2026 Q1 -tulosraportti
Vain PDF
58 päivää sitten
Tarjoustasot
Ei dataa
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
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 4.8. |
| Menneet tapahtumat | ||
|---|---|---|
Vuosittainen yhtiökokous 2026 10.6. | ||
2026 Q1 -tulosraportti 30.4. | ||
2025 Q4 -tulosraportti 23.2. | ||
2025 Q3 -tulosraportti 20.10.2025 | ||
2025 Q2 -tulosraportti 11.8.2025 |
Asiakkaat katsoivat myös
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
·12.6.A couple of significant insider purchases from the two co-CEOs today, which hopefully forms a bottom around 13 dollars.
·2.6.HARMONi-6: strong news – but the share price fell ~11%. How does that add up? This weekend, Summit/Akeso presented survival data for ivonescimab at the ASCO cancer conference (Monday, June 1), with simultaneous publication in The Lancet. Patients with a certain lung cancer lived longer with ivonescimab + chemotherapy than with established immunotherapy. In numbers: the risk of death decreased by 34% (so-called hazard ratio 0.66). After two years, 64.7% in the ivonescimab group were alive compared to 48.6% in the control group – a clear difference. Yet the stock fell. Why? 1. “Sell the news.” The market had already priced in a good result. When it is confirmed, those who bought before the announcement take home profits. 2. Legitimate concern – not just noise. Bernstein (analyst Jeffrey Walch) reiterated “Underperform” with a price target of 7.70 dollars and recommends selling/shorting. The arguments are serious: • HARMONi-6 was conducted solely in China, with an unusual patient mix – no patients over 75 years old and only 3.8% women. This makes the result difficult to translate to a global population. • The global, crucial study HARMONi-3 has not yet shown statistically significant efficacy on its primary endpoint (PFS, i.e., time without disease progression). A fully reasonable bear-scenario. But note: 7.70 dollars is a very pessimistic view that practically values almost the entire future at zero. The majority of the corps does not agree – price targets range from ~7.70 up to 45 dollars (Stifel 45, UBS 33, Cantor buy). 3. Money is being burned while waiting. Summit has no approved drug and no sales yet. The loss for the first quarter of 2026 was around 189 million dollars. This is common for research-intensive biotech, but it actualizes the risk of new share issues that dilute existing owners. 4. Many are shorting the stock, which amplifies fluctuations in both directions. Next milestones: • HARMONi-3 (global) – final primary results expected H2 2026. The real game-changer, as it compares against the global standard (Keytruda) and is conducted under Summit's own control. • FDA decision November 14, 2026 for another, narrower use – an imminent “yes/no” catalyst. Summary: today's fall does not reflect that science has failed – on the contrary, it was realized this weekend/Monday. It reflects priced-in expectations, a legitimate but controversial bear thesis, and that global confirmation is a few months away. Both bull and bear can be right – everything hinges on HARMONi-3. My own interpretation, not buy/sell advice. Do your own analysis.- ·3.4.Summit Therapeutics – "Now they are dressing the bride" before launch? Something big is happening at Summit Therapeutics (SMMT) – and it's particularly noticeable on the recruitment front. In March and especially April 2026, the company launched an intensive recruitment wave (in just a few days, around 20 new positions were posted globally). Many of these April roles differ, and it's no longer just researchers and clinicians being sought. We now see a clear broadening towards roles in manufacturing, quality assurance, regulatory affairs, and commercial functions. From research to finished product Summit has for several years built its pipeline around ivonescimab – a bispecific antibody targeting PD-1 and VEGF – which is now in late clinical phase. In January 2026, the FDA accepted the company's BLA application for ivonescimab in combination with chemotherapy in EGFR-mutated NSCLC. A PDUFA date is set for November 14, 2026. This is a clear sign that Summit is now entering a new phase: from clinical development to potential commercialization. "Now they are dressing the bride" The expression fits well here. Summit is gearing up its organization for a possible approval and launch: * Manufacturing & Quality: New roles such as Manager, Quality Assurance (GMP) and Executive Director, Analytical Sciences (CMC) show that capacity is being built to handle manufacturing and regulatory compliance – crucial for producing and delivering a biological drug. * Regulatory functions: Positions in Regulatory Affairs in both the USA and Europe (e.g., Dublin) indicate preparations for approval processes in multiple markets. * Commercial expansion: Roles such as Vice President, US National Sales, Director, Patient Marketing, and Director, Market Research signal that they plan to launch ivonescimab themselves – at least in the USA. * Financial strengthening: The company has also strengthened its finance function with roles such as Accounting Manager, R&D and Assistant Controller, which often happens when preparing to scale up operations. What does this mean for us investors? Summit's actions are a textbook example of how a biotech company positions itself for a potential product launch. They are building the internal structures required to go from clinic to market. It's not just a sign of confidence in their own clinical results – it's also a strategic choice: to take the product to market themselves instead of licensing it out. With a PDUFA date in November and interim data from HARMONi-3 already underway during Q2 2026, we could be facing a very eventful period. If the results continue to be positive, it's not unlikely that we will see an approved product by the end of the year – and then it is crucial that "the bride is dressed." Conclusion Summit Therapeutics shows with all desirable clarity that it believes in ivonescimab. The ongoing recruitment wave is not just an HR phenomenon – it's a strategic signal to the market. For us shareholders, it's a sign that the company is about to take the next step: from clinical developer to commercial player.
Thanks for the input. It's just a matter of holding the shares you have and buying more on bigger dips, if you have something to buy with... - ·15.3.SUMMIT THERAPEUTICS – BRIGHT SPOTS AHEAD FOR US SHAREHOLDERS Summit Therapeutics (SMMT) recently participated in two significant investor conferences: TD Cowen’s 46th Health Care Conference (March 2) and Citizens Life Sciences Conference (March 11). There are several positive signals for those of us following the company and who are shareholders. Here is a summary and analysis of the situation and what may lie ahead. International Reputation – Summit is invited to top conferences That Summit is invited to speak at TD Cowen and Citizens Life Sciences is a clear sign that the company has a strong reputation in the industry. TD Cowen is one of the most prestigious healthcare conferences globally, and that Summit gets a dedicated fireside chat with Cowen's senior biotech analyst shows that the company is taken seriously by the market. Qualified Questions – and Strong Answers During both conferences, Summit received thoughtful and challenging questions from analysts and moderators. These concerned the FDA process, study design, patient distribution, market potential, and competition. Summit responded with clarity, transparency, and strategic sharpness. This shows that management has good control over both regulatory requirements and the commercial plan, which strengthens confidence in the company. Ability to Communicate – an Important Asset Summit's management, led by Dave Gancarz and Dr. Allen Yang, has shown that they can explain the company's strategy and scientific basis in an educational and convincing manner. They succeed in conveying complex relationships in a way that both analysts and investors appreciate. This is an important quality in an industry where credibility and clear communication are crucial. Bright Spots Ahead FDA has accepted the BLA application for ivonescimab. The PDUFA date is set for November 14, 2026. Interim analysis for HARMONi-3 (first-line lung cancer) is already expected in the second quarter of 2026. New Phase III studies are underway in colorectal cancer and head and neck cancer. Summit is expected to participate in more important conferences during the spring, including Bank of America Global Healthcare Conference (May 12–14) and H.C. Wainwright BioConnect @ Nasdaq (May 19). Ivonescimab has already shown to outperform pembrolizumab in direct comparison in Phase III, both in low and high PD-L1 expression. What could this mean? Summit is on its way to moving from clinical development to potential commercialization. The company has a pipeline with the potential to change the treatment of several cancer types. That they receive attention from leading analysts, get qualified questions, and deliver strong answers is a clear indication that they are on their way to establishing themselves as a serious player in the biotech sector. It is worth keeping an eye on: Results from the interim analysis in HARMONi-3 Any new partnerships or licensing agreements Continued presence at investor conferences FDA's continued review ahead of PDUFA in November An additional strength is that the company's founder and current CEO, Robert W. Duggan, previously made a very successful exit in biotech. He has significant equity and has expressed a clear willingness to finance Summit all the way to commercialization – provided that the research continues to deliver.
- ·16.1.Summit Therapeutics – Important milestone for ivonescimab and the company's future On January 12, 2026, Summit Therapeutics announced one of its most important news to date: the company has now submitted a so-called Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its drug ivonescimab in combination with chemotherapy. The application concerns the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) in the second line or later – a patient group with high medical need and few effective alternatives. What is ivonescimab? Ivonescimab is a new type of drug – a bispecific antibody that combines two mechanisms of action: immunotherapy (PD-1 inhibition) and anti-angiogenesis (VEGF inhibition). It is an innovative molecule designed to specifically target tumor tissue, thereby improving efficacy and reducing side effects. What did the study show? The global Phase III study HARMONi showed that patients treated with ivonescimab + chemotherapy had a significantly improved progression-free survival (PFS) compared to chemotherapy alone. This is the first time an immunotherapy has shown efficacy in this patient group, where previous PD-1 inhibitors like Keytruda have not succeeded. It is a clear statement of strength. What does this mean for us shareholders? - Summit has now taken a decisive step towards becoming a commercial pharmaceutical company. - FDA decision expected Q4 2026 – a clear trigger. - If approved, ivonescimab will be the first immune-based drug with documented efficacy in this indication. - The market potential in the USA is estimated at over 14 000 patients per year – with a potential value in the billion-dollar range. - Summit has a strong cash position (~$710M) to finance launch and further development. - Several ongoing Phase III studies (HARMONi-3, HARMONi-7, HARMONi-GI3) broaden the area of use – including first-line NSCLC and colorectal cancer. - Ivonescimab is already approved in China (under the name Cardieva®), which strengthens credibility. For new shareholders: This is a classic example of a biotech company transitioning from research to market. The BLA submission is the formal step before a drug can be sold in the USA. It is a process that takes approximately 10 months, and if the FDA approves the application, the door opens to revenues, partnerships, and potential acquisition interest. Conclusion: Summit has delivered on an important milestone. We have a drug with clinically proven efficacy in a difficult-to-treat form of cancer, a regulatory process underway, and a growing pipeline. For us shareholders, this means that 2026 could be a decisive year – with several potential value drivers in sight.
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
Ei uutisia tällä hetkellä
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.
2026 Q1 -tulosraportti
Vain PDF
58 päivää sitten
Uutiset
Ei uutisia tällä hetkellä
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
- ·12.6.A couple of significant insider purchases from the two co-CEOs today, which hopefully forms a bottom around 13 dollars.
- ·2.6.HARMONi-6: strong news – but the share price fell ~11%. How does that add up? This weekend, Summit/Akeso presented survival data for ivonescimab at the ASCO cancer conference (Monday, June 1), with simultaneous publication in The Lancet. Patients with a certain lung cancer lived longer with ivonescimab + chemotherapy than with established immunotherapy. In numbers: the risk of death decreased by 34% (so-called hazard ratio 0.66). After two years, 64.7% in the ivonescimab group were alive compared to 48.6% in the control group – a clear difference. Yet the stock fell. Why? 1. “Sell the news.” The market had already priced in a good result. When it is confirmed, those who bought before the announcement take home profits. 2. Legitimate concern – not just noise. Bernstein (analyst Jeffrey Walch) reiterated “Underperform” with a price target of 7.70 dollars and recommends selling/shorting. The arguments are serious: • HARMONi-6 was conducted solely in China, with an unusual patient mix – no patients over 75 years old and only 3.8% women. This makes the result difficult to translate to a global population. • The global, crucial study HARMONi-3 has not yet shown statistically significant efficacy on its primary endpoint (PFS, i.e., time without disease progression). A fully reasonable bear-scenario. But note: 7.70 dollars is a very pessimistic view that practically values almost the entire future at zero. The majority of the corps does not agree – price targets range from ~7.70 up to 45 dollars (Stifel 45, UBS 33, Cantor buy). 3. Money is being burned while waiting. Summit has no approved drug and no sales yet. The loss for the first quarter of 2026 was around 189 million dollars. This is common for research-intensive biotech, but it actualizes the risk of new share issues that dilute existing owners. 4. Many are shorting the stock, which amplifies fluctuations in both directions. Next milestones: • HARMONi-3 (global) – final primary results expected H2 2026. The real game-changer, as it compares against the global standard (Keytruda) and is conducted under Summit's own control. • FDA decision November 14, 2026 for another, narrower use – an imminent “yes/no” catalyst. Summary: today's fall does not reflect that science has failed – on the contrary, it was realized this weekend/Monday. It reflects priced-in expectations, a legitimate but controversial bear thesis, and that global confirmation is a few months away. Both bull and bear can be right – everything hinges on HARMONi-3. My own interpretation, not buy/sell advice. Do your own analysis.
- ·3.4.Summit Therapeutics – "Now they are dressing the bride" before launch? Something big is happening at Summit Therapeutics (SMMT) – and it's particularly noticeable on the recruitment front. In March and especially April 2026, the company launched an intensive recruitment wave (in just a few days, around 20 new positions were posted globally). Many of these April roles differ, and it's no longer just researchers and clinicians being sought. We now see a clear broadening towards roles in manufacturing, quality assurance, regulatory affairs, and commercial functions. From research to finished product Summit has for several years built its pipeline around ivonescimab – a bispecific antibody targeting PD-1 and VEGF – which is now in late clinical phase. In January 2026, the FDA accepted the company's BLA application for ivonescimab in combination with chemotherapy in EGFR-mutated NSCLC. A PDUFA date is set for November 14, 2026. This is a clear sign that Summit is now entering a new phase: from clinical development to potential commercialization. "Now they are dressing the bride" The expression fits well here. Summit is gearing up its organization for a possible approval and launch: * Manufacturing & Quality: New roles such as Manager, Quality Assurance (GMP) and Executive Director, Analytical Sciences (CMC) show that capacity is being built to handle manufacturing and regulatory compliance – crucial for producing and delivering a biological drug. * Regulatory functions: Positions in Regulatory Affairs in both the USA and Europe (e.g., Dublin) indicate preparations for approval processes in multiple markets. * Commercial expansion: Roles such as Vice President, US National Sales, Director, Patient Marketing, and Director, Market Research signal that they plan to launch ivonescimab themselves – at least in the USA. * Financial strengthening: The company has also strengthened its finance function with roles such as Accounting Manager, R&D and Assistant Controller, which often happens when preparing to scale up operations. What does this mean for us investors? Summit's actions are a textbook example of how a biotech company positions itself for a potential product launch. They are building the internal structures required to go from clinic to market. It's not just a sign of confidence in their own clinical results – it's also a strategic choice: to take the product to market themselves instead of licensing it out. With a PDUFA date in November and interim data from HARMONi-3 already underway during Q2 2026, we could be facing a very eventful period. If the results continue to be positive, it's not unlikely that we will see an approved product by the end of the year – and then it is crucial that "the bride is dressed." Conclusion Summit Therapeutics shows with all desirable clarity that it believes in ivonescimab. The ongoing recruitment wave is not just an HR phenomenon – it's a strategic signal to the market. For us shareholders, it's a sign that the company is about to take the next step: from clinical developer to commercial player.Thanks for the input. It's just a matter of holding the shares you have and buying more on bigger dips, if you have something to buy with...
- ·15.3.SUMMIT THERAPEUTICS – BRIGHT SPOTS AHEAD FOR US SHAREHOLDERS Summit Therapeutics (SMMT) recently participated in two significant investor conferences: TD Cowen’s 46th Health Care Conference (March 2) and Citizens Life Sciences Conference (March 11). There are several positive signals for those of us following the company and who are shareholders. Here is a summary and analysis of the situation and what may lie ahead. International Reputation – Summit is invited to top conferences That Summit is invited to speak at TD Cowen and Citizens Life Sciences is a clear sign that the company has a strong reputation in the industry. TD Cowen is one of the most prestigious healthcare conferences globally, and that Summit gets a dedicated fireside chat with Cowen's senior biotech analyst shows that the company is taken seriously by the market. Qualified Questions – and Strong Answers During both conferences, Summit received thoughtful and challenging questions from analysts and moderators. These concerned the FDA process, study design, patient distribution, market potential, and competition. Summit responded with clarity, transparency, and strategic sharpness. This shows that management has good control over both regulatory requirements and the commercial plan, which strengthens confidence in the company. Ability to Communicate – an Important Asset Summit's management, led by Dave Gancarz and Dr. Allen Yang, has shown that they can explain the company's strategy and scientific basis in an educational and convincing manner. They succeed in conveying complex relationships in a way that both analysts and investors appreciate. This is an important quality in an industry where credibility and clear communication are crucial. Bright Spots Ahead FDA has accepted the BLA application for ivonescimab. The PDUFA date is set for November 14, 2026. Interim analysis for HARMONi-3 (first-line lung cancer) is already expected in the second quarter of 2026. New Phase III studies are underway in colorectal cancer and head and neck cancer. Summit is expected to participate in more important conferences during the spring, including Bank of America Global Healthcare Conference (May 12–14) and H.C. Wainwright BioConnect @ Nasdaq (May 19). Ivonescimab has already shown to outperform pembrolizumab in direct comparison in Phase III, both in low and high PD-L1 expression. What could this mean? Summit is on its way to moving from clinical development to potential commercialization. The company has a pipeline with the potential to change the treatment of several cancer types. That they receive attention from leading analysts, get qualified questions, and deliver strong answers is a clear indication that they are on their way to establishing themselves as a serious player in the biotech sector. It is worth keeping an eye on: Results from the interim analysis in HARMONi-3 Any new partnerships or licensing agreements Continued presence at investor conferences FDA's continued review ahead of PDUFA in November An additional strength is that the company's founder and current CEO, Robert W. Duggan, previously made a very successful exit in biotech. He has significant equity and has expressed a clear willingness to finance Summit all the way to commercialization – provided that the research continues to deliver.
- ·16.1.Summit Therapeutics – Important milestone for ivonescimab and the company's future On January 12, 2026, Summit Therapeutics announced one of its most important news to date: the company has now submitted a so-called Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its drug ivonescimab in combination with chemotherapy. The application concerns the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) in the second line or later – a patient group with high medical need and few effective alternatives. What is ivonescimab? Ivonescimab is a new type of drug – a bispecific antibody that combines two mechanisms of action: immunotherapy (PD-1 inhibition) and anti-angiogenesis (VEGF inhibition). It is an innovative molecule designed to specifically target tumor tissue, thereby improving efficacy and reducing side effects. What did the study show? The global Phase III study HARMONi showed that patients treated with ivonescimab + chemotherapy had a significantly improved progression-free survival (PFS) compared to chemotherapy alone. This is the first time an immunotherapy has shown efficacy in this patient group, where previous PD-1 inhibitors like Keytruda have not succeeded. It is a clear statement of strength. What does this mean for us shareholders? - Summit has now taken a decisive step towards becoming a commercial pharmaceutical company. - FDA decision expected Q4 2026 – a clear trigger. - If approved, ivonescimab will be the first immune-based drug with documented efficacy in this indication. - The market potential in the USA is estimated at over 14 000 patients per year – with a potential value in the billion-dollar range. - Summit has a strong cash position (~$710M) to finance launch and further development. - Several ongoing Phase III studies (HARMONi-3, HARMONi-7, HARMONi-GI3) broaden the area of use – including first-line NSCLC and colorectal cancer. - Ivonescimab is already approved in China (under the name Cardieva®), which strengthens credibility. For new shareholders: This is a classic example of a biotech company transitioning from research to market. The BLA submission is the formal step before a drug can be sold in the USA. It is a process that takes approximately 10 months, and if the FDA approves the application, the door opens to revenues, partnerships, and potential acquisition interest. Conclusion: Summit has delivered on an important milestone. We have a drug with clinically proven efficacy in a difficult-to-treat form of cancer, a regulatory process underway, and a growing pipeline. For us shareholders, this means that 2026 could be a decisive year – with several potential value drivers in sight.
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
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
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
Asiakkaat katsoivat myös
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
2026 Q2 -tulosraportti 4.8. |
| Menneet tapahtumat | ||
|---|---|---|
Vuosittainen yhtiökokous 2026 10.6. | ||
2026 Q1 -tulosraportti 30.4. | ||
2025 Q4 -tulosraportti 23.2. | ||
2025 Q3 -tulosraportti 20.10.2025 | ||
2025 Q2 -tulosraportti 11.8.2025 |
2026 Q1 -tulosraportti
Vain PDF
58 päivää sitten
Uutiset
Ei uutisia tällä hetkellä
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 4.8. |
| Menneet tapahtumat | ||
|---|---|---|
Vuosittainen yhtiökokous 2026 10.6. | ||
2026 Q1 -tulosraportti 30.4. | ||
2025 Q4 -tulosraportti 23.2. | ||
2025 Q3 -tulosraportti 20.10.2025 | ||
2025 Q2 -tulosraportti 11.8.2025 |
Foorumi
Liity keskusteluun Nordnet Socialissa
Kirjaudu
- ·12.6.A couple of significant insider purchases from the two co-CEOs today, which hopefully forms a bottom around 13 dollars.
- ·2.6.HARMONi-6: strong news – but the share price fell ~11%. How does that add up? This weekend, Summit/Akeso presented survival data for ivonescimab at the ASCO cancer conference (Monday, June 1), with simultaneous publication in The Lancet. Patients with a certain lung cancer lived longer with ivonescimab + chemotherapy than with established immunotherapy. In numbers: the risk of death decreased by 34% (so-called hazard ratio 0.66). After two years, 64.7% in the ivonescimab group were alive compared to 48.6% in the control group – a clear difference. Yet the stock fell. Why? 1. “Sell the news.” The market had already priced in a good result. When it is confirmed, those who bought before the announcement take home profits. 2. Legitimate concern – not just noise. Bernstein (analyst Jeffrey Walch) reiterated “Underperform” with a price target of 7.70 dollars and recommends selling/shorting. The arguments are serious: • HARMONi-6 was conducted solely in China, with an unusual patient mix – no patients over 75 years old and only 3.8% women. This makes the result difficult to translate to a global population. • The global, crucial study HARMONi-3 has not yet shown statistically significant efficacy on its primary endpoint (PFS, i.e., time without disease progression). A fully reasonable bear-scenario. But note: 7.70 dollars is a very pessimistic view that practically values almost the entire future at zero. The majority of the corps does not agree – price targets range from ~7.70 up to 45 dollars (Stifel 45, UBS 33, Cantor buy). 3. Money is being burned while waiting. Summit has no approved drug and no sales yet. The loss for the first quarter of 2026 was around 189 million dollars. This is common for research-intensive biotech, but it actualizes the risk of new share issues that dilute existing owners. 4. Many are shorting the stock, which amplifies fluctuations in both directions. Next milestones: • HARMONi-3 (global) – final primary results expected H2 2026. The real game-changer, as it compares against the global standard (Keytruda) and is conducted under Summit's own control. • FDA decision November 14, 2026 for another, narrower use – an imminent “yes/no” catalyst. Summary: today's fall does not reflect that science has failed – on the contrary, it was realized this weekend/Monday. It reflects priced-in expectations, a legitimate but controversial bear thesis, and that global confirmation is a few months away. Both bull and bear can be right – everything hinges on HARMONi-3. My own interpretation, not buy/sell advice. Do your own analysis.
- ·3.4.Summit Therapeutics – "Now they are dressing the bride" before launch? Something big is happening at Summit Therapeutics (SMMT) – and it's particularly noticeable on the recruitment front. In March and especially April 2026, the company launched an intensive recruitment wave (in just a few days, around 20 new positions were posted globally). Many of these April roles differ, and it's no longer just researchers and clinicians being sought. We now see a clear broadening towards roles in manufacturing, quality assurance, regulatory affairs, and commercial functions. From research to finished product Summit has for several years built its pipeline around ivonescimab – a bispecific antibody targeting PD-1 and VEGF – which is now in late clinical phase. In January 2026, the FDA accepted the company's BLA application for ivonescimab in combination with chemotherapy in EGFR-mutated NSCLC. A PDUFA date is set for November 14, 2026. This is a clear sign that Summit is now entering a new phase: from clinical development to potential commercialization. "Now they are dressing the bride" The expression fits well here. Summit is gearing up its organization for a possible approval and launch: * Manufacturing & Quality: New roles such as Manager, Quality Assurance (GMP) and Executive Director, Analytical Sciences (CMC) show that capacity is being built to handle manufacturing and regulatory compliance – crucial for producing and delivering a biological drug. * Regulatory functions: Positions in Regulatory Affairs in both the USA and Europe (e.g., Dublin) indicate preparations for approval processes in multiple markets. * Commercial expansion: Roles such as Vice President, US National Sales, Director, Patient Marketing, and Director, Market Research signal that they plan to launch ivonescimab themselves – at least in the USA. * Financial strengthening: The company has also strengthened its finance function with roles such as Accounting Manager, R&D and Assistant Controller, which often happens when preparing to scale up operations. What does this mean for us investors? Summit's actions are a textbook example of how a biotech company positions itself for a potential product launch. They are building the internal structures required to go from clinic to market. It's not just a sign of confidence in their own clinical results – it's also a strategic choice: to take the product to market themselves instead of licensing it out. With a PDUFA date in November and interim data from HARMONi-3 already underway during Q2 2026, we could be facing a very eventful period. If the results continue to be positive, it's not unlikely that we will see an approved product by the end of the year – and then it is crucial that "the bride is dressed." Conclusion Summit Therapeutics shows with all desirable clarity that it believes in ivonescimab. The ongoing recruitment wave is not just an HR phenomenon – it's a strategic signal to the market. For us shareholders, it's a sign that the company is about to take the next step: from clinical developer to commercial player.Thanks for the input. It's just a matter of holding the shares you have and buying more on bigger dips, if you have something to buy with...
- ·15.3.SUMMIT THERAPEUTICS – BRIGHT SPOTS AHEAD FOR US SHAREHOLDERS Summit Therapeutics (SMMT) recently participated in two significant investor conferences: TD Cowen’s 46th Health Care Conference (March 2) and Citizens Life Sciences Conference (March 11). There are several positive signals for those of us following the company and who are shareholders. Here is a summary and analysis of the situation and what may lie ahead. International Reputation – Summit is invited to top conferences That Summit is invited to speak at TD Cowen and Citizens Life Sciences is a clear sign that the company has a strong reputation in the industry. TD Cowen is one of the most prestigious healthcare conferences globally, and that Summit gets a dedicated fireside chat with Cowen's senior biotech analyst shows that the company is taken seriously by the market. Qualified Questions – and Strong Answers During both conferences, Summit received thoughtful and challenging questions from analysts and moderators. These concerned the FDA process, study design, patient distribution, market potential, and competition. Summit responded with clarity, transparency, and strategic sharpness. This shows that management has good control over both regulatory requirements and the commercial plan, which strengthens confidence in the company. Ability to Communicate – an Important Asset Summit's management, led by Dave Gancarz and Dr. Allen Yang, has shown that they can explain the company's strategy and scientific basis in an educational and convincing manner. They succeed in conveying complex relationships in a way that both analysts and investors appreciate. This is an important quality in an industry where credibility and clear communication are crucial. Bright Spots Ahead FDA has accepted the BLA application for ivonescimab. The PDUFA date is set for November 14, 2026. Interim analysis for HARMONi-3 (first-line lung cancer) is already expected in the second quarter of 2026. New Phase III studies are underway in colorectal cancer and head and neck cancer. Summit is expected to participate in more important conferences during the spring, including Bank of America Global Healthcare Conference (May 12–14) and H.C. Wainwright BioConnect @ Nasdaq (May 19). Ivonescimab has already shown to outperform pembrolizumab in direct comparison in Phase III, both in low and high PD-L1 expression. What could this mean? Summit is on its way to moving from clinical development to potential commercialization. The company has a pipeline with the potential to change the treatment of several cancer types. That they receive attention from leading analysts, get qualified questions, and deliver strong answers is a clear indication that they are on their way to establishing themselves as a serious player in the biotech sector. It is worth keeping an eye on: Results from the interim analysis in HARMONi-3 Any new partnerships or licensing agreements Continued presence at investor conferences FDA's continued review ahead of PDUFA in November An additional strength is that the company's founder and current CEO, Robert W. Duggan, previously made a very successful exit in biotech. He has significant equity and has expressed a clear willingness to finance Summit all the way to commercialization – provided that the research continues to deliver.
- ·16.1.Summit Therapeutics – Important milestone for ivonescimab and the company's future On January 12, 2026, Summit Therapeutics announced one of its most important news to date: the company has now submitted a so-called Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its drug ivonescimab in combination with chemotherapy. The application concerns the treatment of EGFR-mutated non-small cell lung cancer (NSCLC) in the second line or later – a patient group with high medical need and few effective alternatives. What is ivonescimab? Ivonescimab is a new type of drug – a bispecific antibody that combines two mechanisms of action: immunotherapy (PD-1 inhibition) and anti-angiogenesis (VEGF inhibition). It is an innovative molecule designed to specifically target tumor tissue, thereby improving efficacy and reducing side effects. What did the study show? The global Phase III study HARMONi showed that patients treated with ivonescimab + chemotherapy had a significantly improved progression-free survival (PFS) compared to chemotherapy alone. This is the first time an immunotherapy has shown efficacy in this patient group, where previous PD-1 inhibitors like Keytruda have not succeeded. It is a clear statement of strength. What does this mean for us shareholders? - Summit has now taken a decisive step towards becoming a commercial pharmaceutical company. - FDA decision expected Q4 2026 – a clear trigger. - If approved, ivonescimab will be the first immune-based drug with documented efficacy in this indication. - The market potential in the USA is estimated at over 14 000 patients per year – with a potential value in the billion-dollar range. - Summit has a strong cash position (~$710M) to finance launch and further development. - Several ongoing Phase III studies (HARMONi-3, HARMONi-7, HARMONi-GI3) broaden the area of use – including first-line NSCLC and colorectal cancer. - Ivonescimab is already approved in China (under the name Cardieva®), which strengthens credibility. For new shareholders: This is a classic example of a biotech company transitioning from research to market. The BLA submission is the formal step before a drug can be sold in the USA. It is a process that takes approximately 10 months, and if the FDA approves the application, the door opens to revenues, partnerships, and potential acquisition interest. Conclusion: Summit has delivered on an important milestone. We have a drug with clinically proven efficacy in a difficult-to-treat form of cancer, a regulatory process underway, and a growing pipeline. For us shareholders, this means that 2026 could be a decisive year – with several potential value drivers in sight.
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
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
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