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Strong Buy PT $26 (AnalystsReview.com)
http://get.analystsreview.com/pdf/?c=Aradigm&d=26-Feb-2015&s=ARDM
Aradigm Corporation (Aradigm) announced that the European Patent Office has granted key composition of matter for Pulmaquin in Europe and Australia. The patent is entitled "Dual Action, Inhaled Formulations Providing Both an Immediate and Sustained Release Profile" (E.U. Patent No. 2,079,443), and has been issued to Aradigm for formulations of liposomal and free ciprofloxacin. This patent provides coverage for Aradigm's lead product candidate, the inhaled ciprofloxacin drug Pulmaquin®, in Europe until at least October 23, 2027. In its release dated January 1, 2015, Aradigm revealed that the Company also has four issued U.S. patents and one issued Japanese patent (JP5254239) which provide coverage for Pulmaquin in the U.S. until 2031 and in Japan until 2027. "Long term patent protection of our lead product Pulmaquin is an important component of our corporate strategy," said Igor Gonda, Aradigm's President and CEO. "Our global efforts in this area are running in parallel with our Phase 3 clinical trials of Pulmaquin for non-cystic fibrosis bronchiectasis currently being conducted across five continents in 14 different countries."
INSIDERS STOCK BUYING FORM-4(5)
CEO Igor Gonda acquired 42852 shares
http://www.sec.gov/Archives/edgar/data/1013238/000120919115006741/xslF345/doc4.xml
VP and CFO Pecota Nancy E acquired 11429 shares
http://www.sec.gov/Archives/edgar/data/1013238/000120919115006738/xslF345/doc4.xml
Chief Medical Officer Froehlich Juergen Kurt acquired 2061 shares (price $8.15/share)
http://www.sec.gov/Archives/edgar/data/1013238/000120919115012027/xslF345/doc5.xml
Aradigm Corp. PT $100 within 2-5 years. It is my opinion.
Janney Capital initiates coverage on Insmed (NASDAQ: INSM) with a Buy rating and a $33.00 price target.
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
Aradigm Granted Key Composition of Matter Patents for Pulmaquin in Europe and Australia
http://investor.aradigm.com/releasedetail.cfm?releaseid=891220
Recommendation from Zacks Investment Research
http://www.zacks.com/stock/news/155611/investors--radars-failed-to-catch-aradigm-ardm-has-yours
Insider acquired 38500 shares
http://www.sec.gov/Archives/edgar/data/1013238/000120919114063844/xslF345/doc4.xml
The Market Is Underestimating The Potential Of Aradigm's Lead Product Candidate
http://seekingalpha.com/article/2517345-the-market-is-underestimating-the-potential-of-aradigms-lead-product-candidate
Price $50 per share gives a mkt cap $727 million and it is comparable with mkt cap $690 million of INSM.
Aradigm has better product than INSM, but current valuation of ARDM is $152 million (22% of INSM).
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
Aradigm could restart inhalable insuline (AERx iDMS) clinical trials in near future also.
http://www.aradigm.com/products_iDMS.html
Leading Health Care Stock for Small-Cap Stars...
http://www.equities.com/editors-desk/stocks/market-movers/leading-health-care-stock-for-small-cap-stars-is-provectus-biopharmaceuticals-inc-pvct-for-august-18
6 Reasons Aradigm Corporation Is An Excellent Risk Vs. Reward Opportunity
http://seekingalpha.com/article/2401935-6-reasons-aradigm-corporation-is-an-excellent-risk-vs-reward-opportunity
Hearing Sujan Lahiri Article on Aradigm Will Appear on Seeking Alpha Today
Read more: http://www.benzinga.com/news/14/08/4767710/hearing-sujan-lahiri-article-on-aradigm-will-appear-on-seeking-alpha-today#ixzz39oLjdVMi
Aradigm Announces Second Quarter 2014 Financial Results
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=864897
Aradigm to Host Analyst Meeting and Webcast on August 12 in New York City
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=864540
Top Pre-Market News Mover
Central European Media Enterprises (NASDAQ: CETV) shares gained 10.3% in pre-market trading after the company reported a strong rise in its Q2 core profit.
Countdown...
Are you ready? The short squeeze could come soon.
Central European Media Enterprises Ltd. ("CME") (Nasdaq:CETV) (Prague Stock Exchange:CETV) announced that it will release its second quarter 2014 financial results before U.S. market hours on Wednesday, July 30, 2014 at 9 a.m. New York time (2 p.m. London time and 3 p.m. Prague time).
I have registered a more activity from July 11, 2014. Maybe a slow accumulation before clinical trials results.
1) Trial of Autologous, Hapten-Modified Vaccine, OVAX, in Patients With Relapsed Stage III or IV Ovarian Cancer
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014
http://clinicaltrials.gov/ct2/show/NCT00660101?term=avax&rank=3
2) M-Vax + Low Dose Interleukin-2 Versus Placebo Vaccine in Metastatic Melanoma in Patients With Stage IV Melanoma
Estimated Primary Completion Date: January 2015
http://clinicaltrials.gov/ct2/show/NCT00477906?term=avax&rank=1
Top 37% Zacks Industry Rank
http://www.zacks.com/stock/quote/ARDM?q=ardm
Be Social-Network Smart
http://www.jw.org/en/bible-teachings/family/teenagers/whiteboard-animations/social-network-smart/
Very helpfull!
Be Social-Network Smart
http://www.jw.org/en/bible-teachings/family/teenagers/whiteboard-animations/social-network-smart/
Very helpfull!
Aradigm to Host Corporate Update Conference Call on June 26
HAYWARD, Calif. --(BUSINESS WIRE)-- Aradigm Corporation (Nasdaq:ARDM) (the "Company") will host a corporate update conference call at 8:00 am ET ( 5:00 am PT ) on Thursday, June 26, 2014 .
The Company will review recent significant milestones, as well as progress with the Pulmaquin(R) program in non-cystic fibrosis bronchiectasis.
Aradigm Corporation Announces the Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)
Aradigm’s Pulmaquin - A Potential New Therapy to Treat an Unmet Medical Need in Patients with Severe Respiratory Disease
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=855907
Insmed Shares Rise 35% Premarket on FDA Breakthrough Therapy Designation for Arikayce
07:51 AM EDT, 06/18/2014 (MT Newswires) -- Insmed (INSM) said ARIKAYCE, or liposomal amikacin for inhalation, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration for the treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease who are treatment refractory.
The designation is based on findings from the company's U.S. phase 2 clinical trial of ARIKAYCE to treat NTM lung infections. The company has plans to meet with the FDA to discuss the regulatory pathway for ARIKAYCE.
ARDM should be a mover today also.
See earlier news here:
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
http://www.marketwired.com/press-release/lifesci-advisors-initiates-coverage-of-aradigm-corporation-otcbb-ardm-1845844.htm
The move to NASDAQ is a significant milestone for Aradigm and underscores our commitment to grow the value of our Company and broaden our shareholder base," said Igor Gonda, President and CEO of Aradigm Corporation. "As we continue to build on the positive momentum generated throughout this year with the start of our ORBIT-3 and ORBIT-4 Phase III clinical trials with Pulmaquin® for bronchiectasis and our recent QIDP designation from FDA for Pulmaquin for this disease, we are very pleased to begin trading on NASDAQ. We believe it will provide more liquidity for our shareholders. The strong fundamentals of the Company together with the increased visibility that NASDAQ will provide should assist us in maximizing shareholder value over the short and long term.
Trading on NASDAQ on June 11.
Aradigm expects its shares to begin trading on NASDAQ on Wednesday, June 11, 2014. The Company will trade under the ticker symbol "ARDM.”
http://www.reuters.com/finance/stocks/ARDMD.PK/key-developments/article/3006270
The NASDAQ Securities Registration
http://www.sec.gov/Archives/edgar/data/1013238/000119312514226973/d736370d8a12b.htm
Aradigm Receives $5 Million Milestone For Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis
http://www.marketwatch.com/story/aradigm-receives-5-million-milestone-fordosing-of-the-first-patient-in-phase-iii-study-of-pulmaquin-in-non-cystic-fibrosis-bronchiectasis-2014-06-03
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=852036
Aradigm Corporation has got a new ticker ARDMD. You should own 1/40 shares for approximately $8 per share.
Following the Reverse Split, Aradigm Corp plans to apply to list shares on the NASDAQ Capital Market (“NASDAQ”). NASDAQ may provide more liquidity for shareholders.
The most important are pipeline and market cap (114 M now) and there should be a huge potential within 2-3 years.
ARDM versus INSM
ARDM Pipeline:
1) ARD-3150 Pulmaquin® Inhaled Ciprofloxacin for the Management of Infections in Non-Cystic Fibrosis Bronchiectasis (BE) Patients
2) ARD-3100 Lipoquin® Inhaled Ciprofloxacin for the Management of Infections in Cystic Fibrosis (CF) Patients
3) ARD-1100 Biodefense (inhalational tularemia, pneumonic plague, Q-fever)
4) ARD-1600 Smoking Cessation
Other Applications:
1) AERx Pure Nicotine Inhaler
2) Pain Management System
3) Diabetes Management System AERx iDMS
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
http://www.marketwired.com/press-release/lifesci-advisors-initiates-coverage-of-aradigm-corporation-otcbb-ardm-1845844.htm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment of severe respiratory diseases. Aradigm has product candidates addressing the treatment of non-CF BE, cystic fibrosis and prevention of respiratory and other diseases in tobacco smokers through smoking cessation. Aradigm is also developing Pulmaquin and a liposomal ciprofloxacin formulation as potential medications for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, Q fever and inhaled anthrax.
Aradigm has been granted orphan drug designations for liposomal ciprofloxacin for cystic fibrosis (CF) in the U.S. and the E.U., and liposomal ciprofloxacin and free ciprofloxacin for inhalation for the management of bronchiectasis in the U.S.
INSM Pipeline:
1) ARIKAYCE® Pseudomonas aeruginosa Lung Infections in CF
2) ARIKAYCE® Nontuberculous mycobacteria Lung Infections
3) ARIKAYCE® Pseudomonas aeruginosa Lung Infections in Non-CF Bronchiectasis
ARDM Market cap: 114 M
INSM Market cap: 534 M
Aradigm Announces First Quarter 2014 Financial Results
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=847768
DRUG DELIVERY TECHNOLOGIES MARKET FORECAST 2014-2024
Opportunities for Leading Companies
Leading companies and potential for market growth
Overall world revenue for drug delivery technologies will reach $138.1bn in 2014, our work forecasts. We predict steady growth from 2014 to 2024. Our work shows you what organisations hold greatest potential. See profiles of 18 leading companies, including these:
• 3M
• Aradigm Corporation
• Vectura Group
• Applied Pharma Research
• Catalent Pharma Solutions
• Emisphere Technologies
• Ethypharm
• Glycologic
• Alkermes
• Antares Pharma
• Bioject Medical Technologies
• Pacira Pharmaceuticals
• Nanopass Technologies
• Noven Pharmaceuticals
• CIMA Labs
• Columbia Laboratories
• Generex Biotechnology Corporation
• pSivida
https://www.visiongain.com/Report/1252/Drug-Delivery-Technologies-Market-Forecast-2014-2024
Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
This study is currently recruiting participants.
http://clinicaltrials.gov/ct2/show/NCT01515007?term=aradigm&rank=4
Aradigm Corporation Announces the Dosing of the First Patient in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
Aradigm's Pulmaquin - A Potential New Therapy to Treat an Unmet Medical Need in Patients with Severe Respiratory Disease
HAYWARD, Calif.--(BUSINESS WIRE)-- Aradigm Corporation (OTCBB:ARDM.OB) ("Aradigm" or the "Company") today announced the dosing of the first patient in the ORBIT-3 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).
The first patient was dosed by respiratory physician Dr. Douglas Fiedler at Nebraska Pulmonary Specialties, LLC. "I am very pleased to participate in this study to investigate the potential benefits of a new medication for my patients with a chronic debilitating respiratory disease for which we do not have any good evidenced-based treatments yet," said Dr. Fiedler.
"With our Phase III trials under way now, it is gratifying that many clinicians around the world will be joining our effort to find a treatment for an unmet medical need in patients with the severe condition of non-cystic fibrosis bronchiectasis," said Juergen Froehlich, MD, Chief Medical Officer of Aradigm.
The Phase III clinical program for Pulmaquin in BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial will enroll approximately 255 patients into a 48 week double blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double blind period will be evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function will be monitored as a safety indicator.
"The start of the Phase 3 program in non-CF BE is marking the accomplishment of a critical milestone for Aradigm," said Igor Gonda, President and CEO of Aradigm. "We are grateful for the interest of patients with this disease to participate in this program, as well as for the support that we have been receiving from the COPD Foundation Bronchiectasis Consortium Registry."
Bronchiectasis is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=843923
Results from Non-Tuberculous Mycobacteria (NTM) Study Using Aradigm's Liposomal Ciprofloxacin to be Presented at the American Thoracic Society 2014 International Conference
HAYWARD, Calif.--(BUSINESS WIRE)-- Scientists from the Oregon State University, Corvallis (OSU) and Aradigm Corporation (OTCBB: ARDM) (the "Company") demonstrated that after 4 days of in vitro treatment of macrophages infected with Mycobacterium avium and Mycobacterium abscessus, Aradigm's liposomal ciprofloxacin was associated with a decrease of greater than 99% of these infections at ciprofloxacin concentrations of 200 mcg/ml, which approximate the peak sputum levels observed in humans in prior Aradigm clinical studies. At a lower concentration of 20mcg/ml, the liposomal concentrations still showed statistically significant decreases greater than 70% for M. avium and greater than 90% for M. abscessus. Unencapsulated ciprofloxacin showed smaller decreases which were only statistically significant at 200 mcg/ml. Liposomal ciprofloxacin at a concentration of 100 mcg/ml significantly reduced the population of these mycobacteria in a biofilm assay by more than 50% whereas unencapsulated ciprofloxacin did not show statistically significant decreases.
"These results are very encouraging as the current treatments are not particularly effective and have many side-effects. The airway delivery of ciprofloxacin in a vehicle that shows capability of killing specific mycobacteria harbored in macrophages and biofilms may be a promising way to help patients with these debilitating chronic infections," said Dr. Luiz Bermudez, professor of Biomedical Sciences at OSU.
The detailed description of this research and its findings will be presented at Session C30 entitled "Late Breaking Abstracts in Disease Treatment and Clinical Outcomes at 8:15 am-10:45 am on Tuesday, May 20, 2014 (Abstract ID/Title: #57372 - Liposomal Ciprofloxacin Preparation is Active against Mycobacterium Avium Subsp Hominissuis and Mycobacterium Abscessus in Macrophages and in Biofilm) at the American Thoracic Society 2014 International Conference in San Diego, CA.
The research reported in this publication was supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R43AI106188. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Pulmonary Non-Tuberculous Mycobacteria (PNTM) Infections
NTM is found almost everywhere - for example, in tap water and the soil. People with severe pulmonary diseases including cystic fibrosis, chronic obstructive pulmonary disease (COPD), and Alpha-1 Antitrypsin deficiency are particularly vulnerable to pulmonary non-tuberculous mycobacteria (PNTM) infections. PNTM symptoms include: fever, cough (including coughing up blood), weight loss/loss of appetite, fatigue and night sweats.
PNTM patients are treated with antibiotics. Some species of mycobacteria may also be resistant to certain antibiotics. Treatment may last more than one year.
A publication from the National Institutes of Health based on U.S. Medicare data from 1997-2007 determined that the annual prevalence of patients infected with PNTM in the U.S. increased 8.2% per year from 20 cases/100,000 to 47 cases/100,000 in people over 65.
About Aradigm's inhaled ciprofloxacin formulation brands - Pulmaquin® and Lipoquin®
Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute and chronic lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria such as Pseudomonas aeruginosa. Pulmaquin is a dual release formulation that is a mixture of liposome encapsulated (Lipoquin) and unencapsulated ciprofloxacin. It will be evaluated in two Phase III studies to be started in the first half of 2014 to determine its safety and effectiveness as a once-a-day inhaled formulation for the treatment of non-cystic fibrosis (CF) bronchiectasis.
Pulmaquin has been extensively tested through preclinical studies and a Phase IIb study (ORBIT-2). Previous studies have demonstrated no significant clinical safety concerns.
Aradigm has been granted orphan drug designation for the combination of liposomal ciprofloxacin and free ciprofloxacin for non-CF bronchiectasis in the U.S.
Phase 3 Study With Pulmaquin in Non-CF Bronchiectasis (ORBIT-4)
Study Start Date: June 2014
http://clinicaltrials.gov/ct2/show/NCT02104245?term=aradigm&rank=2
FDA panel recommends approving MannKind's Afrezza - inhalable insulin!
http://www.reuters.com/article/2014/04/01/us-mannkind-fda-diabetes-idUSBREA301Z620140401
The next great news for ARDM!
ARDM has huge potential with AERx iDMS (inhlalble insulin) now!
AERx iDMS is being developed to control blood glucose levels in patients with diabetes. The drug was in the last lap of clinical testing. The Phase 3 clinical trials halted in 2008. I believe ARDM will continue in Phase 3 asap.
http://www.aradigm.com/products_iDMS.html
http://www.aradigm.com/products_1700.html
I love ARDM, MNKD, INSM...
June 2014 - Start Date of Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis (ORBIT-3).
http://clinicaltrials.gov/ct2/show/NCT01515007?term=aradigm&rank=3
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors.