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KG Analysis & Videos »
KG: Bull or Bear?
FDA Calendar Updates: KG, PTIE, DRRX, ALTH, TRIB, CBST, DYAX
KG
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+27.43%
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149 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 243 entries as of 7/7/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending...
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FDA Calendar Updates: ACUR, KG, MYRX, NEPH, Eisai
KG
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-1.56%
in
5 days
(closed on 07/07/09)
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st...
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FDA Calendar Updates: Royal Returns for King Pharma
KG
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+4.45%
in
52 days
(closed on 07/02/09)
<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions...
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BioMed Stock Movers: DNDN, EXAS, KG
KG
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+20.21%
in
33 days
(closed on 05/11/09)
Dendreon (DNDN) has stalled out around $6.50 per share after a major rally on news of upcoming presentation at a medical conference later this month. DNDN expects to report Provenge clinical trial results some time before the end of April, although it did not guarantee this would occur at the upcoming presentation. The recent spike in shares of DNDN and upcoming presentation do not provide any clarity on whether Provenge results will be sufficient for attaining FDA approval and the pending data release will determine the Company's fate. <> <> <>http://biomedreports.com/article...
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King Pharma: A Value Play on New Drug Approvals
KG
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+11.00%
in
20 days
(closed on 04/08/09)
King Pharma (KG) is a specialty pharmaceutical company which recently acquired Alpharma for $1.6B and has three pending NDAs at the FDA for new drug approvals and received a complete response late last year for Remoxy (an abuse deterrent form of extended-release oxycodone) along with Pain Therapeutics (PTIE). BioMedReports.com FDA and Clinical Trial Calendars: <> King is currently trading at around decade lows in terms of stock price at a market cap of $1.7B and enterprise value of $2.2B. Consensus analyst est...
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BioDelivery Sciences: A Bet on FDA Approval of Onsolis
KG
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-11.63%
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14 days
(closed on 03/19/09)
While pending FDA new product decisions are never a sure thing, BioDelivery Sciences (BDSI) appears to have the odds stacked in its favor for approval of cancer breakthrough pain drug candidate Onsolis. <> BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis (BEMA fentanyl) based on the feedback it received from a complete response ruling by the FDA last August. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (...
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FDA Decision Calendar: Pain Drug Delays Likely
KG
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-25.87%
in
23 days
(closed on 03/05/09)
FDA Decision Calendar: Pain Drug Delays Likely By Mike Havrilla on 2/9/09 ETF Innovators The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars. New FDA Decision Calendar Entries: <> 1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA...
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Stock Ideas from ETF Innovators New Indexes
KG
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-14.71%
in
64 days
(closed on 02/10/09)
<> Below is a list of 14 stock opportunities from various ETF Innovators [ETFI] indexes, which includes a database of over 1,000 companies. The companies are chosen across a full spectrum of market cap and risk level from a variety of industry groups.
From the ETFI Highly Defensive PerformIdex , I believe Altria Group (MO) and Pfizer (PFE) are defensive dividend, value buys at current levels as each company currently pays a dividend of $1.28 per share annually – resulting in historically high dividend yields for bot<>< />< /><><><>< />< /><><><>< />< /><><>< />< /><><>< />< /><><>< />< /><><><><><><>< />< /><><><><>< />< />< />< />< />< />< />< />...
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Full Calendar of FDA Decisions
KG
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+4.71%
in
7 days
(closed on 12/07/08)
<> 
The accompanying table [click to enlarge] includes an updated calendar of 73 expected FDA decision dates. Click here for my previous articles and FDA calendars , including several companies with expected decisions before year-end expected to have major stock price impacts, but keep in mind the backlog of delayed decisions that is building means that none of the dates are certain to produce final decisions. <> Genzyme (GENZ) could hear back from the FDA as early as Monday for approval of Myozyme at the 2,000L...
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Stock Picks for Healthy Returns
KG
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-0.95%
in
5 days
(closed on 11/30/08)
<> Abbott Labs (ABT) is a consistent performer with diversified healthcare operations, including pharmaceuticals, diagnostics, medical nutrition products, and medical devices/stents. ABT is back to the lower end of its trading range near 50 bucks, presenting an excellent entry point with a 2.8% dividend yield and forward PE of about 14X.
Celgene (CELG) is also trading at the low end of its trading range around 50 bucks as a large-cap growth stock focused on cancer biotech products and research with an estimated PEG ratio below one.
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Full Calendar on Tap for FDA through Year-End
KG
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-2.07%
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12 days
(closed on 11/25/08)
<> 
<>
The accompanying table presents an updated calendar of 30 decision dates which either have deadlines before year-end or represent delays in previously expected decisions in which the FDA has not issued a new date for a final decision.
After the close today, Pain Therapeutics (PTIE) and King Pharma (KG) announced mixed results from a FDA panel review of Remoxy, which is designed to be an abuse-resistant opiate pain drug in response to abuse and diversion issues with drugs such as Purdue Pharma's OxyCont...
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More Pain to Come from the FDA?
KG
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+10.80%
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22 days
(closed on 11/13/08)
<> 
The accompanying table (click on image to enlarge) presents an updated calendar of expected FDA decision dates. Surprisingly, the FDA issued a complete response letter to Abbott Labs (ABT) for Vicodin CR, an extended-release version of the widely used painkiller that the company expected to be approved this quarter. Three more companies face key FDA decision in the month of December for abuse-resistant forms of opiate pain drug candidates. King Pharma (KG) and Pain Therapeutics (PTIE) await a decision on Remoxy while Alpharma (ALO) ...
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FDA Decision Date Calendar for 2009
KG
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-11.59%
in
28 days
(closed on 10/22/08)
<> 
<> <> <> The accompanying table presents a calendar of expected FDA regulatory approval decisions for 2009, including a March 1st deadline to expand the label of cancer drug Erbitux in what has now become a hostile takeover attempt by Bristol-Myers (BMY) for the remaining 83% stake in ImClone Systems (IMCL) it does not already own. Two other companies which are highly leveraged to their upcoming FDA decision include Pain Therapeutics (PTIE) and King Pharma (KG) for Remoxy, which are due to hear back from the agency this yea...
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King Pharmaceuticals Inc.
KG
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+5.23%
in
499 days
King Pharmaceuticals, Inc. provides branded prescription pharmaceutical products worldwide. It primarily offers branded prescription products for primary care physicians, neurologists, orthopedic surgeons, hospitals, internal medicine physicians, allergists, pediatricians, and pain specialists. These products include neuroscience products, such as Skelaxin, Avinza, and Sonata; hospital products, such as Thrombin-JMI and Synercid; acute care products that comprise Bicillin and Intal; and legacy products consisting of Altace, Levoxyl, and Cytomel. The company also develops, manufactures, and ...
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King Pharmaceuticals a buy - market has overreacted in selloff
KG
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-28.65%
in
856 days
Down about 20% in a few months. market has overreacted to the possibility that Altace patent might be invalidated early which is set to expire in April 2009.
Cash flow has grown about 25% per year for the past seven years. Altace currently makes up 32% of sales.
Assuming no further growth the current cash flow discounted to present value valued KG at almost double the current price. Subtracting 100% of the altace sales makes KG still undervalued by greater than 30%. A great bargain for a company with a good history of increasing cash flow. Seems likely to grow at least 50% in ...
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About King Pharmaceuticals Inc.
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