10 Year-End Stock Trades on FDA Binary Events

by: Mike Havrilla

Below is a selection of 10 companies with pending FDA decisions or Advisory Panel meetings that are expected through year-end as a follow-up to my article published two weeks ago, highlighting 190 stocks with FDA decisions expected through the end of October.

1.) MannKind (NASDAQ:MNKD) $6.06, $799 million (M) market cap

  • FDA Decision (NDA Class 2 Re-submission)
  • AFREZZA (orally inhaled device for ultra-rapid onset human insulin, rDNA origin)

On 7/20/10, announced FDA accepted New Drug Application (NDA) resubmission with a Class 2 (six-month) review period and PDUFA action goal date of 12/29/10 for an expected FDA decision, received CRL from FDA in March 2010 and has submitted additional clinical efficacy / safety data plus data on next-generation MedTone inhaler device requested by Agency

2.) Cadence Pharma (NASDAQ:CADX) $8.36, $423M market cap

  • FDA Decision (NDA) (Class 2 Re-submission)
  • OFIRMEV (Intravenous/IV Acetaminophen)

FDA issued CRL 2/10/10, citing third-party manufacturer deficiencies, no additional studies were required, seeking approval for pain and the reduction of fever in adults and children, Class 2 resubmission (six-month review) with new PDUFA action goal date of 11/4/10 for expected FDA decision

3.) Amgen (NASDAQ:AMGN) $56.32 $50 billion (B) market cap

  • FDA Decision (BLA) (Priority Review)
  • Denosumab (a subcutaneous RANK Ligand inhibitor) (bone protecting drug)

On 7/19/10, announced FDA priority review (six-month) for Biologics License Application (BLA) seeking approval for reduction of skeletal related events (SREs) in patients with advanced cancer with PDUFA action date of 11/18/10 for expected FDA decision

4.) Human Genome Sciences (NASDAQ:HGSI) $28.63 $5.4B market cap

  • FDA Advisory Panel Meeting (11/16/10), FDA Decision (BLA) (Priority Review) (12/9/10)
  • BENLYSTA (belimumab)

On 8/19/10, announced FDA priority review (six-month) designation, seeking approval for treatment of lupus, partner GlaxoSmithKline (NYSE:GSK) submitted MAA to EMA for European approval on 6/4/10, FDA Advisory Panel meeting scheduled for 11/16/10

5.) MELA Sciences (NASDAQ:MELA) $6.74 $170M market cap

  • FDA Devices Advisory Panel Meeting, FDA Decision (NYSEARCA:PMA) Medical Device / Diagnostic
  • MelaFind (a non-invasive computer vision system for early melanoma detection)

FDA General / Plastic Surgery Medical Devices Advisory Panel meeting scheduled for 11/18/10 to review PMA originally filed in June 2009, expects CE Mark (Europe) clearance during 1Q11, FDA requested additional info for PMA filing on 3/19/10 and MELA responded on 5/7/10

6.) Lannett (AMEX:LCI) $4.35 $108M market cap

  • FDA Decision (NDA)
  • Morphine Sulfate Oral Solution

Filed NDA for morphine on 2/26/10 for estimated FDA decision by 12/26/10 under a standard (10-month) review period, halted production and removed from market in July 2010, currently has $2M in morphine inventory

7.) Orexigen Therapeutics (NASDAQ:OREX) $5.67 $269M market cap

  • FDA Advisory Panel Meeting (12/7/10), FDA Decision (NDA) (1/31/11)
  • CONTRAVE 32 (32mg naltrexone SR + 360mg bupropion SR)

On 9/2/10, announced deal with Takeda (OTC:TKPHY) for North America including $50M upfront + over $1B potential regulatory / sales milestone payments and double-digit royalties on net sales, PDUFA action goal date 1/31/11 (10-month standard review) with Metabolic / Endocrine Drug Products FDA Advisory Panel meeting scheduled for 12/7/10

8.) Salix Pharma (NASDAQ:SLXP) $42.83 $2.5B market cap

  • FDA Decision (NDA) (Priority Review)
  • XIFAXAN (rifaximin) 550mg Tablet

On 8/9/10, announced FDA accepted and issued priority (six-month) review for proposed indication to treat non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating with PDUFA action goal date of 12/7/10 for expected FDA decision

9.) AstraZeneca (NYSE:AZN) $52.69 $71.4B market cap

  • FDA Decision (NDA)
  • BRILINTA (ticagrelor) (oral anti-platelet blood thinner)

On 9/15/10, announced 3-month delay with new PDUFA action goal date of 12/16/10, seeking approval for the reduction of major adverse cardiac events in patients with acute coronary syndrome, FDA Panel voted 7-1 in favor of approval on 7/28/10, recommended for EU approval by EMA on 9/24/10

10.) Cumberland Pharma (NASDAQ:CPIX) $5.91 $120M market cap

  • FDA Decision (sNDA) (Priority Review)
  • Acetadote (acetyl-cysteine for injection)

Seeking to expand use in patients with non-acetaminophen (TYLENOL) acute liver failure, FDA accepted the supplemental New Drug Application (sNDA) for review and granted a priority review (six-month) in May 2010 with PDUFA action goal date of 9/10/10, Aug. 2009 IPO at $17/share, on 8/20/10 announced a three-month delay until 12/10/10 for expected FDA decision

Disclosure: Author is long LCI

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