Wed, Mar. 11, 10:56 AM
- Biotech investors, giddy over the robust demand for hepatitis C drugs like Gilead's (GILD +0.4%) Sovaldi and Harvoni, are eagerly anticipating the next wave of new therapies for non-alcoholic steatohepatitis (NASH) or "fatty liver disease." It resembles the alcoholic variety but affects people who drink little or no alcohol. According to the NIH, it affects 2 - 5% of Americans.
- Publicly-traded companies with NASH-related development programs include: Tobira Therapeutics (RGDO +2.3%), Islet Sciences (OTCQB:ISLT), Merck (MRK -0.5%), Intercept Pharmaceuticals (ICPT +3.4%), Gilead Sciences, Shire plc (SHPG -0.6%), Galectin Therapeutics (GALT), La Jolla Pharmaceutical (LJPC -1.5%), Conatus Pharmaceuticals (CNAT -1.2%), Raptor Pharmaceutical (RPTP -1.3%), Galmed Pharmaceuticals (GLMD +1.9%) and Genfit (OTCPK:GNFTF).
- TheStreet's Adam Feuerstein says that comparing clinical trial results between firms will require scrutiny because of differences in the designs of the studies, including efficacy criteria and treatment duration. In an article published today, he compares the ongoing trials of Genfit and Intercept. Genfit's efficacy endpoint of its mid-stage study is less stringent than Intercept's but it may make it more difficult to demonstrate a statistically significant benefit versus placebo. Results from Genfit's trial are expected later this month. If positive, it should rally NASH-related stocks.
Thu, Feb. 26, 4:08 PM
Wed, Jan. 14, 9:42 AM
- In an all-stock transaction, privately-held Tobira Therapeutics will merge with a wholly-owned subsidiary of Regado Biosciences (RGDO +59.3%). The combined organization, renamed as Tobira Therapeutics, will focus on the development of novel treatments for liver and inflammatory diseases. Tobira CEO Laurent Fischer, M.D., will lead the firm.
- Tobira's lead product is cenicriviroc (CVC), a Fast Track-designated anti-fibrotic agent currently in Phase 2 development for non-alcoholic steatohepatitis (NASH).
- A Tobira investor syndicate has committed to invest up to $22M to fund CVC's development through Phase 2. Tobira's quick asset balance will be ~$60M after the investment.
- Under the terms of the merger, Regado shareholders will own ~32% of the combined entity while Tobira shareholders will own ~68%. The specific allocation will depend on Regado's net cash balance at the time of the transaction.
- NASH-related tickers: (NASDAQ:ICPT) (NASDAQ:GILD) (NASDAQ:GALT) (NASDAQ:SHPG) (NASDAQ:LJPC) (NASDAQ:CNAT) (NASDAQ:RPTP)
Wed, Jan. 7, 8:50 AM
- Thinly-traded nano cap Galectin Therapeutics (NASDAQ:GALT) is up 49% premarket on robust volume in response to its report of results from a 30-patient Phase 1 study of GR-MD-02 in patients with nonalcoholic steatohepatitis (NASH).
- The principal objective of the trial was to assess the safety, tolerability and pharmacokinetics of GR-MD-02 but investigators also noted a potential therapeutic effect on fibrosis as measured by a serum biomarker (FibroTest) and liver stiffness (FibroScan). Patients in cohort 3 who received 8 mg/kg GR-MD-02 showed a statistically significant reduction in FibroTest score versus placebo in one of the cohorts.
- Fibrotest is a composite score of six blood tests that correlate to the extent of liver fibrosis.
- NASH represents the next big potential payoff for drug firms after HCV.
- Previously: Galectin NASH treatment meets primary endpoint in Phase 1 (Nov. 10, 2014)
- NASH-associated tickers: (NASDAQ:GILD) (NASDAQ:SHPG) (NASDAQ:LJPC) (NASDAQ:CNAT) (NASDAQ:ICPT) (NASDAQ:RPTP)
Nov. 6, 2014, 5:29 PM
Aug. 8, 2014, 3:49 PM
- First the good news:
- Tekmira (TKMR +38.1%) on a massive 25M share turnover; Raptor Pharmaceuticals (RPTP +28.2%) on a 4x surge in volume; Clovis Oncology (CLVS +11.6%) on 50% higher volume; RadNet (RDNT +20.4%) on 2x higher volume and Relypsa (RLYP +15%) on 2x higher volume.
- Now the bad news:
- TearLab (TEAR -21.2%) on 4x higher volume; Masimo (MASI -10.6%) on 3x higher volume; Volcano (VOLC -19.9%) on a 12x surge in volume and Hanger (HGR -24.9%) on a 16x surge in volume.
Aug. 8, 2014, 12:47 PM
Aug. 8, 2014, 9:45 AM
- Raptor Pharmaceuticals (RPTP +19.7%) Q2 results: Net Product Sales: $16.3M (-22.4%); Operating Expenses: $24.4M (+56.4%); Operating Loss: ($9.1M) (+43.1%); Net Loss: ($12.7M) (+47.3%); Loss Per Share: ($0.20) (+53.5%); Quick Assets: $58.1M (-30.0%).
- 2014 Guidance: Net product sales: $65M - 70M from $55M - 65M; non-GAAP operating expenses: $80M - 90M; quick assets will be sufficient to fund operations through at least 1H 2016.
Aug. 7, 2014, 4:18 PM
Jul. 7, 2014, 5:59 PM
- Christopher Starr, Raptor Pharma's (RPTP) CEO since 2006, will be retiring at year's end. COO Julie Anne Smith will replace him.
- Starr will remain on Raptor's board following his resignation as CEO, and will conitnue to "consult on Raptor development projects."
- Smith has been Raptor's COO since Sep. '12. Prior to joining Raptor, she was the sales chief for Enobia Pharma.
Jun. 20, 2014, 5:36 PM
Jun. 17, 2014, 5:35 PM
May 8, 2014, 4:35 PM
Mar. 14, 2014, 12:48 PM
Mar. 13, 2014, 5:42 PM
Mar. 13, 2014, 5:02 PM
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