Fri, Apr. 10, 12:45 PM
Mon, Mar. 30, 12:45 PM
Mon, Mar. 30, 9:11 AM
Fri, Mar. 27, 10:03 PM
- Thinly-traded nano cap Adamis Pharmaceuticals (NASDAQ:ADMP) craters 35% after hours on robust volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for its lead product candidate, Epinephrine Pre-filled Syringe (PFS), for the emergency treatment of acute anaphylaxis (severe allergic reaction).
- The FDA's questions relate to the general area of Chemistry, Manufacturing and Controls (CMC) and specifically to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim.
- President and CEO Dr. Dennis J. Carlo says, "We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications. Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."
- The company submitted its NDA in May of last year.
- Previously: Adamis submits NDA for adrenaline product (May 29, 2014)
Fri, Jan. 9, 12:47 PM
Fri, Jan. 9, 9:10 AM
Sep. 2, 2014, 12:47 PM
- Shares of thinly traded nano cap Adamis Pharmaceuticals (ADMP +24.9%) jump on a 5x surge in volume albeit on turnover of only ~540K. Prices peaked at $5.27 earlier today representing a 100% gain from the August 15 low of $2.62. Shares are now poised to break the long-term downtrend line. Prices peaked at $18.70 almost two years ago.
- There is no specific news today to account for the move. CEO Dennis Carlo reshuffled the BOD last week, though.
- Nine mutual funds have positions, up from one a year ago.
Sep. 2, 2014, 12:45 PM
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Jan. 28, 2014, 9:10 AM
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Aug. 6, 2013, 10:16 AM
- 3M (MMM) agrees to license and then sell its Taper Dry Powder Inhaler (DPI) technology, which is being developed to treat asthma and chronic obstructive pulmonary disease, to Adamis Pharmaceuticals Pharmaceuticals (ADMP.OB +5%).
- 3M will also supply the drug delivery tape for the platform to Adamis under a separate agreement.
- The DPI is being developed to compete with other dry powder inhalers such as GlaxoSmithKline's Advair Diskus, which generates $13B a year. Adamis intends to develop a branded generic version using 3M's Taper DPI tech.
- Adamis will pay an undisclosed fee for the license and then a further amount before December in order to acquire the tech. (PR)
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Adamis Pharmaceuticals Corp is is a biopharmaceutical company engaged in the development and commercialization of specialty pharmaceutical and biotechnology products in the therapeutic areas of respiratory disease, allergy, oncology and immunology.
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