Nuvo Research Inc.(NRIFF)- OTCPK - Current
  • Wed, Aug. 10, 5:03 PM
    | Wed, Aug. 10, 5:03 PM
  • Wed, May 11, 5:15 PM
    | Wed, May 11, 5:15 PM
  • Wed, Feb. 17, 5:27 PM
    • Nuvo Research (OTCPK:NRIFF): Q4 EPS of C$0.03
    • Revenue of C$7.8M (+129.4% Y/Y)
    | Wed, Feb. 17, 5:27 PM
  • Feb. 11, 2015, 3:42 PM
    • Anika Therapeutics (ANIK +0.9%) files a premarket approval application (PMA) with the FDA and an application seeking CE Mark clearance in the E.U. for approval to commercialize Cingal (sodium hyaluronate with triamcinolone hexatonide) for the single-injection treatment of osteoarthritis of the knee. The product utilizes the same hyaluronic acid as Monovisc plus a commonly used steroid.
    • Related tickers: (FLXN -0.4%)(HZNP +0.8%)(OTCPK:NRIFF +4.6%)(AMPE +6.7%)(MNK -1.3%)(XENE -0.9%) (NASDAQ:CBYL)
    | Feb. 11, 2015, 3:42 PM
  • Feb. 2, 2015, 4:27 PM
    • The first patient has been dosed in a 450-patient Phase 3 clinical trial assessing Flexion Therapeutics' (NASDAQ:FLXN) lead product candidate, FX006, for the treatment of moderate-to-severe pain associated with osteoarthritis of the knee.
    • FX006 is a novel, non-opioid, sustained release, intra-articular formulation of triamcinolone acetonide. The company expects top line data in 2016.
    • The FDA lifted its clinical hold on the company's Phase 2b trial in early December after it concluded its investigation of a case of septic shock in one patient.
    • Previously: Clinical hold lifted for Flexion's lead product (Dec. 1, 2014)
    | Feb. 2, 2015, 4:27 PM | 3 Comments
  • Jan. 27, 2015, 1:13 PM
    • Palo Alto, CA-based Carbylan Therapeutics (Pending:CBYL) is set for its IPO of 5.8M shares of common stock at $12 - 14. Underwriters over-allotment is an additional 870K shares.
    • The clinical stage specialty pharmaceutical firm develops novel and combination therapies that address significant unmet medical needs. The technological basis for its products is a methodology that cross-links hyaluronic acid to form hydrogels. Alterations in the formula enable the formation of hydrogels in a wide range of textures, from soft to hard. Biologically-active agents can be directly incorporated into the gels, which can be applied topically or parenterally.
    • Its lead product candidate is Hydros-TA, currently in Phase 3 development, an injectable therapy to treat the pain associated with osteoarthritis of the knee. The company expects to submit a New Drug Application (NDA) to the FDA for this indication in early 2017.
    • Net losses for 2014 (9 mo.) and 2013 were $8.6M and $5.7M, respectively.
    | Jan. 27, 2015, 1:13 PM | 3 Comments
  • Oct. 17, 2014, 10:17 AM
    • Horizon Pharma plc (HZNP +5.3%) acquires the U.S. rights to Nuvo Research's (OTCPK:NRIFF) Pennsaid (diclofenac sodium topical solution) 2% for the treatment of pain due to osteoarthritis of the knee for a one-time payment of $45M in cash.
    • Pennsaid 2% is a second generation version of Pennsaid 1.5%. Effective January 1, 2015 Pennsaid 1.5% will no longer be marketed in the U.S.
    • Nuvo retains its existing rights to both products ex-U.S.
    • The FDA approved Pennsaid 2% on January 16, 2014.
    | Oct. 17, 2014, 10:17 AM
  • Jan. 17, 2014, 7:32 AM
    • The FDA has approved Mallinckrodt's (MNK) NDA for Pennsaid 2%, a topical non-steroidal anti-inflammatory treatment for osteoarthritis of the knee.
    • U.S. sales and marketing rights for Pennsaod are licensed to Mallinckrodt by Nuvo Research (NRIFF).
    • The approval comes with warnings about the risks of non-steroidal anti-inflammatories to the heart and the rest of the cardiovascular system, and to the liver. (PR)
    | Jan. 17, 2014, 7:32 AM