On Tuesday, H.C. Wainwright adjusted its stock price target for Syros Pharmaceuticals (NASDAQ:SYRS), lowering it to $6.00 from the previous $15.00, while maintaining a Buy rating on the stock. The revision follows Syros's announcement on Monday that it has halted enrollment in the SELECT-AML-1 Phase 2 study of tamibarotene for acute myeloid leukemia (AML) due to a recent data review.
The study, which was examining the effectiveness of tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression, showed a complete response (CR) or complete response with incomplete blood count recovery (CRi) rate of 65% in the triplet arm.
This is in comparison to a 70% CR/CRi rate in the doublet arm, both out of a total of 20 patients. These results come from a pre-specified non-binding futility analysis, and full data is expected to be presented at the SOHO meeting in September 2024.
The analyst noted that the data challenges the previous positive narrative around the program, which had shown a 100% CR/CRi rate for the triplet combination, compared to a 70% CR/CRi rate for the doublet alone in a smaller patient set. The recent analysis suggests that the probability of the triple regimen being favored when the full 80 patients are randomized is low.
Despite the setback in the SELECT-AML-1 study, the analyst pointed out that no new safety signals were associated with the triplet regimen. This is seen as a positive sign for the ongoing Phase 3 SELECT-MDS-1 study, which is expected to release data in the fourth quarter of 2024. The analyst emphasized the importance of examining trends in the upcoming data, especially concerning patient criteria such as diversity, depth, and median time to CR/CRi response.
Due to the discontinuation of enrollment in the SELECT-AML-1 study, all associated revenue has been removed from the valuation of Syros Pharmaceuticals. Nonetheless, the firm reiterated its Buy rating on the stock while revising the price target downward to reflect the recent developments.
In other recent news, Syros Pharmaceuticals has made significant strides in its clinical trials and financial planning. The company recently halted enrollment in its SELECT-AML-1 Phase 2 clinical trial for acute myeloid leukemia (AML) patients, following an interim analysis revealing comparable response rates between the trial's drug regimen and a standard treatment.
Despite this, Syros remains committed to the development of hematologic malignancies treatments, with ongoing trials such as the SELECT-MDS-1 Phase 3 for higher-risk myelodysplastic syndrome (MDS) patients.
In the financial realm, Syros reported its Q2 2024 outcomes and provided updates on its drug, tamibarotene. The company is preparing for its first New Drug Application (NDA) filing, with plans for an independent launch in the US. Syros is also seeking a partner in Europe to commercialize tamibarotene, implementing cost reduction measures to focus on data collection and preparation for the commercial launch.
In their latest earnings call, the company highlighted the potential market opportunity for tamibarotene due to a lack of late-stage development frontline therapies for AML and MDS. Syros is optimistic about its upcoming data readouts, expecting to report Phase II AML data in September and pivotal Phase III MDS data by mid-Q4 2024. The company is carefully managing expenses in anticipation of these commercialization efforts. These developments are part of Syros Pharmaceuticals' recent operational and financial strategy.
InvestingPro Insights
In light of H.C. Wainwright's revised price target for Syros Pharmaceuticals, real-time data and insights from InvestingPro can provide a broader context for investors considering the stock's potential. Syros Pharmaceuticals currently holds a market capitalization of $134.32 million and is trading at a previous close of $5.01.
Analysts have taken note of the company's financial health, with two key InvestingPro Tips highlighting that Syros holds more cash than debt on its balance sheet and liquid assets exceed short-term obligations, offering some financial stability despite the recent clinical trial challenges.
However, the company is not without its concerns. It's important to note that Syros is rapidly burning through cash and has weak gross profit margins, which are reflected in a gross profit margin of -2223.26% for the last twelve months as of Q2 2024.
The stock has also experienced significant volatility, with a 1-month price total return of -16.5%, indicating a rocky period for investors. Moreover, analysts do not anticipate the company will be profitable this year, and the stock has fared poorly over the last month, aligning with the recent price target adjustment.
For investors looking for more comprehensive analysis and additional insights, there are 11 more InvestingPro Tips available for Syros Pharmaceuticals, which can be accessed on the InvestingPro platform.
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