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NEW YORK - Schrödinger, Inc. (NASDAQ:SDGR), a $1.5 billion market cap biotech company with strong liquidity metrics and 22% revenue growth over the last twelve months, announced that the U.S. Food and Drug Administration has granted Fast Track designation to its clinical stage MALT1 inhibitor, SGR-1505, for treating adult patients with Waldenström macroglobulinemia who have failed at least two lines of therapy, including a Bruton’s tyrosine kinase inhibitor. According to InvestingPro analysis, the company maintains a healthy balance sheet with more cash than debt and a robust current ratio of 3.45.
The FDA Fast Track program is designed to expedite development and review of drugs that address serious conditions with unmet medical needs. The designation makes SGR-1505 eligible for more frequent FDA communications and potential accelerated approval pathways.
"Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients," said Karen Akinsanya, president and head of therapeutics R&D at Schrödinger.
SGR-1505 is currently in a Phase 1 clinical study evaluating its effectiveness in patients with relapsed/refractory B-cell malignancies. Initial data presented at recent medical conferences showed the drug had a favorable safety profile and was well tolerated, with encouraging preliminary efficacy observed in multiple B-cell malignancy subtypes.
The company plans to discuss its Phase 1 study results and recommended Phase 2 dose with the FDA later this year. The FDA previously granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma in August 2023.
According to the company’s press release statement, SGR-1505 was designed using Schrödinger’s computational platform and was discovered approximately 10 months after the company initiated its MALT1 program. While the company’s stock has shown volatility, InvestingPro data reveals multiple additional insights about the company’s financial health and growth prospects. Subscribers can access the comprehensive Pro Research Report, which provides detailed analysis of Schrödinger’s business model, market position, and future potential among 1,400+ top US stocks.
In other recent news, Schrodinger Inc. reported its first-quarter 2025 earnings, beating expectations with an EPS of -$0.64, surpassing the forecast of -$0.74. The company also exceeded revenue projections, reporting $59.6 million against the anticipated $54.6 million, marking a 63% year-over-year increase. This growth was largely driven by the software segment, which saw a 46% increase, contributing $48.8 million to the total revenue. Additionally, Schrodinger has appointed Richie Jain as the new Chief Financial Officer, replacing Geoffrey Porges, who will remain as an advisor until June 2025 to ensure a smooth transition.
The company has reaffirmed its financial projections for the full year and the second quarter of 2025, maintaining its previously set financial targets. Schrodinger continues to project full-year software revenue growth of 10-15% and drug discovery revenue between $45-50 million. Meanwhile, the firm maintains a strong cash position with $512 million in marketable securities, despite reporting a net loss of $60 million for the quarter.
The appointment of Richie Jain as CFO is expected to bring continuity to the finance organization, given his significant role in strategic initiatives and collaborations during his tenure. Jain’s previous experience includes a managing director position at Morgan Stanley in healthcare investment banking and mergers & acquisitions. Schrodinger’s leadership change and strong financial results reflect the company’s strategic focus on innovation and cash management, positioning it robustly in the competitive biotech landscape.
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