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4D Molecular (FDMT) to Start Studies on Cystic Fibrosis, Wet AMD
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4D Molecular Therapeutics (FDMT - Free Report) announced that the FDA has cleared two investigational new drug applications (“IND”) for its gene-therapy candidates 4D-710 and 4D-150 as potential treatment for cystic fibrosis lung disease and wet AMD, respectively.
Following IND clearance by the FDA, the company anticipates initiating separate phase I/II clinical study sites for each of the candidates before 2021-end.
The phase I/II study for 4D-710 will evaluate the candidate in patients who are not eligible for cystic fibrosis transmembrane conductance regulator (“CFTR”) modulator therapy or have discontinued therapy due to adverse effects.
The phase I/II study for 4D-150 will evaluate the candidate in patients with wet AMD in two phases - dose escalation and dose expansion. While multiple dose levels of 4D-150 will be examined with an initial dose of 3E10 vg/eye in the dose-escalation phase, the dose expansion will randomly assign patients to three different groups - two groups administered different dose levels of 4D-150 and one group administered with Bayer(BAYRY - Free Report) /Regeneron’s (REGN - Free Report) blockbuster drug Eylea (aflibercept).
The primary endpoints of both these studies are safety and tolerability of the candidate administered to the study participants.
The company’s stock has plunged 37.7% so far this year in comparison with the industry’s 16.7% decline.
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Please note that 4D-710 is an aerosol-delivered gene therapy candidate designed to target CFTR protein within lung airway epithelial cells. Conversely, 4D-150 is an intravitreal gene therapy with R100 capsid designed to inhibit four distinct angiogenic factors with dual transgenes to prevent angiogenesis and vascular permeability in the treatment of wet AMD.
Following the IND clearance for 4D-710, the CF Foundation will purchase the common stock of the company for approximately $4 million, which will be used to support the candidate’s clinical development.
Apart from 4D-710 and 4D-150, the company is also developing gene-therapy candidates across multiple indications in early-stage clinical studies. These include 4D-110 (for choroideremia), 4D-125 (for X-linked retinitis pigmentosa) and 4D-310 (for fabry disease). The successful development of any of its pipeline candidates will provide an impetus to its prospects.
4D Molecular Therapeutics presently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Horizon Therapeutics , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $4.46 to $4.61 in the past 60 days. The same for 2022 has risen from $5.84 to $6.08 over the same period. The stock has rallied 54.6% in the year so far.
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4D Molecular (FDMT) to Start Studies on Cystic Fibrosis, Wet AMD
4D Molecular Therapeutics (FDMT - Free Report) announced that the FDA has cleared two investigational new drug applications (“IND”) for its gene-therapy candidates 4D-710 and 4D-150 as potential treatment for cystic fibrosis lung disease and wet AMD, respectively.
Following IND clearance by the FDA, the company anticipates initiating separate phase I/II clinical study sites for each of the candidates before 2021-end.
The phase I/II study for 4D-710 will evaluate the candidate in patients who are not eligible for cystic fibrosis transmembrane conductance regulator (“CFTR”) modulator therapy or have discontinued therapy due to adverse effects.
The phase I/II study for 4D-150 will evaluate the candidate in patients with wet AMD in two phases - dose escalation and dose expansion. While multiple dose levels of 4D-150 will be examined with an initial dose of 3E10 vg/eye in the dose-escalation phase, the dose expansion will randomly assign patients to three different groups - two groups administered different dose levels of 4D-150 and one group administered with Bayer(BAYRY - Free Report) /Regeneron’s (REGN - Free Report) blockbuster drug Eylea (aflibercept).
The primary endpoints of both these studies are safety and tolerability of the candidate administered to the study participants.
The company’s stock has plunged 37.7% so far this year in comparison with the industry’s 16.7% decline.
Please note that 4D-710 is an aerosol-delivered gene therapy candidate designed to target CFTR protein within lung airway epithelial cells. Conversely, 4D-150 is an intravitreal gene therapy with R100 capsid designed to inhibit four distinct angiogenic factors with dual transgenes to prevent angiogenesis and vascular permeability in the treatment of wet AMD.
Following the IND clearance for 4D-710, the CF Foundation will purchase the common stock of the company for approximately $4 million, which will be used to support the candidate’s clinical development.
Apart from 4D-710 and 4D-150, the company is also developing gene-therapy candidates across multiple indications in early-stage clinical studies. These include 4D-110 (for choroideremia), 4D-125 (for X-linked retinitis pigmentosa) and 4D-310 (for fabry disease). The successful development of any of its pipeline candidates will provide an impetus to its prospects.
4D Molecular Therapeutics, Inc. Price
4D Molecular Therapeutics, Inc. price | 4D Molecular Therapeutics, Inc. Quote
Zacks Rank & Stock to Consider
4D Molecular Therapeutics presently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Horizon Therapeutics , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $4.46 to $4.61 in the past 60 days. The same for 2022 has risen from $5.84 to $6.08 over the same period. The stock has rallied 54.6% in the year so far.