2020-09-10 08:45:37 NBRV Nabriva Therapeutics
09/10/20 09/1008:45 09/10/2008:45 | Nabriva Therapeutics granted NTAP for XENLETA, CONTEPO by CMSNabriva Therapeutics announced that the Centers for Medicare & Medicaid Services has granted a new technology add-on payment for XENLETA for injection when administered in the hospital inpatient setting. XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia. Both the IV and oral formulations of XENLETA were granted Qualified Infectious Disease Product and Fast Track designation by the FDA. Beginning on October 1, 2020, CMS will provide an additional maximum payment of $1,275.75 for XENLETA when used in the inpatient hospital setting for fiscal year 2021. The U.S. Food and Drug Administration approved the IV and oral versions of XENLETA for the treatment of adult patients with CABP in August 2019. Nabriva also announced that CMS has granted an NTAP for CONTEPO, making CONTEPO the first QIDP to be granted conditional NTAP approval prior to receiving FDA approval. CONTEPO was granted QIDP and Fast Track Designation by the FDA for the treatment of complicated urinary tract infections, including acute pyelonephritis. If CONTEPO receives FDA approval prior to July 1, 2021, the maximum add-on payment for a case involving the administration of CONTEPO is $2,343.75 for fiscal year 2021, which would become effective beginning in the first quarter after FDA approval is granted. The NTAP will provide hospitals with a payment on top of the standard-of-care Diagnostic Related Group reimbursement. This additional payment is provided to offset some of the costs of new drugs and devices when certain criteria are met. For the fiscal year 2021, add-on payments for QIDPs are limited to the lesser of 75 percent of the average cost of the product, or 75 percent of the amount by which the costs of the case exceeds the standard DRG payment. NTAP designation lasts no more than three years for a specific indication. |
---|
Hot Stocks
|
Smart for Life Inc trading halted, news pending
19:50
04/19/24
04/19
19:50
04/19/2419:50
SMFL
Smart for Life
|
Hot Stocks
|
Windtree Therapeutics Inc trading halted, news pending
19:50
04/19/24
04/19
19:50
04/19/2419:50
WINT
Windtree Therapeutics
|
Hot Stocks
|
Portland General Electric raises quarterly dividend 5.3% to 50c per share »
18:04
04/19/24
04/19
18:04
04/19/2418:04
POR
Portland General Electric
On April 19, the board of… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
NovaBay receives NYSE American notice of non-compliance »
18:01
04/19/24
04/19
18:01
04/19/2418:01
NBY
NovaBay
NovaBay Pharmaceuticals… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Oragenics announces NYSE American noncompliance notification »
17:53
04/19/24
04/19
17:53
04/19/2417:53
OGEN
Oragenics
Oragenics announced that… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Wrap Technologies receives noncompliance notification from Nasdaq »
17:30
04/19/24
04/19
17:30
04/19/2417:30
WRAP
Wrap Technologies
Wrap Technologies… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
HII awarded $120.3M Navy contract modification »
17:25
04/19/24
04/19
17:25
04/19/2417:25
HII
HII
HII was awarded a $120.3M… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Arista Networks COO Anshul Sadana to resign, effective May 21 »
17:19
04/19/24
04/19
17:19
04/19/2417:19
ANET
Arista Networks
In a regulatory filing,… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Syndicate
|
InnSuites Hospitality Trust files to sell 1M shares of common stock
17:16
04/19/24
04/19
17:16
04/19/2417:16
IHT
InnSuites Hospitality Trust
|
Syndicate
|
Inhibikase Therapeutics files to sell common stock, warrants, no amount given »
17:16
04/19/24
04/19
17:16
04/19/2417:16
IKT
Inhibikase Therapeutics
Maxim Group is acting as… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Aslan Pharmaceuticals receives Nasdaq notice »
17:13
04/19/24
04/19
17:13
04/19/2417:13
ASLN
Aslan Pharmaceuticals
Aslan Pharmaceuticals… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Syndicate
|
Zai Lab files automatic ordinary shares offering
17:13
04/19/24
04/19
17:13
04/19/2417:13
ZLAB
Zai Lab
|
Syndicate
|
Endra Life Sciences files to sell common stock, warrants, no amount given »
17:12
04/19/24
04/19
17:12
04/19/2417:12
NDRA
Endra Life Sciences
Craig-Hallum is sole… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Hepion Pharmaceuticals falls 42% after wind down of ASCEND-NASH trial »
17:08
04/19/24
04/19
17:08
04/19/2417:08
HEPA
Hepion Pharmaceuticals
In after-hours trading,… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
NLS Pharmaceutics receives staff delisting determination letter from Nasdaq »
17:05
04/19/24
04/19
17:05
04/19/2417:05
NLSP
NLS Pharmaceutics
NLS Pharmaceutics… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Conference/Events
|
Steelcase management to meet with Benchmark »
17:04
04/19/24
04/19
17:04
04/19/2417:04
SCS
Steelcase
Group breakfast at 7:45am… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Syndicate
|
AIM ImmunoTech files to sell 9.98M shares of common stock for holders
17:03
04/19/24
04/19
17:03
04/19/2417:03
AIM
AIM ImmunoTech
|
Hot Stocks
|
Lion Group receives noncompliance notification from Nasdaq »
17:03
04/19/24
04/19
17:03
04/19/2417:03
LGHL
Lion Group
Lion Group announced that… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Syndicate
|
RenovoRx files to sell 6.13M shares of common stock for holders
17:03
04/19/24
04/19
17:03
04/19/2417:03
RNXT
RenovoRx
|
Syndicate
|
Yoshiharu files to sell 237,885 shares of Class A common stock for holders
17:02
04/19/24
04/19
17:02
04/19/2417:02
YOSH
Yoshiharu
|
Hot Stocks
|
Hepion Pharmaceuticals trading resumes
17:00
04/19/24
04/19
17:00
04/19/2417:00
HEPA
Hepion Pharmaceuticals
|
General news
|
Treasury Market Summary: »
16:55
04/19/24
04/19
16:55
04/19/2416:55
$ECON
Economic Data
Treasury Market Summary:… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Conference/Events
|
Oppenheimer healthcare analysts hold an analyst/industry conference callssssssss »
16:51
04/19/24
04/19
16:51
04/19/2416:51
Healthcare Analysts,… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Hot Stocks
|
Asbury Automotive chief legal officer George Villasana to retire »
16:40
04/19/24
04/19
16:40
04/19/2416:40
ABG
Asbury Automotive
Asbury Automotive… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |
Conference/Events
|
Editas Medicine management to meet with Oppenheimer »
16:36
04/19/24
04/19
16:36
04/19/2416:36
EDIT
Editas Medicine
Meeting to be held on… Available to The Fly Members Only Breaking content available to members only. Sign up or login for access. Create FREE Account |