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Swedish pharmaceutical company developing tobacco-free nicotine pouch products
enorama.seLast updated
In short: Enorama Pharma faced FDA refusal, sued the agency, secured loans, divested gum unit and changed CEOs.
The company has received the FDA's written opinion in the dispute regarding the RTF decision for the PMTA application. The administrative act will be submitted no later than October 9, 2026.
The company received a Refuse-to-File notice from the FDA, entered into a loan agreement and divested its nicotine gum business. Amy Walker is appointed acting CEO after Bengt Jönsson's departure.
The purchase price is 100,000 EUR. The deal includes marketing authorizations and patents.
Net sales decreased to -109 KSEK, operating profit -10,877 KSEK.
Close Agenda: Rusta, Zalando and definitive KPI. Thursday's highlights with Noel Hermansson The equity in Enorama Pharma, a company active in tobacco-free white snus, is below...
Enorama Pharma AB (publ) ("Enorama Pharma" or "the Company") announces today an organizational change in the board and management group. The board has, in agreement with managing director Daniel Schröder...
Enorama Pharma Inc. filed a lawsuit against the U.S. Food and Drug Administration in federal court in Washington, D.C., alleging the agency unlawfully imposed costly...
The board of directors in Enorama Pharma, active in tobacco-free white snus, has decided to prepare a control balance sheet.
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