Altamira Submits FDA 510(k) Premarket Notification For Bentrio

  • Altamira Therapeutics Ltd CYTO has submitted a 510(k) premarket notification to the FDA for Bentrio for hay fever.
  • Once cleared, the Company anticipates partnering Bentrio for the U.S. market rather than commercializing it there on its own.
  • Bentrio is a nasal spray for protection against airborne viruses and allergens.
  • Bentrio was launched first in Germany under the CE mark in late July and subsequently also in Austria. 
  • During the initial launch stage, the nasal spray product has been marketed solely through leading online pharmacies.
  • In the next phase of the European launch in Q4 2021, the Company will also target traditional 'brick-and-mortar' pharmacy stores.
  • Altamira has also executed letters of understanding with distributors in two key Southeast Asian countries.
  • Concurrent with the commercial activities outlined above, the Company is also advancing its clinical development programs for Bentrio. 
  • Two studies are moving through the approval process in allergy: one for house dust allergy as a challenge study and another for seasonal allergic rhinitis. 
  • These studies will be conducted in Canada and Australia, with data read-outs expected for Q1 and Q2 2022. 
  • In a viral infection, Altamira is awaiting the approval of a placebo-controlled COVID-19 study by the Drugs Controller General of India.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: CYTO stock is down 4.60% at $2.28 during the market session on the last check Monday.
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