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Milestone's (MIST) Tachycardia Study Data Fail to Impress Investors
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Shares of Milestone Therapeutics (MIST - Free Report) fell 21.67% during market hours on Oct 17, after rising 41% in premarket, post the company’s announcement of top-line results from a late-stage study evaluating its lead candidate, etripamil.
Milestone’s shares have returned 1.5% in the year-to-date period against the industry’s decline of 25.9%:
Image Source: Zacks Investment Research
Etripamil is a potent short-acting calcium channel blocker designed by Milestone. The company is developing it as a rapid-onset nasal spray to treat paroxysmal supraventricular tachycardia (PSVT), atrial fibrillation and other cardiovascular indications.
The phase III RAPID study evaluated the safety and efficacy of etripamil in patients with PSVT, a type of abnormal heart rhythm or arrhythmia.
However, RAPID is the second part of a study, the first part of which, NODE-301, failed to achieve its primary endpoint, as reported by Milestone Therapeutics in March 2020.
With guidance from the FDA in July 2020, Milestone altered the size and design of the NODE-301 study, which was later renamed RAPID.
The multi-center, double-blind, placebo-controlled phase III RAPID study achieved its primary endpoint of converting sinus rhythm within 30 minutes of the subject’s self-administering etripamil.
The candidates taking etripamil exhibited a statistically and clinically significant difference in time to PSVT conversion against a placebo. Among the subjects, 64.3% that were administered with etripamil converted within 30 minutes compared with 31.2% who took a placebo. Additionally, the median time for conversion for patients who took etripamil was three times faster than the subjects on placebo.
The safety and tolerability data from the RAPID study was consistent with the data observed in the prior clinical studies evaluating the potential of self-administering etripamil in PSVT patients.
The RAPID study reported a significantly better hazard ratio (HR) of 2.62 compared to the HR of 1.87 in the NODE-301 study.
Pooled data from the NODE-301 and RAPID study demonstrated that the etripamil treatment provided a statistically significant reduction in the additional use of medical interventions and visits to the emergency department for the patients.
Thus, the positive data from the RAPID study and the data from the previously completed NODE-301 study are expected to fulfill the efficacy requirement for Milestone to submit a new drug application (NDA) for etripamil in PSVT patients. The company intends to submit an NDA for etripamil by the middle of 2023.
However, Milestone’s data from the late-stage RAPID study for PSVT did not impress the investors, thereby causing a fall in the company’s share prices.
Acadia’s loss per share estimates for 2022 have narrowed down from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has also narrowed down from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions. The average negative earnings surprise for ACAD is 6.83%.
BioMarin’s earnings per share estimates for 2022 are down by a cent at $1.98 in the past 30 days. The same for 2023 has improved by a cent from $3.80 to $3.81 in the same time frame.
Earnings of BioMarin beat estimates in all of the trailing four quarters. The average earnings surprise for BMRN is 98.90%.
Pliant’s loss estimates for 2022 have remained steady at $3.01 over the past 30 days. The earnings estimate for 2023 also remained steady at $3.26 per share in the same time frame.
PLRX earnings were in-line in one of the trailing four quarters, beat the same in one, and missed the same in the remaining two occasions. The average earnings surprise for Pliant is 0.90%.
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Milestone's (MIST) Tachycardia Study Data Fail to Impress Investors
Shares of Milestone Therapeutics (MIST - Free Report) fell 21.67% during market hours on Oct 17, after rising 41% in premarket, post the company’s announcement of top-line results from a late-stage study evaluating its lead candidate, etripamil.
Milestone’s shares have returned 1.5% in the year-to-date period against the industry’s decline of 25.9%:
Image Source: Zacks Investment Research
Etripamil is a potent short-acting calcium channel blocker designed by Milestone. The company is developing it as a rapid-onset nasal spray to treat paroxysmal supraventricular tachycardia (PSVT), atrial fibrillation and other cardiovascular indications.
The phase III RAPID study evaluated the safety and efficacy of etripamil in patients with PSVT, a type of abnormal heart rhythm or arrhythmia.
However, RAPID is the second part of a study, the first part of which, NODE-301, failed to achieve its primary endpoint, as reported by Milestone Therapeutics in March 2020.
With guidance from the FDA in July 2020, Milestone altered the size and design of the NODE-301 study, which was later renamed RAPID.
The multi-center, double-blind, placebo-controlled phase III RAPID study achieved its primary endpoint of converting sinus rhythm within 30 minutes of the subject’s self-administering etripamil.
The candidates taking etripamil exhibited a statistically and clinically significant difference in time to PSVT conversion against a placebo. Among the subjects, 64.3% that were administered with etripamil converted within 30 minutes compared with 31.2% who took a placebo. Additionally, the median time for conversion for patients who took etripamil was three times faster than the subjects on placebo.
The safety and tolerability data from the RAPID study was consistent with the data observed in the prior clinical studies evaluating the potential of self-administering etripamil in PSVT patients.
The RAPID study reported a significantly better hazard ratio (HR) of 2.62 compared to the HR of 1.87 in the NODE-301 study.
Pooled data from the NODE-301 and RAPID study demonstrated that the etripamil treatment provided a statistically significant reduction in the additional use of medical interventions and visits to the emergency department for the patients.
Thus, the positive data from the RAPID study and the data from the previously completed NODE-301 study are expected to fulfill the efficacy requirement for Milestone to submit a new drug application (NDA) for etripamil in PSVT patients. The company intends to submit an NDA for etripamil by the middle of 2023.
However, Milestone’s data from the late-stage RAPID study for PSVT did not impress the investors, thereby causing a fall in the company’s share prices.
Milestone Pharmaceuticals Inc. Price
Milestone Pharmaceuticals Inc. price | Milestone Pharmaceuticals Inc. Quote
Zacks Rank and Stocks to Consider
Milestone Therapeutics currently holds a Zacks Rank #2 (Buy).
Some similar-ranked stocks worth considering in the same sector include ACADIA Pharmaceuticals (ACAD - Free Report) , BioMarin Pharmaceuticals (BMRN - Free Report) , and Pliant Therapeutics (PLRX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Acadia’s loss per share estimates for 2022 have narrowed down from $1.30 to $1.29 in the past 30 days. The loss per share for 2023 has also narrowed down from 67 cents to 60 cents in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions. The average negative earnings surprise for ACAD is 6.83%.
BioMarin’s earnings per share estimates for 2022 are down by a cent at $1.98 in the past 30 days. The same for 2023 has improved by a cent from $3.80 to $3.81 in the same time frame.
Earnings of BioMarin beat estimates in all of the trailing four quarters. The average earnings surprise for BMRN is 98.90%.
Pliant’s loss estimates for 2022 have remained steady at $3.01 over the past 30 days. The earnings estimate for 2023 also remained steady at $3.26 per share in the same time frame.
PLRX earnings were in-line in one of the trailing four quarters, beat the same in one, and missed the same in the remaining two occasions. The average earnings surprise for Pliant is 0.90%.