On Tuesday, Piper Sandler adjusted its outlook on Milestone Pharmaceuticals (NASDAQ:MIST), reducing the stock price target from $6.00 to $5.00 while maintaining an Overweight rating on the company's stock.
The revision follows a Type A meeting with the FDA, after which Milestone confirmed that no additional trials for CARDAMYST (etripamil) would be necessary. The company plans to resubmit the New Drug Application (NDA) for the treatment of paroxysmal supraventricular tachycardia (PSVT) in the second quarter of 2024.
According to the firm's analysis, Milestone Pharmaceuticals will update the NDA submission to include the start times of reported adverse events (AEs) and reformat electrocardiogram (ECG) data for the FDA's review. The expectation is that CARDAMYST could receive approval for the treatment of PSVT in the second quarter of 2025. This could potentially trigger a $75 million milestone payment from RTW Investments, LP to support the U.S. launch of the drug in the second half of 2025.
Milestone is also expanding the potential use of CARDAMYST to include the treatment of Atrial Fibrillation with Rapid Ventricular Rate (Afib-RVR), indicating further development in its pipeline. The company recently bolstered its financial position by issuing 23 million shares and pre-funded warrants, which resulted in gross proceeds of approximately $34.5 million. This fundraising effort has increased the company's pro forma cash to an estimated $98 million, which is projected to fund its operations into 2026.
The adjustment in the price target to $5 reflects the dilutive impact of the recent financing on the company's shares. Despite this adjustment, Piper Sandler reaffirms its positive Overweight rating on Milestone Pharmaceuticals, signaling confidence in the company's future prospects and drug development endeavors.
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