Key Developments: Ablynx NV (ABLX.BR)

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Latest Key Developments (Source: Significant Developments)

Ablynx NV to Receive EUR 1.68 Million Grant Funding to Advance Inhaled Nanobody in Infants
Thursday, 31 Oct 2013 02:31am EDT 

Ablynx NV announced that it has received notice of a EUR 1.68 million in grant funding from the Flemish Agency for Innovation by Science and Technology (IWT) to help advance the Company's inhaled Nanobody, ALX-0171, in infants. The grant funding, which is available over a period of one year, will also be used to explore new applications of nebulised Nanobodies.  Full Article

Ablynx NV Receives Milestone Payment As Partner of Boehringer Ingelheim
Tuesday, 29 Oct 2013 02:30am EDT 

Ablynx NV announced that its partner Boehringer Ingelheim has dosed the first healthy volunteers in a Phase I clinical trial as part of the evaluation of a Nanobody for the treatment of Alzheimer's disease. The start of the Phase I study triggers a milestone payment of EUR 5 million to Ablynx NV. The Phase I study involves a single-centre, partially randomised, single-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of intravenous and subcutaneous injections with the Nanobody in healthy subjects. The trial is expected to recruit 80 healthy volunteers and results are anticipated during the second half of 2014.  Full Article

Ablynx NV to Present Pre-Clinical Proof-of-Concept Data on ALX-0761 at ACR
Monday, 28 Oct 2013 02:30am EDT 

Ablynx NV announced that pre-clinical proof-of-concept data from ALX-0761, a Nanobody partnered with Merck Serono, will be presented at the Annual Meeting of the American College of Rheumatology (ACR), 26 to 30 October 2013, San Diego, California. The poster presentation will include data from in vivo experiments that assessed the efficacy of ALX-0761 in a cynomolgus monkey model that mimics human rheumatoid arthritis. In addition, total target levels of both IL-17A and IL-17F, pharmacodynamic biomarkers, immunogenicity and drug exposure were analyzed. The proof-of-concept results demonstrated that both IL-17A and IL-17F play a role in the onset and/or maintenance of rheumatoid arthritis and that ALX-0761 improved the clinical endpoints: X-ray score B (the score for bone erosion or architectural joint destruction accompanied by bone erosion) and the arthritis score (the total of the swelling scores of the individual joints). Furthermore, promising biomarkers were identified to aid further clinical development.  Full Article

Ablynx NV Signs Exclusive License Agreement With Eddingpharm To Develop And Commercialise Anti-Rankl Nanobody In Greater China
Friday, 18 Oct 2013 01:31am EDT 

Ablynx NV announced that it has granted an exclusive, royalty-bearing license to Eddingpharm, ALX-0141, in the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases. Under the terms of the agreement, Eddingpharm will be responsible for the clinical development, registration and commercialisation in Greater China of anti-RANKL Nanobody therapeutics. Ablynx will have access to the data generated by Eddingpharm to support potential licensing discussions in other geographic regions. Ablynx will receive a EUR2 million upfront payment from Eddingpharm and is entitled to receive commercial payments plus tiered, double-digit royalties of up to 20%, based on annual net sales of ALX-0141 generated by Eddingpharm in Greater China. ALX-0141 is a bivalent bi-specific therapeutic molecule composed of two Nanobodies targeting the Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL). This bivalent anti-RANKL construct is linked to a Nanobody that binds to human serum albumin, extending the drug's in vivo half-life, and which may in turn lead to preferential targeting of diseased tissue. A Phase I study in healthy post-menopausal women showed that a single administration of ALX-0141 has a long lasting inhibitory effect on bone resorption biomarkers and was well tolerated with no serious adverse events or dose-limiting toxicity being observed.  Full Article

Gimv Nv Sells Stake in Ablynx NV
Thursday, 17 Oct 2013 11:45am EDT 

Gimv Nv announced that the Company and its subsidiary Biotech Fonds Vlaanderen sold their remaining stake in the Belgian biotech company Ablynx NV.  Full Article

Ablynx NV Elects New Chairman Of Board
Monday, 7 Oct 2013 01:31am EDT 

Ablynx NV announced that it is the intention of the Board to separate the roles of Chairman and CEO. The Board intends to elect Dr Fellner as Chairman to succeed Dr Moses who will remain Chief Executive Officer. The Company also announced that it is the intention of Dr Stephen Bunting and Mr Denis Lucquin to resign from the Ablynx Board.  Full Article

Ablynx NV And Merck KGaA's Merck Serono Further Strengthen Their Collaboration On Co-discovery And Co-development Of Nanobodies
Thursday, 26 Sep 2013 01:31am EDT 

Ablynx NV and Merck Serono, the biopharmaceutical division of Merck KGaA, announced that they have further expanded their relationship through a multi-year research alliance that could lead to at least four co-discovery and co-development collaborations. Under the terms of the agreement, Merck Serono will fund a dedicated discovery group at Ablynx. Both partners will jointly select disease targets against which this group will develop Nanobodies, up to in vivo proof-of-principle. The dedicated group will focus on the discovery and development of Nanobodies against a number of targets across multiple disease areas. The collaboration will span all of Merck Serono's core research and development fields, including oncology, immuno-oncology, immunology and neurology.  Full Article

Ablynx NV And AbbVie Inc Sign Global License Agreement For anti-IL-6R Nanobody, ALX-0061, To Treat Inflammatory Diseases
Monday, 23 Sep 2013 01:01am EDT 

Ablynx NV and AbbVie Inc announced that they have entered into a global license agreement to develop and commercialize the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases. ALX-0061 is Ablynx's anti-IL-6R Nanobody that successfully completed a Phase IIa study in February 2013 reporting efficacy and safety data in patients with moderately to severely active rheumatoid arthritis (RA) on a stable background of methotrexate. Under the terms of the agreement, Ablynx will be responsible for completing Phase II clinical development in both RA and systemic lupus erythematosus (SLE). Upon the achievement of pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialization. Ablynx will retain an option for co-promotion rights in Belgium, the Netherlands and Luxembourg. Ablynx will receive an upfront payment of $175 million, which will partly be used to fund the next phases of clinical development of ALX-0061. Upon achievement of certain development, regulatory, commercial and sales-based milestones, Ablynx will be eligible to receive additional milestone payments totalling up to $665 million as well as double-digit tiered royalties on net sales upon commercialization.  Full Article

Ablynx NV Announces Exercise of Warrants for EUR EUR 884,476.40
Tuesday, 23 Jul 2013 12:01pm EDT 

Ablynx NV announced that an additional 273,913 common shares have been issued by the Company in exchange for EUR 884,476.40 as the result of the exercise of warrants by some employees and consultants of the Company. As a result of this transaction, Ablynx NV has 48,802,115 shares outstanding.  Full Article

Ablynx NV Starts Additional Phase 1 Studies with Anti-RSV Nanobody ALX-0171
Thursday, 4 Jul 2013 01:31am EDT 

Ablynx NV announced that it has initiated two additional Phase I studies with its anti-RSV Nanobody, ALX-0171, with the goal of commencing paediatric development during the second half of 2014. Respiratory Syncytial Virus (RSV) is a respiratory virus that infects the lungs and respiratory tract and is the most common cause of bronchiolitis and pneumonia in children under one year of age. The additional Phase I studies are being performed to determine the appropriate dosing regimen in the subsequent paediatric development of the Nanobody, and will include a safety study in adults with hyper-responsive airways and a local and systemic pharmacokinetic (PK) study in healthy volunteers. The results of both Phase I studies are expected during the first half of 2014.  Full Article

BRIEF-Ablynx says awarded 2.1 mln euros grant by Flemish Agency

* Ablynx : Ablynx awarded EUR 2.1 million grant to support development of novel nanobodies for ocular applications

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