2025 Q3 -tulosraportti
84 päivää sitten
‧36 min
Tarjoustasot
Spotlight Stock Market DK
Määrä
Osto
911
Myynti
Määrä
163
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| 78 | NON | DDB | ||
| 40 | NON | AVA | ||
| 12 | NON | NON | ||
| 777 | NON | NON | ||
| 283 | NON | NON |
Ylin
17,5VWAP
Alin
15,65VaihtoMäärä
1 62 001
VWAP
Ylin
17,5Alin
15,65VaihtoMäärä
1 62 001
Välittäjätilasto
Ostaneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Danske Bank A/S | 9 293 | 2 500 | +6 793 | 125 |
| Avanza Bank AB | 7 826 | 6 054 | +1 772 | 59 |
| Svenska Handelsbanken AB | 1 050 | 0 | +1 050 | 0 |
| Skandinaviska Enskilda Banken AB | 300 | 40 | +260 | 0 |
| SSW Market Making GmbH | 3 945 | 3 945 | 0 | 0 |
| Swedbank AB | 0 | 200 | −200 | 0 |
Myyneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Nordnet Bank AB | 36 609 | 44 261 | −7 652 | 25 081 |
| Nordea Bank Abp | 2 978 | 5 001 | −2 023 | 0 |
| Swedbank AB | 0 | 200 | −200 | 0 |
| SSW Market Making GmbH | 3 945 | 3 945 | 0 | 0 |
| Skandinaviska Enskilda Banken AB | 300 | 40 | +260 | 0 |
| Svenska Handelsbanken AB | 1 050 | 0 | +1 050 | 0 |
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2025 Q4 -tulosraportti 26.2. | 3 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q3 -tulosraportti 1.12.2025 | ||
2025 Q2 -tulosraportti 28.8.2025 | ||
2025 Q1 -tulosraportti 25.4.2025 | ||
2024 Q4 -tulosraportti 27.2.2025 | ||
2024 Q3 -tulosraportti 21.11.2024 |
Asiakkaat katsoivat myös
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
·5 t sitten · MuokattuWhere is the Curasight case right now? It is in a classic clinical transition phase: • Running business-as-usual • Positioning Upar • Expanding international relations • Keeping the investor community warm The crucial triggers are in Phase I (uTREAT) and are still not published: • Reproducible dosimetry • Inter-patient variance • Comfortable organ-margin uptake The Q2-topline readout is the first real data point that can seriously change the case and send it significantly upwards, as it is crucial for the entire theranostic platform's mindset. Until then, Curasight is running business-as-usual. This means they: • follow their clinical plan • participate in relevant conferences • update the market within regulatory frameworks • prepare basket • keep BD-dialogues open All of this they would do regardless of whether: • There were concrete acquisition dialogues • There were NDAs • It is pure execution of their strategy/pipeline Conferences can legitimize, visualize, and position UPAR as the potentially new RLT platform - which is part of their strategy and necessary. What do the upcoming events mean? TD Cowen (March) Realistic expectation: • Pipeline status • Confirmation of recruitment • Strategic framing of theranostic platform • Emphasis on “continued progress” We should not expect: • Concrete Gy-numbers • Variance • Tumor-shrink-data • Basket-details It is a positioning and meeting platform – not a data-event. -------------------------------------- General Assembly Expectations: • Operational status • Capital preparedness • Governance But no clinical data showing breakthroughs. --------------------------------------- SNMMI (May/June) Will be used to position uPAR as a serious target in the RLT environment and show data to the professional audience, as well as create academic traction. It's about getting uPAR into the professional conversation on par with PSMA, SSTR, and FAPI. If it is to be a platform, it must be accepted in the environment. __________________________________ SO, this is how dead cold we are with the case: • Phase I is running • No safety-issues • Target engagement confirmed • Dosimetry missing • Reproducibility missing • Basket (Phase II) not started -> awaiting Phase I • No agreements announced -> awaiting the above Everything else is secondary and speculation/hype..! ------------------------------------------------------ Ps: ALL price-sensitive information MUST be disclosed via FBM. That is, information that: - Is precise - Is not public - Directly or indirectly concerns the company - Would have a noticeable price-impact ….so that matter is probably settled 😉
·21 t sittenIsn't this a somewhat unpleasant uncertainty, which this announcement also represents? Correct me if I'm wrong: 1) It CAN'T be anything business-critical. It should surely be announced to the market and not released in a planned manner? 2) Even a reached Curium milestone should surely be announced immediately after? 3) Partnership, possible acquisition, all of that concerns the expansion of the business core area which could have a direct impact on the share price - that should surely be announced and one must be able to deduce that it is NOT such a thing? 4) Someone on FB mentioned that it could be something with personnel. - and that seems fundamentally more likely, doesn't it? Or that one, for example, moves headquarters, office, makes a restructuring or something else. Because these are surely things one can get away with not announcing immediately? Truly an exciting situation + puzzle. I could well imagine the share price skyrocketing Monday morning - in anticipation of something completely wild... But really.. can it even be something wild in that sense? I know there are many smart minds in here who have also followed it for many years - maybe someone has a vibe on something. But to believe it's something directly related to acquisition, partnership, Curium milestone or anything else that has a direct connection with the share price is mega naive, isn't it? At best, it's something about establishing a US office which, as per -something-or-other, will function as the commercial center with a handful of newly hired stars leading the company. (because that would precisely be a preliminary exercise for an acquisition where it's probably not unthinkable that power is transferred, even if, for example, Andreas 'stays on'. Shit, it will be many, many days now where there will be insane speculation. Personally, I'm not entirely a fan of this announcement. I think it's something Curasight has done well since last summer especially. Kept themselves too proper to 'play' with the market. They've had a timeline and essentially just worked their way through it. This is a bit of a shift, I think, regarding external communication. They know how much focus there is right now on what Big Stuff is going to happen when - and then they make such a +1 week long teaser for something that surely can't be something one dreamed could happen so quickly. Exciting. Wow, there will be activity everywhere and surely both with and without tin foil hats.
·3 t sittenOr why not a listing change?. The future will simply show, and it feels unnecessary to speculate. Feels exciting anyway.
·1 päivä sitten·21 t sittenWell.... It's quite a strange thing, isn't it. Because people are generally waiting for potentially "big" news, and something like that cannot be hidden and released this way... Or can it? Anyone dare to speculate what it could be about? Which apparently isn't big and relevant enough to be announced to the market, but enough that one dares to make such a big deal out of it (as it feels – I think it's a pretty bold announcement that teases heavily).
·3 päivää sittenIt must be positive for Curasight. Does anyone know what it could mean for the case? Faster and cheaper to get to market? Here's ChatGPT's answer: Here is the concrete, investor-relevant meaning of FDA’s new “one pivotal trial”-standard for Curasight: ⸻ 🧬 What Curasight does (briefly) • uTRACE: diagnostics (PET-tracer that shows uPAR expression in tumor) • uTREAT: targeted radionuclide therapy against the same target The strategy is theranostics: first find the patients (uTRACE), then treat them (uTREAT). ⸻ 🎯 What the change means – broken down 1) uTRACE (diagnostics) → clearly positive With FDA’s new standard, Curasight can increasingly aim for: 👉 One strong pivotal study + supplementary evidence instead of two Consequences: • 🕒 Shorter path to market in USA • 💰 Lower development costs • 🤝 Better partnering position (Big Pharma loves shorter, cheaper development processes) What FDA will look at in one study: • Sensitivity/specificity vs. standard imaging • Correlation between uPAR signal and clinical decision (does it change treatment?) • Reproducibility across centers ➡️ If they get it right, uTRACE could potentially reach registration basis with one main study. ⸻ 2) uTREAT (therapy) → positive, but not a “free pass” For treatments, FDA is still more cautious. The new policy means: • It can be approved on one pivotal study • but only if the effect is clear and clinically meaningful (e.g. PFS/OS or strong surrogates) Consequences for Curasight: • Still likely a larger, robust study • FDA may require: • more safety data • longer follow-up • possibly supplementary evidence ➡️ So: time saving possible, but not as significant as for uTRACE ⸻ 📊 Capital & risk – what you really care about 💰 Capital needs The new FDA line can: • reduce the need for two phase 3 studies • save many millions euro • reduce dilution 📉 Risk • One study = greater binary risk • If it fails → no fallback-trial 📈 Valuation The market usually reacts positively to: • shorter path to approval • lower capex • greater likelihood of M&A/partnership ⸻ 🇪🇺 EU angle (relevant for you) Although European Medicines Agency does not automatically copy FDA: • Studies are often designed globally (FDA + EMA in one setup) • If FDA accepts one study, EMA can sometimes: • accept the same dataset • or require an extra European cohort/extension ➡️ The net: global development becomes easier ⸻ 🧾 Bottom line for Curasight Bull case: • uTRACE approved on one pivotal study • faster partner agreement • uTREAT can follow with strong data Base case: • uTRACE: one study + extra supporting data • uTREAT: still one large study, but with high requirements Risk case: • One study fails → greater setback (because there is no “study #2” in reserve) ⸻ 👉 In short For Curasight, the change means: Faster, cheaper and more partner-friendly path to market – especially for uTRACE – but still with high requirements for uTREAT
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Sharevillen 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
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.
2025 Q3 -tulosraportti
84 päivää sitten
‧36 min
Uutiset
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.
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
- ·5 t sitten · MuokattuWhere is the Curasight case right now? It is in a classic clinical transition phase: • Running business-as-usual • Positioning Upar • Expanding international relations • Keeping the investor community warm The crucial triggers are in Phase I (uTREAT) and are still not published: • Reproducible dosimetry • Inter-patient variance • Comfortable organ-margin uptake The Q2-topline readout is the first real data point that can seriously change the case and send it significantly upwards, as it is crucial for the entire theranostic platform's mindset. Until then, Curasight is running business-as-usual. This means they: • follow their clinical plan • participate in relevant conferences • update the market within regulatory frameworks • prepare basket • keep BD-dialogues open All of this they would do regardless of whether: • There were concrete acquisition dialogues • There were NDAs • It is pure execution of their strategy/pipeline Conferences can legitimize, visualize, and position UPAR as the potentially new RLT platform - which is part of their strategy and necessary. What do the upcoming events mean? TD Cowen (March) Realistic expectation: • Pipeline status • Confirmation of recruitment • Strategic framing of theranostic platform • Emphasis on “continued progress” We should not expect: • Concrete Gy-numbers • Variance • Tumor-shrink-data • Basket-details It is a positioning and meeting platform – not a data-event. -------------------------------------- General Assembly Expectations: • Operational status • Capital preparedness • Governance But no clinical data showing breakthroughs. --------------------------------------- SNMMI (May/June) Will be used to position uPAR as a serious target in the RLT environment and show data to the professional audience, as well as create academic traction. It's about getting uPAR into the professional conversation on par with PSMA, SSTR, and FAPI. If it is to be a platform, it must be accepted in the environment. __________________________________ SO, this is how dead cold we are with the case: • Phase I is running • No safety-issues • Target engagement confirmed • Dosimetry missing • Reproducibility missing • Basket (Phase II) not started -> awaiting Phase I • No agreements announced -> awaiting the above Everything else is secondary and speculation/hype..! ------------------------------------------------------ Ps: ALL price-sensitive information MUST be disclosed via FBM. That is, information that: - Is precise - Is not public - Directly or indirectly concerns the company - Would have a noticeable price-impact ….so that matter is probably settled 😉
- ·21 t sittenIsn't this a somewhat unpleasant uncertainty, which this announcement also represents? Correct me if I'm wrong: 1) It CAN'T be anything business-critical. It should surely be announced to the market and not released in a planned manner? 2) Even a reached Curium milestone should surely be announced immediately after? 3) Partnership, possible acquisition, all of that concerns the expansion of the business core area which could have a direct impact on the share price - that should surely be announced and one must be able to deduce that it is NOT such a thing? 4) Someone on FB mentioned that it could be something with personnel. - and that seems fundamentally more likely, doesn't it? Or that one, for example, moves headquarters, office, makes a restructuring or something else. Because these are surely things one can get away with not announcing immediately? Truly an exciting situation + puzzle. I could well imagine the share price skyrocketing Monday morning - in anticipation of something completely wild... But really.. can it even be something wild in that sense? I know there are many smart minds in here who have also followed it for many years - maybe someone has a vibe on something. But to believe it's something directly related to acquisition, partnership, Curium milestone or anything else that has a direct connection with the share price is mega naive, isn't it? At best, it's something about establishing a US office which, as per -something-or-other, will function as the commercial center with a handful of newly hired stars leading the company. (because that would precisely be a preliminary exercise for an acquisition where it's probably not unthinkable that power is transferred, even if, for example, Andreas 'stays on'. Shit, it will be many, many days now where there will be insane speculation. Personally, I'm not entirely a fan of this announcement. I think it's something Curasight has done well since last summer especially. Kept themselves too proper to 'play' with the market. They've had a timeline and essentially just worked their way through it. This is a bit of a shift, I think, regarding external communication. They know how much focus there is right now on what Big Stuff is going to happen when - and then they make such a +1 week long teaser for something that surely can't be something one dreamed could happen so quickly. Exciting. Wow, there will be activity everywhere and surely both with and without tin foil hats.·3 t sittenOr why not a listing change?. The future will simply show, and it feels unnecessary to speculate. Feels exciting anyway.
- ·1 päivä sitten·21 t sittenWell.... It's quite a strange thing, isn't it. Because people are generally waiting for potentially "big" news, and something like that cannot be hidden and released this way... Or can it? Anyone dare to speculate what it could be about? Which apparently isn't big and relevant enough to be announced to the market, but enough that one dares to make such a big deal out of it (as it feels – I think it's a pretty bold announcement that teases heavily).
- ·3 päivää sittenIt must be positive for Curasight. Does anyone know what it could mean for the case? Faster and cheaper to get to market? Here's ChatGPT's answer: Here is the concrete, investor-relevant meaning of FDA’s new “one pivotal trial”-standard for Curasight: ⸻ 🧬 What Curasight does (briefly) • uTRACE: diagnostics (PET-tracer that shows uPAR expression in tumor) • uTREAT: targeted radionuclide therapy against the same target The strategy is theranostics: first find the patients (uTRACE), then treat them (uTREAT). ⸻ 🎯 What the change means – broken down 1) uTRACE (diagnostics) → clearly positive With FDA’s new standard, Curasight can increasingly aim for: 👉 One strong pivotal study + supplementary evidence instead of two Consequences: • 🕒 Shorter path to market in USA • 💰 Lower development costs • 🤝 Better partnering position (Big Pharma loves shorter, cheaper development processes) What FDA will look at in one study: • Sensitivity/specificity vs. standard imaging • Correlation between uPAR signal and clinical decision (does it change treatment?) • Reproducibility across centers ➡️ If they get it right, uTRACE could potentially reach registration basis with one main study. ⸻ 2) uTREAT (therapy) → positive, but not a “free pass” For treatments, FDA is still more cautious. The new policy means: • It can be approved on one pivotal study • but only if the effect is clear and clinically meaningful (e.g. PFS/OS or strong surrogates) Consequences for Curasight: • Still likely a larger, robust study • FDA may require: • more safety data • longer follow-up • possibly supplementary evidence ➡️ So: time saving possible, but not as significant as for uTRACE ⸻ 📊 Capital & risk – what you really care about 💰 Capital needs The new FDA line can: • reduce the need for two phase 3 studies • save many millions euro • reduce dilution 📉 Risk • One study = greater binary risk • If it fails → no fallback-trial 📈 Valuation The market usually reacts positively to: • shorter path to approval • lower capex • greater likelihood of M&A/partnership ⸻ 🇪🇺 EU angle (relevant for you) Although European Medicines Agency does not automatically copy FDA: • Studies are often designed globally (FDA + EMA in one setup) • If FDA accepts one study, EMA can sometimes: • accept the same dataset • or require an extra European cohort/extension ➡️ The net: global development becomes easier ⸻ 🧾 Bottom line for Curasight Bull case: • uTRACE approved on one pivotal study • faster partner agreement • uTREAT can follow with strong data Base case: • uTRACE: one study + extra supporting data • uTREAT: still one large study, but with high requirements Risk case: • One study fails → greater setback (because there is no “study #2” in reserve) ⸻ 👉 In short For Curasight, the change means: Faster, cheaper and more partner-friendly path to market – especially for uTRACE – but still with high requirements for uTREAT
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Sharevillen 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
Spotlight Stock Market DK
Määrä
Osto
911
Myynti
Määrä
163
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| 78 | NON | DDB | ||
| 40 | NON | AVA | ||
| 12 | NON | NON | ||
| 777 | NON | NON | ||
| 283 | NON | NON |
Ylin
17,5VWAP
Alin
15,65VaihtoMäärä
1 62 001
VWAP
Ylin
17,5Alin
15,65VaihtoMäärä
1 62 001
Välittäjätilasto
Ostaneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Danske Bank A/S | 9 293 | 2 500 | +6 793 | 125 |
| Avanza Bank AB | 7 826 | 6 054 | +1 772 | 59 |
| Svenska Handelsbanken AB | 1 050 | 0 | +1 050 | 0 |
| Skandinaviska Enskilda Banken AB | 300 | 40 | +260 | 0 |
| SSW Market Making GmbH | 3 945 | 3 945 | 0 | 0 |
| Swedbank AB | 0 | 200 | −200 | 0 |
Myyneet eniten
| Välittäjä | Ostettu | Myyty | Netto | Sisäinen |
|---|---|---|---|---|
| Nordnet Bank AB | 36 609 | 44 261 | −7 652 | 25 081 |
| Nordea Bank Abp | 2 978 | 5 001 | −2 023 | 0 |
| Swedbank AB | 0 | 200 | −200 | 0 |
| SSW Market Making GmbH | 3 945 | 3 945 | 0 | 0 |
| Skandinaviska Enskilda Banken AB | 300 | 40 | +260 | 0 |
| Svenska Handelsbanken AB | 1 050 | 0 | +1 050 | 0 |
Asiakkaat katsoivat myös
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2025 Q4 -tulosraportti 26.2. | 3 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q3 -tulosraportti 1.12.2025 | ||
2025 Q2 -tulosraportti 28.8.2025 | ||
2025 Q1 -tulosraportti 25.4.2025 | ||
2024 Q4 -tulosraportti 27.2.2025 | ||
2024 Q3 -tulosraportti 21.11.2024 |
2025 Q3 -tulosraportti
84 päivää sitten
‧36 min
Uutiset
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 | |
|---|---|
2025 Q4 -tulosraportti 26.2. | 3 päivää |
| Menneet tapahtumat | ||
|---|---|---|
2025 Q3 -tulosraportti 1.12.2025 | ||
2025 Q2 -tulosraportti 28.8.2025 | ||
2025 Q1 -tulosraportti 25.4.2025 | ||
2024 Q4 -tulosraportti 27.2.2025 | ||
2024 Q3 -tulosraportti 21.11.2024 |
Shareville
Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
- ·5 t sitten · MuokattuWhere is the Curasight case right now? It is in a classic clinical transition phase: • Running business-as-usual • Positioning Upar • Expanding international relations • Keeping the investor community warm The crucial triggers are in Phase I (uTREAT) and are still not published: • Reproducible dosimetry • Inter-patient variance • Comfortable organ-margin uptake The Q2-topline readout is the first real data point that can seriously change the case and send it significantly upwards, as it is crucial for the entire theranostic platform's mindset. Until then, Curasight is running business-as-usual. This means they: • follow their clinical plan • participate in relevant conferences • update the market within regulatory frameworks • prepare basket • keep BD-dialogues open All of this they would do regardless of whether: • There were concrete acquisition dialogues • There were NDAs • It is pure execution of their strategy/pipeline Conferences can legitimize, visualize, and position UPAR as the potentially new RLT platform - which is part of their strategy and necessary. What do the upcoming events mean? TD Cowen (March) Realistic expectation: • Pipeline status • Confirmation of recruitment • Strategic framing of theranostic platform • Emphasis on “continued progress” We should not expect: • Concrete Gy-numbers • Variance • Tumor-shrink-data • Basket-details It is a positioning and meeting platform – not a data-event. -------------------------------------- General Assembly Expectations: • Operational status • Capital preparedness • Governance But no clinical data showing breakthroughs. --------------------------------------- SNMMI (May/June) Will be used to position uPAR as a serious target in the RLT environment and show data to the professional audience, as well as create academic traction. It's about getting uPAR into the professional conversation on par with PSMA, SSTR, and FAPI. If it is to be a platform, it must be accepted in the environment. __________________________________ SO, this is how dead cold we are with the case: • Phase I is running • No safety-issues • Target engagement confirmed • Dosimetry missing • Reproducibility missing • Basket (Phase II) not started -> awaiting Phase I • No agreements announced -> awaiting the above Everything else is secondary and speculation/hype..! ------------------------------------------------------ Ps: ALL price-sensitive information MUST be disclosed via FBM. That is, information that: - Is precise - Is not public - Directly or indirectly concerns the company - Would have a noticeable price-impact ….so that matter is probably settled 😉
- ·21 t sittenIsn't this a somewhat unpleasant uncertainty, which this announcement also represents? Correct me if I'm wrong: 1) It CAN'T be anything business-critical. It should surely be announced to the market and not released in a planned manner? 2) Even a reached Curium milestone should surely be announced immediately after? 3) Partnership, possible acquisition, all of that concerns the expansion of the business core area which could have a direct impact on the share price - that should surely be announced and one must be able to deduce that it is NOT such a thing? 4) Someone on FB mentioned that it could be something with personnel. - and that seems fundamentally more likely, doesn't it? Or that one, for example, moves headquarters, office, makes a restructuring or something else. Because these are surely things one can get away with not announcing immediately? Truly an exciting situation + puzzle. I could well imagine the share price skyrocketing Monday morning - in anticipation of something completely wild... But really.. can it even be something wild in that sense? I know there are many smart minds in here who have also followed it for many years - maybe someone has a vibe on something. But to believe it's something directly related to acquisition, partnership, Curium milestone or anything else that has a direct connection with the share price is mega naive, isn't it? At best, it's something about establishing a US office which, as per -something-or-other, will function as the commercial center with a handful of newly hired stars leading the company. (because that would precisely be a preliminary exercise for an acquisition where it's probably not unthinkable that power is transferred, even if, for example, Andreas 'stays on'. Shit, it will be many, many days now where there will be insane speculation. Personally, I'm not entirely a fan of this announcement. I think it's something Curasight has done well since last summer especially. Kept themselves too proper to 'play' with the market. They've had a timeline and essentially just worked their way through it. This is a bit of a shift, I think, regarding external communication. They know how much focus there is right now on what Big Stuff is going to happen when - and then they make such a +1 week long teaser for something that surely can't be something one dreamed could happen so quickly. Exciting. Wow, there will be activity everywhere and surely both with and without tin foil hats.·3 t sittenOr why not a listing change?. The future will simply show, and it feels unnecessary to speculate. Feels exciting anyway.
- ·1 päivä sitten·21 t sittenWell.... It's quite a strange thing, isn't it. Because people are generally waiting for potentially "big" news, and something like that cannot be hidden and released this way... Or can it? Anyone dare to speculate what it could be about? Which apparently isn't big and relevant enough to be announced to the market, but enough that one dares to make such a big deal out of it (as it feels – I think it's a pretty bold announcement that teases heavily).
- ·3 päivää sittenIt must be positive for Curasight. Does anyone know what it could mean for the case? Faster and cheaper to get to market? Here's ChatGPT's answer: Here is the concrete, investor-relevant meaning of FDA’s new “one pivotal trial”-standard for Curasight: ⸻ 🧬 What Curasight does (briefly) • uTRACE: diagnostics (PET-tracer that shows uPAR expression in tumor) • uTREAT: targeted radionuclide therapy against the same target The strategy is theranostics: first find the patients (uTRACE), then treat them (uTREAT). ⸻ 🎯 What the change means – broken down 1) uTRACE (diagnostics) → clearly positive With FDA’s new standard, Curasight can increasingly aim for: 👉 One strong pivotal study + supplementary evidence instead of two Consequences: • 🕒 Shorter path to market in USA • 💰 Lower development costs • 🤝 Better partnering position (Big Pharma loves shorter, cheaper development processes) What FDA will look at in one study: • Sensitivity/specificity vs. standard imaging • Correlation between uPAR signal and clinical decision (does it change treatment?) • Reproducibility across centers ➡️ If they get it right, uTRACE could potentially reach registration basis with one main study. ⸻ 2) uTREAT (therapy) → positive, but not a “free pass” For treatments, FDA is still more cautious. The new policy means: • It can be approved on one pivotal study • but only if the effect is clear and clinically meaningful (e.g. PFS/OS or strong surrogates) Consequences for Curasight: • Still likely a larger, robust study • FDA may require: • more safety data • longer follow-up • possibly supplementary evidence ➡️ So: time saving possible, but not as significant as for uTRACE ⸻ 📊 Capital & risk – what you really care about 💰 Capital needs The new FDA line can: • reduce the need for two phase 3 studies • save many millions euro • reduce dilution 📉 Risk • One study = greater binary risk • If it fails → no fallback-trial 📈 Valuation The market usually reacts positively to: • shorter path to approval • lower capex • greater likelihood of M&A/partnership ⸻ 🇪🇺 EU angle (relevant for you) Although European Medicines Agency does not automatically copy FDA: • Studies are often designed globally (FDA + EMA in one setup) • If FDA accepts one study, EMA can sometimes: • accept the same dataset • or require an extra European cohort/extension ➡️ The net: global development becomes easier ⸻ 🧾 Bottom line for Curasight Bull case: • uTRACE approved on one pivotal study • faster partner agreement • uTREAT can follow with strong data Base case: • uTRACE: one study + extra supporting data • uTREAT: still one large study, but with high requirements Risk case: • One study fails → greater setback (because there is no “study #2” in reserve) ⸻ 👉 In short For Curasight, the change means: Faster, cheaper and more partner-friendly path to market – especially for uTRACE – but still with high requirements for uTREAT
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