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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib
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SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that it has completed the submission of a new drug application (“NDA”) for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.
The NDA filing was 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 primary endpoint of the ReNeu study was the confirmed objective response rate, which is noted as ≥ 20% reduction in target tumor volume as assessed by blinded independent central review and per MRI.
Data from the study showed that treatment with mirdametinib resulted in significant objective response rates confirmed by blinded independent central review and led to improvements in pain and quality of life in both pediatric and adult cohorts.
The data was recently presented at the annual meeting of the American Society of Clinical Oncology 2024.
Shares of SpringWorks have risen 3.1% year to date against the industry’s decline of 6.3%.
Image Source: Zacks Investment Research
In March 2024, the company initiated the rolling submission of the NDA to the FDA for mirdametinib in NF1-PN, a rare genetic disorder.
The FDA and the European Commission have already granted Orphan Drug designation to mirdametinib for the treatment of NF1.
The FDA has also granted Fast Track designation to mirdametinib for the treatment of patients aged two years and above with NF1-PN that is progressing or causing significant morbidity.
The company plans to file a marketing application with the European Medicines Agency seeking approval for mirdametinib for the treatment of children and adults with NF1-PN later in the second half of 2024.
The FDA approved SpringWorks’ Ogsiveo (nirogacestat) for treating adult patients with desmoid tumors who require systemic treatment in November 2023. Following the nod, Ogsiveo became the first and only FDA-approved therapy for treating adults living with desmoid tumors, a rare, aggressive tumor of the soft tissues.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 17.8%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, ALGS shares have declined 44.3%.
ALGS’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, RAPT shares have declined 88.4%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib
SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that it has completed the submission of a new drug application (“NDA”) for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.
The NDA filing was 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 primary endpoint of the ReNeu study was the confirmed objective response rate, which is noted as ≥ 20% reduction in target tumor volume as assessed by blinded independent central review and per MRI.
Data from the study showed that treatment with mirdametinib resulted in significant objective response rates confirmed by blinded independent central review and led to improvements in pain and quality of life in both pediatric and adult cohorts.
The data was recently presented at the annual meeting of the American Society of Clinical Oncology 2024.
Shares of SpringWorks have risen 3.1% year to date against the industry’s decline of 6.3%.
Image Source: Zacks Investment Research
In March 2024, the company initiated the rolling submission of the NDA to the FDA for mirdametinib in NF1-PN, a rare genetic disorder.
The FDA and the European Commission have already granted Orphan Drug designation to mirdametinib for the treatment of NF1.
The FDA has also granted Fast Track designation to mirdametinib for the treatment of patients aged two years and above with NF1-PN that is progressing or causing significant morbidity.
The company plans to file a marketing application with the European Medicines Agency seeking approval for mirdametinib for the treatment of children and adults with NF1-PN later in the second half of 2024.
The FDA approved SpringWorks’ Ogsiveo (nirogacestat) for treating adult patients with desmoid tumors who require systemic treatment in November 2023. Following the nod, Ogsiveo became the first and only FDA-approved therapy for treating adults living with desmoid tumors, a rare, aggressive tumor of the soft tissues.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. (ACRV - Free Report) , Aligos Therapeutics, Inc. (ALGS - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 17.8%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, ALGS shares have declined 44.3%.
ALGS’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, RAPT shares have declined 88.4%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.