Foghorn Therapeutics Inc. (FHTX - Free Report) recently announced that the FDA has placed a full clinical hold on the phase I dose escalation study of pipeline candidate FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
Shares of this clinical-stage biotechnology company are down in response to the news.
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.
Earlier, in May, the regulatory body had placed the study on a partial clinical hold following the report of a death in a subject with potential differentiation syndrome.
Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286.
The FDA observed additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 in the data submitted in response to the partial hold.
Consequently, the FDA has placed a full clinical hold on the AML/MDS study.
The regulatory body has additional questions and requires further analyses before the clinical hold may be lifted.
The clinical hold is a setback for the company, and investors are clearly disappointed.
Shares of Foghorn have plunged 52.8% in the year so far compared with the industry’s decrease of 21.5%.
Nevertheless, the dose escalation phase I study of FHD-286 in metastatic uveal melanoma (mUM) continues per protocol. The company plans to report data from the mUM study in the first half of 2023.
The company is also developing FHD-609, a targeted protein degrader that is currently being evaluated in a phase I study in synovial sarcoma.
In December 2021, FHTX entered into a collaboration agreement with pharma giant Eli Lilly (LLY - Free Report) , for which it received an upfront payment of $300 million in January 2022.
The collaboration with Eli Lilly is for the development of novel oncology drugs by applying Foghorn’s proprietary Gene Traffic Control platform. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s selective BRM oncology target, consisting of two programs and one additional undisclosed oncology target. The partnership includes three additional discovery programs.
Zacks Rank and Stocks to Consider
Foghorn currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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Foghorn Therapeutics Inc. (FHTX - Free Report) recently announced that the FDA has placed a full clinical hold on the phase I dose escalation study of pipeline candidate FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
Shares of this clinical-stage biotechnology company are down in response to the news.
FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM.
Earlier, in May, the regulatory body had placed the study on a partial clinical hold following the report of a death in a subject with potential differentiation syndrome.
Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286.
The FDA observed additional suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 in the data submitted in response to the partial hold.
Consequently, the FDA has placed a full clinical hold on the AML/MDS study.
The regulatory body has additional questions and requires further analyses before the clinical hold may be lifted.
The clinical hold is a setback for the company, and investors are clearly disappointed.
Shares of Foghorn have plunged 52.8% in the year so far compared with the industry’s decrease of 21.5%.
Nevertheless, the dose escalation phase I study of FHD-286 in metastatic uveal melanoma (mUM) continues per protocol. The company plans to report data from the mUM study in the first half of 2023.
The company is also developing FHD-609, a targeted protein degrader that is currently being evaluated in a phase I study in synovial sarcoma.
In December 2021, FHTX entered into a collaboration agreement with pharma giant Eli Lilly (LLY - Free Report) , for which it received an upfront payment of $300 million in January 2022.
The collaboration with Eli Lilly is for the development of novel oncology drugs by applying Foghorn’s proprietary Gene Traffic Control platform. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s selective BRM oncology target, consisting of two programs and one additional undisclosed oncology target. The partnership includes three additional discovery programs.
Zacks Rank and Stocks to Consider
Foghorn currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax have surpassed estimates in two of the trailing four quarters.
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Globally, electric car sales continue their remarkable growth even after breaking records in 2021. High gas prices have fueled his demand, but so has evolving EV comfort, features and technology. So, the fervor for EVs will be around long after gas prices normalize. Not only are manufacturers seeing record-high profits, but producers of EV-related technology are raking in the dough as well. Do you know how to cash in? If not, we have the perfect report for you – and it’s FREE! Today, don't miss your chance to download Zacks' top 5 stocks for the electric vehicle revolution at no cost and with no obligation.
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