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Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis
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Cidara Therapeutics, Inc. (CDTX - Free Report) announced that the European Commission or EC has approved Rezzayo (rezafungin acetate) for the treatment of adult patients with invasive candidiasis, a severe infection of the bloodstream. Shares of the company were up 11.1% on Dec 22, following the announcement of the news.
Following the nod, Rezzayo became the first new treatment option to be approved for the given patient population in more than 15 years and should be able to address an area of significant unmet medical need.
The EC’s approval was based on data from the pivotal phase III ReSTORE study, which evaluated Rezzayo in invasive candidiasis. Data from the same showed that treatment with Rezzayo (dosed once weekly) demonstrated statistical non-inferiority compared with the current standard of care, caspofungin (dosed once daily).
Per management, the above findings were supported by data from the phase II STRIVE study and an extensive nonclinical development program.
The approval in the European Union (EU) was expected as in November 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion for Rezzayo for the treatment of invasive candidiasis in adults.
Shares of CDTX have gained 24% in the past year against the industry’s decline of 15.1%.
Image Source: Zacks Investment Research
We note that, in March 2023, the FDA approved Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults.
Cidara has granted commercial rights to Rezzayo to Mundipharma in ex-U.S. markets as well as Japan.
The approval for Rezzayo in the EU is likely to trigger a milestone payment of around $11.14 million for Cidara from Mundipharma.
The companies entered into a licensing and collaboration agreement in 2019. Per the agreement, CDTX is also entitled to receive potential development and regulatory milestones payments of up to approximately $470 million from Mundipharma, along with double-digit royalties in the teens on tiers on the product’s annual net sales.
Cidara is also developing Rezzayo for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.
In the past 60 days, estimates for Taro Pharmaceutical’s 2024 earnings per share have improved from 96 cents to $1.10. In the past year, shares of TARO have surged 45.9%.
Earnings of Taro Pharmaceutical beat estimates in two of the last four quarters while missing the same on the remaining two occasions. TARO delivered a four-quarter earnings surprise of 10.06%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have gained 9.7%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining one occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 56 cents to 64 cents. In the past year, shares of PBYI have gained 3.5%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining one occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Cidara (CDTX) Up on EC Nod for Rezzayo in Invasive Candidiasis
Cidara Therapeutics, Inc. (CDTX - Free Report) announced that the European Commission or EC has approved Rezzayo (rezafungin acetate) for the treatment of adult patients with invasive candidiasis, a severe infection of the bloodstream. Shares of the company were up 11.1% on Dec 22, following the announcement of the news.
Following the nod, Rezzayo became the first new treatment option to be approved for the given patient population in more than 15 years and should be able to address an area of significant unmet medical need.
The EC’s approval was based on data from the pivotal phase III ReSTORE study, which evaluated Rezzayo in invasive candidiasis. Data from the same showed that treatment with Rezzayo (dosed once weekly) demonstrated statistical non-inferiority compared with the current standard of care, caspofungin (dosed once daily).
Per management, the above findings were supported by data from the phase II STRIVE study and an extensive nonclinical development program.
The approval in the European Union (EU) was expected as in November 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use rendered a positive opinion for Rezzayo for the treatment of invasive candidiasis in adults.
Shares of CDTX have gained 24% in the past year against the industry’s decline of 15.1%.
We note that, in March 2023, the FDA approved Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive candidiasis in adults.
Cidara has granted commercial rights to Rezzayo to Mundipharma in ex-U.S. markets as well as Japan.
The approval for Rezzayo in the EU is likely to trigger a milestone payment of around $11.14 million for Cidara from Mundipharma.
The companies entered into a licensing and collaboration agreement in 2019. Per the agreement, CDTX is also entitled to receive potential development and regulatory milestones payments of up to approximately $470 million from Mundipharma, along with double-digit royalties in the teens on tiers on the product’s annual net sales.
Cidara is also developing Rezzayo for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation.
Zacks Rank & Stocks to Consider
Cidara currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Taro Pharmaceutical Industries Ltd. (TARO - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - 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 Taro Pharmaceutical’s 2024 earnings per share have improved from 96 cents to $1.10. In the past year, shares of TARO have surged 45.9%.
Earnings of Taro Pharmaceutical beat estimates in two of the last four quarters while missing the same on the remaining two occasions. TARO delivered a four-quarter earnings surprise of 10.06%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have gained 9.7%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining one occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 56 cents to 64 cents. In the past year, shares of PBYI have gained 3.5%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining one occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.