Nano cap Galectin Therapeutics (NASDAQ:GALT) perks up 11% premarket, albeit on only 810 shares, in response to its announcement of positive interim results from a Phase 2a study assessing lead product candidate GR-MD-02 for the treatment of moderate-to-severe plaque psoriasis.
All five patients who have completed treatment with 8 mg/kg of GR-MD-02 administered every other week have shown clinical improvement as measured by a scale called PASI (Psoriasis Area and Severity Index), with an average of 52%. The patient with the most severe disease experienced a 72% improvement after 13 infusions over 24 weeks. Complete data will be presented at a future scientific conference.
The product candidate is also being investigated for the treatment of severe atopic dermatitis. The company has engaged a business development firm to assist it in recruiting a development partner in severe skin diseases.
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. It was unsuccessful in demonstrating a significant treatment effect in patients with nonalcoholic steatohepatitis (NASH).
Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.
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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.
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.
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.
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.