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2025 Q4 -tulosraportti
13 päivää sitten

Tarjoustasot

DenmarkNasdaq Copenhagen
Määrä
Osto
-
Myynti
Määrä
-

Viimeisimmät kaupat

AikaHintaMääräOstajaMyyjä
500--
200--
4 000--
950--
2 988--

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

Ostaneet eniten

Ostaneet eniten
VälittäjäOstettuMyytyNettoSisäinen
Anonyymi130 891130 89100

Myyneet eniten

Myyneet eniten
VälittäjäOstettuMyytyNettoSisäinen
Anonyymi130 891130 89100

Yhtiötapahtumat

Datan lähde: FactSet, Quartr
Seuraava tapahtuma
2026 Q1 -tulosraportti
21.5.
Menneet tapahtumat
2025 Q4 -tulosraportti
26.3.
2025 Q3 -tulosraportti
19.11.2025
2025 Q2 -tulosraportti
15.8.2025
2025 Q1 -tulosraportti
8.5.2025
2024 Q4 -tulosraportti
20.3.2025

Shareville

Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
  • 19 t sitten
    ·
    19 t sitten
    ·
    Let's now clean up and sell and take losses - and keep those who still believe in the stock.
    2 t sitten · Muokattu
    ·
    2 t sitten · Muokattu
    ·
    Onkel Charly The following is not a buy or sell recommendation, only my strategy for this stock. The Bioporto stock will become valuable for those of us who hold the stock in our portfolio. CB has stated that Bioporto's objective is to acquire at least 22 new hospitals as customers before 2026 runs out, and he very clearly emphasized AT LEAST. See last webcast. Currently, Bioporto has all 10 largest children's hospitals in the USA as customers. The sales representatives will naturally use these 10 hospitals as their references, at every place where they need to promote the NGAL test for children. Regardless of whether it's a new hospital, at trade fairs and conferences. I took a shortcut and used Google to get the precise numbers for how many children's and adult hospitals exist in the USA. As you can see, there are several hundred hospitals for children. In the USA, there are also many clinics, and I have not included them. There are several thousands of hospitals for adults, and here I have also not included clinics. They have also acquired a new distributor. Hospitals for children For children, the need is concentrated in specialized facilities or large hospitals with pediatric departments. Children's Hospitals: There are over 250 specialized children's hospitals in the USA that are members of the Children's Hospital Association (CHA). These will benefit most from a pediatric NGAL test. Hospitals for adults The majority of American hospitals treat adult patients. Acute Care Hospitals: There are approximately 5,989 acute care hospitals (acute care hospitals) in the USA. These hospitals are the primary users of the NGAL test for adults, as they handle acute cases where the risk of kidney failure is high. Intensive Care Capacity: Among the acute care hospitals, about 2,814 hospitals have dedicated intensive care beds (ICU), where monitoring of kidney function with advanced tests like NGAL is most critical.
    53 min sitten
    ·
    53 min sitten
    ·
    And sells virtually nothing to hospitals despite many agreements. The sparse growth that exists is due to ROU sales despite 3D's high expectations for ongoing orders, so virtually nothing has happened in the last 12 months.
  • 1 päivä sitten
    ·
    1 päivä sitten
    ·
    As I see it today, various investors are trying to push the price in a negative direction. I hold 30,000 units and will not let myself be influenced at all. I still believe in the stock and a significant increase in the price.
    45 min sitten · Muokattu
    ·
    45 min sitten · Muokattu
    ·
    @Onkel Charly: It would be easier if you shared your portfolio instead of continuously informing what you have and what you expect, but that is naturally your, and others who are also anonymous trolls', choice
  • 1.4.
    ·
    1.4.
    ·
    BioPorto reported a revenue increase of 11% to 40.3 MDDK in 2025, with significant growth in NGAL sales in the USA and revenue from new distributors from ProNephro AKI. https://www.inderes.se/research/bioporto-investerings-case-genomfor-framatstrategin-med-ansokan-for-vuxna-inlamnad-under-q1-2026?utm_source=nordnet&utm_medium=integration
    1 päivä sitten
    ·
    1 päivä sitten
    ·
    When is the latest response deadline from FDA? I have inserted a link to the original text, and it doesn't say anything about a response deadline from FDA. Maybe someone here knows the answer? BioPorto advances U.S. adult urine NGAL program with FDA pre-submission request after positive EPACRA AKI cut-off analysis https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
  • 31.3.
    ·
    31.3.
    ·
    ChatGPT’s assessment of today's KDIGO announcement for BioPorto: Yes — it is clearly positive for BioPorto. Here is the short explanation – and then a more detailed assessment of why the KDIGO draft is a strong positive indicator for BioPorto (NGAL-tests), both commercially and regulatorily. ⸻ ✅ Short answer: The KDIGO 2026 draft's way of including biomarkers is a significantly positive development for BioPorto, because: 1. Biomarkers are now for the first time genuinely incorporated into KDIGO’s diagnostic framework. 2. NGAL is one of the most important and most validated early AKI injury markers. 3. When KDIGO shifts diagnostics from “only creatinine and urine output” → to “function + injury”, NGAL becomes necessary. 4. Hospitals follow KDIGO. When the guideline shifts, the market shifts. ⸻ Why it is positive for BioPorto – detailed 1️⃣ KDIGO now officially opens for biomarkers This has never happened before in the AKI guideline. When KDIGO: • writes an entire chapter on biomarkers • creates tables dedicated to “select kidney biomarkers” • includes NGAL in the biomarker list • mentions multimarker strategies … it means that biomarkers are normalized in clinical practice. For BioPorto, this means: ➡️ AKI-tests go from “nice-to-have” to guideline-supported diagnostics. ⸻ 2️⃣ NGAL is in the top 3 of the most studied AKI-biomarkers KDIGO will only include biomarkers in the tables if they are: • robust • validated • clinically applicable NGAL fulfills all three. TIMP-2·IGFBP7 and KIM-1 do too — but NGAL has more studies and a longer history. ➡️ If KDIGO mentions NGAL in the biomarker section, it indirectly becomes an endorsement. BioPorto is one of the few that has a regulatorily clear NGAL-test (cf. The NGAL Test™). ⸻ 3️⃣ KDIGO’s new approach → multimarker = greater clinical adoption The draft shows that KDIGO is moving towards: • injury + function • early warning + progression • risk stratification This is the setup for NGAL. BioPorto sells precisely the type of test that KDIGO now plans to highlight as a necessity. ⸻ 4️⃣ When KDIGO changes, strategic purchasers change This is essential: • Hospital systems • ICU protocols • Pediatric nephrology • Sepsis and surgical pathways All lean directly on KDIGO. This means: When the final guideline comes, the market for NGAL-tests will grow significantly. BioPorto stands well here, especially because: • There are few competing NGAL suppliers with CE-IVDR / FDA pathways. • BioPorto specializes in NGAL in precisely clinical scenarios such as children and critically ill patients. ⸻ 5️⃣ The KDIGO draft comes simultaneously with increased regulatory momentum In recent years, BioPorto has: • achieved pediatric positioning • secured partnership in the USA • reached relevant IVDR and FDA milestones • strengthened focus on ICU/ER And now comes the KDIGO draft, which potentially accelerates global adoption. ➡️ It hits at a perfect time for BioPorto, commercially and strategically. ⸻ Overall assessment: This is the strongest guideline-related “pre-signal” for NGAL ever. And therefore significantly positive for BioPorto. If biomarkers end up in the final guideline — even just as “can be used for X” — it is a game changer for the market. BioPorto is positioned to be a leading supplier of NGAL in precisely this clinical application. ⸻
    1.4.
    ·
    1.4.
    ·
    It's Easter and many are on holiday, maybe that's why not many have traded today. Also, there is new management that needs to prove their worth, and they ensure to make money on Bioporto. After that, the stock will probably start to rise.
  • 31.3.
    ·
    31.3.
    ·
    BioPorto submits request for FDA pre‑submission for U.S. adult program for urine‑NGAL after positive EPACRA‑analysis of AKI‑cut‑off https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
    2.4.
    ·
    2.4.
    ·
    BioPorto (investment case): Implement future strategy with adult application submitted in Q1 2026 Close yesterday at 16:38 ∙ Inderes In connection with the publication of BioPorto's annual report for 2025 and the latest announcements, we have updated our investment case. 2025 was a year of strategic repositioning for BioPorto. Revenue increased by 11% to 40,3 MDKK, driven by a 25% growth in NGAL RUO sales in the USA to 18,4 MDKK and the first distributor revenue for ProNephro AKI of 4,3 MDKK via Roche. The gross margin improved to 75% from 68%, while the adjusted EBITDA loss increased to -76,5 MDKK (from -70,6 MDKK) as research and development costs rose to 50,5 MDKK, driven by the adult clinical trial. BioPorto ended 2025 with 44 active hospitals in the USA and 54,9 MDKK in cash after two private placements totaling approx. 77 MDKK.
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.

Tuotteita joiden kohde-etuutena tämä arvopaperi

2025 Q4 -tulosraportti
13 päivää sitten

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
  • 19 t sitten
    ·
    19 t sitten
    ·
    Let's now clean up and sell and take losses - and keep those who still believe in the stock.
    2 t sitten · Muokattu
    ·
    2 t sitten · Muokattu
    ·
    Onkel Charly The following is not a buy or sell recommendation, only my strategy for this stock. The Bioporto stock will become valuable for those of us who hold the stock in our portfolio. CB has stated that Bioporto's objective is to acquire at least 22 new hospitals as customers before 2026 runs out, and he very clearly emphasized AT LEAST. See last webcast. Currently, Bioporto has all 10 largest children's hospitals in the USA as customers. The sales representatives will naturally use these 10 hospitals as their references, at every place where they need to promote the NGAL test for children. Regardless of whether it's a new hospital, at trade fairs and conferences. I took a shortcut and used Google to get the precise numbers for how many children's and adult hospitals exist in the USA. As you can see, there are several hundred hospitals for children. In the USA, there are also many clinics, and I have not included them. There are several thousands of hospitals for adults, and here I have also not included clinics. They have also acquired a new distributor. Hospitals for children For children, the need is concentrated in specialized facilities or large hospitals with pediatric departments. Children's Hospitals: There are over 250 specialized children's hospitals in the USA that are members of the Children's Hospital Association (CHA). These will benefit most from a pediatric NGAL test. Hospitals for adults The majority of American hospitals treat adult patients. Acute Care Hospitals: There are approximately 5,989 acute care hospitals (acute care hospitals) in the USA. These hospitals are the primary users of the NGAL test for adults, as they handle acute cases where the risk of kidney failure is high. Intensive Care Capacity: Among the acute care hospitals, about 2,814 hospitals have dedicated intensive care beds (ICU), where monitoring of kidney function with advanced tests like NGAL is most critical.
    53 min sitten
    ·
    53 min sitten
    ·
    And sells virtually nothing to hospitals despite many agreements. The sparse growth that exists is due to ROU sales despite 3D's high expectations for ongoing orders, so virtually nothing has happened in the last 12 months.
  • 1 päivä sitten
    ·
    1 päivä sitten
    ·
    As I see it today, various investors are trying to push the price in a negative direction. I hold 30,000 units and will not let myself be influenced at all. I still believe in the stock and a significant increase in the price.
    45 min sitten · Muokattu
    ·
    45 min sitten · Muokattu
    ·
    @Onkel Charly: It would be easier if you shared your portfolio instead of continuously informing what you have and what you expect, but that is naturally your, and others who are also anonymous trolls', choice
  • 1.4.
    ·
    1.4.
    ·
    BioPorto reported a revenue increase of 11% to 40.3 MDDK in 2025, with significant growth in NGAL sales in the USA and revenue from new distributors from ProNephro AKI. https://www.inderes.se/research/bioporto-investerings-case-genomfor-framatstrategin-med-ansokan-for-vuxna-inlamnad-under-q1-2026?utm_source=nordnet&utm_medium=integration
    1 päivä sitten
    ·
    1 päivä sitten
    ·
    When is the latest response deadline from FDA? I have inserted a link to the original text, and it doesn't say anything about a response deadline from FDA. Maybe someone here knows the answer? BioPorto advances U.S. adult urine NGAL program with FDA pre-submission request after positive EPACRA AKI cut-off analysis https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
  • 31.3.
    ·
    31.3.
    ·
    ChatGPT’s assessment of today's KDIGO announcement for BioPorto: Yes — it is clearly positive for BioPorto. Here is the short explanation – and then a more detailed assessment of why the KDIGO draft is a strong positive indicator for BioPorto (NGAL-tests), both commercially and regulatorily. ⸻ ✅ Short answer: The KDIGO 2026 draft's way of including biomarkers is a significantly positive development for BioPorto, because: 1. Biomarkers are now for the first time genuinely incorporated into KDIGO’s diagnostic framework. 2. NGAL is one of the most important and most validated early AKI injury markers. 3. When KDIGO shifts diagnostics from “only creatinine and urine output” → to “function + injury”, NGAL becomes necessary. 4. Hospitals follow KDIGO. When the guideline shifts, the market shifts. ⸻ Why it is positive for BioPorto – detailed 1️⃣ KDIGO now officially opens for biomarkers This has never happened before in the AKI guideline. When KDIGO: • writes an entire chapter on biomarkers • creates tables dedicated to “select kidney biomarkers” • includes NGAL in the biomarker list • mentions multimarker strategies … it means that biomarkers are normalized in clinical practice. For BioPorto, this means: ➡️ AKI-tests go from “nice-to-have” to guideline-supported diagnostics. ⸻ 2️⃣ NGAL is in the top 3 of the most studied AKI-biomarkers KDIGO will only include biomarkers in the tables if they are: • robust • validated • clinically applicable NGAL fulfills all three. TIMP-2·IGFBP7 and KIM-1 do too — but NGAL has more studies and a longer history. ➡️ If KDIGO mentions NGAL in the biomarker section, it indirectly becomes an endorsement. BioPorto is one of the few that has a regulatorily clear NGAL-test (cf. The NGAL Test™). ⸻ 3️⃣ KDIGO’s new approach → multimarker = greater clinical adoption The draft shows that KDIGO is moving towards: • injury + function • early warning + progression • risk stratification This is the setup for NGAL. BioPorto sells precisely the type of test that KDIGO now plans to highlight as a necessity. ⸻ 4️⃣ When KDIGO changes, strategic purchasers change This is essential: • Hospital systems • ICU protocols • Pediatric nephrology • Sepsis and surgical pathways All lean directly on KDIGO. This means: When the final guideline comes, the market for NGAL-tests will grow significantly. BioPorto stands well here, especially because: • There are few competing NGAL suppliers with CE-IVDR / FDA pathways. • BioPorto specializes in NGAL in precisely clinical scenarios such as children and critically ill patients. ⸻ 5️⃣ The KDIGO draft comes simultaneously with increased regulatory momentum In recent years, BioPorto has: • achieved pediatric positioning • secured partnership in the USA • reached relevant IVDR and FDA milestones • strengthened focus on ICU/ER And now comes the KDIGO draft, which potentially accelerates global adoption. ➡️ It hits at a perfect time for BioPorto, commercially and strategically. ⸻ Overall assessment: This is the strongest guideline-related “pre-signal” for NGAL ever. And therefore significantly positive for BioPorto. If biomarkers end up in the final guideline — even just as “can be used for X” — it is a game changer for the market. BioPorto is positioned to be a leading supplier of NGAL in precisely this clinical application. ⸻
    1.4.
    ·
    1.4.
    ·
    It's Easter and many are on holiday, maybe that's why not many have traded today. Also, there is new management that needs to prove their worth, and they ensure to make money on Bioporto. After that, the stock will probably start to rise.
  • 31.3.
    ·
    31.3.
    ·
    BioPorto submits request for FDA pre‑submission for U.S. adult program for urine‑NGAL after positive EPACRA‑analysis of AKI‑cut‑off https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
    2.4.
    ·
    2.4.
    ·
    BioPorto (investment case): Implement future strategy with adult application submitted in Q1 2026 Close yesterday at 16:38 ∙ Inderes In connection with the publication of BioPorto's annual report for 2025 and the latest announcements, we have updated our investment case. 2025 was a year of strategic repositioning for BioPorto. Revenue increased by 11% to 40,3 MDKK, driven by a 25% growth in NGAL RUO sales in the USA to 18,4 MDKK and the first distributor revenue for ProNephro AKI of 4,3 MDKK via Roche. The gross margin improved to 75% from 68%, while the adjusted EBITDA loss increased to -76,5 MDKK (from -70,6 MDKK) as research and development costs rose to 50,5 MDKK, driven by the adult clinical trial. BioPorto ended 2025 with 44 active hospitals in the USA and 54,9 MDKK in cash after two private placements totaling approx. 77 MDKK.
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

DenmarkNasdaq Copenhagen
Määrä
Osto
-
Myynti
Määrä
-

Viimeisimmät kaupat

AikaHintaMääräOstajaMyyjä
500--
200--
4 000--
950--
2 988--

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

Ostaneet eniten

Ostaneet eniten
VälittäjäOstettuMyytyNettoSisäinen
Anonyymi130 891130 89100

Myyneet eniten

Myyneet eniten
VälittäjäOstettuMyytyNettoSisäinen
Anonyymi130 891130 89100

Yhtiötapahtumat

Datan lähde: FactSet, Quartr
Seuraava tapahtuma
2026 Q1 -tulosraportti
21.5.
Menneet tapahtumat
2025 Q4 -tulosraportti
26.3.
2025 Q3 -tulosraportti
19.11.2025
2025 Q2 -tulosraportti
15.8.2025
2025 Q1 -tulosraportti
8.5.2025
2024 Q4 -tulosraportti
20.3.2025

Tuotteita joiden kohde-etuutena tämä arvopaperi

2025 Q4 -tulosraportti
13 päivää sitten

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
2026 Q1 -tulosraportti
21.5.
Menneet tapahtumat
2025 Q4 -tulosraportti
26.3.
2025 Q3 -tulosraportti
19.11.2025
2025 Q2 -tulosraportti
15.8.2025
2025 Q1 -tulosraportti
8.5.2025
2024 Q4 -tulosraportti
20.3.2025

Tuotteita joiden kohde-etuutena tämä arvopaperi

Shareville

Liity keskusteluun SharevillessäShareville on aktiivisten yksityissijoittajien yhteisö, jossa voit seurata muiden asiakkaiden kaupankäyntiä ja omistuksia.
Kirjaudu
  • 19 t sitten
    ·
    19 t sitten
    ·
    Let's now clean up and sell and take losses - and keep those who still believe in the stock.
    2 t sitten · Muokattu
    ·
    2 t sitten · Muokattu
    ·
    Onkel Charly The following is not a buy or sell recommendation, only my strategy for this stock. The Bioporto stock will become valuable for those of us who hold the stock in our portfolio. CB has stated that Bioporto's objective is to acquire at least 22 new hospitals as customers before 2026 runs out, and he very clearly emphasized AT LEAST. See last webcast. Currently, Bioporto has all 10 largest children's hospitals in the USA as customers. The sales representatives will naturally use these 10 hospitals as their references, at every place where they need to promote the NGAL test for children. Regardless of whether it's a new hospital, at trade fairs and conferences. I took a shortcut and used Google to get the precise numbers for how many children's and adult hospitals exist in the USA. As you can see, there are several hundred hospitals for children. In the USA, there are also many clinics, and I have not included them. There are several thousands of hospitals for adults, and here I have also not included clinics. They have also acquired a new distributor. Hospitals for children For children, the need is concentrated in specialized facilities or large hospitals with pediatric departments. Children's Hospitals: There are over 250 specialized children's hospitals in the USA that are members of the Children's Hospital Association (CHA). These will benefit most from a pediatric NGAL test. Hospitals for adults The majority of American hospitals treat adult patients. Acute Care Hospitals: There are approximately 5,989 acute care hospitals (acute care hospitals) in the USA. These hospitals are the primary users of the NGAL test for adults, as they handle acute cases where the risk of kidney failure is high. Intensive Care Capacity: Among the acute care hospitals, about 2,814 hospitals have dedicated intensive care beds (ICU), where monitoring of kidney function with advanced tests like NGAL is most critical.
    53 min sitten
    ·
    53 min sitten
    ·
    And sells virtually nothing to hospitals despite many agreements. The sparse growth that exists is due to ROU sales despite 3D's high expectations for ongoing orders, so virtually nothing has happened in the last 12 months.
  • 1 päivä sitten
    ·
    1 päivä sitten
    ·
    As I see it today, various investors are trying to push the price in a negative direction. I hold 30,000 units and will not let myself be influenced at all. I still believe in the stock and a significant increase in the price.
    45 min sitten · Muokattu
    ·
    45 min sitten · Muokattu
    ·
    @Onkel Charly: It would be easier if you shared your portfolio instead of continuously informing what you have and what you expect, but that is naturally your, and others who are also anonymous trolls', choice
  • 1.4.
    ·
    1.4.
    ·
    BioPorto reported a revenue increase of 11% to 40.3 MDDK in 2025, with significant growth in NGAL sales in the USA and revenue from new distributors from ProNephro AKI. https://www.inderes.se/research/bioporto-investerings-case-genomfor-framatstrategin-med-ansokan-for-vuxna-inlamnad-under-q1-2026?utm_source=nordnet&utm_medium=integration
    1 päivä sitten
    ·
    1 päivä sitten
    ·
    When is the latest response deadline from FDA? I have inserted a link to the original text, and it doesn't say anything about a response deadline from FDA. Maybe someone here knows the answer? BioPorto advances U.S. adult urine NGAL program with FDA pre-submission request after positive EPACRA AKI cut-off analysis https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
  • 31.3.
    ·
    31.3.
    ·
    ChatGPT’s assessment of today's KDIGO announcement for BioPorto: Yes — it is clearly positive for BioPorto. Here is the short explanation – and then a more detailed assessment of why the KDIGO draft is a strong positive indicator for BioPorto (NGAL-tests), both commercially and regulatorily. ⸻ ✅ Short answer: The KDIGO 2026 draft's way of including biomarkers is a significantly positive development for BioPorto, because: 1. Biomarkers are now for the first time genuinely incorporated into KDIGO’s diagnostic framework. 2. NGAL is one of the most important and most validated early AKI injury markers. 3. When KDIGO shifts diagnostics from “only creatinine and urine output” → to “function + injury”, NGAL becomes necessary. 4. Hospitals follow KDIGO. When the guideline shifts, the market shifts. ⸻ Why it is positive for BioPorto – detailed 1️⃣ KDIGO now officially opens for biomarkers This has never happened before in the AKI guideline. When KDIGO: • writes an entire chapter on biomarkers • creates tables dedicated to “select kidney biomarkers” • includes NGAL in the biomarker list • mentions multimarker strategies … it means that biomarkers are normalized in clinical practice. For BioPorto, this means: ➡️ AKI-tests go from “nice-to-have” to guideline-supported diagnostics. ⸻ 2️⃣ NGAL is in the top 3 of the most studied AKI-biomarkers KDIGO will only include biomarkers in the tables if they are: • robust • validated • clinically applicable NGAL fulfills all three. TIMP-2·IGFBP7 and KIM-1 do too — but NGAL has more studies and a longer history. ➡️ If KDIGO mentions NGAL in the biomarker section, it indirectly becomes an endorsement. BioPorto is one of the few that has a regulatorily clear NGAL-test (cf. The NGAL Test™). ⸻ 3️⃣ KDIGO’s new approach → multimarker = greater clinical adoption The draft shows that KDIGO is moving towards: • injury + function • early warning + progression • risk stratification This is the setup for NGAL. BioPorto sells precisely the type of test that KDIGO now plans to highlight as a necessity. ⸻ 4️⃣ When KDIGO changes, strategic purchasers change This is essential: • Hospital systems • ICU protocols • Pediatric nephrology • Sepsis and surgical pathways All lean directly on KDIGO. This means: When the final guideline comes, the market for NGAL-tests will grow significantly. BioPorto stands well here, especially because: • There are few competing NGAL suppliers with CE-IVDR / FDA pathways. • BioPorto specializes in NGAL in precisely clinical scenarios such as children and critically ill patients. ⸻ 5️⃣ The KDIGO draft comes simultaneously with increased regulatory momentum In recent years, BioPorto has: • achieved pediatric positioning • secured partnership in the USA • reached relevant IVDR and FDA milestones • strengthened focus on ICU/ER And now comes the KDIGO draft, which potentially accelerates global adoption. ➡️ It hits at a perfect time for BioPorto, commercially and strategically. ⸻ Overall assessment: This is the strongest guideline-related “pre-signal” for NGAL ever. And therefore significantly positive for BioPorto. If biomarkers end up in the final guideline — even just as “can be used for X” — it is a game changer for the market. BioPorto is positioned to be a leading supplier of NGAL in precisely this clinical application. ⸻
    1.4.
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    1.4.
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    It's Easter and many are on holiday, maybe that's why not many have traded today. Also, there is new management that needs to prove their worth, and they ensure to make money on Bioporto. After that, the stock will probably start to rise.
  • 31.3.
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    31.3.
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    BioPorto submits request for FDA pre‑submission for U.S. adult program for urine‑NGAL after positive EPACRA‑analysis of AKI‑cut‑off https://www.globenewswire.com/news-release/2026/03/31/3265802/0/en/BioPorto-Advances-U-S-Adult-Urine-NGAL-Program-with-FDA-Pre-Submission-Request-After-Positive-EPACRA-AKI-Cut-Off-Analysis.html
    2.4.
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    2.4.
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    BioPorto (investment case): Implement future strategy with adult application submitted in Q1 2026 Close yesterday at 16:38 ∙ Inderes In connection with the publication of BioPorto's annual report for 2025 and the latest announcements, we have updated our investment case. 2025 was a year of strategic repositioning for BioPorto. Revenue increased by 11% to 40,3 MDKK, driven by a 25% growth in NGAL RUO sales in the USA to 18,4 MDKK and the first distributor revenue for ProNephro AKI of 4,3 MDKK via Roche. The gross margin improved to 75% from 68%, while the adjusted EBITDA loss increased to -76,5 MDKK (from -70,6 MDKK) as research and development costs rose to 50,5 MDKK, driven by the adult clinical trial. BioPorto ended 2025 with 44 active hospitals in the USA and 54,9 MDKK in cash after two private placements totaling approx. 77 MDKK.
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