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

Egetis Therapeutics (Buy, TP: SEK11.00) - ReTRIACt recruitment still s...

A key takeaway from the Q2 report was that no new patients were recruited to the pivotal ReTRIACt trial, increasing the risk of delayed data read-out and in turn filing for US approval. We have cut our target price to SEK11 (18) on the missed endpoints in the Triac Trial II and possibly delayed US filing after ReTRIACt, but reiterate our BUY given the still-material upside potential.

Q2 report: pressing ahead with ReTRIACt

Egetis: Q2 reports slower patient recruitment for US trial

Egetis has reported Q2 2024 results showing an operating loss of SEK71.9m and a cash position of SEK192.6m. Regarding the status of the critical US phase 3 trial, the company reported that 13/16 patients (no new patients added) have been recruited, of which six patients have completed the study, tw

Egetis: New data shows Emcitate's benefit on mortality

New data was presented in an abstract, published ahead of the ETA conference, which highlighted that treatment with Emcitate in pediatric and adult patients with MCT8 deficiency was associated with a 3x lower risk of mortality (HR=0.28, p-value

Egetis: Emcitate recommended by the ETA for all patients with MCT8 def...

Yesterday the European Thyroid Association (ETA) published new guidelines (here) recommending the use of Emcitate as long-term therapy for all patients with MCT8 deficiency, and for certain patients with Resistance to Thyroid Hormone (RTH)-beta. Considering these types of recommendations in the med

Weighing the Triac Trial II impact

Triac Trial II results do not compromise approval, but pricing negotiations could be affected. Valuation update, new TP of SEK 12 (15).

EGTX: While Triac II did not meet primary endpoints, we remain positiv...

Egetis announced that the post-approval phase 2 open-label study Triac II (22 patients aged < 30 months old), which aimed to identify whether the early intervention could drive benefits around neurocognitive development, did not meet its co-primary endpoints that focused on neuropsychological ou

Triac Trial II missing neurocognitive endpoints