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$CNAT fam this company is not a pump. Check out $heff's $tation of $tocks & $olid DD for good info on this company. $heff took a position in this company yesterday.
Yeah I'm watching it. I hope it goes to da' moon for you.
$HALO needs more volume. Today's volume(681,300) so far is well below the 3 month average of 1,821,000.
I agree.
Threshold Pharmaceuticals just filed a prospectus, suggesting it plans to soon issue some securities
Threshold Pharmaceuticals just came out with a new prospectus, available here.
http://bit.ly/1naQ9j2
Threshold Pharmaceuticals just filed a prospectus, suggesting it plans to soon issue some securities
Threshold Pharmaceuticals just came out with a new prospectus, available here.
http://bit.ly/1naQ9j2
The author is long $ARNA so I wouldn't expect them to write anything good about $OREX. But this is small change when $OREX has a PDUFA coming up. All this along with the fact that very few people received this article makes me see this as a scare tactic from someone who is obviously short $OREX.
This is old news.
I bought 1k @ 5 this morning. GL to us all.
Washington, D.C. — Citizens for Responsibility and Ethics in Washington (CREW) today requested the Securities and Exchange Commission (SEC) investigate possible illegal manipulation of stock prices in Northwest Biotherapeutics, a biotechnology company developing cancer treatment drugs. Strategically released blog posts by well-known biotech stock analyst and senior columnist for TheStreet.com Adam Feuerstein seem designed to cause the price of the company’s stock to fall at times when short sellers were financially overexposed. CREW has asked the SEC and the U.S. Attorney for the Southern District of New York to conduct a full investigation of the timing of Mr. Feuerstein’s posts and their relationship to short seller financial interests.
http://bit.ly/UB8grE
Definitely over reaction. MMs are having fun today getting cheap shares.
$HALO AdCom notes due any day. AdCom on Thursday 7/31/14.
Equities research analysts at Roth Capital cut their price objective on shares of AcelRx Pharmaceuticals (NASDAQ:ACRX) to $16.00 in a research note issued to investors on Monday. The firm currently has a “buy” rating on the stock. Roth Capital’s target price indicates a potential upside of 47.74% from the stock’s previous close.
A number of other analysts have also recently weighed in on ACRX. Analysts at Canaccord Genuity cut their price target on shares of AcelRx Pharmaceuticals from $16.00 to $8.00 in a research note on Monday. They now have a “hold” rating on the stock. Analysts at JMP Securities initiated coverage on shares of AcelRx Pharmaceuticals in a research note on Tuesday, June 17th. They set an “outperform” rating and a $14.00 price target on the stock. One investment analyst has rated the stock with a hold rating and six have given a buy rating to the company’s stock. The stock currently has an average rating of “Buy” and a consensus price target of $15.21.
Shares of AcelRx Pharmaceuticals (NASDAQ:ACRX) opened at 10.83 on Monday. AcelRx Pharmaceuticals has a 52 week low of $6.04 and a 52 week high of $13.64. The stock has a 50-day moving average of $10.15 and a 200-day moving average of $10.84. The company’s market cap is $469.1 million.
AcelRx Pharmaceuticals (NASDAQ:ACRX) last posted its quarterly earnings results on Thursday, May 8th. The company reported ($0.22) earnings per share for the quarter, beating the analysts’ consensus estimate of ($0.23) by $0.01. Analysts expect that AcelRx Pharmaceuticals will post $-1.05 EPS for the current fiscal year.
http://bit.ly/1rRsOsO
Cowen Maintains An Outperform On AcelRx As FDA Issues CRL For Zalviso’s NDA
July 28, 2014 9:53 AM EDT by SA Staff in Exclusive Area, Healthcare // 0 Comments
In a research report released this morning, Cowen and Company analyst Joon Lee maintained an Outperform rating on AcelRx Pharmaceuticals (ACRX) with a $15 price target, following the news that the FDA issued a CRL for the NDA of Zalviso. Zalviso is a drug-device combination product being developed for moderate to severe in-hospital pain.
Lee wrote, “Zalviso NDA was filed based on two positive pivotal Phase 3 studies in the post-operative setting, one in soft-tissue and one in orthopedic surgeries. Additionally, a head to head Phase 3 study against IVPCA morphine demonstrated superiority of Zalviso over IVPCA. The CRL may delay the launch of Zalviso by approximately 6 to 11 months or potentially longer pending further discussions with the FDA. However, based on the positive results of these three Phase 3 studies and potential pharmacoeconomic benefits associated with Zalviso over IVPCA, we have reasons to believe that Zalviso will eventually be approved and commercialized”.
http://bit.ly/UFJsyd
I'm loving it. In for 2.5k @ 10.04
Wow great post. Lots of good info.
I guess so.
Quiet board here this morning.
I agree.
Yahoo has it at 5.02 mil short.
Share Statistics
Avg Vol (3 month)3: 618,952
Avg Vol (10 day)3: 789,438
Shares Outstanding5: 43.32M
Float: 18.79M
% Held by Insiders1: 49.00%
% Held by Institutions1: 29.50%
Shares Short (as of May 30, 2014)3: 5.02M
Short Ratio (as of May 30, 2014)3: 12.10
Short % of Float (as of May 30, 2014)3: 24.40%
Shares Short (prior month)3: 5.00M
http://yhoo.it/1nF4lkg
I think it was the overall market that brought it down, not a bear raid.
"It's all too clear: FDA denial or CRL next week with the major holders selling already. Stock will go back to $3/share"
Changed your mind already? LOL
Avanir Pharmaceuticals Announces Presentation of Positive Early Results from PRISM II Study
--Interim Results Show NUEDEXTA Provides Meaningful Reduction of PBA Episodes and is Generally Well Tolerated in Alzheimer's Disease/Dementia Population--
ALISO VIEJO, Calif., July 16, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (AVNR) today announced interim data from the phase IV PRISM II study showing that treatment with NUEDEXTA® substantially reduced symptoms of pseudobulbar affect (PBA) in patients with Alzheimer's disease/dementia. PBA is a distressing neurologic condition characterized by sudden and uncontrolled outbursts of laughing and/or crying in patients with neurologic disease and injury. A standard quality of life measure also showed clear improvement over the 3-month treatment period. The data were presented today, Wednesday, July 16, 2014 at the Alzheimer's Association International Conference (AAIC), being held at the Bela Center in Copenhagen, Denmark.
"These initial data showing reduced symptoms of pseudobulbar affect (PBA) in patients with PBA secondary to Alzheimer's and dementia are consistent with the benefits we saw in the pivotal phase III study, in PBA patients with ALS and MS, and provide further evidence that NUEDEXTA may offer relief from the debilitating episodes of PBA," said Joao Siffert, MD, chief medical officer at Avanir. "PRISM II has now completed enrollment of patients with dementia and continues to enroll patients with stroke and traumatic brain injury, two additional important causes of PBA. We look forward to reporting data from these additional cohorts later this year."
http://yhoo.it/1mh0Pfn
Yeah the news on Oral Galectin-3 was leaked!
Nice......good for you.
FDA Approves Anacor Pharmaceuticals’ KERYDIN™ (Tavaborole) Topical Solution, 5% for the Treatment of Onychomycosis of the Toenails
Anacor Pharmaceuticals, Inc. (ANAC) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for KERYDIN™ (tavaborole) topical solution, 5%, the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. Onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today.
“We are pleased to announce the FDA approval of KERYDIN, which provides an important new topical treatment option for the millions of people in the United States who are infected with onychomycosis of the toenails,” said Paul Berns, Chief Executive Officer of Anacor Pharmaceuticals. “We expect to launch KERYDIN in the U.S., either alone or with a partner, as early as the end of this quarter.”
http://yhoo.it/1rMdyhW
$APPY when is their PDUFA?
Now just for a pullback before 7/22 PDUFA Priority Review.
$EGRX receives tentative approval for bendamustine.
$EGRX Under the Hatch-Waxman Act, the holder of patents that the 505(b)(2) application references may file a patent infringement lawsuit after receiving notice of the paragraph IV certification. Filing of a patent infringement lawsuit against the filer of the 505(b)(2) applicant within 45 days of the patent owner's receipt of notice triggers a one-time, automatic, 30-month stay of the FDA's ability to approve the 505(b)(2) NDA, unless patent litigation is resolved in the favor of the paragraph IV filer or the patent expires before that time. Accordingly, we may invest a significant amount of time and expense in the development of one or more product candidates only to be subject to significant delay and patent litigation before such product candidates may be commercialized, if at all. In addition, a 505(b)(2) application will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, or NCE, listed in the Orange Book for the referenced product has expired. The FDA may also require us to perform one or more additional clinical studies or measurements to support the change from the branded reference drug, which could be time consuming and could substantially delay our achievement of regulatory approvals for such product candidates. The FDA may also reject our future 505(b)(2) submissions and require us to file such submissions under Section 505(b)(1) of the FDCA, which would require us to provide extensive data to establish safety and effectiveness of the drug for the proposed use and could cause delay and be considerably more expensive and time consuming. These factors, among others, may limit our ability to successfully commercialize our product candidates.
Companies that produce branded reference drugs routinely bring litigation against abbreviated new drug application, or ANDA, or 505(b)(2) applicants that seek regulatory approval to manufacture and market generic and reformulated forms of their branded products. These companies often allege patent infringement or other violations of intellectual property rights as the basis for filing suit against an ANDA or 505(b)(2) applicant. Likewise, patent holders may bring patent infringement suits against companies that are currently marketing and selling their approved generic or reformulated products. We filed an application with the FDA for our EP-3101 (bendamustine RTD) product candidate through the 505(b)(2) regulatory pathway on September 6, 2013, referencing Teva's Treanda product, including a paragraph IV certification stating our belief that our bendamustine product will not infringe Teva's patents on Treanda. We notified Teva of our 505(b)(2) filing and paragraph IV certification, and Teva filed a patent infringement lawsuit against us in the United States District Court for the District of Delaware on October 21, 2013. Teva's filing of the lawsuit invoked a 30-month stay of FDA approval of our bendamustine product, which will delay the FDA from approving EP-3101 (bendamustine RTD) until the earlier of the March 2016 expiration of the 30-month stay imposed by the Hatch-Waxman Act, or such time as the district court enters judgment in our favor or otherwise acts to shorten the stay. Moreover, regardless of when the 30-month stay is resolved or expires, the FDA may still be prohibited from approving our 505(b)(2) NDA due to Teva's unexpired orphan drug and related pediatric exclusivities for Treanda. Specifically, Teva has received orphan drug and pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications (as defined in "Business—Our Products and Product Portfolio"), respectively. When a drug, such as Treanda, has orphan drug exclusivity, the FDA may not approve any other application to market the same drug for the same indication for a period of up to seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity. In the United States, pediatric exclusivity adds six months to any existing exclusivity period. If we cannot demonstrate that EP-3101 is clinically superior to Treanda, or qualify under certain other limited exceptions, we will not be able to enter the market for the CLL indication until September 2015 (assuming the 30-month stay is resolved by that time) or the NHL indication until May 2016.
Litigation to enforce or defend intellectual property rights is often complex and often involves significant expense and can delay or prevent introduction or sale of our product candidates. If patents are held to be valid and infringed by our product candidates in a particular jurisdiction, we would, unless we could obtain a license from the patent holder, be required to cease selling in that jurisdiction
http://1.usa.gov/1pEdi4K
$MNKD wins approval.
$MNKD wins approval.
That would be nice. PDUFA on 7/27, we may hear on 7/25 Friday.
I added @ 9.94 and 9.85 .
Las $HRTX has had a 30% run in the last 8 days.
No resumption time yet. Still in T1. http://bit.ly/1l63GNH
Wrinks have you tried five letter words? ;~)
Orexigen Receives Three Month Extension of FDA NB32 Review
SAN DIEGO, June 11, 2014 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (OREX) today announced that the United States Food and Drug Administration (FDA) has extended its review of the resubmitted New Drug Application (NDA) for NB32, the Company's investigational medication being evaluated for weight loss. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014.
The FDA has indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. The NDA resubmission package includes interim safety and CV outcomes data from the ongoing 8,900 patient Light Study. Discussions around the package insert and other post-marketing obligations are ongoing.
"We are working expeditiously with the FDA to finalize the review," said Michael Narachi, CEO of Orexigen. "We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation."
Orexigen management will host a conference call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling 1 (800) 708-4540 (domestic) or 1 (847) 619-6397 (international), participant code 37498115. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com/ and will be archived for 14 days following the call.
yhoo.it/1inpkqM
CJ27 Thanks, good info.