4D Molecular Therapeutics Inc. Stock Price, News & Analysis

4D Molecular Therapeutics (Nasdaq: FDMT) announced an underwritten public offering of 4,500,000 shares of its common stock, with a 30-day option for underwriters to purchase an additional 675,000 shares. The offering is managed by Goldman Sachs, SVB Leerink, and Evercore ISI. The registration statement is pending effectiveness with the SEC, and shares cannot be sold before this occurs. 4DMT is focused on targeted gene therapies for ophthalmology, cardiology, and pulmonology, advancing five product candidates currently in clinical development.

4D Molecular Therapeutics (FDMT) presented promising interim clinical data from its Phase 1/2 trial of 4D-310 for Fabry disease, marking the first clinical activity data from a product developed via their proprietary Therapeutic Vector Evolution platform. All three patients treated exhibited serum AGA enzyme activity significantly above the normal range, with increases of 25-fold in two cases. Safety data showed a manageable profile with no dose-limiting toxicities, although one patient experienced a transient adverse event. The company is committed to enrolling a diverse patient population moving forward.

4D Molecular Therapeutics (Nasdaq: FDMT) announced interim data from its Phase 1/2 clinical trial of 4D-125 for advanced X-linked retinitis pigmentosa (XLRP). The treatment was well tolerated in all 8 patients, showing no serious adverse events. Clinical activity was noted with reduced photoreceptor loss and improvements in retinal sensitivity. The company plans to continue patient enrollment in a higher dose cohort and explore treatment for less advanced patients. The results validate the therapeutic potential of their platform, with expectations for further developments in other products.

4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-150 Investigational New Drug Application, enabling the initiation of Phase 1/2 clinical trials for treating wet age-related macular degeneration (wet AMD). The trials are projected to start before year-end and will involve approximately 60 adults. 4D-150 is a dual-transgene intravitreal gene therapy aiming for robust efficacy at lower doses compared to existing therapies. This product candidate marks significant advancements in AAV gene therapy, specifically targeting multiple angiogenic factors.

4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-710 Investigational New Drug Application, allowing the initiation of Phase 1/2 clinical trials for treating cystic fibrosis patients. The trial will evaluate safety, tolerability, and clinical activity in approximately 18 patients who cannot use existing modulator therapies. In conjunction, the CF Foundation will purchase 125,715 shares for about $4 million to support 4D-710's development. This therapy aims to address the unmet needs of 10-15% of cystic fibrosis patients.

4D Molecular Therapeutics (Nasdaq: FDMT) will participate in Chardan's 5th Annual Genetic Medicines Conference on October 4, 2021, at 2:30 p.m. ET. This virtual event will feature a fireside chat format, offering insights into the company's advancements in gene therapy. A live webcast will be accessible on the 4DMT website, with a replay available for two weeks post-event. 4DMT utilizes directed evolution to develop targeted gene therapies focusing on ophthalmology, cardiology, and pulmonology, currently conducting clinical trials for three product candidates.

4D Molecular Therapeutics (Nasdaq: FDMT) announced a late-breaking presentation of preliminary clinical data from its ongoing Phase 1/2 trial of 4D-125 for X-Linked Retinitis Pigmentosa (XLRP) at the Annual Society of Retina Specialists (ASRS) 2021, occurring from October 8-12 in San Antonio, TX. The presentation will be led by Dr. Cagri G. Besirli and is scheduled for October 10 at 2:56 p.m. CDT. This trial aims to evaluate the safety and effectiveness of 4D-125, with a primary focus on safety and secondary goals including visual function and anatomical endpoints.

4D Molecular Therapeutics (FDMT) reported significant advancements in Q2 2021, achieving total revenue of $14.6 million, up from $3.6 million in Q2 2020, largely due to collaboration adjustments with Roche. The company continues to expand its cGMP manufacturing facilities and has made key leadership appointments. Net loss decreased to $7.6 million compared to $15.2 million in the previous year. Upcoming milestones include clinical data announcements for multiple product candidates in the ophthalmology sector.

4D Molecular Therapeutics (Nasdaq: FDMT) announced initial safety data from its Phase 1 clinical trials for 4D-110, targeting choroideremia, and 4D-125, for X-linked retinitis pigmentosa. Both candidates demonstrated good tolerability with no dose-limiting toxicities across 12 patients. Additionally, the company regained full rights to 4D-110 following Roche's termination of their collaboration agreement. Moving forward, 4DMT plans to analyze clinical data and submit a new study protocol to the FDA, aiming for further development of 4D-110 and upcoming milestones in their pipeline.