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Mon, Oct. 20, 12:50 PM
Mon, Oct. 20, 10:57 AM
- Cytokinetics (CYTK +5.5%) reports that its lead drug candidate, tirasemtiv, demonstrated clinically meaningful improvements in Slow Vital Capacity (SVC) versus placebo in ALS patients in a Phase 2b study. SVC is a measure of skeletal muscle strength for breathing and is an important predictor of ALS disease progression and survival.
- The company has begun discussions with the FDA on a Phase 3 trial which would begin in 2015.
- ALS-related tickers: (CUR -6.9%)(BCLI -2.6%)(MNOV -13.7%)(BIIB +1%)
Mon, Oct. 20, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Fri, Oct. 17, 12:52 PM
Wed, Oct. 8, 12:45 PM
Tue, Oct. 7, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Tue, Sep. 16, 12:46 PM
Tue, Sep. 16, 12:00 PM
- Thinly-traded nano cap MediciNova (MNOV -10.9%) is off on 5x higher volume as traders take some money off the table from the sharp run-up that began on August 26 when the firm announced the impending start of a clinical trial evaluating MN-166 as a treatment for patients with ALS.
- Shares peaked yesterday at $3.38 which represented a 62.5% jump from August 25's close of $2.08.
Wed, Sep. 10, 12:47 PM
Wed, Sep. 10, 9:15 AM
Tue, Aug. 26, 11:52 AM
- Nano cap MediciNova (MNOV +8.3%) secures FDA approval to begin a single center clinical trail evaluating MN-166 (ibudilast) as a treatment for patients with amyotrophic lateral sclerosis (ALS) who are on stable dose of riluzole for at least one month. The trial, which is slated to begin in the fall, will be conducted at the Carolinas HealthCare System Neurosciences Institute in Charlotte, NC.
- The 60-patient trial's treatment period is six months followed by a six-month open label extension. The primary endpoint is the safety and tolerability of MN-166 (60 mg/day) compared to placebo when administered for six months with riluzole in patients with ALS.
Thu, Aug. 14, 11:04 AM
Wed, Apr. 2, 12:46 PM
Thu, Jan. 16, 5:35 PM
Tue, Jan. 14, 9:10 AM
Tue, Jan. 14, 8:36 AM
- MediciNova (MNOV) is out with what is says are "positive results" from a study of MN-001 in a mouse model of NASH.
- The treatment "significantly reduced fibrosis area compared with vehicle ... as demonstrated by a reduction in liver hydroxyproline content, supporting MN-001's anti-fibrotic properties," the company says.
- MNOV also notes that MN-001 was "shown to down-regulate certain gene expression levels in the liver."
- The company says that taken together, the data suggest the drug "warrants further evaluation for the treatment of NASH in humans."
- Phase 2 trial is being prepped. (PR)
- MNOV +21% premarket.
- Investors are predisposed to NASH studies, since last week's Intercept news.
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