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EMERYVILLE, Calif. - 4D Molecular Therapeutics (NASDAQ:FDMT), a biotechnology firm with a market capitalization of $156 million, announced today that the U.S. Food and Drug Administration (FDA) has awarded Regenerative Medicine Advanced Therapy (RMAT) designation to its drug candidate 4D-150 for diabetic macular edema (DME) treatment. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently in a rapid cash-burn phase typical of early-stage biotech companies. This designation, which aims to expedite the development and review of promising regenerative therapies for serious conditions, reflects the FDA’s recognition of 4D-150’s potential based on the SPECTRA DME study results.
The company’s Chief Executive Officer, David Kirn, M.D., expressed that this milestone underscores the potential of 4D-150 to sustain visual acuity improvements while reducing treatment burden. Kirn highlighted that 4D-150 is purportedly the first investigational medicine to receive RMAT designation for both DME and wet age-related macular degeneration (wet AMD). While the stock has experienced significant volatility, falling about 87% over the past year, InvestingPro analysis suggests the company is currently undervalued, with analyst price targets ranging from $6 to $51 per share.
4D-150, designed as a long-term therapy, aims to deliver sustained anti-VEGF (aflibercept and anti-VEGF-C) treatment from a single intravitreal injection using the company’s proprietary R100 vector. The therapy is being developed to address the high unmet medical need in DME and wet AMD, both of which affect millions worldwide. The company’s strong liquidity position, with a current ratio of 14.92, provides substantial runway for its development programs. Get deeper insights into FDMT’s financial health and 12+ additional ProTips with a subscription to InvestingPro. DME, a complication of diabetic retinopathy, is characterized by macular swelling due to leaking blood vessels, leading to vision loss. Current treatments involve frequent intravitreal anti-VEGF injections, which have issues with patient compliance.
The RMAT designation, part of the 21st Century Cures Act, provides benefits similar to fast track and breakthrough therapy programs, including closer FDA interactions to expedite drug development. 4D Molecular Therapeutics plans to advance 4D-150 into Phase 3 development for DME, in addition to ongoing Phase 3 trials for wet AMD.
4D Molecular Therapeutics, focused on advancing disease-targeted therapeutics, has other product candidates in clinical or preclinical development, none of which have yet received marketing approval from the FDA or any other regulatory authority. The company cautions that the press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from expectations.
This report is based on a press release statement from 4D Molecular Therapeutics. For comprehensive analysis of FDMT’s financial position, growth prospects, and detailed valuations, access the full Pro Research Report available exclusively on InvestingPro, covering this and 1,400+ other US equities.
In other recent news, 4D Molecular Therapeutics reported positive interim results from its Phase 2b PRISM clinical trial, which evaluated the efficacy of 4D-150 in patients with wet age-related macular degeneration. The trial data indicated a significant reduction in the need for supplemental aflibercept injections, with patients experiencing an 83% reduction and 57% remaining injection-free over 52 weeks. This promising development was highlighted by H.C. Wainwright, which maintained a Buy rating on the company’s stock with a $36 price target, citing the potential impact of these findings on upcoming Phase 3 trials. Additionally, Jefferies revised its price target for 4D Molecular Therapeutics to $40, down from $51, while maintaining a Buy rating, reflecting updated durability data from the Phase 2 trial. The company plans to initiate two Phase 3 trials in 2025, with topline results expected in the second half of 2027. Meanwhile, the broader biotech sector faced turbulence following the resignation of Dr. Peter Marks from the FDA, prompting concerns about potential changes in the agency’s regulatory approach. BMO Capital Markets analyst Evan Seigerman commented on the situation, viewing Marks’ resignation as a significant negative for the sector. These developments highlight the ongoing challenges and opportunities within the biotech industry.
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