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FDA Calendar

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PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

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Company Name
Ticker
Drug
Event
Date
Outcome
Details
ARADIGM CORP
Linhaliq (NDA)
FDA decision on Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections
01/26/2018
Advanced Accelerator Applications S.A.
Lutathera (NDA resubmission)
FDA decision on Lutathera for the treatment of patients with gastroenteropancreatic neuroendocrine tumors
01/26/2018
Synergy Pharmaceuticals, Inc.
TRULANCE (sNDA)
FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
01/24/2018
Spark Therapeutics
LUXTURNA (BLA)
FDA decision on LUXTURNA for treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy.
01/12/2018
FDA approved LUXTURNA on Dec.19, 2017
ARADIGM CORP
Linhaliq (NDA)
FDA panel to review Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections
01/11/2018
FDA panel recommends against approval of Linhaliq
Lipocine Inc
TLANDO (NDA resubmission)
FDA panel review of TLANDO for the proposed indication of testosterone replacement therapy in adult males with hypogonadism
01/10/2018
FDA panel votes against recommending approval for TLANDO
Intersect ENT Inc
SINUVA implant (NDA)
FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
01/07/2018
FDA approved SINUVA on Dec.11, 2017
Pfizer Inc.
Sutent (sNDA)
FDA decision on Sutent as an adjuvant treatment in adult patients at high risk of recurrent renal cell carcinoma following nephrectomy
Jan 2018
Eli Lilly And Co.
Abemaciclib (NDA)
FDA decision on Abemaciclib for the treatment of advanced breast cancer
Q1 2018
FDA approved Abemaciclib under brand name Verzenio for use in combination with Faslodex for patients with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy on Sep.28, 2017
Pfizer Inc.
Sutent(sNDA)
FDA decision on Sutent for use as an adjuvant therapy in patients with renal cell carcinoma
Jan 2018
FDA approved Sutent for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma on Nov.16, 2017
AstraZeneca PLC
AZN.L, AZN
Acalabrutinib (NDA)
FDA decision on Acalabrutinib in patients with relapsed/refractory mantle cell lymphoma
Q1 2018
FDA granted accelerated approval for Calquence (acalabrutinib) on Oct.31, 2017
AEterna Zentaris Inc
AEZ.TO, AEZS
Macrilen (NDA resubmission)
FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
12/30/2017
FDA approved Macrilen on Dec.20, 2017
Valeant Pharmaceuticals International
VRX, VRX.TO
Luminesse (NDA)
FDA decision on Luminesse to be used Over-the-Counter as an eye drop to relieve redness of the eye due to minor eye irritations.
12/27/2017
FDA approved LUMIFY, previously known as Luminesse, on Dec.22, 2017
Agile Therapeutics Inc.
Twirla (NDA resubmission)
FDA decision on contraceptive patch, Twirla
12/26/2017
FDA issued Complete Response Letter for Twirla on Dec.22, 2017
Corium International Inc.
Twirla (NDA resubmission)
FDA decision on contraceptive patch, Twirla
12/26/2017
FDA issued Complete response Letter for Twirla on Dec.22, 2017
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