Diskusjon Triggere Porteføljer Aksjonærlister

Egetis Therapeutics (EGTX)

Biotek
#1

Starter en tråd om PledPharma AB (PLED.ST) siden en del har den i favoritt-listen eller i porteføljen sin :slight_smile:

PledPharma AB, a pharmaceutical company, develops various pharmaceutical products to treat life threatening diseases. It develops PledOx (PP-095) that is in Phase IIb clinical trials to reduce severe side effects of chemotherapy in patients with colorectal cancer; and Aladote (PP-100), which is in Phase II clinical trials for the treatment of acute liver failure caused by acetaminophen/paracetamol poisoning.

The company was founded in 2006 and is based in Stockholm, Sweden. PledPharma AB is a subsidiary of Accelerator Nordic AB.

La oss starte diskusjonen! @babyrage @Calusari @havytt @Korben @greyboss @pdx

#2

PledPharma förväntar sig leverans av studieläkemedel till fas III-programmet med PledOx® i september

https://globenewswire.com/news-release/2018/08/15/1552115/0/sv/PledPharma-förväntar-sig-leverans-av-studieläkemedel-till-fas-III-programmet-med-PledOx-i-september.html?print=1

Lavt verdsatt og interessant teknisk - kan være lurt å følge med på denne utover høsten :slight_smile:

1 Like
#3

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre :slight_smile:

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

  1. @Montebello (1 likes)

Gratulerer!

#4
2 Likes
#5

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre :slight_smile:

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

  1. @larsmkn (2 likes)
  1. @Montebello (1 likes)

Gratulerer!

#6

PLEDPHARMA AB: PLEDPHARMA PRESENTS RESULTS FROM STUDY ON DRUG CANDIDATE ALADOTE FOR PARACETAMOL POISONING AT A GLOBAL TOXICOLOGY CONFERENCE

	08:00
	Stockholm, December 13, 2018. PledPharma AB (publ) announces that the

companys Aladote Phase Ib/IIa study results has been accepted for a
poster presentation during the 58th Annual Meeting of the Society of
Toxicology in March, 2019. The principal investigator Dr James Dear will
be speaker and present the positive study results.

One of the largest global conferences in toxicology is organized by the
Society of Toxicology and takes place March 10-14, 2019 in Baltimore,
Maryland. Dr James Dear, an internationally leading paracetamol toxicity
expert, was the Principal Investigator for the Proof of Principle Phase
Ib/IIa study, conducted at the Royal Infirmary of Edinburgh and the Queens
Medical Research Institute, University of Edinburgh.

Aladote is a first-in-class drug candidate, developed to reduce liver
damage due to paracetamol poisoning. The proof of principle Phase Ib/IIa
study was completed in September 2018. The results showed that Aladote is
safe and tolerable when given together with NAC (N-acetylcysteine, standard
of care). The results also indicate that Aladote can reduce liver damage
in the current patient population based on analyses of the predefined
exploratory biomarkers Keratin-18 (K18) and microRNA-122 (miR-122) in blood
samples. PledPharma is now preparing an orphan drug application to the
Federal Drug Administration, FDA, while planning for the next step of
clinical trial is being finalised.

Paracetamol/Acetaminophen poisoning is very common but the current
therapeutic options are limited to NAC. In patients who start NAC treatment
more than 8 hours after overdose this antidote loses its effectiveness.
There is an unmet need for new therapeutic options and Aladote represents
an exciting new potential therapy says Dr James Dear, University of
Edinburgh.

We are extremely proud, being selected as one of the speakers at the
Society of Toxicology Meeting. It is a sign of the great interest in our
drug candidate. I see presenting the study at one of the worlds largest
toxicology conferences is a confirmation of the quality of the study and
the drugs potential. says Nicklas Westerholm, CEO, PledPharma AB.

#7

Anbefaler å sjekke ut PledPharma. Stikkord: Hovedprodukt med potensielt blockbuster salg i pivotalt studie allerede godt gang - ingen konkurrenter- produkt 2 i fase 2B - Fullfinansiert og partner i Asia - Fin Newsflow og teknisk ser den meget fin ut. Marketcap 870 millioner SEK.

#8

Oppdatert analyse fra RedEye:

2 Likes
#9

Interessant lesning fra redeye. Har du noen tanker om Pled @babyrage ? Du pleier å være ganske oppdatert på svenske biotek selskap.

#10

Nja, intressant data. Studiene fortløper som planlagt. Kasse260 MSEK med burn-rate på 60 MSEK.

1 Like
#11

“Asia deal reinforces PledOx case
Late in 2017 a license deal was struck with the listed Japanese company Solasia Pharma
K.K, , which covers commercial rights in Japan, China, Hong Kong, Macau, South Korea and
Taiwan. The total deal value amounts to JPY 9.3 billion (about USD 85 million or SEK 770
million), including upfront, development, regulatory and commercial milestone payments, as
well as tiered, double-digit royalty on future sales (10-15%). In addition, Solasia pays all
expenses for the expansion of the POLAR trials into Asia. So far the collaboration has run
smoothly and the first patient was recently enrolled in Japan, which activated a milestone
payment of JPY 600 million (~SEK 49 million). The payment was well above our expectation
of USD 3 million (~SEK 27 million).”

PledPharma fikk nylig inn 49 millioner SEK i “milestone”-utbetaling etter at første pasient i Polar-A ble inkludert. Partnerskapet styrker selskapet med ekstra kapital så de mest sannsynlig kan utvikle pipelinen i løpet av året.

#12

Ikke helt ny men men:

Stockholm, 31 januari 2019.** **PledPharma AB (publ) meddelar att abstraktet med de positiva resultaten från Aladotes® Fas Ib/IIa proof of principle-studie har utvalts för muntlig presentation på den globala konferensen EASL ILC 2019.

EASL ILC, också känd som The International Liver Congress, är en av de globalt största vetenskapliga konferenserna inom Hepatologi (leversjukdomar) och pågår den 10-14 april i Wien, Österrike.

Dr James Dear, ansvarig prövningsledare kommer att svara för den muntliga presentationen. Dr James Dear, en internationellt ledande expert inom behandling av paracetamolförgiftning, har varit prövningsledare för proof of principle-fas Ib/IIa-studien som utfördes vid Royal Infirmary of Edinburgh och The Queen’s Medical Research Institute, University of Edinburgh.

”Det är en stor ära att få presentera våra studieresultat på EASL, en av de största och mest respekterade globala hepatologikonferenserna. Vår studie var en av de första tidiga kliniska studierna inom överdosering av paracetamol, ett område med stort kliniskt behov och en väldig vanlig orsak till intag av patienter inom akutvården” säger Dr. James Dear, University of Edinburgh.

”Vi är oerhört stolta över att ha blivit valda till att hålla en muntlig presentation på The International Liver Congress. Att få presentera Aladotes®studieresultat på en av de globalt mest erkända leverkonferenserna är ett erkännande av intresset i Aladotes® potential och det medicinska behovet i denna patientpopulation.” säger Nicklas Westerholm, vd, PledPharma AB.

Mötesinformation: EASL ILC 2019 Vienna, Austria, 10-14 April 2019

Abstract number: 2299. Abstract title: PP100-01 (calmangafodipir) for overdose of paracetamol (The POP trial): Principal results.

2 Likes
#13

Fra Carnegie healthcare seminar:

#14

PledPharma’s drug candidate Aladote® granted Orphan Drug Designation

March 18, 2019

Stockholm, March 18, 2019. PledPharma AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to the drug candidate Aladote®, in development for reducing liver damage due to paracetamol overdose.

Today’s treatment for overdose of paracetamol, N-acetylcysteine (NAC), is most effective if given within eight hours of the overdose. Patients arriving later to the hospital, and for those with a severe overdose, there is a need for more efficacious treatment options. Aladote® is a first-in-class drug candidate in development to reduce liver damage due to paracetamol overdose.

The scientific rationale as well as clinical results from the completed proof-of-principle study indicate that Aladote® in combination with NAC has the potential to reduce liver damage in the specified patient population. PledPharma intends to conduct regulatory interactions to determine the next step in development of Aladote®.

“We are very positive and proud to receive Orphan Drug Designation for Aladote®. This confirms our development strategy to serve this unmet medical need. The ODD status can benefit patients by potentially resulting in shorter development time and for us also lead to lower development costs. In addition, we will receive further dedicated support from the FDA during the drug development process and seven years of market exclusivity.” says Nicklas Westerholm, CEO PledPharma AB.

3 Likes
#15

Fra Redeye

Pledpharma: CMD takeaways

Mar 27 2019

Yesterday’s CMD provided a thorough update of the ongoing activities with PledOx and Aladote.

Our key takeaways: 1) The new POP study results support further development of Aladote, 2) Recruitment to the POLAR trials seem to be on track (no new guidance provided), 3) Preclinical studies will be carried out during 2019 to explore the opportunity of PledOx in taxanes, and 4) Up-listing to the Nasdaq Main Market, expected to happen in Q4 2019.

All in all, we feel a growing conviction of Pledpharma, as a late-stage clinical development play, and we reiterate our base case fair value of SEK 52.

2 Likes
#16

Om du har en 3-4 timer tilovers kan du få med deg CMD til Pled her
https://www.redeye.se/live/pled-kapitalmarknadsdag-2019

2 Likes
#17

PledPharma ser meget interessant ut teknisk om den bryter og 22 SEK i dag.

#18

Ser ikke 22 som spesielt signifikant, mener 20 var viktigere.

Vi ligger over 22 akkurat nå :grinning:

1 Like
#19

Er inne med ca 30k aksjer, men øker på disse nivåene selv. Tror Pled lett kan gå til 45-50 SEK i løpet av de neste 3 månedene.

#20

Takk til @zappa66 for denne Traderhjørnet

Som eg ser det er VolumBalansen så positiv den kan bli.

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2 Likes