Kids Pharma: A Smart Approach To Stem Cell Transplantation
Edison | Sep 15, 2016 08:21AM ET
Kiadis Pharma BV (AS:KDS) is developing T cell-based therapies to address the issues associated with haematopoietic stem cell transplantation (HSCT). The company is leveraging its Theralux technology to develop ATIR101 and ATIR201 as adjunct therapies to HSCT in leukaemia and thalassemia, respectively.
On the back of Phase II data, Kiadis is aiming for accelerated filing of ATIR101 with the European Medicines Agency (EMA) in Q117. A Phase III trial will start in H216. ATIR201 will start a Phase I/II trial in H216. Cash at end June 2016 was €23.7m, sufficient to fund operations until early 2018. We value the company at €327.3m or €27.1/share.
Looking to a fast path to market
Following ATIR101 Phase II data, Kiadis has decided to file for conditional approval with the EMA in Q117, setting a potential approval date in Q118. We believe it is possible that Kiadis may get approval given the precedent set by MolMed, which recently received Conditional Marketing Authorisation (CMA) from the European Commission on data from a small Phase II study that showed a one-year survival rate of 49% vs 37% for historical control.
The regulatory pathway is also clear in the US; the Phase III primary endpoint and active comparator arm have been defined after an end of Phase II meeting with the FDA. This Phase III trial is needed for full approval in both the US and EU.
To read the entire report Please click on the pdf File Below
Kiadis Pharma - A Smart Approach To Stem Cell Transplantation
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.