FOGHORN THERAPEUTICS INC.

(FHTX)
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Delayed Nasdaq  -  04:00 2022-07-05 pm EDT
14.60 USD   +4.43%
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Foghorn Therapeutics Shares Down After FDA Partial Clinical Hold

05/20/2022 | 07:08am EDT

By Michael Dabaie


Foghorn Therapeutics Inc. shares were down 16% to $9.64 premarket Friday after the Food and Drug Administration placed a study of FHD-286 in acute myelogenous leukemia and myelodysplastic syndrome on a partial clinical hold.

The clinical stage biotechnology company said the FDA initiated the partial hold after the report of a recent death of a subject with potential differentiation syndrome.

Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect believed to be on-target for the proposed mechanism of action for FHD-286, the company said.

The FDA requested a review of the safety database, risk mitigation strategies and a breakdown of clinical activity across dose levels, Foghorn said.

"Patient safety remains our top priority. We appreciate the dialogue with the FDA and will work diligently with the agency to resolve the partial clinical hold in AML/MDS as soon as possible," Foghorn Chief Executive Adrian Gottschalk said.

Wedbush analysts Robert Driscoll and Ritika Das said in a research note that they see a short study delay with a clear path to resolution.

The analysts said that based on the parallel to Kura Oncology's ziftomenib recent partial clinical hold, they are expecting a two to three month delay to the dose-escalation study as the protocols for treating differentiation syndrome are reviewed and updated to indicate increased monitoring and more aggressive intervention as necessary.

In November, Kura said the FDA placed a Phase 1b study in acute myeloid leukemia on partial clinical hold after the company reported a patient death potentially associated with differentiation syndrome. Kura in January said the FDA lifted the hold following an agreement on the company's mitigation strategy for differentiation syndrome.


Write to Michael Dabaie at michael.dabaie@wsj.com


(END) Dow Jones Newswires

05-20-22 0908ET

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06/24FOGHORN THERAPEUTICS INC.(NASDAQGM : FHTX) dropped from Russell 3000E Value Index
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06/24FOGHORN THERAPEUTICS INC.(NASDAQGM : FHTX) dropped from Russell 2500 Value Index
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06/24FOGHORN THERAPEUTICS INC.(NASDAQGM : FHTX) dropped from Russell 3000 Value Index
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Financials (USD)
Sales 2022 28,4 M - -
Net income 2022 -96,2 M - -
Net cash 2022 309 M - -
P/E ratio 2022 -5,76x
Yield 2022 -
Capitalization 580 M 580 M -
EV / Sales 2022 9,52x
EV / Sales 2023 12,0x
Nbr of Employees 119
Free-Float 73,6%
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Number of Analysts 5
Last Close Price 14,60 $
Average target price 24,00 $
Spread / Average Target 64,4%
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Managers and Directors
Adrian Gottschalk President, Chief Executive Officer & Director
Allan Jacob Reine Chief Financial Officer
Samuel Agresta Chief Medical Officer
Steven F. Bellon Chief Scientific Officer
Nicola E. Majchrzak Vice President-Clinical Development Operations
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