Seeking Alpha

Mike Havrilla's  Instablog

Mike Havrilla is an index developer, pharmacist, writer, and Co-Founder of BioMedReports.com with experience that includes online investing since August 1997 and writing for investors since April 2007 with a focus on the healthcare sector and small / micro-cap stocks. Mike holds Doctor of... More
My business:
ProActive HavRx BioFund
My blog:
BioMedReports.com FDA Calendar
My book:
ProActive HavRx Stock Indexes
  • FDA Calendar Updates: Royal Returns for King Pharma 0 comments
    May 11, 2009 10:42 AM | about stocks: KG, PTIE, ACUR

    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, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

     
    Shares of King Pharma (NYSE:KG) have gained about 35% since I wrote about the Company in late March as a value play on pending new drug approvals. Below are updates on three new pain drug candidates from King's quarterly results and business update today.  
     
    Embeda (morphine + naltrexone) has a pending NDA for proposed use as a pain drug that is designed to deter abuse and diversion. During 1Q09, KG received feedback from the FDA regarding a Risk Evaluation and Mitigation Strategy (REMS) for Embeda and is in discussions with the agency. KG remains confident that Embeda will be approved in the near future.
     
    The Acurox (oxycodone + niacin) NDA has a priority review (six-month) designation by the FDA along with Acura Pharma (NASDAQ:ACUR) with a PDUFA decision date of 6/30/09. Acurox is an immediate release opioid analgesic with a proposed indication for the relief of moderate-to-severe pain and is designed to deter common methods of misuse and abuse.
     
    During 1Q09, KG assumed full control from Pain Therapeutics (NASDAQ:PTIE) of all activities related to the development of Remoxy, which is a long-acting oxycodone formulation designed to deter abuse and misuse. KG has set a new date with the FDA in the first half of July 2009 to discuss the Complete Response Letter (CRL) issued by the agency in December 2008 to clarify the non-clinical information required to gain approval for Remoxy.
     
    Disclosure: No positions.
    Themes: FDA, FDA Calendar Stocks: KG, PTIE, ACUR
Back To Mike Havrilla's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Full index of posts »
Latest Followers

StockTalks

More »
Posts by Ticker
AAPL, ABII, ABIO, ABT, ABV, ACAD, ACCP.OB, ACOR, ACUR, ACUS, ADAM, ADLS, AET, AEZS, AFFY, AGEN, AGN, ALKS, ALNY, ALPMF.PK, ALTH, ALXA, AMAG, AMGN, AMLN, AMRN, ANPI, APPA, APPY, ARDM.OB, ARKTF.PK, ARNA, ARUXF.PK, ARYX, ATHN, AUXL, AVNR, AZN, BAX, BAYRY.PK, BCRX, BDSI, BFRM, BIIB, BIOD, BMRN, BMTI, BMY, BPAX, BSX,

Latest Comments


Most Commented
  1. BioMedReports.com Mention in BusinessWeek (7 Comments)
  2. Sequenom Splattered, EXACT Sciences on the Rise (3 Comments)
  3. Who Will Take GM's Place in the Dow? (3 Comments)
  4. 13 Extreme FDA Trades: BioMedReports.com 6/1/09 Update (3 Comments)
  5. Mentor Capital: A Stealth Cancer Immunotherapy Play (3 Comments)
Posts by Themes
allos therapeutics, ANDA, ASCO, Avastin, BIO.PA, BioAlliance, biogenerics, biomed, BioMedReports.com, biotech, BLA, Botox, cancer, cancer biotech, cancer stock, China, cholesterol, Clean Energy, Clinical Trial, Clinical Trial Calendar, Clinical Trials, clinical trials, consumer staples, Crestor, DAVANAT, defensive, Dendreon, Diabetes, Discovery Labs, dividends, Dolphin Secure, Dysport, Enablex, ETF Innovators, Extreme Trades, Facebook, FDA, fda, FDA Calendar, Feraheme, Genentech, generic, Generic Drugs, Global Pharma, GTx, Health IT, Health IT Index, healthcare, Impax Labs, Impax Pharma,
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.