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Marinus (MRNS) to Sell Rare Disease PRV to Novo Nordisk
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Marinus Pharmaceutical (MRNS - Free Report) entered into a definitive agreement to sell its Rare Pediatric Priority Review Voucher (PRV) to Novo Nordisk (NVO - Free Report) .
Pursuant to the asset purchase agreement, Novo Nordisk will be paying a lump sum cash amount of $110 million to Marinus upon closing the transaction.
The PRV was issued to Marinus by the FDA on Mar 18, 2022, in connection with the approval of the use of Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
The FDA issues PRV to companies to encourage them to develop treatments for rare pediatric diseases.
Under this FDA program, the PRV is issued to the sponsor of a rare pediatric disease product application. The PRV holder is entitled to get a priority review of a single new drug application (NDA) or a biologics license application (BLA). The holder can choose to sell or transfer the PRV after approval of the rare pediatric disease application.
The sale of the PRV is anticipated to strengthen Marinus Pharmaceuticals’ financial position
The funding received from the deal will allow Marinus to focus on the commercial launch of Ztalmy and also maintain its ongoing momentum in developing its clinical pipeline, which includes two ongoing phase III studies of ganaxolone in other rare seizure disorders in status epilepticus and tuberous sclerosis complex
Shares of Marinus have declined 55.8% so far this year compared with the industry’s decline of 21.9%.
Image Source: Zacks Investment Research
Ztalmy (ganaxolone), Marinus’lead product and a three-times-daily oral therapy, became the first FDA-approved medicine for CDD. Marinus is now focusing on launching and commercializing Ztalmy in the United States.
The company continues to develop ganaxolone in several additional indications like status epilepticus and tuberous sclerosis complex (as mentioned above) in oral and IV formulations and, in acute and chronic care settings, for both adult and pediatric patient populations.
In January 2021, the company enrolled the first patient in phase III RAISE study of IV ganaxolone to treat Refractory Status Epilepticus (RSE).
Earlier this year, the study was paused after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution.
In May 2022, Marinus resumed its screening and recruitment of the RAISE study
The company anticipates top-line results from the RAISE study in the second half of 2023.
The successful development of ganaxolone for additional indications will help the product cater to a broader patient population and drive growth in future quarters
Aquestive Therapeutics’loss per share estimates for 2022 have narrowed from $1.50 to $1.34 cents in the past 30 days. The same for 2023 has narrowed from 95 cents to 74 cents in the same time frame.
Earnings of Aquestuve missed estimates in one of the trailing four quarters and beat the same on the remaining three occasions, the average surprise being 13.78%.
Seagen’s loss per share estimates for 2022 have narrowed from $3.50 to $3.49 in the past 30 days. The same for 2023 has widened from $1.41 to $1.43 cents in the same time frame. SGEN has returned 14% in the year-to-date period.
Earnings of Seagen missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions, the average negative surprise being 40.08%.
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Marinus (MRNS) to Sell Rare Disease PRV to Novo Nordisk
Marinus Pharmaceutical (MRNS - Free Report) entered into a definitive agreement to sell its Rare Pediatric Priority Review Voucher (PRV) to Novo Nordisk (NVO - Free Report) .
Pursuant to the asset purchase agreement, Novo Nordisk will be paying a lump sum cash amount of $110 million to Marinus upon closing the transaction.
The PRV was issued to Marinus by the FDA on Mar 18, 2022, in connection with the approval of the use of Ztalmy (ganaxolone) oral suspension for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
The FDA issues PRV to companies to encourage them to develop treatments for rare pediatric diseases.
Under this FDA program, the PRV is issued to the sponsor of a rare pediatric disease product application. The PRV holder is entitled to get a priority review of a single new drug application (NDA) or a biologics license application (BLA). The holder can choose to sell or transfer the PRV after approval of the rare pediatric disease application.
The sale of the PRV is anticipated to strengthen Marinus Pharmaceuticals’ financial position
The funding received from the deal will allow Marinus to focus on the commercial launch of Ztalmy and also maintain its ongoing momentum in developing its clinical pipeline, which includes two ongoing phase III studies of ganaxolone in other rare seizure disorders in status epilepticus and tuberous sclerosis complex
Shares of Marinus have declined 55.8% so far this year compared with the industry’s decline of 21.9%.
Image Source: Zacks Investment Research
Ztalmy (ganaxolone), Marinus’lead product and a three-times-daily oral therapy, became the first FDA-approved medicine for CDD. Marinus is now focusing on launching and commercializing Ztalmy in the United States.
The company continues to develop ganaxolone in several additional indications like status epilepticus and tuberous sclerosis complex (as mentioned above) in oral and IV formulations and, in acute and chronic care settings, for both adult and pediatric patient populations.
In January 2021, the company enrolled the first patient in phase III RAISE study of IV ganaxolone to treat Refractory Status Epilepticus (RSE).
Earlier this year, the study was paused after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution.
In May 2022, Marinus resumed its screening and recruitment of the RAISE study
The company anticipates top-line results from the RAISE study in the second half of 2023.
The successful development of ganaxolone for additional indications will help the product cater to a broader patient population and drive growth in future quarters
Marinus Pharmaceuticals, Inc. Price
Marinus Pharmaceuticals, Inc. price | Marinus Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Marinus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall health sector are Aquestive Therapeutics (AQST - Free Report) and Seagen , both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aquestive Therapeutics’loss per share estimates for 2022 have narrowed from $1.50 to $1.34 cents in the past 30 days. The same for 2023 has narrowed from 95 cents to 74 cents in the same time frame.
Earnings of Aquestuve missed estimates in one of the trailing four quarters and beat the same on the remaining three occasions, the average surprise being 13.78%.
Seagen’s loss per share estimates for 2022 have narrowed from $3.50 to $3.49 in the past 30 days. The same for 2023 has widened from $1.41 to $1.43 cents in the same time frame. SGEN has returned 14% in the year-to-date period.
Earnings of Seagen missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions, the average negative surprise being 40.08%.