2024-04-16 16:34:36 PXMD PaxMedica
04/16/24 04/1616:34 04/16/2416:34 | PaxMedica announces request from MOH for emergency access to IV suraminPaxMedica announced it has received an urgent request from the Ministry of Health, or MOH, of Malawi, asking for emergency access to IV suramin to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used routinely to save lives in that region of Africa. PaxMedica, which just last week announced that it has completed execution of its three pivotal registration/validation batches of PAX-101, an IV form of suramin, has brought this emergency request to the attention of the FDA to determine potential impact, if any, on the ongoing development program and NDA submission plans for PAX-101. PaxMedica has previously announced the completion of its recent Type B meeting with FDA in preparation for submitting an NDA for the use of PAX-101 in the treatment of the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, caused by the bite of a tsetse fly. The company said, "PaxMedica is in the process of responding to the Malawi Ministry of Health's request and is in contact with regulatory authorities in both the U.S. and Malawi with an intention to help with today's emergency, as well as to work with the FDA to determine the best path forward to submit the PAX-101 NDA for regulatory approval, as well as to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide PaxMedica resources to help ensure a steady supply of suramin to these endemic regions." |
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Earnings
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SBA Communications cuts FY24 FFO view to $13.09-$13.46, consensus $13.29 »
16:13
04/29/24
04/29
16:13
04/29/2416:13
SBAC
SBA Communications
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GeneDx ups FY24 revenue view to $235M-$245M from $220M-$230M, consensus $226.1M »
16:12
04/29/24
04/29
16:12
04/29/2416:12
WGS
GeneDx
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Coursera sees Q2 revenue $$162M-$166M, consensus $177.8M »
16:12
04/29/24
04/29
16:12
04/29/2416:12
COUR
Coursera
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Braze management to meet with JMP Securities »
16:12
04/29/24
04/29
16:12
04/29/2416:12
BRZE
Braze
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TrueCar reports Q1 EPS (6c), consensus (2c) »
16:12
04/29/24
04/29
16:12
04/29/2416:12
TRUE
TrueCar
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Brixmor reports Q1 NAREIT FFO 56c, consensus 51c »
16:12
04/29/24
04/29
16:12
04/29/2416:12
BRX
Brixmor
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Coursera reports Q1 EPS 7c, consensus 0c »
16:12
04/29/24
04/29
16:12
04/29/2416:12
COUR
Coursera
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DSAQ/U Stock trading halted, news pending
16:11
04/29/24
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16:11
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Earnings
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SBA Communications reports Q1 AFFO $3.29, consensus $3.30 »
16:11
04/29/24
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16:11
04/29/2416:11
SBAC
SBA Communications
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Direct Selling Acquisition Corp trading halted, news pending
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Earnings
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F5 Networks raises FY24 EPS growth rate view to 7%-9% from 6%-8% »
16:10
04/29/24
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16:10
04/29/2416:10
FFIV
F5 Networks
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Woodward sees FY24 adjusted EPS $5.70-$6.00, consensus $5.36 »
16:10
04/29/24
04/29
16:10
04/29/2416:10
WWD
Woodward
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Cushman & Wakefield reports Q1 adjusted EPS (13c), consensus (3c) »
16:09
04/29/24
04/29
16:09
04/29/2416:09
CWK
Cushman & Wakefield
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Harmonic sees FY24 non-GAAP EPS 51c-71c, consensus 63c »
16:09
04/29/24
04/29
16:09
04/29/2416:09
HLIT
Harmonic
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Flowserve raises FY24 adjusted EPS view to $2.50-$2.70 from $2.40-$2.60 »
16:09
04/29/24
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16:09
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FLS
Flowserve
Consensus $2.54. Sees… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
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F5 Networks sees Q3 EPS $2.89-$3.01, consensus $3.09 »
16:09
04/29/24
04/29
16:09
04/29/2416:09
FFIV
F5 Networks
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Merchants Bancorp reports Q1 EPS $1.80 vs. $1.07 last year »
16:09
04/29/24
04/29
16:09
04/29/2416:09
MBIN
Merchants Bancorp
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GeneDx reports Q1 EPS (78c), consensus (67c) »
16:09
04/29/24
04/29
16:09
04/29/2416:09
WGS
GeneDx
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Sensata Technologies sees Q2 adjusted EPS 89c-95c, consensus 92c »
16:09
04/29/24
04/29
16:09
04/29/2416:09
ST
Sensata
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F5 Networks reports Q2 EPS $2.91, consensus $2.86 »
16:08
04/29/24
04/29
16:08
04/29/2416:08
FFIV
F5 Networks
Reports Q2 revenue $681M,… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
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Flowserve reports Q1 adjusted EPS 58c, consensus 47c »
16:08
04/29/24
04/29
16:08
04/29/2416:08
FLS
Flowserve
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Sensata Technologies reports Q1 adjusted EPS 89c, consensus 85c »
16:08
04/29/24
04/29
16:08
04/29/2416:08
ST
Sensata
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Harmonic sees Q2 EPS (17c)-(12c), consensus 5c »
16:08
04/29/24
04/29
16:08
04/29/2416:08
HLIT
Harmonic
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Woodward reports Q2 adjusted EPS $1.62, consensus $1.32 »
16:08
04/29/24
04/29
16:08
04/29/2416:08
WWD
Woodward
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Netstreit raises FY24 AFFO guidance to $1.25-$1.28 from $1.24-$1.28 »
16:07
04/29/24
04/29
16:07
04/29/2416:07
NTST
Netstreit
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