Key Developments: Ablynx NV (ABLX.BR)

ABLX.BR on Brussels Stock Exchange

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Latest Key Developments (Source: Significant Developments)

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 initiates phase 1 bioavailability study with subcutaneous formulation of its anti-il-6r nanobody partnered with AbbVie Inc
Wednesday, 23 Apr 2014 01:00am EDT 

Ablynx NV:Says it has started dose administration in healthy volunteers in Phase I clinical trial as part of evaluation of subcutaneous formulation of its anti-IL-6R Nanobody, ALX-0061, for treatment of inflammatory diseases, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).In Sept. 2013, Ablynx and AbbVie entered into a global license agreement, worth up to $840 million plus double-digit royalties, to develop and commercialize ALX-0061.As part of agreement, Ablynx is responsible for Phase I bioavailability study with subcutaneous formulation (sc) of ALX-0061 and Phase II clinical development of ALX-0061 sc in RA and SLE, both of which are expected to start in 2015.Upon achievement of pre-defined Phase II success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialization.Phase I study involves a single-center, open-label trial to evaluate the bioavailability of ALX-0061 after sc and intravenous (iv) administration in healthy volunteers.Study will assess pharmacodynamics, safety, tolerability and immunogenicity of single sc and iv doses of ALX-0061 in healthy subjects.Trial is expected to recruit 70 subjects who will each receive single dose of ALX-0061, either as sc injection (50 mg, 150 mg or 300 mg dose) or iv infusion (50 mg or 300 mg dose).  Full Article

Taiwan Liposome and Ablynx enters into feasibility study agreement
Thursday, 17 Apr 2014 02:00am EDT 

Taiwan Liposome Co Ltd:Entered into an agreement with Ablynx NV to research targeted nanoparticles for potential treatments across different indications combining Taiwan Liposome’s immunoliposome drug delivery platform with Ablynx’s Nanobody targeting agents.  Full Article

BRIEF-Ablynx launches sponsored Level I ADR programme in the U.S.

* Ablynx establishes sponsored Level I ADR programme in the united states

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