EMA page updatedMar11 2025, collectedSep8: EU authorizationFeb12 2025 for peripheral thyrotoxicosis in MCT8deficiency from birth. Uncontrolled46patient mainstudy meanT3 4.97to1.82nmol/L at12months; supportive small clinical improvements. EU risk-benefit finding supports that indication, not US decision or proven neurological recovery; one independent regulatory origin distinct from sponsor.
https://www.ema.europa.eu/en/medicines/human/EPAR/emcitate
EGTX.ST Triac II neurodevelopment endpoint failure = 0
Catalyst run-ups2026-09-08 04:04
Jun19 2024 18:50CEST issuer-origin release, collectedSep8: youngpatients<30months did not meet GMFM88/BSIDIII co-primary superiority versus historical controls; T3 reduction remained. Sponsor viewed peripheral-thyrotoxicosis approval case unaffected; do not equate biochemical success with neurological efficacy.
https://view.news.eu.nasdaq.com/view?id=b6932fc249aad17eed868793c5ebb91ad&lang=en&src=micro
EGTX.ST ReTRIACt endpoint hierarchy and SAP revision = 0.034
Catalyst run-ups2026-09-08 04:04
Nov14 2025 sponsor release collectedSep8: 15 randomized stabilized males>=4y; withdrawal30days. AfterOct2025 preNDA discussion SAP revised, added PE1 T3 rate before existing rescue PE2, alpha recycling. PE1 ratio1.494 CI1.035–2.155,p.034; placebo8/tiratricol7. Observedrescues4/8vs0/6,p.070; SAPimputed discontinuation gives4/8vs1/7,p.182 PE2. Sponsor says complementary rather than pivotal after FDA discussion; regulator meeting minutes not obtained. Endpoint modification not alone proof of invalidity; no approval probability inferred.
https://www.egetis.com/sv/mfn_news/egetis-meddelar-positiva-resultat-fran-retriact-studien-med-emcitate-tiratricol-vid-mct8-brist/
CollectedSep8 04UTC: pipeline page says NDA completedSep29 2026 while anticipating decisionSep2026, internally future-dated. Jan29 2026 dated completion https://www.egetis.com/mfn_news/egetis-completes-the-u-s-rolling-nda-submission-for-emcitate-tiratricol-for-treatment-of-mct8-deficiency/ and Mar27 acceptance https://www.egetis.com/mfn_news/egetis-announces-fda-acceptance-and-priority-review-of-nda-for-emcitate-tiratricol-for-mct8-deficiency/ support Jan submission and Sep28 target. Treat undated text as chronology error, not amendment; all sponsor sources one origin.
https://www.egetis.com/pipeline/
EGTX.ST Q2 primary financing and conditional voucher economics = 378.4
Catalyst run-ups2026-09-08 04:04
Issuer Aug21, collectedSep8 04UTC, periodQ2/H1 2026; sponsor-origin unaudited. Cash378.4MSEK; Q2 CFO-93.9,investing-2.7,financing326.8; raise350 less18.9fees; loans/leases repayment8.7. Ordinary shares464947224 versus395162672Jan1; treasury C25881381 distinct; options/warrants42311653. Revenue17.4MSEK Q2; retains50% NET PRV proceeds, conditional on approval/issuance/sale. Sep28 PDUFA retained after mid/latecycle meetings; no adcom planned per sponsor, not FDA approval. EAP~60patients/17hospitals not paid US sales.
https://attachment.news.eu.nasdaq.com/aa8bae6e3da62b95404c23eb6ec2cc25a
{"paths":100000,"training_days":1004,"mean":-0.061527122874909045,"win_rate":46.983000000000004,"p05":-6.345440125778401,"p95":8.769283877572454,"stop_pct":29.830000000000002,"target_pct":17.638,"time_pct":52.532000000000004,"stop":8.191214697701591,"target":9.513178621019636,"one_share_loss_gt_risk_pct":0,"full49_gap30pct_loss":14.741999999999999,"allocation":0}. Researchonly not executablevenueprices; simulation100kresamplesnotindependentcatalysts,seed90802,training1004dailyvectors. Hypotheticallevels notorders.
https://query1.finance.yahoo.com/v8/finance/chart/PLAY
PLAY Technical measurements September4
Catalyst run-ups2026-09-08 02:11
{"date":"2026-09-04","close":8.720000267028809,"SMA20":9.715000009536743,"SMA50":10.21159999847412,"SMA200":13.491475009918213,"RSI14":39.45454053893305,"ATR14":0.5287855693272182,"ADR20":0.5204499244689942,"return20":-15.092503618762066,"corr60SPY":0.14445113163091383,"low20":8.300000190734863,"high20":11.100000381469727,"volume20":1481435,"affordable_shares":5}. Researchonly not executablevenueprices; simulation100kresamplesnotindependentcatalysts,seed90802,training1004dailyvectors. Hypotheticallevels notorders.
https://query1.finance.yahoo.com/v8/finance/chart/PLAY
PLAY Primary earnings date manifest part4 = 4
Catalyst run-ups2026-09-08 02:11
Actual first earningsrelease dates fromItem2.02body; excludes3nonquarterlyupdates and corrects2coverdates. Historical advance notices remain gap. [{"date":"2021-12-07","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465921147225/tm2134830d1_8k.htm"},{"date":"2021-09-09","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465921114204/tm2127215d1_8k.htm"},{"date":"2021-06-10","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465921079458/tm2119154d1_8k.htm"},{"date":"2021-03-31","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465921044754/tm2111439d1_8k.htm"}]
https://ir.daveandbusters.com/news-events/events-presentations
PLAY Primary earnings date manifest part3 = 6
Catalyst run-ups2026-09-08 02:11
Actual first earningsrelease dates fromItem2.02body; excludes3nonquarterlyupdates and corrects2coverdates. Historical advance notices remain gap. [{"date":"2023-06-06","url":"https://www.sec.gov/Archives/edgar/data/1525769/000162828023021106/play-20230606.htm"},{"date":"2023-03-28","url":"https://www.sec.gov/Archives/edgar/data/1525769/000162828023009536/play-20230328.htm"},{"date":"2022-12-06","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465922124897/tm2232067d1_8k.htm"},{"date":"2022-09-07","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465922098201/tm2225331d1_8k.htm"},{"date":"2022-06-07","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465922068780/tm2217845d1_8k.htm"},{"date":"2022-03-28","url":"https://www.sec.gov/Archives/edgar/data/1525769/000110465922038871/tm2210617d1_8k.htm"}]
https://ir.daveandbusters.com/news-events/events-presentations