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Estimated Study Completion Date: January 2021
https://www.clinicaltrials.gov/ct2/show/NCT00477906?term=avax&draw=2&rank=1
Boxer Capital Llc Reports 5.9 Percent Passive Stake In Aradigm Corp As Of November 30 - Sec Filing
https://www.sec.gov/Archives/edgar/data/1465837/000119312517366366/0001193125-17-366366-index.htm
FORM 4 - SEC Filing
GONDA IGOR - Stock Option (Right to Buy) 60000 shares
https://www.sec.gov/Archives/edgar/data/1013238/000112329217001763/xslF345X03/edgar.xml
PECOTA NANCY E - Stock Option (Right to Buy) 40000 shares
https://www.sec.gov/Archives/edgar/data/1013238/000112329217001762/xslF345X03/edgar.xml
Froehlich Juergen Kurt - Stock Option (Right to Buy) 50000 shares
https://www.sec.gov/Archives/edgar/data/1013238/000112329217001761/xslF345X03/edgar.xml
January 11, 2018: Antimicrobial Drugs Advisory Committee public meeting (Hyattsville, MD) - The committee will discuss new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.
Aradigm Announces FDA Advisory Committee Meeting for Linhaliq
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=1050394
The FDA's Antimicrobial Drugs Advisory Committee will meet on Thursday, January 11 to discuss Aradigm's New Drug Application (NDA) seeking approval for Linhaliq (ciprofloxacin) for the treatment of non-cystic fibrosis bronchiectasis in patients with chronic infections due to Pseudomonas aeruginosa.
See new edited Intro...
Aradigm (ARDM) Shares March Higher, Can It Continue?
https://www.zacks.com/stock/news/278799/aradigm-ardm-shares-march-higher-can-it-continue
Aradigm Regains Compliance with NASDAQ Listing Requirements
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=1043285
Key financials in the licensing ageement:
Partnership with Grifols, S.A.
* The royalty rate is 12.5% on the first $300 milion of annual sales for all territories and all indications, and 20% for annual sales in excess of $300 milion
* $20 milion in pre-approval and approval milestones remaining
* Aradigm responsible for the product supply
Aradigm believes the NCFBE indication for Linhaliq exceed $500MM of sales by 2021. Ladenburhg analysts project $1B sales by 2022, Nektar projected $750 milion for their NCFBE product with Bayer.
Key Investment Highlights
* Aradigm believes the NCFBE indication for Linhaliq exceed $500MM of sales by 2021.
Ladenburhg analysts project $1B sales by 2022, Nektar projected $750 milion for their NCFBE product with Bayer
* US Orphan Drug Designation with no existing approved therapies
* QIDP Designation and Fast Track received
FDA priority review accompanies QIDP designation
* Strong IP protection to 2031
8 patents issued in US; 41 issued patents in 37 countries outside the US
* Important objectives achieved in Phase 3
Prevention and reduction in frequency of pulmonary exacerbations
High persistent drug contrentrations in sputum, low in blood
Sustained powerful antipseudomonal activity even for patients with resistant isolates
Good safety and tolerability
* Commercial Launch in US expected in Q2'2018
EU approval expected Q4'18/Q1'19
* Sole competitor: Bayer's twice dily, dry powder inhaled ciprofloxacin
* Linhaliq is administered once daily:
Active in biofilms, uptake by macrophages
The company has a lot of potential for future growth.
Market value estimate.
See https://seekingalpha.com/article/4108783-aradigm-hidden-binary-event-russian-roulette-fda-spinning-chamber
The part of the page 20:
I made some quick calculations to try to estimate Aradigm's market value.
Grifols will fully commercialize Linhaliq in exchange for between 12.5% and 20% of revenues, by country, with revenues divided by half if there's a competitor in that country. I expect Bayer to begin to become a competitor at least six months after Aradigm and potentially longer if it needs to do another trial, so I estimate 12% royalties. Given that the royalties from revenues are pure earnings, I assign a 12 P/E from the revenue stream. I assume a 15% discount rate, 2021 sales of $750m, and $20m more in milestone payments. I discount the rest of the pipeline to zero.
Given:
A 15% discount rate,
2021 sales of $750m,
12% royalties and a 12 P/E,
a cumulative 40% dilution, and
$20m more in milestone payments...
...then working backwards, Aradigm should be worth perhaps (at least) ~$420m now (the discount rate here factoring in all risk, including chances), which is 18.7 times the market cap as of 9/21/2017 of ~$22.67m...
Aradigm (ARDM) PT Raised to $10 at Ladenburg Thalmann
Ladenburg Thalmann analyst Matthew Kaplan raised his price target on Aradigm (NASDAQ: ARDM) to $10.00 (from $7.50) while maintaining a Buy rating as FDA accepts Linhaliq NDA with priority review.
The analyst notes the PDUDA date is 1/26/18.
Aradigm Awarded NIH Grant to Investigate the Treatment of Pulmonary Non-Tuberculous Mycobacterial (PNTM) Infections with Linhaliq
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=1037303
Changing the Tide of Antibiotic-Resistant Infections
https://www.dvidshub.net/news/219852/changing-tide-antibiotic-resistant-infections
Does somebody know the reason?
Mayby this:
"We will review the next steps towards an application for approval of Pulmaquin in the U.S. at an upcoming meeting scheduled with FDA and are planning to engage soon in discussions of these results with the EMA as well," said Dr. Juergen Froehlich, MD, Aradigm's Chief Medical Officer.
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=1001671
Insider acquired 40900 shares (SEC Form 4)
The shares were purchased in multiple transactions at prices ranging from $2.21 to $2.32, inclusive.
https://www.sec.gov/Archives/edgar/data/1013238/000112329216003039/xslF345/edgar.xml
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP
First Eagle Investment Management, LLC
https://www.sec.gov/Archives/edgar/data/1013238/000114036116088916/xslF345/doc1.xml
Aradigm to Present at the Stifel 2016 Healthcare Conference on November 16
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=998741
Multi-million Dollar DTRA Funding for Biodefense Research with Aradigm's Inhaled Ciprofloxacin
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=994073
Aradigm Announces Australian Research Council Funding to Develop Nanotechnologies Targeting Bacterial and Fungal Biofilms
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=992622
Aradigm Announces Last Patient Dosing Visit in ORBIT-3 and ORBIT-4 Phase 3 Studies of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis Patients
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=990452
Aradigm (ARDM) Shares March Higher, Can It Continue?
http://www.nasdaq.com/article/aradigm-ardm-shares-march-higher-can-it-continue-cm682434
Aradigm to Host Analyst Meeting and Webcast on September 26 in New York City
HAYWARD, Calif. --(BUSINESS WIRE)-- Aradigm Corporation (Nasdaq: ARDM) (the "Company") announced today that it will host an Analyst Lunch on the topic of Non-Cystic Fibrosis Bronchiectasis (non-CF BE) on Monday, September 26, 2016 from 12:00-1:30 pm Eastern Time in New York, NY . The event will feature presentations by two key opinion leaders (KOLs): David E. Griffith , MD and Gregory Tino , MD.
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=990263
Will ARDM Bounce Last Just a Few Days?
Wait for release of Phase 3 (ORBIT 3 and 4) clinical trials results very soon.
See https://clinicaltrials.gov/ct2/show/NCT02104245?term=aradigm
Aradigm to Present at the Ladenburg Thalmann 2015 Healthcare Conference on September 29
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=932731
Aradigm Corporation Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=932534
Results from Pulmonary Non-Tuberculous Mycobacteria (PNTM) Study Using Aradigm's Liposomal Ciprofloxacin to Be Presented at ICAAC/ICC 2015
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=930955
Brokerages Set $26.00 Price Target for Aradigm (NASDAQ:ARDM)
http://www.dakotafinancialnews.com/brokerages-set-26-00-price-target-for-aradigm-nasdaqardm/403364/
Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis (ORBIT-4) is ongoing, but not recruiting participants.
Last updated: August 12, 2015
https://clinicaltrials.gov/ct2/results?term=aradigm
Prices below $7 per share was great opportunity to buy.
https://clinicaltrials.gov/ct2/show/NCT02104245?term=Aradigm&rank=1
https://clinicaltrials.gov/ct2/show/NCT01515007?term=Aradigm&rank=2
Results from Pulmonary Non-Tuberculous Mycobacteria (PNTM) Study Using Aradigm's Liposomal Ciprofloxacin to be Presented at the American Thoracic Society 2015 International Conference
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=912485
http://www.streetinsider.com/Corporate+News/Aradigm+Corp.+(ARDM)+Issues+Positive+Update+on+Lipoquin,+Pulmaquin+in+PNTM+Reduction/10549238.html
I believe in continuous growth of this stock. Strongly undervalued.
ORBIT-3 and ORBIT-4 Estimated Primary Completion Date: July 2016
https://clinicaltrials.gov/ct2/show/NCT02104245?term=aradigm&rank=1
https://clinicaltrials.gov/ct2/show/NCT01515007?term=aradigm&rank=2
Aradigm Announces Appointment of Dr. Robert A. Reed as Vice President, Regulatory (Chemistry, Manufacturing and Controls) and Quality
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=907555
Aradigm to Host Key Opinion Leader Breakfast and Webcast on April 23 in New York City
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=906864
Francisella Tularensis Infections - Pipeline Review, H1 2015
This report provides comprehensive information on the therapeutic development for Francisella Tularensis Infections, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. Companies Involved in Therapeutics Development are Aradigm Corporation, EpiVax, Inc., Evolva SA, Tetraphase Pharmaceuticals Inc. Complete report available at
http://www.rnrmarketresearch.com/francisella-tularensis-infections-pipeline-review-h1-2015-market-report.html
Plague - Pipeline Review, H1 2015
This report provides comprehensive information on the therapeutic development for Plague. Companies discussed in this report include Aradigm Corporation, Cellceutix Corporation, Grifols, S.A., iBio, Inc., Mucosis B.V., Summit Corporation plc, Syntiron LLC, Tetraphase Pharmaceuticals Inc. Complete report available at
http://www.rnrmarketresearch.com/plague-pipeline-review-h1-2015-market-report.html
You are right. "...an Investigation Involving Possible Breaches..." :)
We have bought more shares on the recent dip ;)
Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis (ORBIT-3) Estimated Primary Completion Date: July 2016
Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis (ORBIT-4) Estimated Primary Completion Date: July 2016
see https://clinicaltrials.gov/ct2/results?term=aradigm
Aradigm Corporation President & CEO Dr. Igor Gonda, Ph.D. to Be Interviewed Live on iHeart Radio/ Clear Channel Atlanta Studios - 640 WGST AM's "Health Tech Talk Live"
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=898841