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King Beats, But Earnings Down

Thu, 05 Nov 2009 20:08:54 GMT

King Pharmaceuticals, Inc. (KG) reported third quarter earnings of 29 cents per share, beating the Zacks Consensus Estimate by 2 cents. Despite revenues increasing 19.3% from the year-ago period, earnings declined 25.6% from the year-ago quarter mainly due to higher operating expenses.[More...]

Stock Review: Pain Therapeutics (Nasdaq: PTIE)

Fri, 24 Jul 2009 15:21:35 GMT

Pain Therapeutics is a drug development firm focusing on Remoxy, a tamper-proof version of Oxycontin that could be a big blockbuster for partner King Pharmaceuticals. Read More...[More...]

FDA Calendar Updates: KG, PTIE, DRRX, ALTH, TRIB, CBST, DYAX

Tue, 07 Jul 2009 19:11:39 GMT

Below is a summary of updates to the BioMedReports.com FDA Calendar, 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 BioMedReports.com, 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 respon (...)[More...]

FDA Calendar Updates: Royal Returns For King Pharma (NYSE:KG)

Mon, 11 May 2009 16:18:30 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. 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, s (...)[More...]

King Pharma: A Value Play on New Drug Approvals

Thu, 19 Mar 2009 20:51:00 GMT

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: http://biomedreports.com/fda-calendar.html King is currently trading at around decade lows in terms of stock price at a m (...)[More...]

A Coiled Spring: Near-Term Catalysts & Oversold Stocks

Wed, 03 Dec 2008 16:54:00 GMT

AMAG Pharma (AMAG) more than doubled on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol. A trio of companies expect FDA decisions for abuse-resistant pain drugs before year-end, including Pain Therapeutics (PTIE) + King Pharma (KG) for Remoxy and Alpharma (ALO) for Embeda. Now that Alpharma has accepted King's buyout bid, the latter reflects a way to trade both decisions in a single stock for twice the chances of approval. Caraco Pharma (CPD) offers U.S. investors a way to play India-based Sun Pharma's growth through their distribution agreement and the Company believes it has addressed the issues raised in the FDA warning[More...]

Stock Picks For Healthy Returns

Tue, 25 Nov 2008 14:14:00 GMT

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. China Medical (CMED) is trading near its IPO levels of August 2005 despite excellent growth prospects and is a buy below 20 bucks with a dividend yield of 2.5% and market cap of $540M as uncertainty over a $345M acquisition has spooked some investors, sending the stock down sharply by over 50% in the past three months. The acquisition provides CMED with a molecular diagnostics platform for HPV, including strains[More...]

Pain Therapeutics (PTIE) - Bear of the Day

Mon, 17 Nov 2008 12:37:00 GMT

Pain Therapeutics, Inc. is focused on the development of novel treatments for the management of pain and other therapeutic indications. Lead pipeline candidate, Remoxy, an abuse-deterrent version of pain drug oxycodone, should have significant commercial opportunity upon approval due to its ability to reduce the potential of drug abuse / misuse. While we believe that Remoxy will see significant demand once launched, we are concerned that the candidate may not receive final approval at the upcoming FDA action date of December 10, 2008. Remoxy received a mixed response from an FDA advisory panel recently; we fear that the FDA might require the company to conduct additional studies to establish its abuse-deterrent qualities. We are also concerned about the possibility of the company facing a patent infringement lawsuit for Remoxy. Moreover, the rest of the company's pipeline is too early stage to get excited about. As such, we downgrade our rating to Sell with a[More...]

Full Calendar On Tap for FDA Through Year-End

Thu, 13 Nov 2008 22:18:00 GMT

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 OxyContin. At least 10 members of the panel felt[More...]

A Backlog Of Decisions Is Building At The FDA

Fri, 07 Nov 2008 15:43:00 GMT

The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices. Discovery Labs (DSCO) submitted its complete response to the FDA in response to a May approvable letter for Surfaxin three weeks ago on 10/17 and had expected the agency to respond last week on the[More...]

Pain Therapeutics Reviews Mid-Year Progress, Reports Second Quarter 2009 Financial Results

Tue, 04 Aug 2009 13:52:00 GMT

Hemophilia and Melanoma Data Expected by Year End -
SAN MATEO, Calif., Aug. 4, 2009 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a biopharmaceutical company, today reviewed mid-year progress with its drug candidates and reported financial results for the quarter ended June 30, 2009.
"By year end 2009, we expect to announce top-line results from on-going studies with our drug candidates in two important disease areas - hemophilia and melanoma.

[More...]

King and Pain Therapeutics Announce REMOXY(r) NDA Update

Tue, 07 Jul 2009 14:43:00 GMT

King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. today announced that on July 2, 2009, King met with the U.S. Food and Drug Administration to discuss the Complete Response Letter regarding the New Drug Application for REMOXY. The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter.[More...]

REMOXY(R) NDA Update

Tue, 07 Jul 2009 11:00:00 GMT

DURECT Corporation today reported that King Pharmaceuticals, Inc. and Pain Therapeutics, Inc. have announced that King met with the Food and Drug Administration on July 2, 2009 to discuss the Complete Response Letter regarding the New Drug Application for REMOXY. According to King Pharmaceuticals and Pain Therapeutics, the outcome of the meeting last week provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter.[More...]

Pain Therapeutics Invited to Present At Two Investor Conferences

Thu, 04 Jun 2009 12:27:00 GMT

Pain Therapeutics, Inc. today announced that management will present at the Goldman Sachs Healthcare Conference on Tuesday, June 9th at 3:45 p.m. Eastern Time. Pain Therapeutics' management will also present at the Needham Life Sciences Conference on Thursday, June 11th at 1:30 p.m. Eastern Time.[More...]

King Pharmaceuticals Reports First-Quarter 2009 Financial Results

Mon, 11 May 2009 11:54:00 GMT

King Pharmaceuticals, Inc. (NYSE:KG) announced today that total revenues were $429 million during the first quarter ended March 31, 2009, compared to $432 million in the first quarter of 2008.
Similar to its financial reporting in prior years, King reports financial results determined in accordance with Generally Accepted Accounting Principles ("GAAP") and adjusted financial results.
However, beginning with the first quarter of 2009, King's adjusted financial results will exclude the amortization of intangible assets and non-cash imputed interest expense associated with the Company's $400 million 1Â¼% Convertible Senior Notes, as well as special items.

[More...]

Pain Therapeutics Initiates Clinical Study in Cancer Patients

Tue, 05 May 2009 12:26:00 GMT

Pain Therapeutics, Inc. , announced the initiation of another clinical study for PTI-188, an investigational drug intended to treat a lethal form of skin cancer called metastatic melanoma . This study follows the release of promising data in an earlier Phase I study for PTI-188, published at the Meeting of the Society for Nuclear Medicine.[More...]

Pain Therapeutics Announces First Quarter 2009 Financial Results

Thu, 30 Apr 2009 11:57:00 GMT

Pain Therapeutics, Inc. , a biopharmaceutical company, today reported financial results for the quarter ended March 31, 2009. Net loss for the quarter ended March 31, 2009 was $1.8 million, or $0.04 per diluted share, compared to net income of $2.6 million, or $0.06 per diluted share, for the first quarter of 2008.[More...]

Pain Therapeutics to Present At the Barclays Capital Healthcare Conference

Fri, 06 Mar 2009 12:25:00 GMT

Pain Therapeutics, Inc. today announced that Remi Barbier, the Company's chairman, president and chief executive officer, will present at the Barclays Capital Global Healthcare Conference in Miami Beach, Florida on Wednesday, March 11th at 2:30 p.m. Eastern Time.[More...]

Pain Therapeutics Announces Year-End 2008 Financial Results, Outlines 2009 Business Priorities

Thu, 05 Feb 2009 12:26:00 GMT

Pain Therapeutics, Inc. , a biopharmaceutical company, today reported financial results for the year ended December 31, 2008. The Company also provided an update on its cash position and outlined its business strategy for maintaining financial strength in 2009.[More...]

Pain Therapeutics Receives Complete Response Letter From FDA for REMOXY(R)

Thu, 11 Dec 2008 12:49:00 GMT

Pain Therapeutics, Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for REMOXY, an abuse-resistant controlled-release form of oxycodone. Based on its review, the FDA has determined that the NDA is not approved in its present form.[More...]