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NGM Bio (NGM) Up on Fast Track Tag For Ophthalmology Drug
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NGM Biopharmaceuticals, Inc. announced that the FDA has granted a Fast Track designation to its pipeline candidate, NGM621, for the treatment of patients with geographic atrophy (“GA”) secondary to age-related macular degeneration.
NGM621 is a monoclonal antibody designed to potently inhibit complement C3. The candidate is currently being evaluated in the phase II CATALINA study for the given indication. Top-line data from the same is expected in the fourth quarter of 2022.
Fast Track designation is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over existing treatments.
Shares of NGM Bio were up 5.1% following this announcement on Monday. The stock has plunged 41% in the past year compared with the industry’s decrease of 40.8%.
Image Source: Zacks Investment Research
In November 2021, NGM Bio completed enrollment in the phase II CATALINA study, which evaluated NGM621 for the treatment of GA secondary to age-related macular degeneration. The primary efficacy endpoint of the study is to see the rate of change in GA lesion area, as measured by fundus autofluorescence imaging over a treatment period of 52 weeks.
Data from the phase I study demonstrated that single and multiple intravitreal injection/s of NGM621 appeared to be safe and well tolerated in the given patient population.
NGM Bio discovered NGM621 under its strategic collaboration with pharma giant Merck (MRK - Free Report) .
Upon the completion of the ongoing CATALINA study, Merck has a one-time option to license NGM621 and its related molecules. In 2015, NGM Bio entered into a research collaboration, product development and license agreement with Merck.
NGM Bio’s top line currently constitutes of only related-party revenues from its collaboration with Merck.
Please note that another biotech, Apellis Pharmaceuticals, Inc. (APLS - Free Report) , is developing pegcetacoplan for treating patients with GA.
Apellis plans to submit a new drug application for intravitreal pegcetacoplan to treat GA secondary to age-related macular degeneration in the first half of 2022.
In May 2021, Apellis received the FDA approval for its targeted C3 therapy, pegcetacoplan (trade name, Empaveli), as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Pegcetacoplan is approved under the trade name Aspaveli in Europe.
Image: Shutterstock
NGM Bio (NGM) Up on Fast Track Tag For Ophthalmology Drug
NGM Biopharmaceuticals, Inc. announced that the FDA has granted a Fast Track designation to its pipeline candidate, NGM621, for the treatment of patients with geographic atrophy (“GA”) secondary to age-related macular degeneration.
NGM621 is a monoclonal antibody designed to potently inhibit complement C3. The candidate is currently being evaluated in the phase II CATALINA study for the given indication. Top-line data from the same is expected in the fourth quarter of 2022.
Fast Track designation is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over existing treatments.
Shares of NGM Bio were up 5.1% following this announcement on Monday. The stock has plunged 41% in the past year compared with the industry’s decrease of 40.8%.
In November 2021, NGM Bio completed enrollment in the phase II CATALINA study, which evaluated NGM621 for the treatment of GA secondary to age-related macular degeneration. The primary efficacy endpoint of the study is to see the rate of change in GA lesion area, as measured by fundus autofluorescence imaging over a treatment period of 52 weeks.
Data from the phase I study demonstrated that single and multiple intravitreal injection/s of NGM621 appeared to be safe and well tolerated in the given patient population.
NGM Bio discovered NGM621 under its strategic collaboration with pharma giant Merck (MRK - Free Report) .
Upon the completion of the ongoing CATALINA study, Merck has a one-time option to license NGM621 and its related molecules. In 2015, NGM Bio entered into a research collaboration, product development and license agreement with Merck.
NGM Bio’s top line currently constitutes of only related-party revenues from its collaboration with Merck.
Please note that another biotech, Apellis Pharmaceuticals, Inc. (APLS - Free Report) , is developing pegcetacoplan for treating patients with GA.
Apellis plans to submit a new drug application for intravitreal pegcetacoplan to treat GA secondary to age-related macular degeneration in the first half of 2022.
In May 2021, Apellis received the FDA approval for its targeted C3 therapy, pegcetacoplan (trade name, Empaveli), as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Pegcetacoplan is approved under the trade name Aspaveli in Europe.
Zacks Rank & Stock to Consider
NGM Bio currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Axsome Therapeutics, Inc. (AXSM - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Axsome Therapeutics’ loss per share estimates have narrowed 0.8% for 2022 over the past 60 days.
Earnings of Axsome Therapeutics have surpassed estimates in three of the trailing four quarters, and missed the same on the other occasion.