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

Egetis Therapeutics - Initiation of coverage - A rare opportunity

Egetis Therapeutics is a biotech company with a focus on rare diseases. Lead compound Emcitate (targeting MCT8 deficiency) is under registration in Europe, and a pivotal trial is ongoing in the US. Despite Emcitate’s advanced stage of development, the stock has been rangebound of late: in our view this offers an attractive entry point. We initiate coverage with a BUY and SEK18 target price.

Q1 report: ReTRIACt slower than expected

Egetis reports Q1, on track with US trial

Egetis reported Q1 2024 results with an operating loss of SEK (68.6m) and a cash position of SEK 251.7m. In the pipeline, the most important update has been to the status of the critical US phase 3 trial, where the company reported that 13/16 patients have been recruited, whereof 6 patients have co

Coverage update

Given team and strategy changes, Oscar Haffen Lamm is now assuming coverage of Medincell, Camurus, Valneva, Aelis Pharma, Abivax, Calliditas, Egetis Therapeutics, Basilea, Geneuro, Achilles, Valerio, Innate Pharma, Morphosys, Inventiva Pharma, Vicore, DBV Technologies, and Genfit.Maria Vara is now

Takeaways from the CMD, reiterate BUY rating ahead of key catalyst in ...

Egetis hosted its CMD yesterday featuring i) a KOL presentation on MCT8 deficiency and its unmet need, ii) an update on the ReTRIACT pivotal trial, iii) Emcitate pre-commercial activities and iv) details on the next potential indication for Emcitate - resistance to thyroid hormone beta. Concerning

Emcitate phase 3 readout expected in H1 2024, we remain bullish

Egetis announced yesterday that it now expects to report topline phase 3 results with Emicate in H1 2024. Certainty in the new timeline comes from the main (US) site now being active. Additionally, >30 patients have been identified, while 16 are needed to complete the trial. To conserve cash, th

Reports Q1 2023 results, US pivotal trial to enrol in Q2

Egetis reported Q1 2023 results with an operating loss of SEK 75m and a cash position of SEK 243.5m. In the pipeline, due to updates of clinical trial data, the start of the pivotal ReTRIACt study has been delayed with the first of the 16 patients to be enrolled in Q2. Meanwhile, >30 patients ha

Sector Fast Comment - Hospital data update

Better hospital margins in September Weaker procedure volume momentum into Q4 Small positive for capex exposure

Egetis Therapeutics - Q3 report: on-track for ’23 Emcitate filings

No new material updates in the Q3 report Filing timelines intact: EMA in H1’23 & FDA in mid-’23 Report neutral, still a clear top-pick in our coverage; BUY

Egetis Therapeutics - Q2 report

No new material updates in the Q2 report Filings expected in H1’23 (EMA) and mid-23 (US) Report neutral for case, still an attractive BUY in biotech

Sector Fast Comment - Entering a new era of US drug price control

Pushes and pulls in Biden’s Inflation Reduction Act 2022 Max impact ’26–early ’30s, possible mitigations thereafter Negative but manageable for AZN, biotech largely spared