7 results
10-Q
2024 Q1
GUTS
Fractyl Health Inc.
13 May 24
Quarterly report
4:06pm
to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. Even though the FDA has … pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays. Regulatory authorities outside the United
10-K
2023 FY
GUTS
Fractyl Health Inc.
1 Apr 24
Annual report
7:15am
; and
the impact of adverse macroeconomic conditions, geopolitical events, the recent COVID-19 pandemic and potential future public health crises … was generally well tolerated
As agreed with the FDA, the study was prematurely ended due to the COVID‑19 pandemic and subsequent authorization to proceed
424B4
GUTS
Fractyl Health Inc.
2 Feb 24
Prospectus supplement with pricing info
4:18pm
, such as the FDA, have had to furlough critical employees and stop critical activities.
Separately, in response to the COVID-19 pandemic, the FDA … to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence
S-1/A
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
.
Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points … to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays. Regulatory
S-1
GUTS
Fractyl Health Inc.
14 Dec 23
IPO registration
3:39pm
employees and stop critical activities.
Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign … of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead
DRS/A
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21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
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22 Aug 23
Draft registration statement (amended)
12:00am
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