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Catalyst (CPRX) Seeks to Increase Maximum Daily Dose for Firdapse
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Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) announced that the FDA has accepted its supplemental new drug application ("sNDA") seeking a label expansion for its flagship product, Firdapse (amifampridine).
The sNDA seeks to increase the maximum daily dosage of Firdapse tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").
With the FDA accepting the sNDA for review, a decision from the regulatory body is expected on Jun 4, 2024.
We note that Firdapse tablets in 10 mg dosage are currently approved for the treatment of LEMS in adults as well as patients in the age group of 6 to 17 years in the United States.
Per the press release, management believes that if the sNDA for Firdapse is eventually approved, it is likely to provide an additional indicated dosage option for LEMS patients who might benefit from a daily dosage greater than 80mg of the above drug.
LEMS is an extremely rare autoimmune disease characterized by muscle weakness of the limbs. Catalyst is presently well-positioned as there are very few companies that have an approved treatment approved for LEMS.
Shares of Catalyst have plunged 31.3% so far this year compared with the industry’s decline of 11.4%.
Image Source: Zacks Investment Research
We remind investors that Firdapse is currently the only FDA-approved treatment option for LEMS in the United States. The drug is also approved for treating LEMS in Canada and the European Union.
In the first six months of 2023, Firdapse generated sales worth $122.4 million, reflecting an increase of 27.4% year over year. A potential label extension of the maximum daily dosage of Firdapse will help it to address a broader patient population and propel sales further in 2024 and beyond.
CPRX also has multiple patents for Firdapse issued in the United States that further strengthen the drug’s commercial durability.
This apart, in June 2023, CPRX inked a definitive licensing agreement with Santhera Pharmaceuticals to gain exclusive rights to manufacture and supply the Santhera’s vamorolone in North America.
On Jul 18, 2023, Catalyst acquired an exclusive license for vamorolone, a promising best-in-class dissociative anti-inflammatory steroid treatment for Duchenne muscular dystrophy (“DMD”), in North America.
Vamorolone is currently under FDA review for the treatment of DMD. A decision from the FDA is expected on Oct 26, 2023. CPRX anticipates the launch of the drug in first-quarter 2024, subject to approval.
In the event of vamorolone’s approval, Catalyst will have a diversified commercial portfolio, which is expected to significantly relieve the burden on Firdapse for revenues in the days ahead.
Zacks Rank & Other Stocks to Consider
Catalyst currently sports a Zacks Rank #1 (Strong Buy).
In the past 60 days, estimates per share for Neurocrine Biosciences 2023 have risen from $2.17 to $2.19. During the same period, estimates per share estimates for 2024 have risen from $4.77 to $4.86. Year to date, shares of NBIX have lost 5.5%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, the loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 37.5%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.
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Catalyst (CPRX) Seeks to Increase Maximum Daily Dose for Firdapse
Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) announced that the FDA has accepted its supplemental new drug application ("sNDA") seeking a label expansion for its flagship product, Firdapse (amifampridine).
The sNDA seeks to increase the maximum daily dosage of Firdapse tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").
With the FDA accepting the sNDA for review, a decision from the regulatory body is expected on Jun 4, 2024.
We note that Firdapse tablets in 10 mg dosage are currently approved for the treatment of LEMS in adults as well as patients in the age group of 6 to 17 years in the United States.
Per the press release, management believes that if the sNDA for Firdapse is eventually approved, it is likely to provide an additional indicated dosage option for LEMS patients who might benefit from a daily dosage greater than 80mg of the above drug.
LEMS is an extremely rare autoimmune disease characterized by muscle weakness of the limbs. Catalyst is presently well-positioned as there are very few companies that have an approved treatment approved for LEMS.
Shares of Catalyst have plunged 31.3% so far this year compared with the industry’s decline of 11.4%.
Image Source: Zacks Investment Research
We remind investors that Firdapse is currently the only FDA-approved treatment option for LEMS in the United States. The drug is also approved for treating LEMS in Canada and the European Union.
In the first six months of 2023, Firdapse generated sales worth $122.4 million, reflecting an increase of 27.4% year over year. A potential label extension of the maximum daily dosage of Firdapse will help it to address a broader patient population and propel sales further in 2024 and beyond.
CPRX also has multiple patents for Firdapse issued in the United States that further strengthen the drug’s commercial durability.
This apart, in June 2023, CPRX inked a definitive licensing agreement with Santhera Pharmaceuticals to gain exclusive rights to manufacture and supply the Santhera’s vamorolone in North America.
On Jul 18, 2023, Catalyst acquired an exclusive license for vamorolone, a promising best-in-class dissociative anti-inflammatory steroid treatment for Duchenne muscular dystrophy (“DMD”), in North America.
Vamorolone is currently under FDA review for the treatment of DMD. A decision from the FDA is expected on Oct 26, 2023. CPRX anticipates the launch of the drug in first-quarter 2024, subject to approval.
In the event of vamorolone’s approval, Catalyst will have a diversified commercial portfolio, which is expected to significantly relieve the burden on Firdapse for revenues in the days ahead.
Zacks Rank & Other Stocks to Consider
Catalyst currently sports a Zacks Rank #1 (Strong Buy).
Some other top-ranked stocks in the healthcare sector are Neurocrine Biosciences, Inc. (NBIX - Free Report) , Sarepta Therapeutics, Inc. (SRPT - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) , sporting a Zacks Rank #1 each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates per share for Neurocrine Biosciences 2023 have risen from $2.17 to $2.19. During the same period, estimates per share estimates for 2024 have risen from $4.77 to $4.86. Year to date, shares of NBIX have lost 5.5%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, the loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 37.5%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.