43 results
UPLOAD
GMDAQ
Gamida Cell Ltd
17 Jul 18
Letter from SEC
12:00am
on page
94 to provide rates of "chronic moderate-to-severe GvHD" in the test
group and the
historic controls. Please also disclose … rates of other classifications
of chronic GvHD
in both groups, such as "mild," or disclose why you have limited your
disclosure to
chronic
8-K
EX-99.1
GMDAQ
Gamida Cell Ltd
17 Apr 23
Gamida Cell’s Allogeneic Cell Therapy Omisirge® (omidubicel-onlv) Receives FDA Approval
5:29pm
in 47% of patients (Grade 3 or 4 in 15%), acute graft-versus-host disease (GvHD) in 58% (Grade III-IV in 17%), chronic GvHD in 35% and graft failure … leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia and myelodysplastic syndromes. Allogeneic transplant uses cells from a donor other
6-K
EX-99.1
GMDAQ
Gamida Cell Ltd
10 Feb 21
Current report (foreign)
4:01pm
included acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma. Patients were … patient groups related to grade 3/4 acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent
8-K
EX-99.1
GMDAQ
Gamida Cell Ltd
27 Sep 23
Regulation FD Disclosure
4:43pm
as needed.
Graft-versus-Host Disease
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE … ). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients
6-K
GMDAQ
Gamida Cell Ltd
3 Jan 20
Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel
6:03am
includes approximately 120 patients aged 12-65 with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic
6-K
EX-99.2
zws kyagjoy1
9 Dec 20
Report of Foreign Private Issuer
3:37pm
6-K
EX-99.1
2z8hi4nzr
21 Jul 20
Gamida Cell Announces Appointment of Michele Korfin as Chief Operating and Chief Commercial Officer
8:07am
6-K
EX-99.1
cj4luqpk
11 May 21
Gamida Cell Reports First Quarter 2021 Financial Results and Provides Company Update
8:28am
6-K
EX-99.1
o7f2hbdt
3 Jan 20
Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel
6:03am
6-K
EX-99.1
ohq138
31 May 19
Gamida Cell Announces Data for Omidubicel Presented at the International Society for Cellular and Gene Therapy 2019 Annual Meeting
8:45am
UPLOAD
a8mrhp0a0p9c1koygsz2
27 Jun 18
Letter from SEC
12:00am
6-K
EX-99.1
hj4q ic1vo65fsao
12 May 20
Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies
6:20am
DRSLTR
lpcf6 zo8u322c
3 Jul 18
Correspondence regarding draft registration statement
12:00am
6-K
EX-99.2
uim9l
13 Nov 19
Report of Foriegn Private Issuer
5:18pm
6-K
EX-99.1
8bn8itpsmc1ku
9 Mar 21
Gamida Cell Reports Full Year 2020 Financial Results and Provides Company Update
4:08pm
6-K
EX-99.1
n9q58qrub07yl47p
15 Nov 21
Gamida Cell Reports Third Quarter 2021 Financial Results
7:29am
8-K
EX-99.1
0ftp3anar6hber4uk4c
10 May 22
Gamida Cell Reports First Quarter 2022 Financial Results
7:30am
DRS
scqx7h3
15 Feb 19
Draft registration statement
12:00am
20-F
u3fk1v5972hh
25 Feb 19
Annual report (foreign)
5:08pm
F-1
9y6vru0aaxkse7u42lv
28 Sep 18
Registration statement (foreign)
4:29pm