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e-therapeutics De-risks Clinical Path for GalOmic Candidate ETX-312 with Positive Non-clinical Data
Globenewswire· 2025-07-10 12:00
Core Insights - e-therapeutics plc has made significant progress with its lead candidate ETX-312, a GalOmic siRNA therapy for metabolic dysfunction-associated steatohepatitis (MASH), and is on track to submit a clinical trial application (CTA) in Q4 2025 [1][4] Group 1: Clinical Development Progress - ETX-312 was well tolerated in GLP-compliant toxicology studies at doses far exceeding anticipated clinical exposure, indicating a broad therapeutic window [2][4] - The company has successfully completed GMP manufacturing of the clinical batch of ETX-312, demonstrating operational readiness for first-in-human dosing [3][4] - The tolerability profile of ETX-312 supports the clinical strategy and plans for a CTA filing in Q4 2025 [4] Group 2: Product Details - ETX-312 is a GalNAc-conjugated small-interfering RNA therapeutic candidate aimed at treating MASH, with potential for quarterly subcutaneous dosing [5] - Preclinical studies have shown that ETX-312 leads to significant reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation, and slowed fibrosis progression [5] Group 3: Company Overview - e-therapeutics plc combines computational power and RNAi to develop innovative medicines, utilizing its proprietary GalOmic platform for effective gene silencing [6][7] - The company has established a robust position in applying computational approaches to biology, validated through successful collaborations with biopharma companies [6][7]
Will RXRX's Shift in Pipeline Focus Help Restore Investor Faith?
ZACKS· 2025-07-07 15:26
Core Insights - Recursion Pharmaceuticals (RXRX) faced a significant setback in May 2025 with the discontinuation of three key drug candidates due to disappointing mid-stage study results, impacting investor confidence and leading to a stock price decline [1][8] - The company is now focusing on more promising candidates, particularly REC-4881, which has shown a preliminary median 43% reduction in polyp burden in early phase II data [2][8] - RXRX is also advancing other candidates like REC-1245, REC-617, and REC-3565 to diversify its pipeline and leverage its AI-driven platform for novel therapies [3][8] Company Developments - The discontinuation of REC-994, REC-2282, and REC-3964 was part of a strategic pipeline reprioritization, as these candidates did not demonstrate sufficient efficacy [1][8] - REC-4881 is currently being evaluated in the phase Ib/II TUPELO study for familial adenomatous polyposis, with more comprehensive data expected in the second half of 2025 [2] - Other candidates in development include REC-1245 for biomarker-enriched solid tumors and lymphoma, REC-617 for advanced solid tumors, and REC-3565 for B-cell malignancies [3] Competitive Landscape - In the TechBio industry, competitors like Relay Therapeutics (RLAY) and Schrödinger (SDGR) are emerging, utilizing AI-driven platforms to develop novel therapies [4][5] - RLAY is advancing its lead candidate RLY-2608 into a phase III study for metastatic breast cancer, while SDGR is evaluating SGR-1505 for B-cell malignancies [4][5] Stock Performance - Year to date, RXRX shares have declined by 22%, underperforming the industry, which saw a 1.1% decline [6] - The company's stock is trading at a price/book value ratio of 2.29, below the industry average of 3.13 and significantly below its five-year mean of 3.57 [9] Financial Estimates - Loss estimates for 2025 remain constant at $1.34 per share, while 2026 estimates have narrowed from $1.21 to $1.08 [14] - Recent estimate revisions indicate a positive trend, with increases of 12.82% and 10.74% for Q1 and Q2, respectively [15]