Top alert for 2014: MYGN (50%), LIVE (45%), CTIC (115%), KOOL (88%), PZG (32%), GOLD (6%), IOC (6%), RSOL(18%), PLUG (70%), IMMU (26%)

Sunday, August 24, 2014

Upcoming FDA Approvals for September - October 2014: KERX, NPSP, SLXP, MDVN, PSDV, GILD, PCYC, NVS, AUXL, REGN, PGNX, ALIM, NPSP

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.
  • 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.

09/07/2014 Keryx Biopharmaceuticals Inc (KERX):
FDA decision on Zerenex for the treatment of hyperphosphatemia in dialysis-dependent chronic kidney disease (CKD) patients

09/12/2014 NPS Pharmaceuticals Inc (NPSP):
FDA panel to review Natpara for the treatment of hypoparathyroidism

09/15/2014 Salix Pharmaceuticals Ltd (SLXP):
FDA decision on Budesonide 2 mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis

FDA decision on XTANDI for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy

09/26/2014 pSivida Limited  (PSDV), (ALIM):
FDA decision on ILUVIEN for treatment of Diabetic Macular Edema

9/29/2014 Progenics (PGNX), SLXP
FDA Assigns September 29, 2014 Prescription Drug User Fee Act Goal Date for RELISTOR® Subcutaneous Injection sNDA for the Treatment of Opioid-induced Constipation in Patients with Chronic Non-cancer Pain

10/03/2014 Gilead Sciences Inc. (GILD):
FDA decision on Cobicistat as a boosting agent for HIV therapy

10/04/2014 Gilead Sciences Inc. (GILD):
FDA decision on Elvitegravir or the treatment of HIV-1 infection in treatment-experienced adults

10/07/2014 Pharmacyclics Inc. (PCYC):
FDA decision on IMBRUVICA in the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who have received at least one prior therapy for a full approval.

10/10/2014 Gilead Sciences Inc. (GILD):
FDA decision on Ledipasvir/Sofosbuvir for chronic hepatitis C genotype 1 infection

10/20/2014 Novartis AG (NVS):
FDA panel to review Secukinumab for the proposed treatment of moderate to severe plaque psoriasis

10/20/2014 Auxilium Pharmaceuticals Inc. (AUXL):
FDA decision on XIAFLEX for the treatment of two Dupuytren's contracture (DC) cords concurrently

10/23/2014 Regeneron Pharmaceuticals (REGN):
FDA decision on EYLEA for the expanded indication of of Macular Edema following Branch Retinal Vein Occlusion

10/24/2014 NPS Pharmaceuticals Inc (NPSP):
FDA decision on Natpara for the treatment of hypoparathyroidism

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