Kiadis Pharma

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JoachimDM
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Re: Kiadis Pharma

Berichtdoor JoachimDM » 31 Jan 2018 08:36

Last patient dosed with ATIR101™ in the Phase II ‘008’ clinical trial

Results from the single dose 1-year follow up consistent with prior Phase II study
Data supports already submitted marketing authorization application

Amsterdam-Duivendrecht, The Netherlands, January 31, 2018 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell therapy products aiming to make bone marrow transplantations safer and more effective for patients, today announces that the last patient in the Phase II CR-AIR-008 (‘008’) trial has received a single dose of ATIR101™.

This exploratory Phase II trial (clinicaltrials.gov identifier: NCT02500550) was designed to evaluate the safety and efficacy of two doses of ATIR101™ in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical (half-matched) donor.

A total of 15 patients were recruited into the trial. Six of these patients received two doses of ATIR101™ before the independent data monitoring committee (IDMC) recommended that the trial should continue treating patients with one dose of ATIR101™ (announced on December 21, 2016). The remaining nine patients on the trial have now been treated with a single dose of ATIR101™. Of these nine patients, five patients are 1-year post treatment and results are consistent with the previously conducted 23-patient CR-AIR-007 single dose Phase II trial.

Arthur Lahr, CEO of Kiadis Pharma, commented: “We are pleased to have completed enrollment into this Phase II study and can now fully focus on enrollment of the Phase III study. The single dose 1-year results from this study further increase and support the data in the marketing authorization application (MAA) we submitted to the European Medicines Agency (EMA) in April 2017. The Company remains on track to potentially obtain (conditional) EMA approval for ATIR101™ in Q4 2018 which would allow for a European launch in H2 2019.”

About Kiadis Pharma
Kiadis Pharma’s allodepleted T-cell immunotherapy product can make haploidentical hematopoietic stem cell transplantations (HSCT) safer and more effective. Single dose Phase 2 data with lead product ATIR101™ given after a HSCT in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol, without the risk of severe chronic Graft versus Host Disease (GVHD). Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the EU as an adjunctive treatment in HSCT for malignant disease. Kiadis Pharma received Day 120 questions in September 2017 and is on track for potential (conditional) approval in Q4 2018 and launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101™ across Europe and North America (head to head against the Baltimore protocol). The first patient was enrolled in December 2017.

In September 2017 the US Food and Drug Administration (FDA) granted ATIR101™ the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.

The Company’s shares are listed on Euronext Amsterdam and Brussels under the ticker KDS.

Website: http://www.kiadis.com

Company presentation: http://www.kiadis.com/company-presentation/
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beeck
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Re: Kiadis Pharma

Berichtdoor beeck » 31 Jan 2018 09:14

Kiadis en Mitra, beiden +- 2.5j na ipo boven de introductiekoers :-)

roefdewoef
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Re: Kiadis Pharma

Berichtdoor roefdewoef » 31 Jan 2018 19:52

alles kan beter liked last!

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Re: Kiadis Pharma

Berichtdoor alles kan beter » 01 Feb 2018 07:45

alles kan beter schreef:Jefferies start opvolging Kiadis met koopadvies
Jefferies volgt vanaf nu ook Kiadis Pharma
op en plakt meteen een koopadvies op het Nederlandse biotechbedrijf en een koersdoel van 22 euro..

als ze zo hard gaan blijven gaan staan we in april al op 22 euro.
nu, mij niet gelaten. :D
be the reason someone smiles today. or the reason they drink. whatever works

brando
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Re: Kiadis Pharma

Berichtdoor brando » 01 Feb 2018 09:35

ook maar ingestapt. wel te hoog maar het zekere voor het onzekere genomen.
in port: Suez @ 11.91, Argenx @ 65.82, kiadis @ 13.42, genmab @ 1151 dkk, Thrombogenics @ 22 :-(

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Re: Kiadis Pharma

Berichtdoor beurssukkel » 02 Feb 2018 11:18

Ik had kiadis gemist de vorige dagen.
Daarnet kunnen kopen aan 11.68€

Hopelijk was het de bodem.

Dominiquetg
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Re: Kiadis Pharma

Berichtdoor Dominiquetg » 02 Feb 2018 17:45

beurssukkel schreef:Ik had kiadis gemist de vorige dagen.
Daarnet kunnen kopen aan 11.68€

Hopelijk was het de bodem.


Aan 11.72 ingestapt vandaag...
Argen-X Kiadis Pharming Biocartis Celyad Mithra

athoSz
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Re: Kiadis Pharma

Berichtdoor athoSz » 09 Feb 2018 21:21

Wat is belangrijk volgend nieuws waar we moeten naar uitkijken? :)

gregoire
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Re: Kiadis Pharma

Berichtdoor gregoire » 12 Feb 2018 21:13

binnen een goede maand het eerste nieuws:

- rond 27 maart 2018: beantwoording 120 days List of Questions (EMA)
- half mei 2018: ontvangst 180 days List of outstanding Issues (EMA)
- Q4 2018: uitkomst aanvraag (conditional) approval ATIR101 (EMA)

- 2019 Potential commercial launch ATIR101 in EU

:arrow: :arrow: :arrow:

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Re: Kiadis Pharma

Berichtdoor athoSz » 23 Feb 2018 10:27

Sectoral Asset Management Has Lifted Portola Pharmaceuticals (PTLA) Holding By $4.55 Million; Shorts at KIADIS PHARMA N V ORDINARY SHARES NETHE (KIADF) Lowered By 42.9%

February 22, 2018 - By reb123z

Sectoral Asset Management Inc increased Portola Pharmaceuticals (PTLA) stake by 19.96% reported in 2017Q3 SEC filing. Sectoral Asset Management Inc acquired 84,271 shares as Portola Pharmaceuticals (PTLA)’s stock rose 22.73%. The Sectoral Asset Management Inc holds 506,414 shares with $27.36 million value, up from 422,143 last quarter. Portola Pharmaceuticals now has $2.94 billion valuation. The stock increased 0.38% or $0.17 during the last trading session, reaching $45.08. About 529,767 shares traded. Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) has risen 51.17% since February 22, 2017 and is uptrending. It has outperformed by 34.47% the S&P500.

KIADIS PHARMA N V ORDINARY SHARES NETHE (OTCMKTS:KIADF) had a decrease of 42.9% in short interest. KIADF’s SI was 41,400 shares in February as released by FINRA. Its down 42.9% from 72,500 shares previously. With 100 avg volume, 414 days are for KIADIS PHARMA N V ORDINARY SHARES NETHE (OTCMKTS:KIADF)’s short sellers to cover KIADF’s short positions. The SI to KIADIS PHARMA N V ORDINARY SHARES NETHE’s float is 0.36%. It closed at $13.94221 lastly. It is down 0.00% since February 22, 2017 and is . It has underperformed by 16.70% the S&P500.

Kiadis Pharma N.V., a clinical stage biopharmaceutical company, focuses on the research and development of cell immunotherapy products for the treatment of blood cancers and inherited blood disorders in the Netherlands. The company has market cap of $247.53 million. The firm focuses on therapeutic indications, including leukaemia, a common form of blood cancer; and thalassemia, an inherited blood disorder. It currently has negative earnings. The Company’s products comprise ATIR101 , a Phase II clinical trial product, which addresses the risk and limitations of hematopoietic stem cell transplantation in blood cancer; and ATIR201, which is in Phase I/II clinical development for inherited blood disorders with an initial focus on thalassemia.


Sectoral Asset Management Inc decreased Envision Healthcare stake by 19,620 shares to 113,600 valued at $5.11 million in 2017Q3. It also reduced Pfizer Inc (NYSE:PFE) stake by 448,297 shares and now owns 957,673 shares. Edwards Lifescience (NYSE:EW) was reduced too.

Investors sentiment increased to 2.16 in 2017 Q3. Its up 0.85, from 1.31 in 2017Q2. It increased, as 20 investors sold PTLA shares while 37 reduced holdings. 38 funds opened positions while 85 raised stakes. 56.33 million shares or 15.80% more from 48.64 million shares in 2017Q2 were reported. Kazazian Asset Mgmt Limited Liability owns 12,241 shares. Teacher Retirement System Of Texas owns 5,310 shares. Panagora Asset Mngmt holds 0% or 8,537 shares in its portfolio. Evanson Asset Mgmt Limited Liability Corporation invested in 5,000 shares or 0.06% of the stock. Cubist Systematic Strategies Limited stated it has 4,039 shares or 0.01% of all its holdings. Laurion Capital Mgmt LP stated it has 0.11% in Portola Pharmaceuticals, Inc. (NASDAQ:PTLA). Atika Capital Mngmt Ltd Llc holds 0.9% or 58,000 shares in its portfolio. State Board Of Administration Of Florida Retirement System reported 24,946 shares. Moreover, Victory Inc has 0% invested in Portola Pharmaceuticals, Inc. (NASDAQ:PTLA). 120,362 were accumulated by Guggenheim Cap Limited Liability Company. Rosenblum Silverman Sutton S F Inc Ca accumulated 129,330 shares. The Pennsylvania-based Sei Investments has invested 0% in Portola Pharmaceuticals, Inc. (NASDAQ:PTLA). Wellington Management Grp Llp has 0.07% invested in Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) for 5.46 million shares. San Francisco Sentry Investment Gp (Ca) holds 150 shares. Fortaleza Asset Mgmt Inc reported 0.29% in Portola Pharmaceuticals, Inc. (NASDAQ:PTLA).

Since December 15, 2017, it had 0 insider purchases, and 1 insider sale for $563,950 activity. $563,950 worth of Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) shares were sold by Wolff Henry Ward.
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