On Tuesday, H.C. Wainwright maintained a Buy rating on Allogene (NASDAQ:ALLO) shares with a $9.00 price target. The firm's endorsement comes after Allogene's recent announcement that the U.S. Food and Drug Administration (FDA) awarded Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316. This designation is for the treatment of adult patients with CD70+ advanced or metastatic renal cell carcinoma (RCC).
The RMAT designation was granted based on clinical data from the TRAVERSE trial. It highlights ALLO-316's potential to meet the need for patients with difficult-to-treat RCC who have not responded to multiple standard therapies. These therapies include an immune checkpoint inhibitor and a VEGF-targeting therapy.
Initial results from the TRAVERSE trial indicated that out of ten CD70+ RCC patients, three showed a partial response, with one unconfirmed PR, a 100% disease control rate (DCR), and a median progression-free survival (mPFS) of 5.0 months. It was noted that most patients in this data set were from the initial dose levels, and dose escalation was ongoing, suggesting the possibility of improved response rates at higher doses.
From a safety perspective, the trial observed that 5% of patients developed grade 3 or higher cytokine release syndrome (CRS), and 11% experienced neurotoxicity. The updated Phase 1 results from the TRAVERSE trial are expected to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) meeting.
The endorsement by H.C. Wainwright reflects a steady outlook for Allogene, with the RMAT designation potentially accelerating the development and review of ALLO-316 for RCC treatment. The $9.00 price target suggests a positive view of the stock's potential over the next 12 months.
In other recent news, Allogene has announced its intention to present pre-clinical data for ALLO-329, an AlloCAR T candidate targeting autoimmune diseases, at the upcoming ACR Convergence 2024. The company plans to file an investigational new drug application with the FDA in the first quarter of 2025, with proof-of-concept data expected by the end of the same year.
Financial firm Piper Sandler has maintained its Overweight rating on Allogene, following a study published in the Cell journal detailing the use of allogeneic CD19 CAR-T treatment in patients with autoimmune diseases. These recent developments provide investors with a snapshot of Allogene Therapeutics (NASDAQ:ALLO)' ongoing projects and potential future directions.
InvestingPro Insights
While Allogene (NASDAQ:ALLO) has received a positive endorsement from H.C. Wainwright and an RMAT designation for ALLO-316, it's crucial to consider the company's financial position. According to InvestingPro data, Allogene has a market capitalization of $585.51 million, which reflects its current valuation in the biotech sector.
InvestingPro Tips highlight that Allogene holds more cash than debt on its balance sheet, which could be advantageous for funding ongoing clinical trials and research. However, the company is quickly burning through cash, a common characteristic of biotech firms in the development stage. This cash burn rate is particularly relevant given the ongoing TRAVERSE trial and potential acceleration of ALLO-316 development.
Another InvestingPro Tip notes that analysts do not anticipate the company will be profitable this year. This aligns with the company's focus on research and development, as evidenced by the ALLO-316 trial results discussed in the article. The company's revenue for the last twelve months as of Q2 2024 was only $0.07 million, underscoring its pre-commercial stage.
For investors interested in a deeper analysis, InvestingPro offers additional tips and insights that could provide a more comprehensive view of Allogene's financial health and market position. There are 7 more InvestingPro Tips available for Allogene, which could be valuable for those considering an investment in this promising but still developing biotech company.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.