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Syros (SYRS) Up on FDA Fast Track Tag for Tamibarotene in AML
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Syros Pharmaceuticals, Inc. (SYRS - Free Report) announced that the FDA has granted a Fast Track designation to its lead pipeline candidate, tamibarotene, for the treatment of acute myeloid leukemia (AML). The FDA’s prestigious tag has been given to tamibarotene in combination with azacitidine and Roche (RHHBY - Free Report) /AbbVie’s (ABBV - Free Report) drug Venclexta (venetoclax) for treating newly diagnosed AML with RARA gene overexpression in adult patients aged more than 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
Shares of Syros were up 22.2% on Apr 9 following the announcement of the news.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
The Fast Track designation enables therapeutic candidates to receive priority review and accelerated approval if supported by clinical data.
SYRS is currently developing tamibarotene, an oral, selective retinoic acid receptor alpha or RARα agonist in combination studies as a frontline treatment for AML and higher-risk myelodysplastic syndrome (HR-MDS).
Shares of Syros have plunged 29.4% so far this year compared with the industry’s decline of 5.4%.
Image Source: Zacks Investment Research
Notably, the phase II SELECT-AML-1 study is evaluating tamibarotene in combination with Roche/AbbVie’s Venclexta and azacitidine in newly diagnosed, unfit patients with AML and RARA gene overexpression.
Venclexta is being jointly commercialized by ABBV and RHHBY in the United States.
The primary endpoint of the study is to check the complete response rate (CR)/complete response with incomplete hematologic recovery (Cri).
Initial data from the SELECT-AML-1 study showed that patients treated with the combo of tamibarotene plus Venclexta and azacytidine had a 100% CR/CRi rate compared with 70% for patients who were treated with Venclexta and azacytidine alone.
The triplet regimen of tamibarotene, Venclexta and azacytidine was generally well tolerated, with no new safety signals reported.
Additional data from the SELECT-AML-1 study is expected later in 2024.
Meanwhile, the phase III SELECT-MDS-1 study is investigating tamibarotene in combination with azacitidine in patients with HR-MDS with RARA overexpression. Enrollment in the study was completed in the first quarter of 2024, while pivotal CR data is expected mid fourth-quarter 2024.
The FDA had also earlier granted a Fast Track Designation to tamibarotene for treating HR-MDS.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 21.6%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
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Syros (SYRS) Up on FDA Fast Track Tag for Tamibarotene in AML
Syros Pharmaceuticals, Inc. (SYRS - Free Report) announced that the FDA has granted a Fast Track designation to its lead pipeline candidate, tamibarotene, for the treatment of acute myeloid leukemia (AML). The FDA’s prestigious tag has been given to tamibarotene in combination with azacitidine and Roche (RHHBY - Free Report) /AbbVie’s (ABBV - Free Report) drug Venclexta (venetoclax) for treating newly diagnosed AML with RARA gene overexpression in adult patients aged more than 75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
Shares of Syros were up 22.2% on Apr 9 following the announcement of the news.
The Fast Track designation from the FDA facilitates rapid development and expedites the review of drug candidates that are being developed to treat serious conditions and for which clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients in need.
The Fast Track designation enables therapeutic candidates to receive priority review and accelerated approval if supported by clinical data.
SYRS is currently developing tamibarotene, an oral, selective retinoic acid receptor alpha or RARα agonist in combination studies as a frontline treatment for AML and higher-risk myelodysplastic syndrome (HR-MDS).
Shares of Syros have plunged 29.4% so far this year compared with the industry’s decline of 5.4%.
Image Source: Zacks Investment Research
Notably, the phase II SELECT-AML-1 study is evaluating tamibarotene in combination with Roche/AbbVie’s Venclexta and azacitidine in newly diagnosed, unfit patients with AML and RARA gene overexpression.
Venclexta is being jointly commercialized by ABBV and RHHBY in the United States.
The primary endpoint of the study is to check the complete response rate (CR)/complete response with incomplete hematologic recovery (Cri).
Initial data from the SELECT-AML-1 study showed that patients treated with the combo of tamibarotene plus Venclexta and azacytidine had a 100% CR/CRi rate compared with 70% for patients who were treated with Venclexta and azacytidine alone.
The triplet regimen of tamibarotene, Venclexta and azacytidine was generally well tolerated, with no new safety signals reported.
Additional data from the SELECT-AML-1 study is expected later in 2024.
Meanwhile, the phase III SELECT-MDS-1 study is investigating tamibarotene in combination with azacitidine in patients with HR-MDS with RARA overexpression. Enrollment in the study was completed in the first quarter of 2024, while pivotal CR data is expected mid fourth-quarter 2024.
The FDA had also earlier granted a Fast Track Designation to tamibarotene for treating HR-MDS.
Zacks Rank & Stock to Consider
Syros currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is ANI Pharmaceuticals, Inc. (ANIP - Free Report) , 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 ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 21.6%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.