CBMG On Track, NAVB Chugs Along, Nuvo Gets Decision Date, VICL Trims Staff

By RTT News, August 22, 2013, 10:35:00 PM EDT

(RTTNews.com) - Cellular Biomedicine Group (CBMG) has completed patient enrollment for its phase I trial of TC-DC (Tumor Stem Cell Specific Dendritic Cell) therapy in liver cancer. The company noted that it is on track to complete the phase I trial in the fourth quarter of this year.

CBMG.OB closed Thursday's trading at $6, unchanged from the previous day's close.

Navidea Biopharmaceuticals Inc. ( NAVB ) has reached agreement with FDA on Special Protocol Assessments for its pivotal phase III program with NAV5001, an investigational radiopharmaceutical imaging agent. NAV5001 is being developed as an aid in the differential diagnosis of Parkinsonian syndromes.

The company is actively preparing for the initiation of the pivotal phase III trials for NAV5001 later this year.

NAVB closed Thursday's trading at $2.96, up 3.14%.

Nuvo Research Inc. (NRI.TO) said that the NDA for pain product PENNSAID 2% submitted by its business partner Mallinckrodt ( MNK ) on August 7, 2013 has been accepted for review by FDA. The regulatory decision is expected by February 7, 2014.

PENNSAID 2% is an improved version of Pennsaid, a non-steroidal anti-inflammatory drug, approved to treat signs and symptoms of osteoarthritis of the knee.

This is the second time that PENNSAID 2% faces FDA review. Mallinckrodt was issued a complete response letter for PENNSAID 2% in March of this year and was required to the complete a pharmacokinetic study comparing PENNSAID 2% to original PENNSAID. The resubmitted NDA included data from the pharmacokinetic study too.

NRI.TO lost 10.11% on Thursday to close at C$1.69.

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CBMG On Track, NAVB Chugs Along, Nuvo Gets Decision Date, VICL Trims Staff