Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I agree, would love to hear about the partnerships coming and also, the fact the on January 2nd they are bringin on Dr. Polisky who was not only the CSO for the previous company (RNAI) that the ceo sold to Merck for $1.1 Billion but was also the vice president of research for Merck. Could we see a possible buyout?
Good Morning all! I see we are at #1 on most active boards this morning and the board marks are well up nicely!!! Should be a fun day on MRNA. GLTA!!
LOL, thats right Edward!!! No recession will stop these picks:)
I'm expecting it to blow right through it!
Thanks Edward! It finished at .81 after hours also. Looking for a nice day on it tomorrow.
It wont slide back, I think it will be up from here on out. Just too much potential.
MRNA- thought I would mention this one since it was such a great play today and I think the run is just beginning on it:
MDRNA, Inc. Announces Tentative FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis
BOTHELL, WA, Dec 15, 2008 (MARKET WIRE via COMTEX News Network) -- MDRNA, Inc. (NASDAQ: MRNA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.
MDRNA's generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin(R) marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin(R) were approximately $147 million in 2007.
http://phx.corporate-ir.net/phoenix.zhtml?c=83674&p=irol-newsArticle&ID=1236042&highlight=
Here is the approval by the FDA:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Was trading up in after hours at .80 which was a .54 cent gain for the day. Company is bringing on Barry Polisky, Ph.D as CSO on January 2nd, he was previously the vice president of research for Merck & Co. This is significant as the current ceo of MRNA sold his previous company to Merck for $1.1 Billion last year and at that time Mr Polisky was the CSO of that company. MRNA holds over 200 patents in the RNAi field which makes them worth more than than $1.1 Billion. Could be a potential buyout, but even without that is severly undervalued right now.
The technology really is incredible, I would love to see that study. The more I read about it the more interested I am in finding out more about it. It seems that MRNA really is going to be a leader in this field:
MDRNA is developing a diverse pre-clinical pipeline of therapeutics based on novel approaches utilizing proprietary RNAi technologies and delivery systems. First among these are the following development programs:
Oncology
Metabolic disorders
Inflammation
To fuel its pipeline, MDRNA is building one of the broadest and extensive patent estates in the RNAi field, with more than 260 filed patents addressing 144 gene sequences including numerous disease-validated targets.
http://www.mdrnainc.com/mdrna/newpipeline
Heres a great link showing just how important this companies RNAi research could be to the medical world, potentially treating cancer, aids and huntingtons disease.
http://www.pbs.org/wgbh/nova/sciencenow/3210/02.html
Exactly, or is just upset he didnt get in sooner.
You mean the one time it did that? Lets post a full chart, shall we? Now keep in mind that this was before they received FDA approval:
Looks to me like it could very well go back to 3.00, heck maybe even 12.00 just from looking at the chart.
They are a research and development company, they just got FDA approval, I dont think revenues will be an issue from here on out.
Here is their approval:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
Drug Details
Drug Name(s) CALCITONIN SALMON (Generic Drug)
FDA Application No. (ANDA) 076979
Active Ingredient(s) CALCITONIN SALMON
Company NASTECH PHARMA
Original Approval or Tentative Approval Date December 11, 2008
There are no Therapeutic Equivalents
Labels are not available
Approval History, Letters, Reviews, and Related Documents
Products on Application (ANDA) #076979
Click on a column header to re-sort the table:
Drug Name
Active Ingredients
Strength
Dosage Form/Route
Marketing
Status
RLD
TE
Code
CALCITONIN SALMON CALCITONIN SALMON 200IU SPRAY; NASAL None (Tentative Approval) No None
Yep, this company will do well, especially in this day and age where people are looking for the most convenient ways to protect themselves from fraud.
Read the filing, part of my post was a paste directly from the filing, everything is shown in the financials.
According to MRNAs last 10Q they have $21 million in assets and the following shows that there is only a difference of 4,462,629 in outstanding common shares over nine months, for all I know that was for insiders.
Common stock and additional paid-in capital, $0.006 par value; 90,000,000 authorized:
26,753,430 shares issued and outstanding as of December 31, 2007 and 31,216,059 issued and outstanding as of September 30, 2008
The great thing is that the FDA approval will allow them to access none dilutive financing with ease.
Interesting consider from MRNAs last 10Q they have $21 million in assets and the following shows that there is only a difference of 4,462,629 in outstanding common shares over nine months, for all I know that was for insiders.
Common stock and additional paid-in capital, $0.006 par value; 90,000,000 authorized:
26,753,430 shares issued and outstanding as of December 31, 2007 and 31,216,059 issued and outstanding as of September 30, 2008
The great thing is that the FDA approval will allow them to access none dilutive financing with ease.
Its still up .43 cent for the day, if thats what you call a pull back then I would mind seeing more of that tomorrow. The so called AH trade was at the ask, btw.
There will be no pull back.
They have 9 months from the notification to the meet the listing requirements. This was just day one of huge run coming.
Good for you, too bad that will never happen.
I agree, I'm also expecting more news soon, contracts will be huge and really get peoples attention.
Thank you very much!
Thanks, not sure why they put that in the PRs, too late to edit my post unfortunately but the link at the end is working thankfully.
LOL, I could see that happening actually. Give it a good day for the news to sink in.
I guess I should have called 1.00 for MRNA and not tomorrow, lol. Looking good!!!
Its insane undiscovered MRNA is, one the safe plays in a scary market thats for sure.
Agreed, getting close!
Yep, I think its severely undervalued where its at.
I'm seeing at least .80 today from MRNA and then into the dollars tomorrow, imo.
MRNA- Nasdaq listed-currently .60 up 135% today on the following news, should be trading in the 3.00 to 5.00 range as they are the only public company with the RNAi technology:
MDRNA, Inc. Announces Tentative FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis
Monday December 15, 9:18 am ET
BOTHELL, WA--(MARKET WIRE)--Dec 15, 2008 -- MDRNA, Inc. (NasdaqGM:MRNA - News) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.
ADVERTISEMENT
MDRNA's generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $147 million in 2007.
On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for U.S. distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.
"We are pleased that our generic calcitonin-salmon nasal spray has received tentative FDA approval and we look forward to full FDA approval in mid 2009," stated J. Michael French, President and CEO of MDRNA. "Although we are now a company solely focused in the research and development of RNAi-based therapeutics, we are pleased to see the successful culmination of years of hard work on the part of many current and former members of the MDRNA/Nastech team. I want to personally thank them all for their efforts in bringing this product forward. We are assessing our short- and long-term options to understand how this tentative approval can be leveraged toward the continued advancement of our RNAi drug discovery engine."
About Calcitonin
MDRNA's calcitonin-salmon nasal spray is a generic version of Miacalcin®, an FDA approved calcitonin-salmon nasal spray marketed by Novartis for the treatment of osteoporosis. Calcitonin is a natural peptide hormone produced by the thyroid gland that acts primarily on bone. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency is greater due to a longer duration of action. Novartis' Miacalcin® has been shown to increase spinal bone mass in post-menopausal women with established osteoporosis.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Our goal is to improve human health through the development of RNAi-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Over the past decade, we have developed substantial capabilities in molecular biology, cellular biology, lipid chemistry, peptide chemistry, pharmacology and bioinformatics, which we are applying to a wide range of RNAi technologies and delivery approaches. These capabilities plus the in-licensing of key RNAi-related intellectual property have rapidly enabled us to become a leading RNAi-based therapeutics company with a pre-clinical pipeline in key therapeutic areas including oncology, metabolic disorders and inflammation. Through our capabilities, expertise and know-how, we are incorporating multiple RNAi technologies as well as peptide- and lipid-based delivery approaches into a single integrated drug discovery platform that will be the engine for our clinical pipeline as well as a versatile platform for establishing broad therapeutic partnerships with biotechnology and pharmaceutical companies. We are also investing in new technologies that we expect to lead to safer and more effective RNAi-based therapeutics while aggressively building upon our broad and extensive intellectual property estate. By combining broad expertise in siRNA science with proven delivery platforms and a strong IP position, MDRNA is well positioned as a leading RNAi-based drug discovery and development company. Additional information about MDRNA, Inc. is available at http://www.mdrnainc.com.
MDRNA Forward-Looking Statement
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of MDRNA or a subsidiary to obtain additional funding; (ii) the ability of MDRNA or a subsidiary to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of MDRNA, a subsidiary and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of MDRNA, a subsidiary and/or a partner to obtain required governmental approvals; and (v) the ability of MDRNA, a subsidiary and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in MDRNA's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. MDRNA assumes no obligation to update and supplement forward-looking statements because of subsequent events.
Contact:
Contact:
Matthew D. Haines
Senior Director, Investor Relations and Corporate Communications
(212) 209-3874
Email Contact
McKinney|Chicago (Media)
Alan Zachary
(312) 944-6784 x 316 or
(708) 707-6834
Email Contact
--------------------------------------------------------------------------------
MRNA (this should be trading in the 3.00-5.00 range currently .60 up 135%:
http://biz.yahoo.com/iw/081215/0460354.html
MDRNA, Inc. Announces Tentative FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis
Monday December 15, 9:18 am ET
BOTHELL, WA--(MARKET WIRE)--Dec 15, 2008 -- MDRNA, Inc. (NasdaqGM:MRNA - News) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.
MDRNA's generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $147 million in 2007.
On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for U.S. distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.
"We are pleased that our generic calcitonin-salmon nasal spray has received tentative FDA approval and we look forward to full FDA approval in mid 2009," stated J. Michael French, President and CEO of MDRNA. "Although we are now a company solely focused in the research and development of RNAi-based therapeutics, we are pleased to see the successful culmination of years of hard work on the part of many current and former members of the MDRNA/Nastech team. I want to personally thank them all for their efforts in bringing this product forward. We are assessing our short- and long-term options to understand how this tentative approval can be leveraged toward the continued advancement of our RNAi drug discovery engine."
About Calcitonin
MDRNA's calcitonin-salmon nasal spray is a generic version of Miacalcin®, an FDA approved calcitonin-salmon nasal spray marketed by Novartis for the treatment of osteoporosis. Calcitonin is a natural peptide hormone produced by the thyroid gland that acts primarily on bone. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency is greater due to a longer duration of action. Novartis' Miacalcin® has been shown to increase spinal bone mass in post-menopausal women with established osteoporosis.
About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Our goal is to improve human health through the development of RNAi-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Over the past decade, we have developed substantial capabilities in molecular biology, cellular biology, lipid chemistry, peptide chemistry, pharmacology and bioinformatics, which we are applying to a wide range of RNAi technologies and delivery approaches. These capabilities plus the in-licensing of key RNAi-related intellectual property have rapidly enabled us to become a leading RNAi-based therapeutics company with a pre-clinical pipeline in key therapeutic areas including oncology, metabolic disorders and inflammation. Through our capabilities, expertise and know-how, we are incorporating multiple RNAi technologies as well as peptide- and lipid-based delivery approaches into a single integrated drug discovery platform that will be the engine for our clinical pipeline as well as a versatile platform for establishing broad therapeutic partnerships with biotechnology and pharmaceutical companies. We are also investing in new technologies that we expect to lead to safer and more effective RNAi-based therapeutics while aggressively building upon our broad and extensive intellectual property estate. By combining broad expertise in siRNA science with proven delivery platforms and a strong IP position, MDRNA is well positioned as a leading RNAi-based drug discovery and development company. Additional information about MDRNA, Inc. is available at http://www.mdrnainc.com.
MDRNA Forward-Looking Statement
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of MDRNA or a subsidiary to obtain additional funding; (ii) the ability of MDRNA or a subsidiary to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of MDRNA, a subsidiary and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of MDRNA, a subsidiary and/or a partner to obtain required governmental approvals; and (v) the ability of MDRNA, a subsidiary and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in MDRNA's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. MDRNA assumes no obligation to update and supplement forward-looking statements because of subsequent events.
Contact:
Contact:
Matthew D. Haines
Senior Director, Investor Relations and Corporate Communications
(212) 209-3874
Email Contact
McKinney|Chicago (Media)
Alan Zachary
(312) 944-6784 x 316 or
(708) 707-6834
Email Contact
--------------------------------------------------------------------------------
It is a great play and I think we will see much more from this company in the near future.
Same here!! Looking for a very nice run here!
Mobiclear Commercial:
Thanks Blues!
.019x.02 time to move back up!
MOBI .019x.02 ask getting hit!!!
GLTU also!