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Saturday, November 24, 2012

Upcoming Fda Approval in December - January: EXEL, THRX, ONXX, ZGNX, PATH, HEB

Below are the  list of companies waiting for FDA approval. Here is a guideline you should keep in mind while buying /shorting this stocks.
  • If a stocks get FDA approval, it jumps 30-40% easily but it depends on market cap.
  • If the market cap is below 1B and FDA denies or give complete response letter then the stocks falls down by 30-40%. For market cap above 5 -10B, there is movement of up or down by 2%.
  • Buying activity in stock starts 3-4 month ahead of FDA decision. Selling activity starts after 3 days of approval.
  • If FDA panel decision doesn't back up drug,  it will  fall. After FDA panel decision, official approval from FDA comes within 1 month.
  • If FDA panel back any stock, it will keep rising till it gets final decision. On final decision date, if stock get approval, stock rises in the morning and then it falls.
  • On receiving complete response, stocks falls and keep falling for atleast 15 -20 days. Buying activity starts after 15 days on anticipation that company will resubmit for FDA approval. 
  • Delay of 3 month from Fda can lead to 10% drop.
November 29th EXELIXIS INC (EXEL) FDA decision on Cabozantinib for metastatic medullary thyroid cancer

November 29th THERAVANCE, INC.(THRX) FDA panel to review VIBATIV for treatment of nosocomial pneumonia.

November 28th, 2012: Bayer HealthCare and Onyx Pharmaceuticals (Nasdaq: ONXX) FDA Approval for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

December 7th, Zogenix, Inc. (ZGNX) FDA panel to review Zohydro ER for management of chronic pain

December 8th, 2012: BioMimetic Therapeutics, Inc. (Nasdaq: BMTI), Fda approval for Augment(R) Bone Graft for its use as an alternative to autograft in hindfoot and ankle fusion procedures.

December 15th: GlaxoSmithKline (GSK) Fda approval for the anthrax treatment raxibacumab.

December 16th, 2012: NuPathe Inc. (Nasdaq: PATH), New Drug Application (NDA), FDA approval for its migraine patch (NP101)

December 20th Hemispherx Biopharma, Inc.(HEB) FDA panel to review Ampligen for Chronic Fatigue Syndrome.

December 21st. Alexza (Nasdaq: ALXA) seeking approval for ADASUVE for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

December 28th Biogen Idec (BIIB) FDA decision on BG-12 for treatment of multiple sclerosis

December 30th NPS Pharmaceuticals Inc (NPSP) FDA decision on Gattex for treatment of short bowel syndrome in adults.

January 16th: Santarus Inc. (SNTS) FDA decision on UCERIS for induction of remission of mild to moderate active ulcerative colitis.

January 17th: NuPathe Inc.(PATH) FDA decision on Zecuity for treatment of migraine.

January 20th: Raptor Pharmaceuticals Corp. (RPTP) FDA decision on RP103 for potential treatment of nephropathic cystinosis

January 21st: Impax Laboratories Inc (IPXL) FDA decision on Rytary for treatment of idiopathic Parkinson's disease


January 23rd: Hyperion Therapeutics, Inc. (HPTX) FDA decision on Ravicti for treatment of urea cycle disorder.


January 29th: ISIS Pharmaceuticals Inc (ISIS) FDA decision on KYNAMRO for treatment of patients with homozygous familial hypercholesterolemia.

January 30th, 2013: Raptor Pharmaceutical Corp. (Nasdaq:RPTP), Cysteamine Bitartrate Delayed-Release Capsules ("RP103"), for the potential treatment of nephropathic cystinosis.

February 10th: Celgene Corporation (CELG) FDA decision on Pomalidomide for treatment of relapsed and refractory multiple myeloma.

Complete Response Letter:
10/29/2012 Cornerstone Therapeutics Inc.(CRTX) FDA decision on Lixivaptan, formerly CRTX 080, for treatment of hyponatremia

10/27/2012 United Therapeutics Corp(UTHR) FDA decision on oral Treprostinil for pulmonary arterial hypertension

09/10/2012 Navidea Biopharmaceuticals, Inc.(NEOP, NAVB) FDA rejects Lymphoseek, citing manufacturing deficiencies.

The U.S. Food & Drug Administration has sent Salix Pharmaceuticals Ltd. (NASDAQ: SLXP) and Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) a Complete Response Letter (CRL) regarding the drug Relistor’s supplemental new drug application. Relistor is an injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients who suffer from chronic, noncancer pain.

06/21/2012   RGEN SecreFlo (NDA) FDA issues complete response letter for SecreFlo (RG1068)
06/05/2012   ARIA        FDA issues complete response letter for Ridaforolimus. Says additional trial(s) would need to be conducted to further assess safety and efficacy.
05/04/2012   ALXA    FDA issues complete response letter for Adasuve
04/26/2012   AMGN   FDA issues Complete Response Letter for addnl. indication of XGEVA
04/25/2012   FURX     FDA issues complete response letter for Alogliptin, and fixed-dose combination therapy Alogliptin and Pioglitazone.
04/16/2012   NRI.TO      Pliaglis (sNDA) FDA issued complete response letter for Pliaglis
03/28/2012   CHTP       FDA issues complete response letter for Northera
03/26/2012   MAPP      FDA issued complete response letter for Levadex

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