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Travere (TVTX) Up on Latest Portfolio Updates & Reorganization
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Shares of Travere Therapeutics, Inc. (TVTX - Free Report) were up 17.6% on Dec 5 after the company provided updates on its marketed drug Filspari (sparsentan) and a strategic reorganization to cut costs.
Travere completed a pre-NDA meeting with the FDA to discuss the confirmatory data from the phase III PROTECT study evaluating its IgA nephropathy (“IgAN”) therapy, Filspari.
Following positive feedback from the regulatory body, the company is planning to submit a supplemental new drug application (“sNDA”) seeking to convert the existing accelerated approval for Filspari to full approval for treating IgAN, a rare progressive kidney disease. It is anticipated that the sNDA will be submitted in the first quarter of 2024.
The company is also evaluating sparsentan in the phase III DUPLEX study to address focal segmental glomerulosclerosis (“FSGS”). Travere has completed a planned Type C meeting with the FDA to discuss the previously reported data from the DUPLEX study.
The regulatory body has stated that the two-year data from the DUPLEX study alone is not sufficient enough to support an sNDA submission on sparsentan in FSGS. TVTX plans to conduct additional analyses of the above study data and will re-engage with the FDA later in 2024 to decide the regulatory path forward for sparsentan in FSGS.
Shares of Travere have plunged 64.8% year to date compared with the industry’s decline of 20.7%.
Image Source: Zacks Investment Research
This apart, Travere also announced a strategic reorganization, including the clinical development of its pipeline candidate, pegtibatinase, as the first potential disease-modifying treatment for classical homocystinuria.
As part of the reorganization, the company is looking to reduce its current workforce by almost 20%, which in return is expected to make an estimated annualized savings of around $25 million starting in 2024.
TVTX also anticipates operating expenses to be less than $400 million in 2024. The company had cash and cash equivalents worth $634.6 as of Sep 30, 2023.
Per management, cash and cash equivalents, along with the planned cost reduction measure, are expected to extend the cash runway into 2028.
In the past 60 days, estimates for Avalo Therapeutics’ 2023 loss per share have narrowed from $4.12 to 40 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $4.62 to 7 cents. Year-to-date, shares of AVTX have lost 98.8%.
Earnings of Avalo Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. AVTX delivered a four-quarter earnings surprise of 9.20%, on average.
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 increased by 3.9%.
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 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year-to-date, shares of PBYI have lost 12.1%.
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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Travere (TVTX) Up on Latest Portfolio Updates & Reorganization
Shares of Travere Therapeutics, Inc. (TVTX - Free Report) were up 17.6% on Dec 5 after the company provided updates on its marketed drug Filspari (sparsentan) and a strategic reorganization to cut costs.
Travere completed a pre-NDA meeting with the FDA to discuss the confirmatory data from the phase III PROTECT study evaluating its IgA nephropathy (“IgAN”) therapy, Filspari.
Following positive feedback from the regulatory body, the company is planning to submit a supplemental new drug application (“sNDA”) seeking to convert the existing accelerated approval for Filspari to full approval for treating IgAN, a rare progressive kidney disease. It is anticipated that the sNDA will be submitted in the first quarter of 2024.
The company is also evaluating sparsentan in the phase III DUPLEX study to address focal segmental glomerulosclerosis (“FSGS”). Travere has completed a planned Type C meeting with the FDA to discuss the previously reported data from the DUPLEX study.
The regulatory body has stated that the two-year data from the DUPLEX study alone is not sufficient enough to support an sNDA submission on sparsentan in FSGS. TVTX plans to conduct additional analyses of the above study data and will re-engage with the FDA later in 2024 to decide the regulatory path forward for sparsentan in FSGS.
Shares of Travere have plunged 64.8% year to date compared with the industry’s decline of 20.7%.
Image Source: Zacks Investment Research
This apart, Travere also announced a strategic reorganization, including the clinical development of its pipeline candidate, pegtibatinase, as the first potential disease-modifying treatment for classical homocystinuria.
As part of the reorganization, the company is looking to reduce its current workforce by almost 20%, which in return is expected to make an estimated annualized savings of around $25 million starting in 2024.
TVTX also anticipates operating expenses to be less than $400 million in 2024. The company had cash and cash equivalents worth $634.6 as of Sep 30, 2023.
Per management, cash and cash equivalents, along with the planned cost reduction measure, are expected to extend the cash runway into 2028.
Zacks Rank & Stocks to Consider
Travere currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Avalo Therapeutics, Inc. (AVTX - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Avalo Therapeutics’ 2023 loss per share have narrowed from $4.12 to 40 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $4.62 to 7 cents. Year-to-date, shares of AVTX have lost 98.8%.
Earnings of Avalo Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. AVTX delivered a four-quarter earnings surprise of 9.20%, on average.
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 increased by 3.9%.
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 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year-to-date, shares of PBYI have lost 12.1%.
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%.