Wed, Oct. 5, 11:21 AM
- 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.
- SA subscribers should use their 90-day coupon code SA_Sub16.
- NASH-related tickers: (NYSE:PFE)(NASDAQ:GALT)(NASDAQ:BLRX)(NASDAQ:GLMD)(NASDAQ:CNAT)(NASDAQ:MNOV)(NASDAQ:RGLS)(NASDAQ:ICPT)(NASDAQ:SHPG)(NYSEMKT:CANF)(NASDAQ:VBLT)(OTCPK:ISLT)(OTCPK:GNFTF)(NASDAQ:GILD)
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).
Wed, Apr. 20, 12:45 PM
Wed, Apr. 20, 7:21 AM
- Interim data from a Phase 2 clinical trial show patients with amyotrophic lateral sclerosis (ALS) treated with MediciNova's (NASDAQ:MNOV) lead product candidate MN-166 (ibudilast) experienced a slower worsening of their condition. The results will be presented today at the American Academy of Neurology 68th Annual Meeting in Vancouver, BC.
- The interim analysis was performed on 25 patients without non-invasive ventilator support who completed the six-month double-blind treatment period with complete respiratory function test data. The mean decline in a functional rating scale called ALSFRS-R from baseline to month six was 4.55 in the MN-166 cohort compared to 5.80 for placebo (higher score means a higher rate of decline). The mean decline in the ALSFRS-R Bulbar score (measures speech, salivation and swallowing ability) over the same period was 0.90 for MN-166 versus 1.80 for placebo while the mean decline in ALSFRS-R Arm score (measures fine motor skills like handwriting) was 1.50 for MN-166 compared to 2.40 for placebo. The mean declines in respiratory function for both cohorts, measured by slow vital capacity, were 10.93% and 12.71%, respectively.
- The study was not powered to inform on the assumptions for the next clinical trial of MN-166, however. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is June 2017. The estimated study completion date is December 2017.
- MN-166 is an orally available, small molecule phosphodiesterase-4 and -10 inhibitor and a macrophage migration inhibitory factor inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Its anti-neuroinflammatory and neuroprotective actions are the basis for the potential treatment of diseases like ALS and multiple sclerosis. It has Fast Track status for both. It has been marketed in Japan and Korea since 1989 for the treatment of post-stroke complications and bronchial asthma.
Mon, Apr. 18, 9:20 AM
Wed, Apr. 6, 1:45 PM
- Gilead Sciences' (GILD +2%) acquisition of Nimbus Therapeutics for as much as $1.2B appears to have investors in a lather over other developers of therapies to treat nonalcoholic steatohepatitis (NASH), especially Galmed Pharmaceuticals (GLMD +38.3%).
- NASH-related tickers: (MNOV +0.4%)(RGLS +4.8%)(ICPT +4.4%)(CNAT +10.9%)(VBLT +3%)(GALT +2%)(TBRA -0.1%)(OTCPK:ISLT)(SHPG +7.2%)(RPTP +3.6%)(OTCPK:GNFTF -0.9%)(CANF +11.8%)
- Read now NASH Drugs: A Comprehensive Review Of Current Clinical Trials
Thu, Mar. 31, 9:16 AM
Mon, Mar. 28, 12:47 PM
Mon, Mar. 28, 12:04 PM
- Thinly traded micro cap MediciNova (MNOV +14.9%) is up on a 50% spike in volume in apparent response to its announcement that it has received a Notice of Allowance from the Chinese Patent Office for a patent covering MN-001 (tipelukast).
- Tipelukast is a small molecule anti-fibrotic and anti-inflammatory compound that exerts its effects via several mechanisms, including leukotriene receptor antagonism and inhibiting enzymes known as phosphodiesterases as well as 5-lipoxygenase. It is under development for the treatment of NASH (nonalcoholic steatohepatitis) patients with elevated triglycerides and moderate-to-severe ideopathic pulmonary fibrosis. Both are unmet medical needs in China.
Tue, Mar. 22, 7:09 AM
- The FDA designates MediciNova's (NASDAQ:MNOV) lead product candidate, MN-166 (ibudilast), for Fast Track review for the treatment of patients with progressive multiple sclerosis (MS), a class of MS that includes primary progressive MS and secondary progressive MS. MN-166 is in Phase 2 development in the U.S. for MS.
- MN-166 is an orally available, small molecule phosphodiesterase-4 and -10 inhibitor and a macrophage migration inhibitory factor inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Its anti-neuroinflammatory and neuroprotective actions are the basis for the potential treatment of MS.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
Thu, Mar. 3, 12:53 PM
Thu, Mar. 3, 12:01 PM
- Thinly traded micro cap MediciNova (MNOV -19%) slumps on a 7x surge in volume in response to a bearish article published this morning on Seeking Alpha by Mako Research that sees a potential downside risk of 84%.
- Mako cites a multitude of problems at the firm, including a pipeline of non-starters, dubious conduct of executives and an undisclosed lawsuit against CEO Yuichi Iwaki for participating in an alleged kickback scheme while running a lab called METIC.
- The company's lead product candidate is Stage 2-phase MN-166 (ibudilast), under Fast Track designation for the treatment of amyotrophic lateral sclerosis (AML).
- According to Yahoo Finance, two research firms rate the stock Buy and Strong Buy with a median price target of $6, although this appears to be old data.
- Previously: MediciNova's MN-166 Fast Track'd for ALS (Dec. 16, 2015)
Thu, Feb. 25, 9:12 AM| Thu, Feb. 25, 9:12 AM | 9 Comments
Thu, Feb. 18, 9:22 AM
Tue, Feb. 2, 8:02 AM
- The FDA designates privately held Cambridge, MA-based Nimbus Therapeutics' NDI-010976 for Fast Track review for the treatment of nonalcoholic steatohepatitis (NASH).
- NDI-010976 inhibits an enzyme called aceyl-COa carboxylase that plays a key role in the metabolism of fatty acids. A Phase 2 clinical trial is expected to commence in H1.
- NASH-related tickers: (NASDAQ:ICPT)(NASDAQ:TBRA)(NASDAQ:MNOV)(NASDAQ:GLMD)(NASDAQ:RGLS)(NYSE:AZN)(NASDAQ:DRRX)(NASDAQ:CNAT)(NASDAQ:VBLT)(NYSE:MRK)(NASDAQ:SHPG)(NASDAQ:GILD)(NASDAQ:GALT)(OTCPK:GNFTF)(NYSEMKT:CANF)
Mon, Jan. 25, 9:14 AM