Key Developments: Ablynx NV (ABLX.BR)

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Latest Key Developments (Source: Significant Developments)

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

Ablynx NV's Anti-vwf Nanobody, Caplacizumab, achieves clinical proof-of-concept in Phase II Titan study
Tuesday, 17 Jun 2014 01:07am EDT 

Ablynx NV:Says it has achieved positive results in the Phase II Titan study with the anti-vWF Nanobody, caplacizumab, in patients with acquired thrombotic thrombocytopenic purpura (TTP).TTP is a rare disorder of the blood coagulation system that causes microthrombi to form which can block small blood vessels throughout the body.Primary endpoint of the trial was the time to confirmed platelet normalisation which guides the clinical decision to stop the daily plasma exchanges.  Full Article

Ablynx to present additional positive data on anti-IL-6R Nanobody ALX-0061
Tuesday, 10 Jun 2014 01:00am EDT 

Ablynx NV:To present additional positive data on its anti-IL-6R Nanobody, ALX-0061, at Annual European Congress of Rheumatology (EULAR), taking place from June 11 to 14 in Paris.Presentation to include results from post-hoc analysis of data collected in 24-week combined Phase I/II study in patients with moderately-to-severely active rheumatoid arthritis (RA) on stable background of methotrexate.Data show that, in patients with established RA, intravenously administered ALX-0061 induces and maintains remission as assessed by both DAS28 criteria and Boolean remission definition.Control of disease activity with ALX-0061 results in regaining normal physical function, supporting treat-to-target management of RA.  Full Article

Ablynx NV issues pipeline update
Wednesday, 14 May 2014 01:00am EDT 

Ablynx NV:Says in order to support the start of first-in-infant study during Q4 2014 with the anti-RSV Nanobody, the Company carried out additional pre-clinical study in neonatal lambs together with two additional Phase I studies focusing on safety and pharmacokinetics (PK).Neonatal lamb study successfully demonstrated that daily inhalation of ALX-0171 resulted in reduction of viral titres and lung inflammation, and was effective in alleviating various clinical signs and symptoms.New Phase I results were announced on May 6.Phase I safety study demonstrated that in patients with hyper-reactive airways, if bronchoconstriction occurred after inhalation of ALX-0171, then it could be reversed with standard bronchodilators.Phase I PK study in healthy volunteers showed again that ALX-0171 was well tolerated and that once-daily administration resulted in rapid attainment of clinically relevant Nanobody levels in lung.Says after completing pre-clinical studies with anti-IgE Nanobody, ALX-0962, for use in severe allergic asthma, Ablynx has decided not to move forward with this program into Phase I studies because of insufficient differentiation from competition.Says in May, Boehringer Ingelheim (B.I.) terminated a Phase I study initiated in Oct. 2013, with a Nanobody designed to treat Alzheimer`s disease, prior to completion of volunteer recruitment.Study was stopped according to protocol and B.I. is now reviewing program.  Full Article

Ablynx NV completes two further phase I clinical studies
Tuesday, 6 May 2014 01:30am EDT 

Ablynx NV:Says that it has obtained positive results from two additional Phase I studies, utilising its wholly owned anti-RSV Nanobody(ALX-0171) designed for the treatment of Respiratory Syncytial Viral (RSV) infections.Following on from the successful Phase I study reported in Sept. 2012.ALX-0171 is Ablynx's first inhaled Nanobody and was administered to adults via a nebulizer in a safety study and in a pharmacokinetic study.  Full Article

Ablynx burns more cash in first half of 2015

BRUSSELS, Aug 27 - Belgian biotech firm Ablynx burnt through more cash in the first half of 2015, as it increased spending on research and clinical trials for its experimental drugs.

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