On Wednesday, Chardan Capital Markets maintained a Buy rating and a $38.00 stock price target for 4D Molecular Therapeutics (NASDAQ:FDMT), following the presentation of 24-week data from a phase II trial. The data showed a significant reduction in the need for injections among patients treated with the company's gene therapy, GT 4D-150, for wet age-related macular degeneration (wAMD).
The trial results, which were shared at the American Society of Retina Specialists (ASRS), indicated an 89% decrease in the annualized injection rate, with 77% of patients not requiring any further injections at the dose planned for phase III. This cohort of 45 patients demonstrated positive outcomes, particularly at the 3e10 vg/eye dose, which will be used in phase III trials.
In addition to the lowered injection frequency, improvements were noted in the best-corrected visual acuity (BCVA), with an increase of 3.5 ETDRS letters from baseline at weeks 20 and 24 for the 3e10 dose group. This group also showed better anatomic control with a decrease in central subfield thickness (CST), suggesting a dose response compared to the 1e10 dose group, which experienced a slight decline in BCVA and an increase in CST.
Despite the absence of a comparison group using standard aflibercept treatment and a case of Grade 2 inflammation in the lower dose cohort, the safety profile was considered clean. Chardan Capital Markets has kept its assumptions regarding the probability of success (PoS) in wAMD at 45% and in diabetic macular edema (DME) at 30%, pending further details on the phase III trial design and upcoming data expected in the fourth quarter of 2024.
4D Molecular Therapeutics plans to release 52-week data from both the PRISM trial populations in February 2025. This upcoming data is anticipated to be a crucial factor in assessing the phase III program, which aims to demonstrate non-inferiority in BCVA compared to aflibercept treatment over approximately 52 weeks.
In other recent news, 4D Molecular Therapeutics reported encouraging interim results from its Phase 2 clinical trial of 4D-150 for wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The treatment demonstrated a substantial reduction in the need for anti-VEGF injections, with patients in the planned Phase 3 dose arm showing an 89% reduction in the mean annualized injection rate.
Long-term follow-up results from the Phase 1 trial were also positive, with all three patients treated with the higher dose remaining injection-free for approximately 2 to 2.5 years.
RBC Capital Markets and BMO Capital Markets Corp. reiterated their "Outperform" rating on the biotechnology company, while Barclays Capital Inc. initiated coverage with an "Overweight" rating. RBC highlighted the potential for improved outcomes in the wet AMD population and a discernible treatment effect for Cystic Fibrosis.
The company is working with regulatory agencies to finalize the design of its Phase 3 clinical trial for 4D-150, with an expected announcement in September 2024 and trial commencement in the first quarter of 2025. Further results from the ongoing trials for both wet AMD and diabetic macular edema are anticipated in the coming months. These are recent developments that provide investors with crucial insights into the company's progress and potential.
InvestingPro Insights
4D Molecular Therapeutics (NASDAQ:FDMT) has recently caught the attention of investors with its promising clinical trial results. In light of the company's progress, a glance at some key InvestingPro Data metrics can provide additional context. The company's market capitalization stands at a robust $896.54 million, reflecting investor confidence.
Despite challenges, FDMT has achieved an impressive revenue growth of 826.31% over the last twelve months as of Q1 2024, although it's important to note that quarterly revenue growth has seen a sharp decline of -90.6% in Q1 2024. This signals potential volatility in the company's revenue stream. The company's price to book ratio is at 2.3, which could suggest that the stock is reasonably valued in terms of its assets.
From an InvestingPro Tips perspective, while FDMT has significant return over the last week with a 15.25% increase in stock price, analysts are concerned about the anticipated sales decline in the current year and expect net income to drop. This is a crucial consideration for investors, as it might impact long-term profitability.
Moreover, despite the stock's volatility, FDMT holds more cash than debt, which is a positive sign of financial stability, and its liquid assets exceed short-term obligations, indicating the company has a solid liquidity position.
For those looking to delve deeper into 4D Molecular Therapeutics' financials and future prospects, InvestingPro offers additional valuable insights. There are currently 10 more InvestingPro Tips available which can help investors make a more informed decision. To access these tips and enhance your investment strategy, consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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