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FDA fast tracks Corbus drug for cervical cancer treatment

Published 12/03/2024, 08:06 PM
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NORWOOD, Mass. - Corbus Pharmaceuticals (NASDAQ:CRBP) Holdings, Inc. (NASDAQ: CRBP), a $217 million market cap biopharmaceutical company focused on developing treatments for oncology and obesity, announced that its investigational drug, CRB-701, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory metastatic cervical cancer. The company's stock has shown remarkable performance with a 174% return over the past year, despite recent volatility.InvestingPro analysis reveals that Corbus maintains a "GOOD" overall financial health score, with particularly strong liquidity metrics. Subscribers can access 10+ additional ProTips and comprehensive analysis in the Pro Research Report.

The Fast Track program is designed to expedite the review of drugs that show the potential to address unmet medical needs in serious conditions. CRB-701 is a next-generation antibody drug conjugate (ADC) that targets Nectin-4, a protein known to be highly expressed in certain types of cancer cells, including metastatic cervical cancer. The drug utilizes a site-specific, cleavable linker and a drug-to-antibody ratio of 2, with monomethyl auristatin E (MMAE) as the cytotoxic payload. With a current ratio of 13.84 and minimal debt-to-equity of 0.02, the company appears well-positioned to fund its development programs.

Corbus has recently completed the enrollment for the dose escalation phase of its Phase 1 clinical trial for CRB-701. This trial, which includes participants from both the U.S. and Europe, is evaluating the safety, pharmacokinetics, and efficacy of the drug in patients with advanced solid tumors that have high Nectin-4 expression. The company anticipates reporting the initial data from this study in the first quarter of 2025.

The company's diversified portfolio also includes CRB-601, an anti-integrin monoclonal antibody, and CRB-913, a CB1 receptor inverse agonist for obesity treatment. Corbus, headquartered in Norwood, Massachusetts, emphasizes its commitment to innovative scientific approaches to treat serious illnesses.

The announcement of the Fast Track designation is based on a press release statement from Corbus Pharmaceuticals and reflects the company's optimism regarding the potential of CRB-701 in treating metastatic cervical cancer. While the company's forward-looking statements regarding trial results and product development are subject to risks and uncertainties, and actual outcomes may differ materially from those projected, analyst consensus remains highly positive with price targets ranging from $35 to $75 per share.For detailed financial analysis and valuation metrics, including Fair Value estimates and comprehensive company health scores, visit InvestingPro, where you'll find expert insights and in-depth research reports covering 1,400+ US stocks.

Investors are advised that Corbus' statements are predictions based on current expectations and involve risks and uncertainties. The company has cautioned against placing undue reliance on these forward-looking statements, which are valid only as of the date of the press release. Corbus does not undertake any obligation to update any forward-looking statement publicly, whether as a result of new information, future events, or otherwise.

In other recent news, Corbus Pharmaceuticals has reported strong third-quarter results, with an ending cash total of $159 million, projected to fund operations until the second half of 2027. The company's ADC program, focusing on the drug CRB-701, is expected to provide a data update in the first quarter of 2025. The drug, being developed for the treatment of solid tumors, has shown positive results in a Phase 1 trial, with data from a United States trial expected in 2025.

Corbus is also developing CRB-913, a potential treatment for obesity, with Phase 1 trials slated to begin in the first quarter of 2025. Recently, Anne Altmeyer Ph.D., a board member, initiated a prearranged trading plan for her shares in the company.

In terms of analyst attention, Piper Sandler initiated coverage on Corbus with an Overweight rating and a price target of $35.00, while Oppenheimer maintained its Outperform rating and $60.00 price target. B.Riley reduced its price target to $40 from $85, maintaining a Buy rating, and Mizuho (NYSE:MFG) Securities also maintained its Outperform rating, with a price target set at $74.00. These ratings reflect confidence in Corbus's advanced asset, CRB-701.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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