PledPharma - Et uoppdaget selskap med større potensiale enn NANO
Anbefaler å sjekke ut stream fra Capital Markets Day https://www.redeye.se/live/pled-kapitalmarknadsdag-2019.
Presentasjon: https://www.pledpharma.com/wp-content/uploads//PledPharma-Capital-Markets-Day-Mar-26.pdf
PledPharma har 2 produkter i pipeline:
PledOx som er i Fase 3 mot bivirkninger forårsaket av Oxiplatin hos pasienter som behandles for kolorektalkreft.
https://clinicaltrials.gov/ct2/show/NCT03654729?term=pledpharma&rank=3
Markedspotensiale 1.5 millioner doser årlig * 1000 $ / dose = 1 500 000 000 $
PledOx har ingen konkurrenter.
Aladote som er på vei inn i Fase 2 med Orphan Drug Designation mot leverskader forårsaket av overdose med paracetemol.
https://clinicaltrials.gov/ct2/show/NCT03177395?term=pledpharma&rank=5
Markedspotensiale 135 000 sykehusinnleggelser årlig * 5000 $ / dose = 675 000 000 $
Aladote har ingen konkurrenter.
PledPharma har allerede en partner i Asia som betaler for studiet som gjennomføres i Asia i tillegg betaler de ut "milestone payments" under studiet.
PledPharma er fullfinansiert frem til PledOx' Fase 3 er fullført og har ingen behov for penger i den nærmeste fremtid ser det ut til.
PledPharma - https://www.pledpharma.com/
Presentasjon: https://www.pledpharma.com/wp-content/uploads//PledPharma-Capital-Markets-Day-Mar-26.pdf
PledPharma har 2 produkter i pipeline:
PledOx som er i Fase 3 mot bivirkninger forårsaket av Oxiplatin hos pasienter som behandles for kolorektalkreft.
https://clinicaltrials.gov/ct2/show/NCT03654729?term=pledpharma&rank=3
Markedspotensiale 1.5 millioner doser årlig * 1000 $ / dose = 1 500 000 000 $
PledOx har ingen konkurrenter.
Aladote som er på vei inn i Fase 2 med Orphan Drug Designation mot leverskader forårsaket av overdose med paracetemol.
https://clinicaltrials.gov/ct2/show/NCT03177395?term=pledpharma&rank=5
Markedspotensiale 135 000 sykehusinnleggelser årlig * 5000 $ / dose = 675 000 000 $
Aladote har ingen konkurrenter.
PledPharma har allerede en partner i Asia som betaler for studiet som gjennomføres i Asia i tillegg betaler de ut "milestone payments" under studiet.
PledPharma er fullfinansiert frem til PledOx' Fase 3 er fullført og har ingen behov for penger i den nærmeste fremtid ser det ut til.
PledPharma - https://www.pledpharma.com/
Redigert 21.01.2021 kl 06:02
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SomSa
30.10.2019 kl 11:41
4500
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Peripheral neuropathy symptoms are caused by damages to sensory nerves, most commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can cause such damages, which is then called chemotherapy induced peripheral neuropathy (CIPN). This can be a debilitating adverse reaction to the cancer treatment and may occur at any time after the initiation of chemotherapy. The symptoms often increase as the chemotherapy treatment continues and may often cause discontinuation of the chemotherapy. In many patients, the symptoms are resolved after discontinuing the chemotherapy, but up to 85-95% of the patients have sustained symptoms such as numbness, tingling and pain in hands and feet in case of FOLFOX therapy including oxaliplatin. Discontinuation of chemotherapy contributes improvement of a part of symptoms in 80% of patients and recovered in 40% of patients 6-8 months after discontinuation of chemotherapy. However, discontinuation of chemotherapy sometimes means withdrawal from treatment or change of treatment strategy and it is a clinically significant issue. $$$$$$$$$💥 There is currently no approved drug to prevent or treat CIPN.💥 $$$$$$$$$
Redigert 20.01.2021 kl 22:49
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Ticker
30.10.2019 kl 13:04
4482
Sniker seg oppover som er helt greit for da finner som oftes aksjer mer fotfeste underveis og etablerer bedre nedre støtte..
Håper Napa kommer med skikkelig kursdrivende melding i november så litt kapital kan flyttes over til denne diamanten.
Håper Napa kommer med skikkelig kursdrivende melding i november så litt kapital kan flyttes over til denne diamanten.
Redigert 20.01.2021 kl 22:49
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NoRiskNoReward
30.10.2019 kl 23:01
4456
Interessant at største nettokjøper i dag Goldman Sachs International. Ser ut som fler enn oss som skriver her begynner å se potensiale.
Redigert 20.01.2021 kl 22:49
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Ticker
31.10.2019 kl 10:19
4420
PledPharma's shares commences today on the Nasdaq Stockholm main market
PledPharma AB (publ) announces today the commencement of trading in the company's shares on Nasdaq Stockholm's main market.
"I am very happy and proud that we are now moving up to Nasdaq Stockholm's main market. The listing is an important milestone for PledPharma that can both help create further interest from a broader investor base and reflect the maturity of our business and our global ambitions," said Nicklas Westerholm, CEO of PledPharma.
The shares will be traded on the Nasdaq Stockholm main market under the same ticker (PLED) and ISIN-code (SE0003815604). There is no fund raising or new share issue in connection with the list change, and shareholders in PledPharma do not need to take any actions.
Redigert 20.01.2021 kl 22:49
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SomSa
01.11.2019 kl 12:14
4380
Hva slags nyhet Kommer?
TRADING HALT: ORDER BOOK PLED IN MARKET STO EQUITIES INTRADAY CROSS CCP AT 11:04:02.741
11:04
Trading Halt: Order Book PLED in market STO Equities intraday cross CCP at 11:04:02.741
Redigert 20.01.2021 kl 22:49
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Ticker
06.11.2019 kl 12:03
4256
De har laget et lite regnestykke for PledoX som ikke ser så verst ut om det slår til:
Our price assumption for PledOx amounts to USD 1,200 per treatment cycle in the US and USD 800 in the rest of the world. We assume a high penetration of PledOx, being used as a pretreatment in half of all treatment cycles that involve oxaliplatin regimens. We estimate PledOx peak sales in CRC of USD 350m in the US, USD 400m in Europe and approaching USD 150m in Japan. At this stage, we include no sales in China as we seek more clarity over future development. We calculate the development risk of 60% for PledOx in Phase III We calculate a commercial deal generating an upfront payment of USD 50m (2021), regulatory and sales milestones of USD 550m and sales royalty of 25-30%.
Our price assumption for PledOx amounts to USD 1,200 per treatment cycle in the US and USD 800 in the rest of the world. We assume a high penetration of PledOx, being used as a pretreatment in half of all treatment cycles that involve oxaliplatin regimens. We estimate PledOx peak sales in CRC of USD 350m in the US, USD 400m in Europe and approaching USD 150m in Japan. At this stage, we include no sales in China as we seek more clarity over future development. We calculate the development risk of 60% for PledOx in Phase III We calculate a commercial deal generating an upfront payment of USD 50m (2021), regulatory and sales milestones of USD 550m and sales royalty of 25-30%.
Redigert 20.01.2021 kl 22:49
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Ticker
13.11.2019 kl 18:23
4171
I det kommende kvartalet vil Pledpharma delta på en rekke internasjonale konferanser, og en vil anta at partnerkontakter og mulige lisensavtaler står høyt på dagsordenen. Den nylig utvidede lisensavtalen med Solasia, passerte markedet ganske ubemerket, men hvis de kan lande en annen avtale for PledOx, tror jeg den eksterne valideringen vil bety rent rakettdrivstoff for aksjekursen, spesielt hvis kjøperen er et litt mer kjent selskap.
En form for avtale angående Aladote hadde selvfølgelig ikke vært å fornekte
Dette er virkelig en spennende aksje å følge.
Her er konferansene der selskapet har flagget for deltakelse:
11-13 november 2019 - Bio-Europe, Hamburg
“As Europe"s largest life science partnering conference, BIO-Europe offers countless opportunities to engage with global life science partners. Empower yourself with knowledge from key biotech and pharma leaders who will discuss the latest industry trends in workshops and panels.”
20-21 november 2019 - Jefferies, London
“This year marks the 10th anniversary of now the largest healthcare-dedicated conference in Europe. In 2018, we hosted 500 participating companies, 2,000 attendees and 5,000 business-to-business and investor meetings. Our event will again feature leading public and private companies from the pharmaceuticals, biotechnology, generics, consumer health, animal health, medical technology and healthcare services sectors from the United States, Europe, Africa, Middle East, Latin America, Russia, India, Israel, China and Japan.”
13-15 januari 2020 - JP Morgan, San Fransisco
"The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. The annual J.P. Morgan Healthcare Conference brings thousands of investors from around the world together. The hundreds of companies presenting run the gamut, from start-ups to those with more than $300 billion in market cap, and encompass the entire global healthcare landscape, including pharmaceutical firms, healthcare service providers, profit and not-for-profits, and medical device companies."
https://nyemissioner.se/video/intervju_med_vd_foer_pledpharma_som_nyligen_flyttade_till_nasdaq_stockholm/252
En form for avtale angående Aladote hadde selvfølgelig ikke vært å fornekte
Dette er virkelig en spennende aksje å følge.
Her er konferansene der selskapet har flagget for deltakelse:
11-13 november 2019 - Bio-Europe, Hamburg
“As Europe"s largest life science partnering conference, BIO-Europe offers countless opportunities to engage with global life science partners. Empower yourself with knowledge from key biotech and pharma leaders who will discuss the latest industry trends in workshops and panels.”
20-21 november 2019 - Jefferies, London
“This year marks the 10th anniversary of now the largest healthcare-dedicated conference in Europe. In 2018, we hosted 500 participating companies, 2,000 attendees and 5,000 business-to-business and investor meetings. Our event will again feature leading public and private companies from the pharmaceuticals, biotechnology, generics, consumer health, animal health, medical technology and healthcare services sectors from the United States, Europe, Africa, Middle East, Latin America, Russia, India, Israel, China and Japan.”
13-15 januari 2020 - JP Morgan, San Fransisco
"The annual J.P. Morgan Healthcare Conference is the largest and most informative healthcare investment symposium in the industry, bringing together industry leaders, emerging fast-growth companies, innovative technology creators, and members of the investment community. The annual J.P. Morgan Healthcare Conference brings thousands of investors from around the world together. The hundreds of companies presenting run the gamut, from start-ups to those with more than $300 billion in market cap, and encompass the entire global healthcare landscape, including pharmaceutical firms, healthcare service providers, profit and not-for-profits, and medical device companies."
https://nyemissioner.se/video/intervju_med_vd_foer_pledpharma_som_nyligen_flyttade_till_nasdaq_stockholm/252
Redigert 20.01.2021 kl 22:49
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SomSa
10.12.2019 kl 09:04
3958
PLEDPHARMA: PLEDPHARMAS ASIAN PARTNER SOLASIA ENTERS AGREEMENT WITH JAPANESE MARUHO FOR COMMERCIALIZATION OF PLEDOX
09:00
Stockholm, December 10, 2019. PledPharma AB (STO: PLED) today announced that
its Asian partner Solasia Pharma KK (Solasia) has entered into an exclusive
license agreement with the Japanese pharmaceutical company Maruho Co Ltd
(Maruho) for commercialization of PledPharmas therapeutic agent PledOx
(calmangafodipir) for the treatment of chemotherapy induced peripheral
neuropathy (CIPN) in Japan.
Under the license agreement, Maruho will commercialize PledOx exclusively in
Japan after Solasia and PledPharma completes development of the product in
Japan. The global Phase III program in CIPN with PledOx is ongoing and
consists of two studies.
This agreement between Solasia and Maruho is a strong validation of the
potential for PledOx to address chemotherapy induced nerve damage, a large
unmet medical need. Maruho will bring a strong and experienced Sales &
Marketing team for commercialization of PledOx to maximize the value of the
asset, said Nicklas Westerholm, Chief Executive Officer and President,
PledPharma.
Link (https://solasia.co.jp/en/images/uNVG4MKeddoHym.pdf) to Solasias PR.
Redigert 20.01.2021 kl 22:49
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NoRiskNoReward
12.12.2019 kl 19:16
3894
Solasia steg 43% på dealen som overførte rettighetene til å kommersialisere Pledox i Japan fra Solasia til Maruho.
Upfront-utbetalingen fra Maruho til Solasia, for rettighetene til å kommersialisere Pledox i Japan, var 1 milliard Yen (86 millioner SEK), i tillegg inneholder avtalen milestones-utbetalinger på 18 milliarder Yen (1550 millioner SEK).
Japan tilsvarer ca 7% av det totale verdensmarkedet for legemidler, og Maruho må i tillegg betale royalties på ca 14-15% til PledPharma. Dette betyr at dealen mellom Solasia og Maruho priser Pledox til 86 000 000 /0,07 = 1.23 milliarder SEK upfront og 1550 000 000 / 0,07 = 22.1 milliarder SEK i milestones utbetalinger og 14% royalties. Denne dealen er nå signert på et tidspunkt hvor Pledox fortsatt er i fase 3.
Basert på informasjonen ovenfor er jeg veldig nysgjerrig på hva slags deal PledPharma kan gjøre når selskapet presenterer resultater i fase 3 studiet i slutten av neste år.
https://solasia.co.jp/en/images/uNVG4MKeddoHym.pdf
https://www.bloomberg.com/quote/4597:JP
https://www.maruho.co.jp/english/release/nek5p40000005ei0-att/20191210_pr_eng.pdf
https://www.efpia.eu/publications/data-center/the-pharma-industry-in-figures-economy/world-pharmaceutical-market/
https://www.globenewswire.com/news-release/2017/11/20/1197186/0/en/PledPharma-and-Solasia-enter-license-agreement-to-develop-and-commercialize-PledOx-in-Asia.html
Upfront-utbetalingen fra Maruho til Solasia, for rettighetene til å kommersialisere Pledox i Japan, var 1 milliard Yen (86 millioner SEK), i tillegg inneholder avtalen milestones-utbetalinger på 18 milliarder Yen (1550 millioner SEK).
Japan tilsvarer ca 7% av det totale verdensmarkedet for legemidler, og Maruho må i tillegg betale royalties på ca 14-15% til PledPharma. Dette betyr at dealen mellom Solasia og Maruho priser Pledox til 86 000 000 /0,07 = 1.23 milliarder SEK upfront og 1550 000 000 / 0,07 = 22.1 milliarder SEK i milestones utbetalinger og 14% royalties. Denne dealen er nå signert på et tidspunkt hvor Pledox fortsatt er i fase 3.
Basert på informasjonen ovenfor er jeg veldig nysgjerrig på hva slags deal PledPharma kan gjøre når selskapet presenterer resultater i fase 3 studiet i slutten av neste år.
https://solasia.co.jp/en/images/uNVG4MKeddoHym.pdf
https://www.bloomberg.com/quote/4597:JP
https://www.maruho.co.jp/english/release/nek5p40000005ei0-att/20191210_pr_eng.pdf
https://www.efpia.eu/publications/data-center/the-pharma-industry-in-figures-economy/world-pharmaceutical-market/
https://www.globenewswire.com/news-release/2017/11/20/1197186/0/en/PledPharma-and-Solasia-enter-license-agreement-to-develop-and-commercialize-PledOx-in-Asia.html
Redigert 20.01.2021 kl 22:49
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NoRiskNoReward
16.12.2019 kl 08:15
3774
Global phase III study POLAR-A fully recruited
December 16, 2019
Stockholm, December 16, 2019. PledPharma AB (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announced that the global Phase III study POLAR-A with PledPharma’s lead candidate PledOx® is now fully recruited and top line results expected approximately one year later.
https://www.pledpharma.com/mfn_news/global-phase-iii-study-polar-a-fully-recruited/
December 16, 2019
Stockholm, December 16, 2019. PledPharma AB (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announced that the global Phase III study POLAR-A with PledPharma’s lead candidate PledOx® is now fully recruited and top line results expected approximately one year later.
https://www.pledpharma.com/mfn_news/global-phase-iii-study-polar-a-fully-recruited/
Redigert 20.01.2021 kl 22:49
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SomSa
16.12.2019 kl 11:31
3732
Redeye Research Note 2019/12/13
We reiterate our base case of SEK 50 and believe the current share price does not at all reflect the value of the pipeline. In our opinion, the current price instead suggests very low expectations on the leading asset PledOx and of success in the ongoing Phase 3 studies. With several important news approaching in the next six months, we believe this investor attitude towards the case has the potential to become much brighter.
https://www.redeye.se/research/585029/pledpharma-takeaways-investor-meeting?utm_medium=email&utm_source=MB
Redigert 20.01.2021 kl 22:49
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Ticker
16.12.2019 kl 11:47
3722
Tipper det blir tatt opp dekning av mange litt ut på nyåret.
Fase 3 tar nå opp til ett år men som de sier oppdateringer kan komme underveis
Vi står ikke i 20.- på denne tid neste år,det er sikkert
Fase 3 tar nå opp til ett år men som de sier oppdateringer kan komme underveis
Vi står ikke i 20.- på denne tid neste år,det er sikkert
Redigert 20.01.2021 kl 22:49
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SomSa
09.01.2020 kl 12:49
3454
PledPharma to initiate one pivotal Phase II/III study with Aladote® for marketing authorisation application in both US and EU
January 8, 2020
Stockholm. PledPharma AB (STO: PLED) announced today that following interactions with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the company has finalized the development program for Aladote®, a drug candidate intended to reduce liver damage associated with paracetamol poisoning. The development program consists of one pivotal Phase II/III study which is expected to be sufficient for a marketing authorisation application in both US and EU. The study is planned to be initiated mid-2020.
Aladote is a “first-in-class” drug candidate developed to prevent liver damage caused by paracetamol overdose, which has been granted Orphan Drug Designation in the US. A proof of principle study has been successfully completed, establishing safety and tolerability and providing an indication that Aladote may reduce liver injury.
Following interactions with the FDA and the EMA, PledPharma has finalized the development program for Aladote which consists of one pivotal Phase II/III study. This study is expected to be sufficient for a marketing authorisation application in both US and EU. It is targeting patients arriving late at hospital, more than 8 hours after an overdose, and for which current standard of care, N-acetylcysteine (NAC), is no longer effective. The study will consist of two stages with an interim analysis in between that includes a futility analysis and dose selection where the most effective dose will be continued.
"We are very pleased with our interactions with both the FDA and the EMA which have enabled us to finalize our development strategy for Aladote. In parallel with our interactions with the regulatory agencies to finalize specific study details, we are performing a Contract Research Organisation (CRO) selection and working on a feasibility study to enable a rapid initiation of the clinical study. We look forward to share further details about the study in due time” said PledPharma’s CEO, Nicklas Westerholm.
https://www.pledpharma.com/mfn_news/pledpharma-to-initiate-one-pivotal-phase-ii-iii-study-with-aladote-for-marketing-authorisation-application-in-both-us-and-eu/
Redigert 20.01.2021 kl 22:49
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NoRiskNoReward
10.01.2020 kl 12:43
3418
During H2 2019, Pledpharma met with the US FDA and European EMA to discuss possible ways of advancing Aladote (paracetamol overdose) forward in clinical development. Following the discussions with the agencies, Pledpharma sees an opportunity to advance Aladote directly to a pivotal Phase II/III study where one trial will be enough as the basis of regulatory approval in Europe and the US.
It is positive that authorities do not see the need for two separate studies (Phase IIb and Phase III) nor two registrational trials to reach regulatory approval. We believe this shortens development timeline by at least one year and lowers development costs significantly. The study is expected to be initiated by mid-2020, making it possible for approval in 2022 if everything goes according to the plans.
Pledpharma has yet to communicate the final design of the study, but we expect that the trial size could be limited in number of patients, given the niched (orphan in the US) indication. The trial will include patients that have overdosed paracetamol but arrives late to the hospital (>8 hours after the overdose).
By the last of September 2019, Pledpharma had a cash position of SEK 287m. We believe the current cash holdings are sufficient to support operations to Q2 2021, but there will undoubtedly be a need for further capital to finalize the clinical programs.
Pledpharma: Advances Aladote to the final phase
Following this new development plan of Aladote, we will make an update of our model and expects the changes to have a positive impact on our base case of at least 10%. Before today’s announcement, our base case was SEK 50, indicating an upside of more than 150%.
https://www.redeye.se/research/585157/pledpharma-advances-aladote-final-phase
It is positive that authorities do not see the need for two separate studies (Phase IIb and Phase III) nor two registrational trials to reach regulatory approval. We believe this shortens development timeline by at least one year and lowers development costs significantly. The study is expected to be initiated by mid-2020, making it possible for approval in 2022 if everything goes according to the plans.
Pledpharma has yet to communicate the final design of the study, but we expect that the trial size could be limited in number of patients, given the niched (orphan in the US) indication. The trial will include patients that have overdosed paracetamol but arrives late to the hospital (>8 hours after the overdose).
By the last of September 2019, Pledpharma had a cash position of SEK 287m. We believe the current cash holdings are sufficient to support operations to Q2 2021, but there will undoubtedly be a need for further capital to finalize the clinical programs.
Pledpharma: Advances Aladote to the final phase
Following this new development plan of Aladote, we will make an update of our model and expects the changes to have a positive impact on our base case of at least 10%. Before today’s announcement, our base case was SEK 50, indicating an upside of more than 150%.
https://www.redeye.se/research/585157/pledpharma-advances-aladote-final-phase
Redigert 20.01.2021 kl 22:49
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NoRiskNoReward
10.01.2020 kl 17:23
3398
PledPharma: Interview with CEO Nicklas Westerholm (video)
Following the decision to advance Aladote into a Phase II/III clinical trial by mid-2020, we have interviewed CEO Nicklas Westerholm to get some further details about the development plans, but also to get an update of the POLAR studies.
Intervju med ceo fra i dag: https://www.redeye.se/research/585173/pledpharma-interview-ceo-nicklas-westerholm-video-1 3
Gratis å bli medlem.
Following the decision to advance Aladote into a Phase II/III clinical trial by mid-2020, we have interviewed CEO Nicklas Westerholm to get some further details about the development plans, but also to get an update of the POLAR studies.
Intervju med ceo fra i dag: https://www.redeye.se/research/585173/pledpharma-interview-ceo-nicklas-westerholm-video-1 3
Gratis å bli medlem.
Redigert 20.01.2021 kl 22:49
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Ticker
13.01.2020 kl 20:44
3305
Fra avanza.se
Marknaden uppskattas till 1500 MSEK/år för USA, EU och Japan.
RedEye har även en matris i sin analys med riktkurser vid olika antaganden om peak sales. Riktkursen för peak sales på 1500 MSEK är 72 kr i diskat nuläge (när analysen gjordes). Deras base case antar 900 MSEK i peak sales. Detta utan Aladote och expansioner, om jag förstått rätt.
Company presentationJanuary, 2020
https://www.pledpharma.com/wp-content/uploads//PledPharma-Company-Presentation-Jan-2020.pdf
Marknaden uppskattas till 1500 MSEK/år för USA, EU och Japan.
RedEye har även en matris i sin analys med riktkurser vid olika antaganden om peak sales. Riktkursen för peak sales på 1500 MSEK är 72 kr i diskat nuläge (när analysen gjordes). Deras base case antar 900 MSEK i peak sales. Detta utan Aladote och expansioner, om jag förstått rätt.
Company presentationJanuary, 2020
https://www.pledpharma.com/wp-content/uploads//PledPharma-Company-Presentation-Jan-2020.pdf
Redigert 20.01.2021 kl 22:49
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SomSa
16.01.2020 kl 11:31
3246
Company presentation January, 2020
https://www.pledpharma.com/wp-content/uploads//PledPharma-Company-Presentation-Jan-2020.pdf
P l e d O x Phase III
Prevents nerve damage caused by chemotherapy treatment in colorectal cancer patients
Huge unmet medical need with No approved drug for prevention or treatment of Chemotherapy Induced Peripheral Neuropathy
Limited competition
60% growth in CRC incidence by 2030
License agreement with Solasia to develop and commercialize PledOx® in Asia territory
Fully financed to top line results H2 2020
700k Drug treated CRC patients in US, EU5 & JPN/year
225k Number of oxaliplatin treated patients in US, EU5 & JPN/ /year
1.5m Number of oxaliplatin cycles in US, EU5 & JPN /year
Pricing assumption 1,000 USD/cycle
A l a d o t e Phase II
Prevents acute liver injury caused by paracetamol (acetaminophen) poisoning
No competitor in development
Paracetamol (acetaminophen) poisoning is one of the most common sorts of overdoses
No adequate treatment for high risk patients
Orphan Drug Designation application submitted in the US
135k Hospital admissions POD patients in US and EU5 /year
Pricing assumption 5,000 USD/dose in the US
Redigert 20.01.2021 kl 22:49
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SomSa
23.01.2020 kl 09:07
3173
STOCKHOLM (Nyhetsbyrån Direkt) Pledpharma meddelar att amerikanska läkemedelsverket FDA utfärdat ett så kallat Clinical hold av fas 3-programmet Polar för läkemedelskandidaten Pledox. FDA-beslutet innebär att ett uppehåll kommer att ske i patientrekrytering och dosering i Polar-M studien i USA.
Det framgår av ett pressmeddelande.
Beslutet av FDA är taget av säkerhetsskäl och baseras på ett fåtal observerade fall av biverkningar, skriver bolaget.
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Redigert 20.01.2021 kl 22:49
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SomSa
24.01.2020 kl 08:59
3089
Pledpharma: The clinical hold could be temporary
Redeye Research Note 2020/01/24
as long as the DSMB continues to recommend a continuation of the POLAR program, we believe the decision could be of a temporary nature. We continue to be positive about the current valuation of Pledpharma. Still, we expect the share price to remain under pressure until we get further clarity from the FDA (likely to happen in the next 1-3 months).
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. In our model, the US commercial opportunity of PledOx represents about 30%, why yesterday’s share price drop of 25% almost in full weighs in a permanent clinical hold in the US.
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https://www.redeye.se/research/585246/pledpharma-clinical-hold-could-be-temporary?utm_source=MB&utm_medium=email
Redeye Research Note 2020/01/24
as long as the DSMB continues to recommend a continuation of the POLAR program, we believe the decision could be of a temporary nature. We continue to be positive about the current valuation of Pledpharma. Still, we expect the share price to remain under pressure until we get further clarity from the FDA (likely to happen in the next 1-3 months).
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. In our model, the US commercial opportunity of PledOx represents about 30%, why yesterday’s share price drop of 25% almost in full weighs in a permanent clinical hold in the US.
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https://www.redeye.se/research/585246/pledpharma-clinical-hold-could-be-temporary?utm_source=MB&utm_medium=email
Redigert 20.01.2021 kl 22:49
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Carbo
25.01.2020 kl 17:41
3048
Programmet fortsetter. Det er kun pasientrekrutteringen og dosering i Polar-M studiet som får et opphold.
Dette pga observasjoner av bivirkninger på noen av pasientene.
Pled Pharma mener dette kommer til å være kortvarig.
Kan være en bra inngang nå på NOK 14.
Dette pga observasjoner av bivirkninger på noen av pasientene.
Pled Pharma mener dette kommer til å være kortvarig.
Kan være en bra inngang nå på NOK 14.
Redigert 20.01.2021 kl 22:49
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Ticker
28.01.2020 kl 13:22
2985
Dette er en kort nedgang og absolutt mulighet for tidenes inngang eller snitte ned.
https://twitter.com/Pavas_Pareto/status/1220377828845289473?s=20
https://twitter.com/Pavas_Pareto/status/1220377828845289473?s=20
Redigert 20.01.2021 kl 22:49
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Ticker
03.02.2020 kl 12:34
2897
Sniker seg oppover på en ellers rød børs men er fremdeles meget lav.
PARETO TAR IN DORO OCH PLEDPHARMA I MÅNADSPORTFÖLJ (NY) (Direkt)
2020-02-03 11:05
"Vi tror att aktien kommer att återhämta sig gradvis och vi övertygande om att pausen
kommer att hävas, troligtvis inom tre månader", skriver Pareto om Pledpharma."
https://www.avanza.se/placera/forum/forum/pledpharma-ab.html#7017625
PARETO TAR IN DORO OCH PLEDPHARMA I MÅNADSPORTFÖLJ (NY) (Direkt)
2020-02-03 11:05
"Vi tror att aktien kommer att återhämta sig gradvis och vi övertygande om att pausen
kommer att hävas, troligtvis inom tre månader", skriver Pareto om Pledpharma."
https://www.avanza.se/placera/forum/forum/pledpharma-ab.html#7017625
Redigert 20.01.2021 kl 22:49
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Al dosering og rekruttering af PledOx sat på pause.
Er PledPharma stadig et undervurderet selskab?
Man skal nok være heldig, hvis man kan sælge sine aktier til 5 NOK ved børsåbning i dag...
Er PledPharma stadig et undervurderet selskab?
Man skal nok være heldig, hvis man kan sælge sine aktier til 5 NOK ved børsåbning i dag...
Redigert 20.01.2021 kl 22:49
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