4D Molecular Therapeutics' 4D-150 Phase 2 Data Met Investor Expectations, Analyst Boosts Forecast

Monday, 4D Molecular Therapeutics FDMT released interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients. 

A single intravitreal dose of 4D-150 demonstrated favorable safety results through the data cutoff date.

BMO Capital Markets says the 4D-150 Phase 2 results met investor expectations. 

In the foreseeable future, 4D Molecular Therapeutics’ gene therapy platform, along with the management’s track record of success, is anticipated to achieve success in treating various medical conditions such as diabetic macular edema, geographic atrophy, cystic fibrosis, and Alpha-1 antitrypsin deficiency, mirroring the accomplishments seen in wet Age-Related Macular Degeneration.

Short to medium-term prospects include potential announcements related to data, partnerships, and regulatory developments in 2024, presenting opportunities for significant gains. 

The probability of success for the wet AMD program has been reassessed. Hence, BMO Capital analyst Kostas Biliouris increased the target price to $70 from $50. 

The analyst says 4D Molecular Therapeutics remains rated as Outperform and is their top pick for the first half 2024.

BMO Capital is optimistic about the Phase 2 data, viewing it as highly robust regarding safety and efficacy. The consistency in the central subfield thickness of the high-dose 4D-150 arm, without fluctuations seen in Regeneron Pharmaceutical Inc’s REGN Eylea arm, is a particularly encouraging observation. This suggests a powerful and lasting impact on the disease.

The management is actively exploring partnerships for 4D-150 development and commercialization outside the U.S. The rapid enrollment observed in the ongoing 4D-150 trials, combined with the absence of a 15-letter loss requirement prior to rescue in Phase 3 (unlike TKI Phase 3 trials), allows anticipation of swift patient recruitment, thereby accelerating the overall development timeline.

Price Action: FDMT shares are down 6.6% at $30.15 on the last check Tuesday.

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