Yesterday, 11:00 AM
Yesterday, 8:05 AM
- Resmed (NYSE:RMD) upgraded to Buy from Neutral by Bank of America. Price target raised to $89.00 (39% upside) from $71.50.
- Incyte (NASDAQ:INCY) upgraded to Outperform from Market Perform by Raymond James.
- Eli Lilly (NYSE:LLY) upgraded to Buy from Neutral by Goldman Sachs. Price target raised to $95 (19% upside) from $89.
- Impax Laboratories (NASDAQ:IPXL) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $26 (10% upside) from $25.
- Hologic (NASDAQ:HOLX) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $44 (15% upside) from $42.
- BioDelivery Sciences International (NASDAQ:BDSI) upgraded to Buy from Neutral by Janney Montgomery Scott. Price target raised to $4.00 (47% upside) from $2.45.
- Galectin Therapeutics (NASDAQ:GALT) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $1.50 (23% upside) from $8.00. Downgraded to Sell from Buy by Roth Capital. Price target lowered to $0.75 (39% downside risk) from $3.00.
- Gilead Sciences (NASDAQ:GILD) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $94 (21% upside) from $112.
- Mirna Therapeutics (NASDAQ:MIRN) downgraded to Neutral from Buy by H.C. Wainwright. Price target lowered to $2 (4% upside) from $6.
Thu, Sep. 29, 12:46 PM
Wed, Sep. 28, 12:48 PM
Wed, Sep. 28, 11:01 AM
Wed, Sep. 28, 9:21 AM
Tue, Sep. 27, 4:50 PM
- Nano cap Galectin Therapeutics (NASDAQ:GALT) slumps 44% after hours on robust volume in response to its announcement that a Phase 2a clinical trial assessing lead product candidate GR-MD-02 for the treatment of patients with nonalcoholic steatohepatitis (NASH) with advanced fibrosis failed to achieve its primary and secondary endpoints.
- The primary endpoint of the exploratory single-site, short-treatment duration (four months) randomized study was the mean change in liver fibrosis as measured by a magnetic resonance imaging (MRI) test called LiverMultiScan. The study also missed the secondary endpoints measuring liver stiffness as a surrogate for fibrosis as determined by FibroScan and magnetic resonance elastography (MRE). On the plus side, GR-MD-02 was observed to be safe and well tolerated with no serious adverse events reported.
- Putting a positive spin on the results, principal investigator Stephen Harrison, M.D., says, "Although there was no apparent improvement in the three non-invasive tests for assessment of liver fibrosis in this four-month pilot trial, inhibition of galectin-3 with GR-MD-02 remains promising for treatment of NASH fibrosis. In regard to the potential activity of GR-MD-02, it is encouraging that there is an important clinical effect in moderate-to-severe psoriasis..."
- The company will host a conference call at 5:30 pm ET to discuss the data.
Thu, Sep. 22, 9:18 AM
Wed, Sep. 21, 12:48 PM
Wed, Sep. 21, 11:01 AM
Tue, Sep. 20, 3:20 PM
- H.C. Wainwright analyst Ed Arce is doing a bit of chest thumping today after his bullish call on Tobira Therapeutics (TBRA +722.8%) paid off in spades when Allergan (AGN -2.2%) announced its intent to acquire the company for up to $1.7B. He raised his price target on the tiny biotech to $31 last month based his confidence that NASH candidate cenicriviroc will be successful in late-stage studies. TBRA shares plummeted to a low of $3.76 on August 2 after the company released the results from a failed mid-stage trial that used an endpoint that the company said will not be necessary to support regulatory applications. The trial met the endpoint that will be used in Phase 3 studies.
- In an interview with StreetInsider, Mr. Arce said he likes other players in the NASH space, specifically Galectin Therapeutics (GALT +13.8%), with top-line data from a mid-stage study of NASH candidate GR-MD-02 due this month, and Conatus Pharmaceuticals (CNAT +20.6%), with lead candidate emricasan about to enter a Phase 2 trial using Exalenz Biosciences' BreathID Methacetin Breath Test to monitor patients during the study.
- GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
- Emricasan inhibits a family of enzymes that modulate essential cellular functions called caspases. The functions include those involved in apoptosis and inflammation. Caspases 3 and 7 are major players in apoptosis. These enzymes cleave a key protein called CK18 (cytokeratin-18), part of which is the small fragment cCK18, which correlates to the magnitude of hepatocyte apoptosis. Emricasan inhibits apoptosis regardless of the stimuli that causes it.
- Mr. Arce has an $8 (315% upside) price target on GALT and $15 (608% upside) on CNAT, both rated Buy.
Tue, Sep. 20, 9:19 AM
Tue, Sep. 20, 8:52 AM
- Once investors catch their collective breath over Allergan's (NYSE:AGN) wildly bullish takeout of Tobira Therapeutics (NASDAQ:TBRA), they may want to keep an eye on other NASH players. Some, of course, have more credibility than others.
- Premarket movers: MediciNova (NASDAQ:MNOV) +3.3%; Regulus Pharmaceuticals (NASDAQ:RGLS) +3.1%; Intercept Pharmaceuticals (NASDAQ:ICPT) +6.0%; Conatus Pharmaceuticals (NASDAQ:CNAT) +38.3%; Galectin Therapeutics (NASDAQ:GALT) +24.0%; Shire plc (NASDAQ:SHPG): +1.0%; Can-Fite BioPharma (NYSEMKT:CANF) +23.1%.
- Others: Galmed Pharmaceuticals (NASDAQ:GLMD); Vascular Biogenics (NASDAQ:VBLT); Islet Sciences (OTCPK:ISLT); Genfit (OTCPK:GNFTF).
Thu, Aug. 25, 11:00 AM
Thu, Aug. 25, 8:17 AM
- Galectin Therapeutics (NASDAQ:GALT) says it will not pursue development of NASH candidate GR-MD-02 for the treatment of moderate-to-severe plaque psoriasis after a small open-label Phase 2a study failed to demonstrate at least a 75% improvement in symptoms after 24 weeks of treatment. Results for four patients showed an improvement in PASI scores of 27 - 60% after 13 doses (8 mg/kg infusions every other week).
- The company explored the new indication after one patient in its Phase 1 NASH study reported the resolution of her psoriasis following treatment with GR-MD-02. Her condition remained in remission for 17 months following her fourth infusion.
- GR-MD-02, the company's lead product candidate in its fibrosis program, is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
Tue, Aug. 9, 8:10 AM