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Egetis Therapeutics

Egetis Therapeutics

2026 Q1 -tulosraportti
59 päivää sitten

Tarjoustasot

Ei dataa

Viimeisimmät kaupat

AikaHintaMääräOstajaMyyjä
----

Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.

Välittäjätilasto

Dataa ei löytynyt

Yhtiötapahtumat

Datan lähde: FactSet, Quartr
Seuraava tapahtuma
2026 Q2 -tulosraportti
21.8.
Menneet tapahtumat
2026 Q1 -tulosraportti
29.4.
2025 Q4 -tulosraportti
26.2.
2025 Q3 -tulosraportti
25.11.2025
2025 Q2 -tulosraportti
21.8.2025
2025 Q1 -tulosraportti
30.4.2025

Foorumi

Liity keskusteluun Nordnet Socialissa
Kirjaudu
  • 2 päivää sitten
    ·
    Cantor Fitzgerald, interesting company. Should increase interest in the USA.
    1 päivä sitten
    ·
    But what good does it do when short-term investors sell. One forgets that the FDA will soon issue a midterm statement, approx. 3 months before the final decision. Check this conclusion with AI…. Breakthrough Therapy Designation: This is only granted if preliminary data shows that the drug can provide a significant improvement over existing therapies. It also means that Egetis has had a close dialogue with the FDA throughout the process – they know what the authority wants to see. Priority Review: This shortens the review time from 10 to 6 months. It shows that the FDA considers the disease (MCT8 deficiency) to be serious and that Emcitate is a prioritized solution. Conditionally Acceptable Name: As recently as April 8, 2026, the FDA announced that they had approved the name "Emcitate". Although it is a formality, the FDA rarely does this if they do not plan to approve the product in the end. 2. The clinical data set The FDA application (NDA) does not rest on a single study, but on a broad base of data: Triac Trial I & II as well as the ReTRIACt study. Data from the Expanded Access Program in the USA (where American patients already receive the medicine under license). EMA approval: The fact that Europe has already said yes (February 2025) and that the drug is already on the market in Germany provides enormous reassurance that manufacturing and the safety profile work in practice. 3. The financial evidence (Smart Money) The single strongest sign of a high probability of approval is the directed issue of 350 million SEK (April 21, 2026). Professional funds like Frazier and Invus make a living by analyzing FDA risks. That they choose to invest large sums at zero percent discount just months before the decision indicates that they consider the risk of a "no" to be very low. They have likely done a "Deep Dive" into all available data and concluded that approval is the overwhelmingly most likely scenario. What can still go wrong? (The last 10–15 %) Even if the probability statistically is around 85–90 %, there is always a residual risk: CMC (Chemistry, Manufacturing, and Controls): The FDA may have comments on the factory or how the medicine is manufactured, which could lead to a delay (a so-called Complete Response Letter). Labeling: A discussion about the exact text to be included in the package insert can prolong the process, but rarely leads to a "no". Summary Leading up to September 28, Egetis is in a position that many biotech companies only dream of. Everything points to an approval: the data is solid, the authority is cooperative, and institutional investors have voted with their wallets.
  • 28.5.
    ·
    What is the reason for Redeye discontinuing to follow and comment on Egetis?
    31.5.
    ·
    Redeye has not stopped following and commenting on Egetis. Redeye has now placed Egetis in a group of "Premium Companies", where a subscription must be taken out to get access to comments and ratings.
  • 26.5.
    ·
    One might wonder if someone is securing their holiday fund already now….strange decline.
    9.6.
    ·
    Well, there we had 5,35. Now that can be enough! Hope this level holds!
  • 11.5.
    ·
    A good start to this week too. Now we hold and let the buyers come😎
  • 5.5.
    ·
    Good start to the week, I think😎.
    6.5.
    ·
    Thanks, I'll just stay put now, also watching stenocare ;-)
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin käyttäjiltä, ​​eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.

Uutiset

AI
Viimeisin
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.

Tuotteita joiden kohde-etuutena tämä arvopaperi

2026 Q1 -tulosraportti
59 päivää sitten

Uutiset

AI
Viimeisin
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.

Foorumi

Liity keskusteluun Nordnet Socialissa
Kirjaudu
  • 2 päivää sitten
    ·
    Cantor Fitzgerald, interesting company. Should increase interest in the USA.
    1 päivä sitten
    ·
    But what good does it do when short-term investors sell. One forgets that the FDA will soon issue a midterm statement, approx. 3 months before the final decision. Check this conclusion with AI…. Breakthrough Therapy Designation: This is only granted if preliminary data shows that the drug can provide a significant improvement over existing therapies. It also means that Egetis has had a close dialogue with the FDA throughout the process – they know what the authority wants to see. Priority Review: This shortens the review time from 10 to 6 months. It shows that the FDA considers the disease (MCT8 deficiency) to be serious and that Emcitate is a prioritized solution. Conditionally Acceptable Name: As recently as April 8, 2026, the FDA announced that they had approved the name "Emcitate". Although it is a formality, the FDA rarely does this if they do not plan to approve the product in the end. 2. The clinical data set The FDA application (NDA) does not rest on a single study, but on a broad base of data: Triac Trial I & II as well as the ReTRIACt study. Data from the Expanded Access Program in the USA (where American patients already receive the medicine under license). EMA approval: The fact that Europe has already said yes (February 2025) and that the drug is already on the market in Germany provides enormous reassurance that manufacturing and the safety profile work in practice. 3. The financial evidence (Smart Money) The single strongest sign of a high probability of approval is the directed issue of 350 million SEK (April 21, 2026). Professional funds like Frazier and Invus make a living by analyzing FDA risks. That they choose to invest large sums at zero percent discount just months before the decision indicates that they consider the risk of a "no" to be very low. They have likely done a "Deep Dive" into all available data and concluded that approval is the overwhelmingly most likely scenario. What can still go wrong? (The last 10–15 %) Even if the probability statistically is around 85–90 %, there is always a residual risk: CMC (Chemistry, Manufacturing, and Controls): The FDA may have comments on the factory or how the medicine is manufactured, which could lead to a delay (a so-called Complete Response Letter). Labeling: A discussion about the exact text to be included in the package insert can prolong the process, but rarely leads to a "no". Summary Leading up to September 28, Egetis is in a position that many biotech companies only dream of. Everything points to an approval: the data is solid, the authority is cooperative, and institutional investors have voted with their wallets.
  • 28.5.
    ·
    What is the reason for Redeye discontinuing to follow and comment on Egetis?
    31.5.
    ·
    Redeye has not stopped following and commenting on Egetis. Redeye has now placed Egetis in a group of "Premium Companies", where a subscription must be taken out to get access to comments and ratings.
  • 26.5.
    ·
    One might wonder if someone is securing their holiday fund already now….strange decline.
    9.6.
    ·
    Well, there we had 5,35. Now that can be enough! Hope this level holds!
  • 11.5.
    ·
    A good start to this week too. Now we hold and let the buyers come😎
  • 5.5.
    ·
    Good start to the week, I think😎.
    6.5.
    ·
    Thanks, I'll just stay put now, also watching stenocare ;-)
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin käyttäjiltä, ​​eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.

Tarjoustasot

Ei dataa

Viimeisimmät kaupat

AikaHintaMääräOstajaMyyjä
----

Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.

Välittäjätilasto

Dataa ei löytynyt

Yhtiötapahtumat

Datan lähde: FactSet, Quartr
Seuraava tapahtuma
2026 Q2 -tulosraportti
21.8.
Menneet tapahtumat
2026 Q1 -tulosraportti
29.4.
2025 Q4 -tulosraportti
26.2.
2025 Q3 -tulosraportti
25.11.2025
2025 Q2 -tulosraportti
21.8.2025
2025 Q1 -tulosraportti
30.4.2025

Tuotteita joiden kohde-etuutena tämä arvopaperi

2026 Q1 -tulosraportti
59 päivää sitten

Uutiset

AI
Viimeisin
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.

Yhtiötapahtumat

Datan lähde: FactSet, Quartr
Seuraava tapahtuma
2026 Q2 -tulosraportti
21.8.
Menneet tapahtumat
2026 Q1 -tulosraportti
29.4.
2025 Q4 -tulosraportti
26.2.
2025 Q3 -tulosraportti
25.11.2025
2025 Q2 -tulosraportti
21.8.2025
2025 Q1 -tulosraportti
30.4.2025

Tuotteita joiden kohde-etuutena tämä arvopaperi

Foorumi

Liity keskusteluun Nordnet Socialissa
Kirjaudu
  • 2 päivää sitten
    ·
    Cantor Fitzgerald, interesting company. Should increase interest in the USA.
    1 päivä sitten
    ·
    But what good does it do when short-term investors sell. One forgets that the FDA will soon issue a midterm statement, approx. 3 months before the final decision. Check this conclusion with AI…. Breakthrough Therapy Designation: This is only granted if preliminary data shows that the drug can provide a significant improvement over existing therapies. It also means that Egetis has had a close dialogue with the FDA throughout the process – they know what the authority wants to see. Priority Review: This shortens the review time from 10 to 6 months. It shows that the FDA considers the disease (MCT8 deficiency) to be serious and that Emcitate is a prioritized solution. Conditionally Acceptable Name: As recently as April 8, 2026, the FDA announced that they had approved the name "Emcitate". Although it is a formality, the FDA rarely does this if they do not plan to approve the product in the end. 2. The clinical data set The FDA application (NDA) does not rest on a single study, but on a broad base of data: Triac Trial I & II as well as the ReTRIACt study. Data from the Expanded Access Program in the USA (where American patients already receive the medicine under license). EMA approval: The fact that Europe has already said yes (February 2025) and that the drug is already on the market in Germany provides enormous reassurance that manufacturing and the safety profile work in practice. 3. The financial evidence (Smart Money) The single strongest sign of a high probability of approval is the directed issue of 350 million SEK (April 21, 2026). Professional funds like Frazier and Invus make a living by analyzing FDA risks. That they choose to invest large sums at zero percent discount just months before the decision indicates that they consider the risk of a "no" to be very low. They have likely done a "Deep Dive" into all available data and concluded that approval is the overwhelmingly most likely scenario. What can still go wrong? (The last 10–15 %) Even if the probability statistically is around 85–90 %, there is always a residual risk: CMC (Chemistry, Manufacturing, and Controls): The FDA may have comments on the factory or how the medicine is manufactured, which could lead to a delay (a so-called Complete Response Letter). Labeling: A discussion about the exact text to be included in the package insert can prolong the process, but rarely leads to a "no". Summary Leading up to September 28, Egetis is in a position that many biotech companies only dream of. Everything points to an approval: the data is solid, the authority is cooperative, and institutional investors have voted with their wallets.
  • 28.5.
    ·
    What is the reason for Redeye discontinuing to follow and comment on Egetis?
    31.5.
    ·
    Redeye has not stopped following and commenting on Egetis. Redeye has now placed Egetis in a group of "Premium Companies", where a subscription must be taken out to get access to comments and ratings.
  • 26.5.
    ·
    One might wonder if someone is securing their holiday fund already now….strange decline.
    9.6.
    ·
    Well, there we had 5,35. Now that can be enough! Hope this level holds!
  • 11.5.
    ·
    A good start to this week too. Now we hold and let the buyers come😎
  • 5.5.
    ·
    Good start to the week, I think😎.
    6.5.
    ·
    Thanks, I'll just stay put now, also watching stenocare ;-)
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin käyttäjiltä, ​​eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.

Tarjoustasot

Ei dataa

Viimeisimmät kaupat

AikaHintaMääräOstajaMyyjä
----

Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.

Välittäjätilasto

Dataa ei löytynyt