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SpringWorks (SWTX) Rises on FDA Nod for Desmoid Tumor Drug
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SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that the FDA has granted approval to its oral gamma-secretase inhibitor, Ogsiveo (nirogacestat), for treating adult patients with progressing desmoid tumors who require systemic treatment.
Following the FDA nod, Ogsiveo became the first drug to be approved by the regulatory body for the given indication. Shares of SpringWorks were up 18.7% on Nov 28, following the announcement of the news on Nov 27.
Per the company, Ogsiveo has the potential to become the new standard of care for patients suffering from desmoid tumors. The drug is likely to be launched in the United States in the next few days and will be available through specialty pharmacy and distributor networks.
Shares of SpringWorks have lost 4.9% so far this year compared with the industry’s decline of 23.5%.
Image Source: Zacks Investment Research
The FDA approval was based on data from the phase III DeFi study, which evaluated Ogsiveo for the treatment of desmoid tumors, a rare, aggressive tumor of the soft tissues.
Data from the study showed that treatment with Ogsiveo led to both meaningful antitumor activity and a significant improvement in desmoid tumor symptoms.
In the European Union, a marketing authorization application for Ogsiveo in desmoid tumors is expected to be filed in the first half of 2024.
We note that several other studies are currently ongoing on Ogsiveo, targeting different cancer indications.
A phase II study is investigating Ogsiveo as a monotherapy for treating patients with recurrent ovarian granulosa cell tumors. Initial data from the study is anticipated in 2024.
Ogsiveo is also being studied in combination with various B-cell maturation antigens for treating multiple myeloma.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.3%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 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 3.1%.
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) Rises on FDA Nod for Desmoid Tumor Drug
SpringWorks Therapeutics, Inc. (SWTX - Free Report) announced that the FDA has granted approval to its oral gamma-secretase inhibitor, Ogsiveo (nirogacestat), for treating adult patients with progressing desmoid tumors who require systemic treatment.
Following the FDA nod, Ogsiveo became the first drug to be approved by the regulatory body for the given indication. Shares of SpringWorks were up 18.7% on Nov 28, following the announcement of the news on Nov 27.
Per the company, Ogsiveo has the potential to become the new standard of care for patients suffering from desmoid tumors. The drug is likely to be launched in the United States in the next few days and will be available through specialty pharmacy and distributor networks.
Shares of SpringWorks have lost 4.9% so far this year compared with the industry’s decline of 23.5%.
The FDA approval was based on data from the phase III DeFi study, which evaluated Ogsiveo for the treatment of desmoid tumors, a rare, aggressive tumor of the soft tissues.
Data from the study showed that treatment with Ogsiveo led to both meaningful antitumor activity and a significant improvement in desmoid tumor symptoms.
In the European Union, a marketing authorization application for Ogsiveo in desmoid tumors is expected to be filed in the first half of 2024.
We note that several other studies are currently ongoing on Ogsiveo, targeting different cancer indications.
A phase II study is investigating Ogsiveo as a monotherapy for treating patients with recurrent ovarian granulosa cell tumors. Initial data from the study is anticipated in 2024.
Ogsiveo is also being studied in combination with various B-cell maturation antigens for treating multiple myeloma.
Zacks Rank & Stocks to Consider
SpringWorks currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. (CTMX - Free Report) , Entrada Therapeutics, Inc. (TRDA - 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 CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.3%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 73 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 3.1%.
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%.