15 results
10-Q
2024 Q1
GUTS
Fractyl Health, Inc. Common Stock
13 May 24
Quarterly report
4:06pm
, and even if we are able to, the FDA or comparable foreign regulatory authorities may not permit us to proceed.
In order to conduct a clinical investigation … of the proposed investigation. In addition, if the clinical study involves a “significant risk” (as defined by the FDA) to human health, the sponsor
10-K
2023 FY
GUTS
Fractyl Health, Inc. Common Stock
1 Apr 24
Annual report
7:15am
30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines … the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent
424B4
GUTS
Fractyl Health, Inc. Common Stock
2 Feb 24
Prospectus supplement with pricing info
4:18pm
foreign regulatory authorities may not permit us to proceed.
In order to conduct a clinical investigation involving human subjects for the purpose … , a company must, among other things, apply for and obtain institutional review board, or IRB, approval of the proposed investigation. In addition
S-1/A
EX-10.11
GUTS
Fractyl Health, Inc. Common Stock
29 Jan 24
IPO registration (amended)
6:09am
a charge, complaint, or report with, or otherwise communicating, cooperating, or participating in any investigation or proceeding that may … ) Rmployee from filing a claim or participating in an investigation, hearing or proceeding with a local, state or federal administrative agency, including
S-1/A
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29 Jan 24
IPO registration (amended)
6:09am
S-1/A
EX-10.9
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29 Jan 24
IPO registration (amended)
6:09am
S-1/A
EX-1.1
zw1l5t6410
29 Jan 24
IPO registration (amended)
6:09am
S-1
EX-10.1
zrpcdcipxnl1n93g
14 Dec 23
IPO registration
3:39pm
S-1
EX-10.11
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14 Dec 23
IPO registration
3:39pm
S-1
EX-3.2
wdc4gs j6b
14 Dec 23
IPO registration
3:39pm
S-1
dys8zw0
14 Dec 23
IPO registration
3:39pm
S-1
EX-10.15
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14 Dec 23
IPO registration
3:39pm
DRS/A
g93a0visdp562dax u75
21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
ww95pacgv 9i5lu
22 Aug 23
Draft registration statement (amended)
12:00am
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