Key Developments: Ablynx NV (ABLX.BR)

ABLX.BR on Brussels Stock Exchange

24 Apr 2015
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Latest Key Developments (Source: Significant Developments)

Ablynx initiates second of two phase IIb RA studies partnered with Abbvie
Tuesday, 7 Apr 2015 01:00am EDT 

Ablynx NV:Ablynx initiates second of two phase IIb RA studies with its anti-IL-6R nanobody, partnered with Abbvie.Announces that it has administered first dose in phase IIb study to evaluate efficacy and safety of its anti-IL-6r nanobody, ALX-0061.Study is expected to enroll 228 subjects in United States, Europe and South America.Top line results from two phase IIb studies in RA expected before end of 2016.  Full Article

Ablynx NV announces extension of ion channel research collaboration with Merck & Co., Inc
Thursday, 26 Mar 2015 02:10am EDT 

Ablynx NV:Announces an extension of its initial two-year research collaboration with Merck & Co., Inc., known as MSD outside the United States and Canada, to develop and commercialise Nanobody candidates directed towards an undisclosed voltage gated ion channel.Says Merck & Co., Inc. will extend their funding of the research collaboration with Ablynx to the end of Sept. 2016.Says this ion channel collaboration was announced in Oct. 2012 and included a EUR6.5 million upfront payment and EUR2 million in initial research funding.  Full Article

Ablynx announces decision by board of appeal concerning Domantis patent
Thursday, 22 Jan 2015 01:00am EST 

Ablynx NV:Says it has been successful in opposing appeal lodged by Domantis (now member of Glaxosmithkline group of companies) in 2010 against decision by opposition division of European patent office to revoke Domantis' European patent 1 517 921.As a result of decision by board of appeal, Domantis patent will remain revoked in full without further possibility to appeal.  Full Article

Additional clinical data from the PHASE II Study With Ablynx NV's Anti-vwf Nanobody, Caplacizumab, presented at American Society Of Hematology annual meeting
Monday, 8 Dec 2014 10:06am EST 

Ablynx NV:Says additional clinical results, including some post hoc analyses, from the worldwide Phase II TITAN trial with its anti-von Willebrand Factor (vWF) Nanobody, caplacizumab, in patients with acquired thrombotic thrombocytopenic purpura (TTP).Results were presented (abstract #229 ) by Professor Peyvandi, Principal Investigator for the TITAN trial, at the American Society of Hematology (ASH) Annual Meeting in San Francisco, CA.TTP is a rare disorder of the blood coagulation system that causes formation of microthrombi that block the small blood vessels leading to tissue ischemia.  Full Article

Ablynx NV on track to start Phase III study in patients with acquired TTP in mid 2015
Wednesday, 26 Nov 2014 01:06am EST 

Ablynx NV:Announces positive results from the Phase I trial to demonstrate bioequivalence between the liquid and lyophilised formulations of caplacizumab, Ablynx's anti-von Willebrand factor Nanobody developed for the treatment of acquired TTP.The liquid formulation has been used in clinical trials to date but the lyophilised form is more stable and can be stored and transported at 5°C, which is much more convenient than the liquid formulation, which has to be stored and shipped frozen.Says the lyophilised form will now be used in the forthcoming Phase III trial and would be the formulation of choice for commercialisation.The Phase I trial involved a single-centre, open-label, randomised, single dose cross-over study in 24 healthy male subjects to evaluate the bioequivalence and tolerability of liquid and reconstituted lyophilised formulations of caplacizumab administered subcutaneously.Says the bioequivalence criteria were based on the evaluation of the "area under the plasma concentration versus time curve (AUC)" and the "maximum observed plasma concentration.  Full Article

Ablynx Expects to start first-in-infant phase IIA study with anti-RSV nanobody, ALX-0171, before end of 2014
Thursday, 13 Nov 2014 01:00am EST 

Ablynx NV:Expects to start first-in-infant phase IIA study with anti-RSV nanobody, ALX-0171, before end of 2014.  Full Article

Ablynx NV's anti-Il-6r nanobody partnered with Abbvie demonstrates a bioavailability of more than 80 pct after subcutaneous injection
Thursday, 23 Oct 2014 01:00am EDT 

Ablynx NV:Announces positive results from the Phase I bioavailability study of the subcutaneous formulation of its anti-IL-6R Nanobody, ALX-0061, for the treatment of inflammatory diseases.Bioavailability after subcutaneous administration was higher than 80 pct and there were no significant safety or tolerability signals noted with subcutaneous administration of ALX-0061.In Sept. 2013, Ablynx and AbbVie entered into a global license agreement, worth up to $840 million plus double-digit royalties, to develop and commercialise ALX-0061.  Full Article

Ablynx NV signs exclusive license agreement with Eddinpharm to develop and commercialize its anti TNFa Nanobody in Greater China
Monday, 1 Sep 2014 01:05am EDT 

Ablynx NV:Announces that it has granted Eddingpharm an exclusive license to develop and commercialize Ablynx's anti-TNFa Nanobody, ozoralizumab (ATN-103), in China, Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including rheumatoid arthritis (RA).Says under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialization in Greater China of anti-TNFa Nanobody therapeutics.Says the company will have access to the clinical data generated by Eddingpharm to support potential licensing discussions in other geographic regions.Says the company will receive an upfront payment of 2 million euros, payable in two tranches, and is entitled to receive development and commercial payments plus tiered, double-digit royalties of up to 20 percent, based on annual net sales of ozoralizumab generated by Eddingpharm in Greater China.  Full Article

Ablynx NV successfully raises 41.7 million euros
Monday, 30 Jun 2014 04:41pm EDT 

Ablynx NV:Says it has raised 41,720,822 euros through private placement of new shares via an accelerated book building procedure announced on June 30, 2014.Private placement has allowed Ablynx to place 4,908,332 new shares with domestic and international institutional investors at price of 8.50 euros per share, a 5.56 pct discount to previous day's closing price.New shares represent 10 pct of current number of outstanding shares and will bring the total number of shares after the issue to 53,991,659.New shares will be admitted to trading on Euronext Brussels following their issuance, which is expected to take place on July 07, 2014.Funds will be used to allow flexibility in choices regarding further development of Company's currently fully-owned clinical assets caplacizumab (anti-vWF) and ALX-0171 (anti-RSV).Also uses to continue to build momentum with Nanobodies targeted to immune check-point inhibitors and accelerate the development of such assets both in wholly-owned programmes and with partners.Also uses to initiate, continue to advance, and/or accelerate the pre-clinical and clinical development of wholly- and co-owned programmes to further expand the Company's diverse portfolio of programme assets.Also uses for general corporate purposes. Jefferies International Limited, KBC Securities NV and Kempen & Co N.V. acted as Joint Bookrunners for the placement.  Full Article

Ablynx NV to present pre-clinical proof-of-concept data for Anti-KV1.3 nanobodies at two Ion channel meetings
Thursday, 19 Jun 2014 01:07am EDT 

Ablynx NV:Says it will present pre-clinical proof-of-concept data on anti-Kv1.3 Nanobody at two upcoming ion channel meetings.The four presentations will take place at the Collaborations in Ion Channel Drug Discovery meeting being held in Cambridge, UK from June 19 to 20, and at the 12(th)Annual Ion Channel Retreat being held in Vancouver, Canada from June 25 to 27.  Full Article

BRIEF-Ablynx initiates second of two phase IIb RA studies

* Ablynx initiates the second of two phase IIb RA studies with its anti-IL-6R nanobody, partnered with Abbvie

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