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Still here... Just normal profit taking going on, imo.
GL.
Picked up some more here @ .614.
GLTA.
Yeah, possible .50 break again today?
Hopefully we'll see some big news out of the conference...
HEB moving eom
Back to $1.50 ask... Anyone think we'll close green?
GLTA.
.63s now... May be about to break .64, imo.
GLTA.
BNVI, DARA, ANX, CXM, HEB, and NEXM are the next small caps to move over $1, imo.
GL.
AH currently @ .75. Volume of 1.9M.
GL.
I usually get news for a wide range of biotechs from these different links on Yahoo! Finance:
http://biz.yahoo.com/ic/news/515.html
http://biz.yahoo.com/ic/news/513.html
http://biz.yahoo.com/ic/news/511.html
http://biz.yahoo.com/ic/news/510.html
Hope those links help...
GL.
Almost 1.5m volume after hours. Amazing...
GLTA.
New HOD @ .709
GLTA.
Moving back up!
GLTA.
Thanks!
GLTY.
NEXM on fire today!! Congrats so far to all in NEXM!
GLTA.
New 52wk high! Heading to $1, imo.
GL!
Picked up some more on this dip.
GLTA.
ANX broke thru .50 today!
GLTA.
IMO by the 25th we'll be at $1... Lots of these sub-$1 biotechs are moving up, and NEXM is no exception.
jmo.
GL.
BNVI has broken .61!
GL.
20k shares on ask @ .585...
GLTA.
Looking fantastic... Do I hear $1?!
GO ANX!!!
GLTA!
ANX up almost 20% today. Nice...
GLTA.
Achillion Announces Additional Positive Phase 1b Data With ACH-1625 to Treat Hepatitis C
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported additional preliminary data from its on-going phase 1b clinical trial of ACH-1625 which demonstrated that the second dosing cohort receiving treatment with ACH-1625 achieved a mean 4.25 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
Proof-of-Concept Study Results
Today, Achillion announced additional results from a phase 1b clinical study of ACH-1625. HCV-infected subjects in this second dosing cohort (n=9, randomized to 6 active drug, 3 placebo) received doses of 500 mg BID of ACH-1625. Preliminary results showed that a mean reduction in viral load of 4.25 log10 was achieved in the treatment group, as compared to a mean reduction of 0.29 log10 in the placebo group. Safety results from this dosing group were similar to those observed in both the phase 1a segment of the trial and in the first cohort of HCV-infected subjects. Sustained viral suppression was also similar to the first cohort, with patients maintaining a mean reduction of more than 3.0 log10 from baseline through day 12, 7 days after dosing was completed and the last day of viral load measurement in the study.
In December 2009, Achillion announced proof-of-concept data from this phase 1b study. Subjects in the first dosing cohort of HCV-infected patients received doses of 600 mg BID (n=9, randomized to 6 active drug, 3 placebo). Preliminary results showed that a mean reduction in viral load of 3.94 log10 was achieved in the treatment group, as compared to a mean reduction of 0.22 log10 in the placebo group. All subjects in the treatment group had viral load decline between 3.0 and 4.5 log10, and two subjects reached undetectable levels of HCV RNA. Safety results from this dosing group were similar to those observed in the phase 1a segment of the trial. There were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0 log10 from baseline through day 12, the last day of viral load measurement in the study.
"We are quite pleased to see that these data corroborate and support the preliminary positive data from the first cohort of the study even at this lower dose. ACH-1625 continues to demonstrate a dramatic reduction in viral load after 5 days of monotherapy, and importantly, showed continued suppression of viral load after drug discontinuation. This is significant as it could be a distinguishing feature and competitive advantage for our compound in comparison to other HCV therapeutics," said Michael D. Kishbauch, Chief Executive Officer of Achillion.
"With continued robust antiviral activity even at this lower dose, we are encouraged now to explore both lower doses and different dosing schedules. We expect to conduct studies of additional doses under this protocol over the next few months and to release additional data thereafter, potentially at the upcoming EASL (European Association for the Study of Liver Disease) meeting in April 2010 in Vienna," added Dr. Elizabeth Olek, Chief Medical Officer of Achillion.
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In phase 1a safety studies with ACH-1625, subjects in the single ascending dose (SAD) segment of the study received single doses ranging from 50 mg to 2000 mg. Subjects in the phase 1a multiple ascending dose (MAD) segment of the study received 5 days of ACH-1625 up to a maximal dose of 2000 mg per day. Preliminary data from the SAD and MAD trial segments demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.
About HCV
The hepatitis C virus (HCV) is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-1625, which may not be duplicated in future cohorts at different doses or in future clinical studies of longer duration; Achillion's expectations regarding timing and duration of other clinical trials, including additional dosing cohorts. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2008.
All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
ACHN-G
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Achillion Pharmaceuticals, Inc.
Mary Kay Fenton
(203) 624-7000
mfenton@achillion.com
Lippert/Heilshorn & Associates, Inc.
Investors:
Anne Marie Fields
(212) 838-3777
afields@lhai.com
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Media:
Megan Rusnack
(212) 838-3777
mrusnack@lhai.com
I agree w/ you. Looking forward to the conf. on Wednesday, should be good.
GLTA.
NexMed Provides Corporate Update
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today provided an update on ongoing corporate activities and the status of the Company’s NASDAQ listing
Product Pipeline Topical Alprostadil Treatments NexMed expects to hear from Health Canada concerning the approvability of its New Drug Submission (NDS) for Vitaros®, its topical treatment for erectile dysfunction, sometime in February 2010. As such, management has postponed negotiations with its potential partner until an approval decision from Health Canada is received, as partnering negotiations with a marketing approval would be expected to yield more favorable terms for the Company
In the U.S., NexMed is awaiting a response from the Food and Drug Administration (FDA) regarding the carcinogenicity (CAC) assessment package, which it expects to occur within the next two months. Partnering efforts for Femprox®, NexMed’s topical treatment for female sexual dysfunction, are on hold pending the final decision by the FDA
Outside of North America, NexMed is awaiting Health Canada or the FDA’s response to accelerate partnering efforts and/or filing for marketing approvals. To date, NexMed has received multiple indications of interest from international pharmaceutical companies that might be interested in partnering with NexMed
In addition, through its Bio-Quant research and development team, NexMed is running new efficacy studies on the Vitaros formulation to assess the potential of the compound for other indications such as wound healing and Raynaud’s Syndrome. NexMed’s strategy is to take advantage of the development work already completed for Vitaros and bolster the existing database with new data and apply it to potentially shorten the path of approval. The goal includes commencing partnering discussions in mid-2010 for the new indications, if the pre-clinical data are positive
NM100060 Onychomycosis Treatment NexMed is actively engaged in efforts to re-license this product for the treatment of nail fungus. In the meantime, Novartis continues to transfer the clinical and regulatory dossiers to the Company and the data are being shared with potential partners
Topical psoriasis Treatment NexMed’s Bio-Quant R&D team is also proceeding with extensive pre-clinical efficacy studies to strengthen its psoriasis candidate while actively engaging in partnering discussions
Topical NSAID Program NexMed is also exploring the opportunity to license an early stage NSAID program, which includes an issued U.S. patent. This program was not pursued when NexMed chose to focus its resources on its sexual dysfunction programs. Preclinical data of the NexACT-based ketoprofen cream has shown more rapid and efficient delivery of the drug as compared to the currently marketed products
NexACT technology, Partnering as a Service NexMed has initiated discussions with potential partners regarding the application of its NexACT technology to drugs that will soon be going off-patent to help create a second-generation drug that has patent protection through the mechanism of delivery. The NexACT platform technology has demonstrated the potential to improve the topical absorption of active therapeutic ingredients and/or to develop new patient-friendlier routes of administration. Incorporating older drugs with the NexACT proprietary delivery system can create new products that not only provide patients with added therapeutic benefits, but can also extend the product life for up to an additional 20 years. As such, the Company intends to aggressively pursue these types of potential partnering arrangements going forward
NexACT technology, New Applications In addition to developing innovative topical treatments, NexMed’s new scientific team is evaluating the ability of the NexACT technology to deliver biologics, such as humanized or fully human antibodies, via transdermal application. The delivery of such biologics through the skin represents a novel approach to delivering antibodies to specific areas of the body with limited systemic exposure – potentially reducing side effects and toxicity. We are also evaluating the ability of the NexACT technology to deliver drugs orally, including various first-line oral chemotherapeutics, which currently have poor bioavailability and thus require high doses and result in certain toxic side effects
NASDAQ Listing On January 4, 2010, NexMed received an expected notice of non-compliance from The NASDAQ Stock Market LLC based upon its failure to solicit proxies and hold an annual meeting for fiscal 2008 by December 31, 2009, as required by NASDAQ Listing Rules 5620(a) and 5620(b), which could serve as an additional basis for the delisting of the Company’s securities from The NASDAQ Capital Market. NexMed had discussed this matter with the NASDAQ Listing Qualifications Panel (the “Panel”) at the hearing on November 12, 2009, and explained that it planned to postpone the 2008 annual meeting due to the ongoing acquisition of Bio-Quant and would not be able to incorporate all of the relevant acquisition related materials in the meeting proxy in a timely manner
As NexMed previously announced on December 18, 2009, the Panel granted its request to remain listed on The NASDAQ Capital Market, subject to the condition that it evidence stockholders’ equity of at least $2.5 million or a market value of listed securities of at least $35 million on or before March 31, 2010. The determination followed the hearing before the Panel on November 12, 2009, at which time NexMed presented its plan to evidence compliance with all requirements for continued listing on The NASDAQ Capital Market, including the proxy solicitation/annual meeting and bid price requirements (notwithstanding the fact that NexMed was not yet deficient with respect to those standards)
As provided by NASDAQ’s most recent notice, NexMed plans to timely make a formal written submission to the Panel presenting its plan to evidence compliance with the proxy solicitation and annual meeting requirements. While it intends to file a proxy statement for a special meeting of shareholders to be held within the next sixty days to consider amending its Articles of Incorporation to authorize more common stock for issuance, that meeting may not be conducted as an annual meeting since the proxy statement will not incorporate audited financial statements for the fiscal year ended December 31, 2009. As a result, in order to satisfy NASDAQ’s annual meeting requirement, NexMed plans to file a proxy statement for a joint 2008/2009 annual meeting promptly following the filing of its Annual Report on Form 10-K for fiscal 2009 in March 2010. Accordingly, the Company is asking the Panel to modify its previously issued decision in accordance with the Company’s revised plan of compliance. However, there can be no assurance that the Panel will grant the Company’s request
Also as previously announced, NexMed remains subject to a grace period through January 25, 2010 to evidence compliance with the $1.00 bid price requirement for continued listing on NASDAQ. In the event NexMed does not evidence compliance with the bid price requirement by that date, NexMed expects to receive an additional formal notice of non-compliance and to be afforded an opportunity to request an exception from the Panel to evidence compliance with the minimum bid price requirement. In that regard, NexMed will implement a reverse stock split, if necessary, to evidence compliance with NASDAQ’s minimum bid price requirement, which action may be taken at any time at the discretion of the NexMed Board of Directors
Corporate Integration Subsequent to the December 17, 2009 announcement of the lease of its manufacturing building in New Jersey, NexMed has completed the relocation of its headquarters to 6330 Nancy Ridge Drive, San Diego, CA 92121. NexMed now has 34 full time employees, of whom eight employees hold either Ph.D or MD degrees. NexMed will include the pro forma financial statements for the combined entity in an amendment to its December 17, 2009 Current Report on Form 8-K, to be filed on or before February 26, 2010
About NexMed NexMed, due to its recent acquisition of Bio-Quant, is the largest specialty contract research organization (“CRO”) based in San Diego, CA and is one of the industry’s most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed has a proprietary product pipeline based on its NexACT drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis. For further information, go to www.nexmed.com and www.bio-quant.com
Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that the Company will receive favorable approvability decisions from Health Canada or the FDA within the anticipated time frames or at all, the Company’s research and development activities will yield the desired results, the Company will be able to achieve or will continue to pursue its product development goals, the Company will be able to execute on its partnering strategies, the Company will be able to satisfy NASDAQ continued listing standards, and that the Company will be able to integrate its business following the Bio-Quant acquisition in a successful manner
Thanks for the update on OXBT... Definitely one to keep an eye on!
GL.
Thanks for the post... Great news from NEXM!
Thanks for the post! AEN is definitely a biotech to keep an eye on!
GLTY.
http://www.chemgenex.com/wt/home/index
That's their website...
They have an ODAC (Oncologic Drugs Advisory Committee) Meeting for their drug on February 10, here's a link to the ODAC Meeting PR: http://www.chemgenex.com/wt/No%20Template/pr_1261014391
Any other questions just let me know!
GLTY.
Nice jump on ANX...
GL.
Went away for about 30-45 minutes... Came back to this! Nice surprise! :)
GLTA.
.62 broken... eom
Going crazy today... Anyone know why?
GLTA.
HEPH going crazy today...
GLTA.
Something else interesting from the last 10Q:
4. STOCK OPTIONS
On December 31, 2008 a total of 40,000 options were granted to Bruce Bergman, Aaron Cohen, William Comer and Alf Akerman (10,000 each) for participation on board committees exercisable at $1 per share expiring 10 years from issuance. Expenses totaling $1,600 were charged to “Board Expense” in 2008.
All options are vested immediately. The options are not actively trading and the fair market value is not readily ascertainable, the options are taxable at the time of exercise as opposed to the time of their grant.
The following table presents information regarding weighted-average exercise price and weighted average remaining contractual life as of September 30, 2009.
Options Outstanding and Exercisable
Range of
Exercise Price
$1.00
Number of
Options
11,838,253
Weighted Average
Exercise Price
$1.00
Weighted Average
Remaining Life
9.1
________________________________________________________
If the company was going nowhere, then why would they issue options to their board members for $1/sh exercise price?
jmo.
GLTA.
I'm going to call the company in the morning, and see what's going on... Will repost what I hear (if they answer their phone)...
GLTA.
I like the low shares o/s here w/ TTRX... Some positive news could send it flying, imo.
GLTA.
Could be big if they could get a licensing partner...
From the last 10Q:
Management intends to find a licensing partner to continue our development of Nemifitide, primarily in treatment-resistant patients which currently represents approximately 5 to 10 percent of the overall patient population suffering from the disease. Additionally, management intends to obtain regulatory approval to sell Nemifitide in foreign jurisdictions which management believes will lead to revenue generation. We can offer no assurance that we will be successful in identifying a licensing partner or obtaining regulatory approval in the United States or any foreign jurisdiction.
GLTA.
Aradigm to Present at Biotech Showcase 2010 on January 12
HAYWARD, Calif., Jan 06, 2010 (BUSINESS WIRE) -- Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced that President and Chief Executive Officer Igor Gonda, Ph.D., will present at the Biotech Showcase 2010 on Tuesday, January 12, 2010, at 3:00 p.m. Pacific time.
The event will be held at the Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco, CA.
Investors wishing to attend the event should send an email request with their complete contact information to investor@aradigm.com no later than Friday, January 8 for complimentary tickets.
About Aradigm
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. The Company has product candidates addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections and smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation
Aradigm Corporation
Nancy Pecota, 510-265-9370
Chief Financial Officer
Copyright Business Wire 2010
ANX-514 news out of the conference would be great...
GL.