On Thursday, H.C. Wainwright adjusted its outlook on Cullinan Oncology Inc. (NASDAQ:CGEM), raising the price target to $33.00 from the previous $28.00 while maintaining a Buy rating on the company's shares. Currently trading at $11.25 with a market capitalization of $655 million, the stock appears undervalued according to InvestingPro analysis. This price target adjustment follows the announcement on Sunday that Cullinan's Phase 2b REZILIENT1 trial met its primary endpoint.
The REZILIENT1 trial is a significant study for Cullinan Oncology, focusing on the effectiveness of zipalertinib as a monotherapy for patients with non-small cell lung cancer (NSCLC) who have the EGFR exon20 insertion mutations and have undergone prior therapy. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 24.46, providing ample resources for its clinical programs. Zipalertinib is an oral medication designed to inhibit EGFR and has been granted breakthrough therapy designation by the FDA for treating NSCLC patients with these specific mutations following platinum-based chemotherapy.
The successful results of the trial, based on the Phase 2b segment involving modules B and C, demonstrated that the primary endpoint of overall response rate (ORR) was met. Moreover, the safety profile of zipalertinib was in line with data from previous presentations. Full results from the trial are expected to be unveiled at a medical conference in mid-2025.
Cullinan Oncology, in partnership with Taiho Pharmaceutical (TADAWUL:2070), a subsidiary of Otsuka Holdings Co (OTC:OTSKY). (4578-JP; not rated), is planning to engage in discussions with the FDA and aims to submit for regulatory approval in the United States in the second half of 2025. The company is also conducting the pivotal REZILIENT3 study for first-line treatment in EGFR ex20ins NSCLC patients as well as the parallel cohort study REZILIENT2, both of which are ongoing and enrolling patients.
Looking ahead, H.C. Wainwright analysts project that zipalertinib could be launched in 2026 with initial sales of $41 million, potentially growing to $397 million by 2031. The firm's reiterated Buy rating and increased price target reflect their positive outlook on Cullinan Oncology's prospects following these recent developments. InvestingPro subscribers can access additional insights, including 8 more ProTips and comprehensive financial metrics that could help evaluate the company's long-term potential. Get the full picture with real-time updates and expert analysis by subscribing today.
In other recent news, Cullinan Oncology has been making significant strides in its clinical trials and drug development. The company reported a lower-than-expected Q1 loss of $0.86 per share, beating the projected loss of $0.94. Cullinan Oncology also received FDA approval to initiate a global Phase 1b clinical trial for CLN-978, a novel T cell engager targeting systemic lupus erythematosus (SLE) patients.
Clear Street recently initiated coverage of Cullinan Oncology with a Buy rating and a price target of $30. The firm's analysis suggests that CLN-978 could become a leading treatment in the lucrative market for SLE and rheumatoid arthritis, valued at over $10 billion.
Analyst firms H.C. Wainwright, BTIG, and UBS have reaffirmed their buy ratings for the company, with price targets of $28, $30, and $30 respectively. BTIG highlighted potential advantages of Cullinan's CLN-978 over Chimagen's CMG1A46, indicating that CLN-978 could have a longer half-life and potentially less frequent dosing.
These developments present a promising outlook for Cullinan Oncology, as it continues to progress in its clinical trials and drug development.
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