CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Group, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, today announced that its Bidose (BDS) Liquid Nasal Spray System is the mechanism for delivering the newly approved CARDAMYSTâ"¢ (etripamil) Nasal Spray. CARDAMYST received approval by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhyt. ...

Core Insights - The FDA has accepted the company's response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) Nasal Spray, with a new Prescription Drug User Fee Act (PDUFA) target date set for December 13, 2025 [3][4] - The company completed a public equity offering in July 2025, raising total gross proceeds of up to $170 million, which will strengthen its balance sheet for the commercialization of CARDAMYST if approved [5][6] - A $75 million Royalty Purchase Agreement with RTW Investments has been extended through the end of 2025, which is expected to fund the continued development and commercial launch of CARDAMYST [6] Regulatory Updates - The FDA's acceptance of the response to the CRL is a significant milestone for the company, as it aims for the approval of CARDAMYST for the treatment of paroxysmal supraventricular tachycardia (PSVT) [2][3] - The company has maintained its launch infrastructure and restarted targeted pre-launch activities in anticipation of the new potential approval date [3] Financial Updates - The public equity offering raised approximately $48.7 million in net proceeds after deducting underwriting commissions and estimated offering expenses, which will be used for the development and commercial launch of CARDAMYST [5][11] - As of June 30, 2025, the company reported a net loss of $13.0 million, compared to a net loss of $9.4 million for the same period in the previous year [11][17] - Research and development expenses for the second quarter of 2025 were $3.7 million, an increase from $2.8 million in the prior year period, primarily due to higher consulting and outside service costs [11][17] Product Development - The Phase 3 study protocol for etripamil in patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) has been finalized, although enrollment has been paused to prioritize resources for the expected launch of etripamil in PSVT [4] - Etripamil is designed as a self-administered rapid response therapy for patients, potentially providing a new treatment option for on-demand care and patient self-management [9][10]