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Neovacs SA (ALNEV.PA)

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Latest Key Developments (Source: Significant Developments)

Neovacs announces FDA acceptance of new IND to expand Ifnalpha Kinoid clinical development program in dermatomyositis
Wednesday, 19 Jul 2017 01:30am EDT 

July 19 (Reuters) - NEOVACS SA ::REG-NEOVACS ANNOUNCES FDA ACCEPTANCE OF A NEW IND TO EXPAND IN U.S. IFNALPHA KINOID CLINICAL DEVELOPMENT PROGRAM IN DERMATOMYOSITIS.CAN NOW INITIATE IN THE US ITS PHASE IIA CLINICAL TRIAL ALREADY ON-GOING IN EUROPEAN COUNTRIES.PHASE IIA CLINICAL TRIAL CURRENTLY BEING CONDUCTED IN EUROPE (FRANCE, ITALY, GERMANY, AND SWITZERLAND) IN 30 ADULT PATIENTS.  Full Article

Neovacs syas phase IIb trial Ifnalpha Kinoid in Lupus gets positive IDSMB review
Tuesday, 11 Jul 2017 01:30am EDT 

July 11 (Reuters) - NEOVACS SA :REG-NEOVACS ANNOUNCES POSITIVE IDSMB REVIEW FOR PHASE IIB CLINICAL TRIAL OF IFNALPHA KINOID IN LUPUS.‍THIRD IDSMB DATA REVIEW OF ONGOING PHASE IIB CLINICAL TRIAL​.‍"ALL PATIENTS ARE NOW FOLLOWED DURING 9 MONTHS, AND OUR GOAL IS TO REPORT DATA IN Q2 2018."​.  Full Article

Neovacs announces license agreement for Ifnalpha Kinoid for treatment of lupus in Turkey
Wednesday, 5 Jul 2017 01:00am EDT 

July 5 (Reuters) - NEOVACS SA :REG-NEOVACS ANNOUNCES LICENSE AGREEMENT FOR IFNALPHA KINOID FOR TREATMENT OF LUPUS IN TURKEY.REG-NEOVACS ANNOUNCES LICENSE AGREEMENT FOR IFNALPHA KINOID FOR TREATMENT OF LUPUS IN TURKEY.UNDER TERMS OF AGREEMENT, NEOVACS WILL RECEIVE A TOTAL OF EUR 6 MILLION.WILL RECEIVE DOUBLE DIGIT ROYALTIES ON NET SALES OF IFNALPHA KINOID IN TURKEY.  Full Article

Neovacs FY operating loss widens to 17.3‍​ million euros
Thursday, 30 Mar 2017 11:45am EDT 

Neovacs SA : FY revenue ‍​0.4 million euros versus 1.2 million euros ($1.29 million) year ago . FY operating loss of 17.3‍​ million euros versus loss of 11.3 million euros year ago .FY net loss of ‍​13.9 million euros versus loss of 4.7 million euros year ago.  Full Article

Neovacs and Biosense sign option agreement worth up to €65 million plus royalties
Tuesday, 21 Feb 2017 08:00am EST 

Neovacs SA : Neovacs and Biosense sign option agreement worth up to €65 million plus royalties for Chinese development and commercial rights to ifnα kinoid for lupus and dermatomyositis . Neovacs SA - Neovacs receives an upfront fee and is eligible for additional milestone payments and double-digit sales royalties . Neovacs SA - Biosense receives option for development, commercial rights to ifnα kinoid for lupus and dermatomyositis in China, other selected territories . Neovacs SA - upon completion of Neovacs' ongoing Phase IIB trial for ifnα kinoid in lupus biosense will receive commercial rights for ifnα kinoid . Neovacs SA - Biosense will fund a Phase III clinical trial for ifnα kinoid in China . Neovacs SA - Biosense will bear all costs associated with these development and regulatory-related initiatives . Neovacs SA - Biosense receives first right of refusal in agreed upon asian markets for any further ifnα kinoid indications, including type 1 diabetes .Neovacs SA - additional terms were not disclosed.  Full Article

Neovacs and Biosense sign option agreement worth up to 65 million euros
Tuesday, 21 Feb 2017 01:30am EST 

Neovacs SA : And biosense sign option agreement worth up to 65 million euros ($68.80 million) plus royalties for Chinese development and commercial rights to Ifnalpha Kinoid for lupus and dermatomyositis . Receives an upfront fee and is eligible for additional milestone payments and double digit sales royalties .Receives option for development and commercial rights to Ifnalpha Kinoid for lupus and dermatomyositis in China and other selected territories.  Full Article

Neovacs issued new broad patent in China for IFNalpha Kinoid
Thursday, 9 Feb 2017 02:06am EST 

Neovacs SA : Announced today that it has received notification of a new patent from the Chinese patent office . Issued new broad patent in China for IFNalpha Kinoid .Patent is valid until at least 2032.  Full Article

Neovacs obtains FDA "Fast Track" designation for IFNalpha Kinoid in Lupus (SLE)
Wednesday, 7 Dec 2016 01:00am EST 

Neovacs SA : Neovacs is currently enrolling patients in an international phase IIb trial (IFN-K 002) in Lupus (SLE) .This study, which has already recruited more than half of its targeted 178 patients, is underway in 21 countries in Europe, Asia, Latin America and US.  Full Article

Neovacs announces cooperation agreement with the immunology of diabetes department at the Paris Cochin hospital
Wednesday, 12 Oct 2016 01:35am EDT 

Neovacs SA : Cooperation agreement with the immunology of diabetes department at the Paris Cochin hospital .The objective of this agreement is to achieve proof of concept for IFNa Kinoid in type 1 diabetes.  Full Article

Neovacs H1 net loss widens to 6.8 mln euros
Friday, 30 Sep 2016 11:45am EDT 

Neovacs SA : H1 net loss is 6.8 million euros ($7.6 million) versus a loss of 4.9 million euros a year ago . H1 operating loss is 7.9 million euros versus a loss of 5.6 million euros a year ago . H1 revenue is 104,000 euros versus 94,000 euros a year ago .Neovacs will present at attend bio europe 2016 to be held in cologne November 7-9.  Full Article

BRIEF-Neovacs announces FDA acceptance of new IND to expand Ifnalpha Kinoid clinical development program in dermatomyositis

* REG-NEOVACS ANNOUNCES FDA ACCEPTANCE OF A NEW IND TO EXPAND IN U.S. IFNALPHA KINOID CLINICAL DEVELOPMENT PROGRAM IN DERMATOMYOSITIS