Below are the new list of upcoming Fda approval which are not yet included in FDA Calendar : Here is a guideline you should keep in mind while buying or 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.
August 18th: Kips Bay Medical Inc (Nasdaq:KIPS) filed an application for an Investigational Device Exemption ("IDE") with the U.S. Food & Drug Administration ("FDA") to include four U.S. sites in its "eMESH I" clinical feasibility study of its eSVS(R) Mesh device currently being pursued in Europe.
November 8th: Novo Nordisk A/S (NYSE: NVO) will meet FDA advisory committee for the new diabetes-treating drugs insulin degludec and insulin degludec in combination with insulin aspart.
July - September: Omeros (Nasdaq:Omer) will apply to FDA for trial of schizophrenia drug this quarter.
July - September: Gilead (GILD) intends to seek approval from the FDA for cobicistat in the third quarter of 2012.
July - September: Hemispherx Biopharma,(HEB) to seek FDA approval For Ampligen NDA
December 16th, 2012: NuPathe Inc. (Nasdaq: PATH), New Drug Application (NDA), FDA approval for its migraine patch (NP101)
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 15th: Human Genome Sciences Inc. (HGSI) Fda approval for the anthrax treatment raxibacumab.
August: Pozen (Nasdaq: POZN) plans to hold a follow-up call with the U.S. FDA in the next few weeks to clarify the next steps in satisfying the bioequivalence requirement prior to filing the new drug application (NDA) on PA-325/40.
December: Watson Pharmaceuticals Inc. (WPI) seeking approval for generic version of Pfizer Inc.'s (PFE) Pristiq antidepressant.
December 21st. Alexza (Nasdaq: ALXA) seeking approval for ADASUVE for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
K-V Pharma (NYSE: KV.A) has got FDA-approval for Makena and this stock is easily worth $1.5 to $2.0, its a buy at current price. There is a risk of bankruptcy in this stock.
MAP Pharmaceuticals (Nasdaq: MAPP) Concludes Meeting With FDA For LEVADEX Inhalation Aeroso and likely to file application in third or fourth quarter.
March 1st, 2013: Zogenix, Inc. (ZGNX) announced that the U.S. Food and Drug Administration, or FDA, has accepted for review the New Drug Application, or NDA, for Zohydro ER (hydrocodone bitartrate extended-release capsules).
January 30th, 2013: Raptor Pharmaceutical Corp. (Nasdaq:RPTP), Cysteamine Bitartrate Delayed-Release Capsules ("RP103"), for the potential treatment of nephropathic cystinosis.
February 24, 2013: Dynavax Technologies Corporation (NASDAQ: DVAX) seeking approval for HEPLISAV hepatitis B virus in adults 18 through 70 years of age.
