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

Emcitate receives positive CHMP opinion

Egetis: Next for Emcitate will be RTH-beta

Egetis announced that it has chosen Resistance to Thyroid Hormone beta (RTHβ) as the next indication to be developed for Emcitate (incidence 1-2/40,000), where the company is contemplating to support a multicentered investigator-initiated phase 2 study in collaboration with academia. While this doe

RTH-beta the next step for Emcitate

Egetis Therapeutics (Buy, TP: SEK11.00) - ReTRIACt still has some way ...

Egetis Therapeutics reported weaker than expected sales in its Managed Access Program (MAP). We believe this was more of a timing issue and not a long-term sign of weakness. It was also clear from the Q3 report that the US pivotal trial, ReTRIACt, will take time before it is completed. So far, only eight patients have concluded the randomised part of the trial, and the company needs 16 evaluable patients. Hence, we believe the trial will be completed in H1 2025 rather than H2 2024. We reiterate ...

Q3: Light and shade

Q3 report: ReTRIACt delayed again

Egetis: Q3 reports strong patient recruitment for US trial

Egetis has reported Q3 2024 results, where we are encouraged to see the updated status of the US phase 3 trial, with now 17 patients included (vs 13 previously), keeping in mind that at least 16 patients need to be evaluated in the trial, whereof 8 patients have completed the randomized phase, and

Egetis: Successful SEK300m capital increase

Egetis has successfully raised SEK300m through a directed issuance of c. 66.6m new ordinary shares (subscription price of SEK4.50/share, 0.1% premium to the five-day VWAP). The company intends to use the proceeds i) to continue the development of Emcitate for application of marketing authorisation

Egetis: Multiple abstracts published ahead of the ETA

Ahead of the ETA conference Egetis published seven abstracts related to MCT8 deficiency and tiratricol. While two of the abstracts were already published, of which the tiratricol's benefit on mortality (note here), these new findings will further support the understanding of MCT8 deficiency and esp