H.C. Wainwright adjusted its price target for Briacell Therapeutics (NASDAQ:BCTX), reducing it to $15.00 from the previous $18.00. Despite the price target reduction, the firm maintains a Buy rating on the stock. The adjustment follows Briacell's recent announcement that the FDA has approved an Expanded Access Program (EAP) for Bria-IMT, intended to treat metastatic breast cancer patients beyond the ongoing Phase 3 clinical trial.
The EAP, often referred to as a "compassionate use" program, enables seriously ill patients to access investigational drugs outside of clinical trials, which could be beneficial for those not included in trial sites or in countries not participating in clinical trials.
The EAP is a condition of the Fast Track designation granted to Bria-IMT and could provide Briacell with real-world usage experience. This program is expected to increase the number of patients treated with Bria-IMT, potentially yielding additional patient efficacy data alongside the event-based Phase 3 trial, which has a primary endpoint of overall survival (OS).
The Phase 3 study of Bria-IMT is actively enrolling patients and is open label due to the intramuscular administration of the regimen.
This setup may allow the company to review interim data, which could lead to a Biologics License Application (BLA) submission before the collection of topline data.
H.C. Wainwright's continued optimism regarding the success of Bria-IMT's Phase 3 trial and its potential FDA approval is bolstered by a recent analysis of the Phase 2 study's OS data, which the firm views favorably for the ongoing Phase 3 study.
The price target adjustment to $15 reflects this positive outlook while accounting for the latest developments around the EAP and its implications for Briacell's clinical progress.
BriaCell Therapeutics has been maintaining a strong presence in the biotechnology sector. The company's Phase 2 study involving Bria-IMT combined with retifanlimab has shown promising results in treating patients with metastatic breast cancer. H.C. Wainwright has maintained a Buy rating on BriaCell shares following the announcement of new overall survival data from this study. The latest data indicates an improved median overall survival of 15.6 months for patients treated more recently.
BriaCell has received a non-compliance notice from the Nasdaq Stock Market due to its share price falling below the minimum bid price. The company has until February 18, 2025, to rectify this issue and retain its listing on the Nasdaq Capital Market.
BriaCell announced a partnership with BeiGene (NASDAQ:BGNE), Ltd. to initiate a clinical trial for a new cancer treatment. This study aims to evaluate the safety and efficacy of Bria-OTS, BriaCell's novel immunotherapy, in combination with BeiGene's anti-PD-1 antibody, tislelizumab, specifically targeting advanced, heavily pretreated metastatic breast cancer.
InvestingPro Insights
As Briacell Therapeutics (NASDAQ:BCTX) navigates the clinical and regulatory landscape for its Bria-IMT treatment, real-time data and insights from InvestingPro provide a financial perspective on the company's market performance. With a current market capitalization of $16.06 million and a negative P/E ratio of -1.33, the company's financial standing reflects the challenges it faces in the biotech sector. Notably, BCTX's stock has experienced significant volatility, with a one-week price total return of -16.94% and a staggering one-year price total return of -91.01%, emphasizing the stock's downward trend over the past year.
InvestingPro Tips highlight that the stock is currently in oversold territory according to the RSI, and it has suffered a considerable hit over the last week. Additionally, the stock's price movements have been quite volatile, and short-term obligations exceed its liquid assets. With no dividend payouts to shareholders, investors are likely focused on the stock's growth potential and clinical outcomes. It's worth noting that there are 8 additional InvestingPro Tips available that can provide further insights into BCTX's financial health and stock performance.
These financial metrics and tips from InvestingPro are particularly relevant as they offer a glimpse into the investor sentiment and market confidence in Briacell's ability to successfully commercialize Bria-IMT. The company's next earnings date is set for October 25, 2024, which may provide further clarity on its financial trajectory and the impact of the EAP on its operations.
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