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]