Nuvo's Revamped Strategy Should Unlock Significant Value
Jason Napodano, CFA
Jason Napodano, CFA
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. 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)
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:ANIK) (NYSE:MNK) (NASDAQ:CBYL)
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.
- OA-related tickers: (NASDAQ:HZNP) (OTCPK:NRIFF) (NASDAQ:XENE) (NYSEMKT:AMPE) (NASDAQ:FLXN) (NASDAQ:ANIK) (NYSE:MNK)
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.
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)
Nuvo Research Inc. is a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10.
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