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SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA
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SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that the FDA had accepted its new drug application (“NDA”) seeking approval for the company’s investigational MEK inhibitor, mirdametinib, which is being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Feb. 28, 2025.
At present, the FDA is not planning to hold an advisory committee meeting to discuss the above NDA.
Simultaneously, SWTX announced that the European Medicines Agency (“EMA”) has also validated the marketing authorization application for mirdametinib for the treatment of adult and pediatric patients with NF1-PN.
Per the company, mirdametinib has the potential to be the first approved therapy for adult patients and a best-in-class therapy for children with NF1-PN, a rare tumor with a significant unmet need.
SWTX Stock Outperforming Industry
Shares of SpringWorks have gained 12.9% so far this year against the industry's decline of 0.1%.
Image Source: Zacks Investment Research
This July, the company completed the NDA submission for mirdametinib in NF1-PN.
The NDA filing and the filing in Europe were based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity.
The FDA and the European Commission have already granted Orphan Drug designation to mirdametinib for the treatment of NF1.
SWTX Generates Revenues With Newly Approved Drug Ogsiveo
The FDA approved SpringWorks’ Ogsiveo (nirogacestat) for treating adult patients with desmoid tumors who require systemic treatment in November 2023.
Following the FDA nod, not only Ogsiveo became the first approved product in the company’s portfolio but also became the first approved drug for treating desmoid tumors, a rare, aggressive tumor of the soft tissues.
Ogsiveo's net product revenues were $61.2 million in the first half of 2024. The drug has witnessed a rapid uptake so far, which is driven by strong commercial launches and high demand from both physicians and patients.
A marketing authorization application for Ogsiveo in desmoid tumors is currently under review with the EMA. A potential approval in the European Union is likely to boost sales of the drug.
Zacks Rank & Other Stocks to Consider
SpringWorks currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have gained 64.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA
SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that the FDA had accepted its new drug application (“NDA”) seeking approval for the company’s investigational MEK inhibitor, mirdametinib, which is being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Feb. 28, 2025.
At present, the FDA is not planning to hold an advisory committee meeting to discuss the above NDA.
Simultaneously, SWTX announced that the European Medicines Agency (“EMA”) has also validated the marketing authorization application for mirdametinib for the treatment of adult and pediatric patients with NF1-PN.
Per the company, mirdametinib has the potential to be the first approved therapy for adult patients and a best-in-class therapy for children with NF1-PN, a rare tumor with a significant unmet need.
SWTX Stock Outperforming Industry
Shares of SpringWorks have gained 12.9% so far this year against the industry's decline of 0.1%.
Image Source: Zacks Investment Research
This July, the company completed the NDA submission for mirdametinib in NF1-PN.
The NDA filing and the filing in Europe were based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity.
The FDA and the European Commission have already granted Orphan Drug designation to mirdametinib for the treatment of NF1.
SWTX Generates Revenues With Newly Approved Drug Ogsiveo
The FDA approved SpringWorks’ Ogsiveo (nirogacestat) for treating adult patients with desmoid tumors who require systemic treatment in November 2023.
Following the FDA nod, not only Ogsiveo became the first approved product in the company’s portfolio but also became the first approved drug for treating desmoid tumors, a rare, aggressive tumor of the soft tissues.
Ogsiveo's net product revenues were $61.2 million in the first half of 2024. The drug has witnessed a rapid uptake so far, which is driven by strong commercial launches and high demand from both physicians and patients.
A marketing authorization application for Ogsiveo in desmoid tumors is currently under review with the EMA. A potential approval in the European Union is likely to boost sales of the drug.
Zacks Rank & Other Stocks to Consider
SpringWorks currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 5.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have gained 64.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have jumped 31.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.