May 22, 2015, 9:16 AM
May 21, 2015, 9:16 AM
May 21, 2015, 8:42 AM
- Micro cap Ampio Pharmaceuticals (NYSEMKT:AMPE) is up 28% premarket on robust volume in response to its announcement of positive results from a Phase 3 study, OptimEyes, assessing orally administered Optina (danazol) in 355 adult patients with diabetic macular edema (DME).
- 53% (n=188/355) of trial participants were unresponsive (refractory) to intraocular injection therapy. This group showed a +6.2 letter improvement in visual acuity over the three-month study period (p<0.001). In the remaining 47% (n=167/355), participants who were unable or unwilling to have eye injections (n = unknown) showed a +3.1 letter improvement over the same period (p=0.04). The placebo arm, as expected, failed to demonstrate a significant increase in visual acuity.
- The company neglects to disclose the results for the entire trial (n=355) or the 47% segment (n=167).
- Ampio plans to continue its analysis and present the data to the FDA. After receiving guidance, it will disclose more detailed information. Translation: the study, in its totality, failed to achieve its efficacy endpoint.
Apr. 20, 2015, 12:47 PM
Apr. 20, 2015, 9:32 AM
- Micro cap Ampio Pharmaceuticals (NYSEMKT:AMPE) craters 58% premarket on robust volume in response to its announcement that the Phase 3 clinical trial evaluating AP008 for the reduction in pain associated with osteoarthritis of the knee failed to reach its primary endpoint compared to placebo due to a larger-than-expected range of results in the placebo arm. The company is analyzing the data and will host a conference call in the near future to discuss the results.
Apr. 20, 2015, 9:17 AM
Mar. 23, 2015, 5:37 PM
Feb. 25, 2015, 9:24 AM
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)
Jan. 14, 2015, 3:45 PM
- Micro cap Ampio Pharmaceuticals (AMPE +17.1%) appears to be getting some pop from yesterday's presentation at the Biotech Showcase by wholly-owned subsidiary Vyrix Pharmaceuticals (Pending:VRYX). Shares are up on double normal volume.
- Vyrix's lead product is Zertane (tramadol HCl) for the treatment of premature ejaculation. Tramadol has been marketed for years as an opioid pain medication. It was first launched in Germany in 1977.
Nov. 12, 2014, 9:05 AM
- Nano cap Ampio Pharmaceuticals (NYSEMKT:AMPE) is off 10% premarket in apparent response to this morning's announcement that it will add the 40 patients in the double-blind portion of the STRUT trial to its analysis of results from the seven patients in the open label portion. The results for WOMAC A, B and C scores at week 20 will be available in Q1 2015 but the complete set of data will not be compiled until week 52, which will be late 2015.
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
Aug. 22, 2014, 12:45 PM
Aug. 21, 2014, 1:11 PM
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company, which focuses on the development of therapies to treat prevalent inflammatory conditions. Its product pipeline includes new uses for approved drugs and new molecular entities for important therapeutic areas, including metabolic disease,... More
Industry: Drug Manufacturers - Other
Country: United States
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