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Last Thursday I bought 16K shares of MNOV. @ 5.24 and 5.27 > Held MNOV for about an hour. Sold 16K mnov @ 5.76 > for a profit of $8400.+
You do not have PM. You may want to consider an IHUB upgrade, so folks can message you. Also you have access to premium message boards where traders exchange information. The SmartMoney board is very good. I am a co-moderator with five other traders. GLTY.
Any future you questions I will respond to you, but not on this board. I will respond by your upgraded private messages. The questions you are asking are more suited to PM's.
Bob, Can you point us in the direction of a particular SEC filing by MNOV which represents an ATM issuance of shares?
Thank you for Carl's thoughts. I felt the news, while "important" does not remotely translate to an FDA approval. This is one stock I am willing to do my slow-dance version of swing trading, although most of our shares were untouched.
It was a smart move, Steve. Not one I made but I wasn't around most of yesterday anyway. I'm ok sitting in a few stocks I own; not trading in and out. MNOV is one.
My friend Carl had this to say:
I have a large position in MNOV. I would normally be a seller into today's news. But there is the potential for more news over the balance of the year that could have an enormous positive (which also means negative impact if the numbers are not good) so to answer a few emails, I am not a seller. But if they are good the stock could soar to heights not expected, so I am not a seller. The news today is nice, but not critical to the future of the company, it is one small positive step. Medical tech stocks are the hottest in the market, and they could easily remain so for a very long time. The results of years of research are being released daily and the psychological impact on stock prices will remain dramatic as traders try to figure out which stock has the potential of hitting a home run. Note how the stock ran up to resistance that exists at where the stock traded in 2011.
George, Happy I did sell some yesterday, and part of me wishes my sell orders at higher prices had also gone off.
OTOH, it looks as if the price is slowly decaying toward what it was before the announcements yesterday and that I will be reacquiring those shares I sold yesterday, but at a lower price and reinvesting the profit in more shares.
I do not want to be out of MNOV.
Covered yesterday's short nice profits
Banking nicely on this short of the hype pop
George, Agreed. I've always bought more shares (than I had before) when I repurchase MNOV. LLAP
Here's what I can say: If it drops to $4 it's a buy.
LOL. Any accurate indicator can guide investors.
Using me as a contrary indicator now, huh?
Perhaps. Do you think it will break $4 on the way back down? I don't think it will quite go back to yesterday's price ... but who knows.
I've been out of the loop for a few hours, but no $6. Congratulations Steve!
Sold some MNOV this morning at $5.35. You may now expect it to top $6 this afternoon.
$MNOV recent news/filings
bullish
gap up
## source: finance.yahoo.com
Thu, 16 Apr 2015 12:41:35 GMT ~ Tokyo Stock Exchange Announces New Rule Affecting Trading of MediciNova Stock in Japan
[at noodls] - LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code ...
read full: http://www.noodls.com/view/F394EFDC81C85C68F4F206AFF99741019713604C
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Thu, 16 Apr 2015 12:30:00 GMT ~ Tokyo Stock Exchange Announces New Rule Affecting Trading of MediciNova Stock in Japan
[GlobeNewswire] - LA JOLLA, Calif. -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that the Tokyo Stock ...
read full: http://finance.yahoo.com/news/tokyo-stock-exchange-announces-rule-123000236.html
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Thu, 16 Apr 2015 12:12:43 GMT ~ FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis
[at noodls] - LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code ...
read full: http://www.noodls.com/view/4266772D8FE8435EE91A9DC409082A6E77E7871B
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Thu, 16 Apr 2015 12:01:00 GMT ~ 8:01 am MediciNova announces that FDA grants Fast Track Designation for the co's MN-001 (tipelukast) for the treatment of NASH with Fibrosis
read full: http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#mnov
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Thu, 16 Apr 2015 12:00:00 GMT ~ FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis
[GlobeNewswire] - LA JOLLA, Calif. -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has received ...
read full: http://finance.yahoo.com/news/fda-grants-fast-track-designation-120000998.html
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$MNOV charts
basic chart ## source: stockcharts.com
basic chart ## source: stockscores.com
big daily chart ## source: stockcharts.com
big weekly chart ## source: stockcharts.com
$MNOV company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/MNOV/company-info
Ticker: $MNOV
OTC Market Place: Not Available
CIK code: 0001226616
Company name: Medicinova, Inc.
Incorporated In: DE, USA
Business Description:
$MNOV share structure
## source: otcmarkets.com
Market Value: $86,403,273 a/o Apr 15, 2015
Shares Outstanding: 24,616,317 a/o Mar 09, 2015
Float: Not Available
Authorized Shares: Not Available
Par Value: 0.001
$MNOV extra dd links
Company name: Medicinova, Inc.
## STOCK DETAILS ##
After Hours Quote (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/after-hours
Option Chain (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/option-chain
Historical Prices (yahoo.com): http://finance.yahoo.com/q/hp?s=MNOV+Historical+Prices
Company Profile (yahoo.com): http://finance.yahoo.com/q/pr?s=MNOV+Profile
Industry (yahoo.com): http://finance.yahoo.com/q/in?s=MNOV+Industry
## COMPANY NEWS ##
Market Stream (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/stream
Latest news (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/news - http://finance.yahoo.com/q/h?s=MNOV+Headlines
## STOCK ANALYSIS ##
Analyst Research (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/analyst-research
Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/guru-analysis
Stock Report (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/stock-report
Competitors (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/competitors
Stock Consultant (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/stock-consultant
Stock Comparison (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/stock-comparison
Investopedia (investopedia.com): http://www.investopedia.com/markets/stocks/MNOV/?wa=0
Research Reports (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/research
Basic Tech. Analysis (yahoo.com): http://finance.yahoo.com/q/ta?s=MNOV+Basic+Tech.+Analysis
Barchart (barchart.com): http://www.barchart.com/quotes/stocks/MNOV
DTCC (dtcc.com): http://search2.dtcc.com/?q=Medicinova%2C+Inc.&x=10&y=8&sp_p=all&sp_f=ISO-8859-1
Spoke company information (spoke.com): http://www.spoke.com/search?utf8=%E2%9C%93&q=Medicinova%2C+Inc.
Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Medicinova%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/MNOV
Income Statement (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/financials?query=income-statement
Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/sec-filings
Edgar filings (sec.gov): http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001226616&owner=exclude&count=40
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/filings
Latest financials (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/financials
Short Interest (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/short-interest
Dividend History (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/dividend-history
RegSho (regsho.com): http://www.regsho.com/tools/symbol_stats.php?sym=MNOV&search=search
OTC Short Report (otcshortreport.com): http://otcshortreport.com/index.php?index=MNOV
Short Sales (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/short-sales
Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=MNOV+Key+Statistics
Insider Roster (yahoo.com): http://finance.yahoo.com/q/ir?s=MNOV+Insider+Roster
Income Statement (yahoo.com): http://finance.yahoo.com/q/is?s=MNOV
Balance Sheet (yahoo.com): http://finance.yahoo.com/q/bs?s=MNOV
Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=MNOV+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/MNOV/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=MNOV+Insider+Transactions
Insider transactions (secform4.com): http://www.secform4.com/insider-trading/MNOV.htm
Insider transactions (insidercrow.com): http://www.insidercow.com/history/company.jsp?company=MNOV
Ownership Summary (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/ownership-summary
Institutional Holdings (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/institutional-holdings
Insiders (SEC Form 4) (nasdaq.com): http://www.nasdaq.com/symbol/MNOV/insider-trades
Insider Disclosure (otcmarkets.com): http://www.otcmarkets.com/stock/MNOV/insider-transactions
## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
PST (pennystocktweets.com): http://www.pennystocktweets.com/stocks/profile/MNOV
Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/MNOV
Bloomberg (bloomberg.com): http://www.bloomberg.com/quote/MNOV:US
Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=MNOV
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=MNOV
$MNOV DD Notes ~ http://www.ddnotesmaker.com/MNOV
Crudeoil, Happy to receive the PM but can't respond by PM until happy hour tomorrow.
The question is generally out of curiosity to see how you are approaching this. My guess is that you swing trade and probably prefer to be back in cash by closing on Friday. Nothing wrong with trading and I have friends who primarily do trading. Minding and I both have been known to sell portions of our MNOV shares at what seem to be peaks.
EDIT: But Minding can correct me if he has never sold!
I'll send you a PM.
Nothing wrong indeed!
Yes he does. And he's been enormously successful since the mid-90s.
Crudeoil, So when did you get into MNOV and what is you price and timeline objective? How long do you hold your stocks?
George, Your friend has a good thought process.
Regardless, the huge % gain is exciting. Take some profits. This is the most exciting event here. Nothing wrong in taking profits on your long term investment. GLTY.
Some thoughts from a friend of mine back in January:
MNOV manages to keep making some minor announcements that support the stock. They are not exciting but are representative of the slow and steady process of building a company. What may not be commonly known by many shareholders is that MNOV has a listing also in Japan and often the stock is more active there. It can be found on the Bloomberg website. I have been trying to figure out what future catalysts maybe responsible for the positive activity in the stock. With biotech companies that are in various trial stages it is nothing more than an educated guessing game. If we take a look at the MNOV website and their pipeline MNOV has 5 phase 2 trials in progress. http://medicinova.com/clinical-development/development-pipeline/ . Once the tests are underway it is impossible to know how they maybe proceeding. For example I had a friend in a phase 2 trial. He had a good response but the entire sample did not. You cannot assume that because one is doing well all are.
The NIH has funded a progressive multiple sclerosis trial being run at the Cleveland Clinic. It is impressive that it has been funded by the NIH. If the results come back positive this could set the stock flying. The completion date however is not until 3/17 3 months after the final data collection date. https://clinicaltrials.gov/ct2/show/NCT01982942?intr=ibudilast&rank=6 I suggest reading the history of another trial by MNOV for M.S. http://medicinova.com/clinical-development/core/mn-166/progressive-multiple-sclerosis/ The company also has 3 drug dependency phase 2 trials in various stages of development. They are attempting to eliminate addiction with another drug. Information is on their website. For companies like this a large catalyst would be excellent results in a phase 2 or 3 trial. MNOV is small and the fact that it currently 5 programs in phase 2 trials is impressive. Another for NASH will begin shortly.
Kind regards,
Minding
MNOV is a great $$$$$ opportunity.
MASSIVE VOLUME!!!!!
On second thought, their market cap is $131M which may still be undervalued by half or more given everything in their pipeline.
Heading to $6 now. I have no trading shares so I'm not tempted to sell any shares at this point. They're firing on all cylinders.
This beast has traction & giddy-up horsepower.
MediciNova Gets FDA Fast Track Designation for MN-001 (Tipelukast) to Treat Nonalcoholic Steatohepatitis With Fibrosis *Thursday 04/16/2015 08:02 AM ET - Dow Jones News
FDA Grants Fast Track Designation For MediciNova's MN-001 (Tipelukast) For The Treatment Of NASH With Fibrosis >MNOV *Thursday 04/16/2015 08:00 AM ET - Dow Jones News
Thank you. I'm frankly delighted at the jump to above $5.
I think 6 would be reasonable for a high. I wouldn't be shocked (and of course would be quite pleased) to see 8 if momentum junkies jump in.
FastTrack is great news, but it's not research progress. I think it settles back.
Yes, Premarket looks spectacular. Only question is whether is rises a bit more or does it settle back?
Thanks Steve.
Is that MNOV I see above 5 premkt!
Both items of news today are good for MNOV.
FDA Grants Fast Track Designation for MediciNova's MN-001 (tipelukast) for the Treatment of NASH with Fibrosis
MediciNova, Inc.
LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-001 (tipelukast) for the treatment of patients with nonalcoholic steatohepatitis (NASH) with fibrosis. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases and demonstrate the potential to address unmet medical needs for such diseases. An important feature of the FDA's Fast Track program is that it emphasizes frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval.
In January 2015, MediciNova announced an open Investigational New Drug (IND) application for MN-001 in NASH. Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova may proceed with a Phase 2 study as the first clinical study of MN-001 in NASH.
LA JOLLA, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that the Tokyo Stock Exchange (TSE) has announced a new rule affecting the trading of dual-listed stocks on the Tokyo Stock Exchange, including the stock of MediciNova. Under the old rule, the TSE had used the previous day's closing price of MediciNova's stock on the TSE as the base price to determine the daily limit of the stock price movement on the TSE (also known as the "circuit breaker" rule). Under the new rule that will become effective on April 20, 2015, if (1) the difference between the previous day's closing price of MediciNova's stock on NASDAQ converted to Japanese yen and the previous day's closing price of MediciNova's stock on the TSE ("the price divergence") is greater than the daily limit of the stock price movement on the TSE and (2) the price divergence is greater than 20%, then the TSE will use the previous day's closing price of MediciNova's stock on NASDAQ converted to Japanese yen as the base price to determine the daily limit of the stock price movement on the TSE.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased with this rule change as our stock price movements on NASDAQ and TSE should now occur in a more synchronized fashion than has occurred previously."
Given the direction things are going with antibiotics, I like NBY's approach. And I like investing in things I like.
Kind regards,
Minding
==============
NovaBay’s Avenova Featured in Ophthalmology Management
Nbc Capital (AMEX:NBY)
Intraday Stock Chart
Today : Tuesday 24 March 2015
The RX Perspective feature in Ophthalmology Management reports that NovaBay’s laboratory studies show “Avenova has no toxicity but in solution kills the types of eyelid bacteria that are present in dry eye or blepharitis patients”
NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY), a biopharmaceutical company focusing on the development and commercialization of its non-antibiotic anti-infective products for the global eye care market, today announced that Avenova™, the company’s eyelid cleanser, has been featured in an article in the March issue of Ophthalmology Management.
In the RX Perspective column, contributing editor Rebecca Hanlon quoted four leading ophthalmologists about the benefits of Avenova and the advances it brings to eye care. Terrence O’Brien, MD, of Bascom Palmer Eye Institute in Miami, Fla., for instance, said that Avenova is causing a paradigm shift in our thinking about the management of blepharitis.
O’Brien added that blepharitis has been increasingly difficult to treat using the traditional approach of antibiotics because of the resistance the body builds against these drugs. "In vitro testing shows that Avenova in solution reduces the populations of bacteria that cause blepharitis," he explained.
"It [Avenova] has helped a much higher percentage of blepharitis patients respond to treatment," added Steven Rosenfeld, MD, of Delray Eye Associates in Delray Beach, Fla. "They are feeling better, they are seeing better and it makes for happier patients."
The article also describes how to use Avenova. Simply spray the product on a cotton pad, and then wipe the eyelids with the pad, performing the procedure once in the morning and once at night. "It works," said Ivan Mac, MD, of Metrolina Eye Associates in Monroe, N.C. in the article. "We’re finding a lot of patients want to stay on [Avenova] because their eyelids feel clean and comfortable," he said. "It’s becoming a long-term therapy for a lot of patients."
Avenova works because it contains Neutrox™, NovaBay’s proprietary pure hypochlorous acid (HOCl), the same anti-microbial chemical found in white blood cells. HOCl in the body "…helps to kill microbial invaders and neutralize bacterial toxins," the article explained.
Millions of patients with dry eye and blepharitis may be just the first beneficiaries, suggested Dr. Rosenfeld. "I think we’ve only touched the tip of the iceberg for the potential application of this product," he said.
About Avenova
Avenova* is the only eye care product to contain Neutrox, NovaBay’s proprietary, pure hypochlorous acid (HOCl) without any bleach (sodium hypochlorite) impurities. HOCl is a naturally occurring substance produced by white blood cells to fight microbial invaders. In solution, tests show it has potent antimicrobial activity and yet is non-toxic to mammalian cells. Neutrox neutralizes bacterial inflammatory toxins in vitro. Avenova is uniquely suited for daily use by the millions of Americans who suffer from chronic eye conditions like blepharitis and dry eye. It is the only such product designed for continuous daily eyelid hygiene.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a biopharmaceutical company focused on commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global, topical anti-infective market with its two distinct product categories: the NEUTROX™ Family of Products, including AVENOVA™ for the eye care market and NEUTROPHASE® for wound care, which was initially cleared by FDA, and CELLERX™ for the dermatology market; and its AGANOCIDE® compounds, led by AURICLOSENE™. NovaBay is partnered in the U.S. and around the globe with: PBE, Inc. (USA), IHT, Inc. (USA), Galderma (France), Virbac (France), China Pioneer Pharma (China and Southeast Asia), Shin Poong Pharmaceuticals (South Korea), Biopharm (North African and Middle East), Sarmedic Ltd (Israel) and Alpha Pharma LLC (Ukraine).
*Avenova Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material, including microorganisms and debris from wounds, and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I to IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, and grafted and donor sites.
Forward-looking Statements
This news release contains "forward-looking statements." The forward-looking statements include statements regarding Avenova’s clinical effectiveness and market acceptance. All statements in this news release are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Other risks relating to the company and its products, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk Factors." NovaBay undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Stay informed on NovaBay’s progress: Download our Mobile InvestorApp from the Apple Store or Google Play
Like us on Facebook
NovaBay Pharmaceuticals, Inc.
For NovaBay Avenova purchasing information, please contact:
Toll Free: 1-800-890-0329
www.avenova.com
or
At the Company
Thomas J. Paulson, 510-899-8809
Chief Financial Officer
Contact Thomas Paulson
or
For Investors
LHA
Jody Cain, 310-691-7100
jcain@lhai.com
Thanks Steve! I always like good news.
George
MediciNova Provides Update on Clinical Trial of MN-166 (Ibudilast) in ALS
February 16, 2015 18:00 ET | Source: MediciNova, Inc.
LA JOLLA, Calif., Feb. 16, 2015 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) has enrolled 30 of the 60 subjects planned for participation.
The trial is a randomized, double-blind, placebo-controlled study which includes a six-month treatment period followed by a six-month open-label extension. The study is evaluating several efficacy endpoints including functional activity (ALSFRS-R), respiratory function, muscle strength, and non-invasive ventilation (NIV) utilization in addition to monitoring the safety and tolerability of MN-166 60 mg/day versus placebo when administered in combination with riluzole in subjects with ALS. The principal investigator of the study is Benjamin Rix Brooks, MD, Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute in Charlotte, NC.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are extremely pleased to have completed 50% enrollment in this study during the first four months. ALS clinical trials can be difficult to enroll, but we have the continued support of the CDC (U.S. Centers for Disease Control and Prevention) to spread awareness of our trial to ALS patients. We look forward to providing further updates as the study moves forward."
- See more at: http://globenewswire.com/news-release/2015/02/16/706743/10120219/en/MediciNova-Provides-Update-on-Clinical-Trial-of-MN-166-Ibudilast-in-ALS.html#sthash.UGeXrIPN.dpuf
http://globenewswire.com/news-release/2015/02/16/706743/10120219/en/MediciNova-Provides-Update-on-Clinical-Trial-of-MN-166-Ibudilast-in-ALS.html
George, I've seen no news. EOM
Wowsa. The opening today is a surprise. Anyone finding any news?
Minding
Thank you for posting, George and Harmsen.
The details. Thanks harm.
Kind regards,
Minding
----------------
MediciNova, Inc.(MNOV), a biopharmaceutical company traded on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that FDA (U.S. Food and Drug Administration) has approved the protocol for a clinical trial of MN-001 (tipelukast) for the treatment of moderate to severe IPF (idiopathic pulmonary fibrosis). Importantly, due to safety data from previous clinical studies of MN-001, FDA has agreed that MediciNova(MNOV) may proceed with a Phase 2 study as the first clinical trial of MN-001 in IPF. The IPF protocol was filed under MediciNova's(MNOV) open IND (Investigational New Drug Application) in FDA'sDivision of Pulmonary, Allergy, and Rheumatology Products (DPARP). FDA has granted orphan-drug designation to MN-001 for the treatment of IPF, which will provide MediciNova(MNOV) with seven years of marketing exclusivity if MN-001 is approved for IPF.
"We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-001 in IPF," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.(MNOV)
About Idiopathic Pulmonary Fibrosis
Pulmonary fibrosis (PF) is a progressive disease characterized by scarring of the lungs that thickens the lining, causing an irreversible loss of the tissue's ability to transport oxygen. The causes of PF vary and can be due to anti-cancer drug therapy or exposure to chemicals. Idiopathic pulmonary fibrosis (IPF) is one type of PF without a clear cause. According to the Coalition for Pulmonary Fibrosis, IPF affects approximately 128,000 individuals in the U.S., with about 48,000 new cases diagnosed annually. The prognosis for IPF is poor and about two-thirds of IPF patients die within five years of diagnosis.
About MN-001
MN-001 (tipelukast) is a novel, orally bioavailable small molecule compound which exerts its effects through several mechanisms to produce its anti-fibrotic and anti-inflammatory activity in preclinical models, including leukotriene (LT) receptor antagonism, inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and MN-001's inhibitory effect on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1. MN-001 has also been shown to down-regulate expression of genes that promote inflammation including CCR2 and MCP-1. In addition, histopathological data shows that MN-001 reduces fibrosis in multiple animal models.
Previously, MediciNova(MNOV) evaluated MN-001 for its potential clinical efficacy in asthma and had positive Phase 2 results. MN-001 has been exposed to more than 600 subjects and considered generally safe and well-tolerated.
About MediciNova(MNOV)
MediciNova, Inc. (MNOV) is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova's(MNOV) current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive MS, ALS and substance dependence (e.g., methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF) and other fibrotic disease. MediciNova's(MNOV) pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. MediciNova(MNOV) is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc.(MNOV), please visit www.medicinova.com.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," "considering," "planning" or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's(MNOV) operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova(MNOV) relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's(MNOV) collaborations with third parties, the availability of funds to complete product development plans and MediciNova's(MNOV) ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's(MNOV) filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2013 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova(MNOV) disclaims any intent or obligation to revise or update these forward-looking statements.
MediciNova Announces FDA Approval of Protocol for Phase 2 Trial of MN-001 in IPF
Thank you George.
Note this is a Japan patent. Frequent announcements are keeping the price around 4 but it should, IMO, drop back.
Kind regards,
Minding
==========
MediciNova Receives New Patent Covering MN-029 (denibulin) di-hydrochloride in Japan
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a new patent from the Japanese Patent Office which covers MN-029 (denibulin) di-hydrochloride.
The patent will expire no earlier than July 2032. The allowed claims cover a compound, pharmaceutical composition and method of treating certain cell proliferation diseases, including solid tumors, based on denibulin di-hydrochloride. MediciNova intends to use denibulin di-hydrochloride in future development.
"We are very pleased to receive this new patent as we believe it will substantially increase the length of exclusivity and hence the potential value of MN-029 in Japan," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. "In addition, the new patent allows us more flexibility as we work to determine which solid tumors with high unmet medical needs are best to focus on in future development."
About MN-029
MN-029 is a novel, small molecule vascular disrupting agent (VDA) being developed for the treatment of solid tumor cancers. MediciNova licensed MN-029 from Angiogene Pharmaceuticals, Ltd. Several preclinical pharmacology studies conducted by Angiogene Pharmaceuticals and MediciNova have assessed the mechanism of action and anti-tumor activity of MN-029 in vivo in rodent models of breast adenocarcinoma, colon carcinoma, lung carcinoma and KHT sarcoma. In these studies, MN-029 damaged poorly formed tumor blood vessels by weakening tumor blood vessel walls and causing leakage, clotting and eventual vascular shutdown within the tumor. These studies suggest that MN-029 acts quickly and is rapidly cleared from the body, which may reduce the potential for some adverse effects commonly associated with chemotherapy. Shutdown of tumor blood flow in tumor models was confirmed through the use of dynamic contrast-enhanced MRI. In two Phase I clinical studies conducted by MediciNova, MN-029 was well-tolerated at doses that reduced tumor blood flow.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on MN-166 (ibudilast) for neurological disorders such as progressive MS, ALS and substance dependence (e.g., methamphetamine dependence, opioid dependence) and MN-001 (tipelukast) for nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF) and other fibrotic disease. MediciNova's pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbations of asthma and MN-029 (denibulin) for solid tumor cancers. MediciNova is engaged in strategic partnering and other potential funding discussions to support further development of its programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," "considering," "planning" or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2013 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
The Phase 2 news and the investigational new drug application are great but I don't think this will keep the price above $4.
Kind regards,
Minding
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