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On Thursday, H.C. Wainwright reiterated its Buy rating on iTeos Therapeutics (NASDAQ:ITOS), currently trading at $7.26, with a steady $21.00 price target. The firm’s analyst, Swayampakula Ramakanth, discussed iTeos Therapeutics’ recent 4Q24 financial results and corporate updates for the $277 million market cap biotech company. According to InvestingPro data, analyst targets range from $15 to $47, suggesting significant upside potential. The biotechnology company announced its plans to release an interim dataset from the Phase 2 GALAXIES Lung-201 study in the second quarter of 2025. This study is assessing the efficacy of the combination therapy of belrestotug and dostarlimab in treating PD-L1-high NSCLC.
The previous interim data from the study showed a promising objective response rate (ORR) of 66% at dose B, which consists of 400mg of belrestotug and 500mg of dostarlimab administered every three weeks. However, the data also indicated that 56% of patients experienced treatment-related immune-related adverse events (TR-irAEs), with 16% facing Grade 3 or higher TR-irAEs at this dosage. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 12.62, providing financial flexibility to advance its clinical programs.
In response to these findings, iTeos Therapeutics has amended the study protocol for new and ongoing participants in both the GALAXIES Lung-201 and the Phase 3 registrational GALAXIES Lung-301 studies. The latter is comparing belrestotug plus dostarlimab combination therapy to placebo plus pembrolizumab in first-line treatment for advanced, unresectable, or metastatic PD-L1-high NSCLC.
The upcoming clinical data update from the GALAXIES Lung-201 study is anticipated to reveal not only the efficacy data from the doublet arm with belrestotug and dostarlimab but also from the triplet arm. This arm includes the investigational anti-CD96 antibody, nelistotug, developed by GSK. The full impact of the study protocol amendment is expected to be more evident in the results of the GALAXIES Lung-301 study.
H.C. Wainwright’s analyst remains optimistic about the potential improvements in safety and possibly efficacy that the amended protocol could bring. The firm upholds its positive outlook on iTeos Therapeutics stock and maintains its 12-month price target of $46 per diluted share. While the stock has declined over 50% in the past six months, InvestingPro analysis indicates the company is currently undervalued, with additional ProTips highlighting strong cash positions despite rapid cash burn. Subscribers can access 8 more exclusive ProTips and detailed financial metrics to make informed investment decisions.
In other recent news, iTeos Therapeutics announced interim results from its Phase 2 trial of inupadenant combined with chemotherapy for metastatic non-small cell lung cancer (NSCLC) patients. The trial, known as A2A-005, reported a 63.9% overall response rate (ORR) and a median progression-free survival (PFS) of 7.7 months among evaluable patients. Despite these promising results, iTeos has decided to deprioritize inupadenant, citing insufficient clinical activity to justify further investment. In response to the company’s decision, H.C. Wainwright adjusted its outlook on iTeos Therapeutics, lowering the price target to $21 from $46, while maintaining a Buy rating. The firm, however, remains optimistic about iTeos’ future prospects, particularly with the development of belrestotug, which they consider a major value driver. iTeos plans to focus its resources on other programs, with anticipated updates in 2025, including from the Phase 2 GALAXIES Lung-201 study. The safety profile of inupadenant in combination with chemotherapy was reported as manageable, with no dose-dependent toxicities observed. These developments reflect iTeos Therapeutics’ strategic focus on optimizing its pipeline for better clinical outcomes.
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