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Synthetic Biologics, Inc. (SYN)

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Synthetic Biologics










Synthetics Biologics, Inc., a biotechnology company, focuses on development of novel anti-infective biologics and drug candidates targeting specific pathogens that cause serious infections and other diseases. The company?s product candidates include Trimesta, which has completed phase II clinical trials for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis; SYN-010 that is in preclinical stage for the treatment of constipation-predominant irritable bowel syndrome; SYN-004, which is in preclinical stage for the treatment of clostridium difficile infection prevention; SYN-005 that is in preclinical stage for the treatment of pertussis; SYN-001, which is in discovery stage for the treatment of acinetobacter infection; and SYN-007 that is in discovery stage for the treatment of irritable bowel syndrome. It has a sublicense agreement with Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the United States, Canada, and Japan. The company was formerly known as Adeona Pharmaceuticals, Inc. and changed its name to Synthetics Biologics, Inc. in February 2012. Synthetics Biologics, Inc. was founded in 2001 and is based in Rockville, Maryland.



As of November 2, 2015 the registrant had 90,810,086 shares of common stock outstanding.







management team rule


board of directors rule


advisors rule

 











 



http://www.syntheticbiologics.com/trimesta

http://www.syntheticbiologics.com/SYN-004

http://www.syntheticbiologics.com/index.php?s=150
collaborators rule

The initiation of monocloncal antibody (mAb) development for the treatment of pertussis is the second of three infectious disease indications Synthetic Biologics intends to pursue as part of its August 2012 collaboration with Intrexon Corporation.

To further the development of this potential mAb therapy for pertussis, Synthetic Biologics has entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics


SYN-001 rule


Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. Monoclonal antibodies (mAbs) can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs, SYN-001, for human testing and use to specifically treat Acinetobacter.

infectious diseases collaboration with Intrexon rule

Many infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. In August 2012, Synthetic Biologics announced a second worldwide exclusive channel collaboration with Intrexon Corporation. Using Intrexon’s comprehensive suite of proprietary technologies and processes, Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.


partnered program rule

Effirma™ for Fibromyalgia

Synthetic Biologics has partnered the development of Effirma (flupirtine), a centrally-acting investigational oral drug, for the treatment of fibromyalgia syndrome with Meda AB. Effirma is a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Effirma is a non-opioid, non-NSAID, non-steroidal, analgesic. Preclinical data and clinical experience suggest that Effirma should also be effective for neuropathic pain since it acts in the central nervous system via a mechanism of action distinguishable from most marketed analgesics. Effirma is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception and Effirma may be the N-methyl-D-aspartic acid glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Effirma has strong inhibitory actions on N-methyl-D-aspartic acid-mediated neurotransmission. Flupirtine was originally developed by Asta Medica (subsequently acquired by Meda AB) and has been approved and is marketed by Meda AB in Europe since 1984, as well as other countries, for the treatment of pain. It has never been approved by the FDA for any indication.

On May 6, 2010, Synthetic Biologics and Pipex, its wholly owned subsidiary, entered into a sublicense agreement with Meda AB, a multi-billion dollar international pharmaceutical company, pursuant to which Meda AB assumed all future development costs and may commercialize flupirtine for fibromyalgia in the United States. As consideration for such sublicense, Synthetic Biologics received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon the FDA’s acceptance of the New Drug Application (NDA) for flupirtine for fibromyalgia and $10 million upon FDA approval of such NDA. Pursuant to the sublicense agreement, Synthetic Biologics will also receive a 7% royalty on net sales of flupirtine for fibromyalgia in the United States, Canada and Japan, with such royalties being shared equally with Synthetic Biologic’s licensor, McLean Hospital, a Harvard teaching hospital.

Flupirtine is approved and marketed by Meda AB and its distributors in Europe and other countries for indications other than fibromyalgia and has been prescribed to millions of patients worldwide. Synthetic Biologics believes that such substantial human experience with flupirtine should greatly assist the FDA in its evaluation of the safety of flupirtine upon review of an NDA of flupirtine for fibromyalgia. According to Meda’s 2010 Annual Report, flupirtine for fibromyalgia is currently in Phase II development.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, often accompanied by severe fatigue, insomnia and mood symptoms. According to the National Fibromyalgia Association, fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S.

There are presently three FDA products approved for this indication in the United States – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.



http://www.syntheticbiologics.com

http://www.syntheticbiologics.com/investors


SEC filings
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000894158&type=&dateb=&owner=include&count=40

Finviz quote
http://www.finviz.com/quote.ashx?t=syn&ty=c&ta=1&p=d

http://finance.yahoo.com/q/ks?s=SYN+Key+Statistics

http://finance.yahoo.com/q/ks?s=AEN+Key+Statistics



 
 
 
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SYN News: Proxy Statement (definitive) (def 14a) 08/14/2018 06:06:03 AM
SYN News: Current Report Filing (8-k) 08/13/2018 06:31:53 AM
SYN News: Additional Proxy Soliciting Materials (definitive) (defa14a) 08/09/2018 06:07:15 AM
SYN News: Quarterly Report (10-q) 08/08/2018 05:12:18 PM
SYN News: Current Report Filing (8-k) 08/08/2018 04:16:17 PM
News News Alert: Proxy Statement (definitive) (def 14a) 08/14/2018 06:06:03 AM
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#6620  Sticky Note Link back for charts and links/dd. BooDog 11/30/15 06:33:49 AM
#7906   Nice Cbdpotential 08/13/18 04:31:14 PM
#7905   It sure is - I will wait a shermann7 08/13/18 12:15:12 PM
#7904   Picked some up at $3 when it was BooDog 08/13/18 12:13:09 PM
#7903   Myself also ... It will be interesting to shermann7 08/10/18 10:06:39 AM
#7902   I was expecting a bit more volatility. BooDog 08/10/18 10:01:34 AM
#7901   Ggyyhû g JJBHM 08/10/18 09:45:43 AM
#7900   Lol...you're correct. 420man 08/10/18 07:38:09 AM
#7899   The date is Aug 10th for the 1:35 shermann7 08/10/18 01:03:59 AM
#7898   Conference call at 4:30 http://www.prnewswire.com/news-releases/synthetic-biolog BooDog 08/08/18 04:21:04 PM
#7897   Watching for fluff PR prior to tomorrow's RS 420man 08/07/18 08:21:22 AM
#7896   True. Makes sense to sell before the RS blackcat 08/06/18 06:32:35 PM
#7895   The other advantage is you won't have your BooDog 08/06/18 05:04:35 PM
#7894   Ah- thanks for that info. I hadn't event blackcat 08/06/18 01:38:03 PM
#7893   This is where one does do the .005 BooDog 08/06/18 12:50:52 PM
#7892   Welcome to your future :-) scottsmith 08/03/18 04:55:05 PM
#7891   yikes! TheHound 08/02/18 06:17:49 PM
#7890   where is value here? noretreat 08/02/18 03:46:07 PM
#7889   Float going just under 5M, authorized will be BooDog 08/02/18 10:32:36 AM
#7888   Agreed, R/s coming and lol say goodbye to FORDGT 08/02/18 10:29:55 AM
#7887   No way dreamer sindram 08/02/18 08:28:33 AM
#7886   This will probably drop under 10 cents. buckiii2 08/01/18 09:12:01 PM
#7885   Anyone have idea why 1.43 offering after the xlofer 08/01/18 08:22:42 PM
#7884   I really have no idea what is going shermann7 08/01/18 06:01:48 PM
#7883   I was most curious when they announced the BooDog 08/01/18 06:00:41 PM
#7882   I sold my position awhile ago ... And shermann7 08/01/18 05:56:39 PM
#7881   I was wondering if they would split. https://mma.prnewswire.com/media/319502/sy BooDog 08/01/18 05:53:49 PM
#7880   Never Mind - I missed the news ... shermann7 08/01/18 05:18:53 PM
#7879   Wow!!! I did not see that - Do shermann7 08/01/18 05:16:42 PM
#7878   1 to 35 RS Aug 10th buckiii2 08/01/18 05:15:18 PM
#7877   Getting some free publicity for SYN. BooDog 07/30/18 10:06:06 AM
#7876   What’s going on here. Any word on new leadership? JJBHM 07/26/18 09:15:41 PM
#7875   yikes! TheHound 07/26/18 06:05:24 PM
#7874   Watching 420man 07/05/18 09:05:12 AM
#7873   A bit of volume coming in. Maybe BooDog 07/02/18 09:38:00 AM
#7872   SYN buy 0.2390 stocktrademan 07/01/18 10:26:15 PM
#7871   Big week coming, (hoping) Dreamboyz 06/30/18 02:51:40 PM
#7870   This could be interesting https://thefly.com/landingPageNews.php?id=2752841&hea monmon 06/29/18 02:25:13 PM
#7869   I knew they would take it back down. BooDog 06/12/18 03:39:25 PM
#7868   They're still trying to tease with .0001 with BooDog 06/12/18 01:23:31 PM
#7867   In due time if you believe in the JJBHM 05/23/18 08:18:30 PM
#7866   Dead? Jumpinjackas 05/23/18 11:49:02 AM
#7865   ROCKVILLE, Md., May 22, 2018 /PRNewswire/ -- Synthetic BooDog 05/22/18 07:21:41 AM
#7864   Looks like they're building a solid protocol for BooDog 05/10/18 06:16:01 AM
#7863   got caught on the wrong side of that my name is 04/23/18 08:47:31 PM
#7862   The big "IF" factor in play here for sure. $SYN BooDog 04/23/18 04:08:23 PM
#7861   High odds for making green on those shares. Citrati 04/23/18 03:07:20 PM
#7860   I think the loss of Breakthrough Therapy Designation blackcat 04/23/18 02:02:25 PM
#7859   Over reaction. I just loaded up at 21 gator16 04/23/18 12:59:18 PM
#7858   Is FDA’s agreement for P3 a bad news? sage4 04/23/18 12:18:07 PM
#7857   Nope, always has had another move for six Citrati 04/14/18 11:34:53 PM
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