterday, Emcitate received a positive CHMP opinion for the treatment of MCT8 deficiency. The European Commission (EC) will now review the CHMP recommendation and is expected to make a final decision within 67 days. We consider this final step to be derisked and expect a market launch in the EU in