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SpringWorks (SWTX) Falls Despite Positive Mirdametinib Study Data
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SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced positive top-line data from the pivotal phase IIb ReNeu study evaluating its investigational MEK inhibitor, mirdametinib, for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in pediatric and adult patients.
The ReNeu study evaluated the safety, efficacy and tolerability of mirdametinib in patients aged two years and above. The primary endpoint of the study was confirmed objective response rate, which is noted as ≥ 20% reduction in target tumor volume as assessed by blinded independent central review and per MRI.
As of Sep 20, 2023, data from the above study showed that treatment with mirdametinib resulted in BICR confirmed objective responses in 52% of pediatric patients and 41% of adult patientswithin the 24-cycle treatment period.
Also, treatment with mirdametinib led to statistically significant improvements in pain, quality of life, and physical function from baseline, in multiple patient-reported outcome measures.
Although mirdametinib was generally well tolerated, 25% of pediatric patients and 16% of adult patients experienced grade 3 or higher treatment-related adverse side effects.
Despite the positive data, shares of SpringWorks were down 7.3% on Thursday following the announcement of the news. The stock has lost 21.4% so far this year compared with the industry’s decline of 22.5%.
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The FDA has already granted Orphan Drug designation and Fast Track designation to mirdametinib for the treatment of NF1. In July, SWTX received a Rare Pediatric Disease designationfor mirdametinib from the regulatory body, which made the candidate eligible to receive a priority review voucher in the event of a potential approval.
SpringWorks is planning to file a new drug application for mirdametinib to treat NF1-PN in the first half of 2024 to the FDA.
Currently, SpringWorks has no marketed drugs in its portfolio. SpringWorks is developing its most advanced pipeline candidate, nirogacestat, in the phase III phase III DeFi study for the treatment of desmoid tumors in adult patients.
A regulatory application seeking approval for nirogacestat is currently under review in the United States. A decision from the FDA is expected on Nov 27, 2023.
The company plans to file a marketing authorization application for nirogacestat in the European Union in the first half of 2024.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.1%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have decreased 14.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 5.7%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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SpringWorks (SWTX) Falls Despite Positive Mirdametinib Study Data
SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced positive top-line data from the pivotal phase IIb ReNeu study evaluating its investigational MEK inhibitor, mirdametinib, for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in pediatric and adult patients.
The ReNeu study evaluated the safety, efficacy and tolerability of mirdametinib in patients aged two years and above. The primary endpoint of the study was confirmed objective response rate, which is noted as ≥ 20% reduction in target tumor volume as assessed by blinded independent central review and per MRI.
As of Sep 20, 2023, data from the above study showed that treatment with mirdametinib resulted in BICR confirmed objective responses in 52% of pediatric patients and 41% of adult patientswithin the 24-cycle treatment period.
Also, treatment with mirdametinib led to statistically significant improvements in pain, quality of life, and physical function from baseline, in multiple patient-reported outcome measures.
Although mirdametinib was generally well tolerated, 25% of pediatric patients and 16% of adult patients experienced grade 3 or higher treatment-related adverse side effects.
Despite the positive data, shares of SpringWorks were down 7.3% on Thursday following the announcement of the news. The stock has lost 21.4% so far this year compared with the industry’s decline of 22.5%.
The FDA has already granted Orphan Drug designation and Fast Track designation to mirdametinib for the treatment of NF1. In July, SWTX received a Rare Pediatric Disease designationfor mirdametinib from the regulatory body, which made the candidate eligible to receive a priority review voucher in the event of a potential approval.
SpringWorks is planning to file a new drug application for mirdametinib to treat NF1-PN in the first half of 2024 to the FDA.
Currently, SpringWorks has no marketed drugs in its portfolio. SpringWorks is developing its most advanced pipeline candidate, nirogacestat, in the phase III phase III DeFi study for the treatment of desmoid tumors in adult patients.
A regulatory application seeking approval for nirogacestat is currently under review in the United States. A decision from the FDA is expected on Nov 27, 2023.
The company plans to file a marketing authorization application for nirogacestat in the European Union in the first half of 2024.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.1%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have decreased 14.5%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have lost 5.7%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.