Breaking News

Thursday
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Hot Stocks
Calliditas Therapeutics provides regulatory timeline update for Nefecon » 08:56
09/16/21
09/16
08:56
09/16/21
08:56
CALT

Calliditas Therapeutics

$22.66 /

-2.125 (-8.58%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that the European Medicine Agency's Committee for Human Medicinal Products has decided to continue the assessment of the marketing authorization application, or MAA, for Nefecon under standard procedure assessment timelines. Calliditas was in April granted an accelerated assessment procedure on its MAA for Nefecon in IgA Nephropathy and submitted the MAA in May. With the revised standard assessment timeline Calliditas estimates a potential impact of 3 months on the previously communicated timelines with an expected decision by EMA in 1Q22. If approved, Nefecon could be available to patients in Europe in mid-2022.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$22.66 /

-2.125 (-8.58%)

CALT Calliditas Therapeutics
$22.66 /

-2.125 (-8.58%)

07/07/21 SEB Equities
Calliditas Therapeutics initiated with a Buy at SEB Equities
02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$22.66 /

-2.125 (-8.58%)

Tuesday
Hot Stocks
Calliditas announces PDUFA goal date extension for Nefecon NDA » 15:37
09/14/21
09/14
15:37
09/14/21
15:37
CALT

Calliditas Therapeutics

$28.82 /

+0.51 (+1.80%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that the U.S. Food and Drug Administration has extended the PDUFA goal date for its New Drug Application, or NDA, seeking accelerated approval for Nefecon to December 15, 2021. "Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy, requiring an in-depth review process. We will continue to cooperate closely with the FDA as they complete the review of our NDA," said Renee Aguiar-Lucander, CEO at Calliditas. "In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which the company has provided to the FDA. The Agency has classified these analyses as a major amendment to the NDA. The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the NDA submission," the company added.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$28.82 /

+0.51 (+1.80%)

CALT Calliditas Therapeutics
$28.82 /

+0.51 (+1.80%)

07/07/21 SEB Equities
Calliditas Therapeutics initiated with a Buy at SEB Equities
02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$28.82 /

+0.51 (+1.80%)

Over a month ago
Hot Stocks
Calliditas Therapeutics receives FTD from FDA for setanaxib » 05:12
08/09/21
08/09
05:12
08/09/21
05:12
CALT

Calliditas Therapeutics

$29.48 /

+0.18 (+0.61%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that the FDA has granted fast track designation, or FTD, for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan liver disease primary biliary cholangitis, or PBC. Setanaxib has previously been granted orphan drug designation for PBC in the U.S. and Europe. Following results from a Phase 1 study conducted in 2020 which evaluated higher doses of setanaxib in healthy volunteers, Calliditas is planning to initiate a pivotal Phase 2/3 study in PBC, starting in 2H 2021.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$29.48 /

+0.18 (+0.61%)

CALT Calliditas Therapeutics
$29.48 /

+0.18 (+0.61%)

07/07/21 SEB Equities
Calliditas Therapeutics initiated with a Buy at SEB Equities
02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$29.48 /

+0.18 (+0.61%)

Hot Stocks
Calliditas, STADA enter license agreement for potential IgAN treatment » 05:19
07/21/21
07/21
05:19
07/21/21
05:19
CALT

Calliditas Therapeutics

$29.91 /

-0.23 (-0.76%)

Calliditas Therapeutics…

Calliditas Therapeutics and STADA Arzneimittel announced that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy, or IgAN, in the European Economic Area, or EEA, member states, Switzerland and the UK. Under the terms of the agreement, Calliditas is entitled receive an initial upfront payment of $24M upon signing and up to an additional $91M in future payments linked to pre-defined regulatory and commercialization milestones. STADA is also obligated pay tiered royalties on net sales expressed as a percentage between the low twenties and the low thirties. The partnership relates to a novel oral formulation, developed under the project name Nefecon, of an active substance, budesonide, designed to target down regulation of IgA1 with a view to be disease modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known as Berger's disease, is a progressive autoimmune disease in which up to 50% of patients end up at risk of developing end stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at four in 10,000, translating into approximately 200,000 patients.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$29.91 /

-0.23 (-0.76%)

CALT Calliditas Therapeutics
$29.91 /

-0.23 (-0.76%)

07/07/21 SEB Equities
Calliditas Therapeutics initiated with a Buy at SEB Equities
02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$29.91 /

-0.23 (-0.76%)

Syndicate
Calliditas Therapeutics files automatic mixed securities shelf  17:14
07/12/21
07/12
17:14
07/12/21
17:14
CALT

Calliditas Therapeutics

$31.35 /

-0.775 (-2.41%)

 
ShowHide Related Items >><<
CALT Calliditas Therapeutics
$31.35 /

-0.775 (-2.41%)

CALT Calliditas Therapeutics
$31.35 /

-0.775 (-2.41%)

07/07/21 SEB Equities
Calliditas Therapeutics initiated with a Buy at SEB Equities
02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$31.35 /

-0.775 (-2.41%)

Initiation
Calliditas Therapeutics initiated with a Buy at SEB Equities » 05:55
07/07/21
07/07
05:55
07/07/21
05:55
CALT

Calliditas Therapeutics

$31.49 /

+1.24 (+4.10%)

SEB Equities initiated…

SEB Equities initiated coverage of Calliditas Therapeutics with a Buy rating and SEK 170 price target.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$31.49 /

+1.24 (+4.10%)

CALT Calliditas Therapeutics
$31.49 /

+1.24 (+4.10%)

02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
  • 29
    Jan
CALT Calliditas Therapeutics
$31.49 /

+1.24 (+4.10%)

Over a quarter ago
Hot Stocks
Calliditas Therapeutics submits MAA for Nefecon to European Medicines Agency » 09:08
05/28/21
05/28
09:08
05/28/21
09:08
CALT

Calliditas Therapeutics

$29.70 /

-0.46 (-1.53%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that the company submitted a Marketing Authorisation Application to the European Medicines Agency for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy. The submission is based on positive data from Part A of the NefIgArd pivotal Phase 3 study, a randomized, double-blind, placebo-controlled, international multicenter study designed to evaluate the efficacy and safety of Nefecon compared to placebo in 200 adult patients with IgAN. The study achieved its primary endpoint of proteinuria reduction compared to placebo, and also showed a renal protective effect by way of stabilization of eGFR at 9 months. The submission also includes clinical data from the Phase 2 NEFIGAN trial, which met the same primary and secondary endpoint as the NefIgArd study. The NefIgArd trial also showed that Nefecon was generally well-tolerated, with a safety profile in keeping with the Phase 2b results. Calliditas is the only company which has achieved positive data in randomized, double-blind, placebo-controlled Phase 2b and Phase 3 clinical trials in IgAN. If approved, Nefecon could be available to patients in Europe in H1 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which has the potential to be disease modifying

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$29.70 /

-0.46 (-1.53%)

CALT Calliditas Therapeutics
$29.70 /

-0.46 (-1.53%)

02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
07/01/20 Citi
Calliditas Therapeutics initiated with a Buy at Citi
06/30/20 Jefferies
Calliditas Therapeutics initiated with a Buy at Jefferies
  • 29
    Jan
  • 05
    Jun
CALT Calliditas Therapeutics
$29.70 /

-0.46 (-1.53%)

On The Fly
Fly Intel: Pre-market Movers » 09:02
04/28/21
04/28
09:02
04/28/21
09:02
CALT

Calliditas Therapeutics

$29.04 /

+0.14 (+0.48%)

, ADMA

ADMA Biologics

$1.90 /

+0.04 (+2.16%)

, SHOP

Shopify

$1,157.17 /

-7.43 (-0.64%)

, BSX

Boston Scientific

$42.37 /

+0.11 (+0.26%)

, HUM

Humana

$449.06 /

+2.66 (+0.60%)

, GD

General Dynamics

$185.95 /

+0.74 (+0.40%)

, SWK

Stanley Black & Decker

$207.74 /

+1.45 (+0.70%)

, IPG

Interpublic Group

$29.86 /

+0.14 (+0.47%)

, EAT

Brinker

$65.58 /

+0.21 (+0.32%)

, GOOG

Alphabet

$2,307.58 /

-18.91 (-0.81%)

, GOOGL

Alphabet Class A

$2,290.20 /

-19.4 (-0.84%)

, BA

Boeing

$242.28 /

+0.89 (+0.37%)

, ADP

ADP

$195.89 /

+0.77 (+0.39%)

, SPOT

Spotify

$293.22 /

-4.905 (-1.65%)

, SIRI

Sirius XM

$6.28 /

-0.075 (-1.18%)

, DISCA

Discovery

$39.03 /

+0.21 (+0.54%)

, MSFT

Microsoft

$262.19 /

+0.61 (+0.23%)

, PLX

Protalix

$5.84 /

-0.28 (-4.58%)

Check out this morning's…

ShowHide Related Items >><<
SWK Stanley Black & Decker
$207.74 /

+1.45 (+0.70%)

SPOT Spotify
$293.22 /

-4.905 (-1.65%)

SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

PLX Protalix
$5.84 /

-0.28 (-4.58%)

MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

IPG Interpublic Group
$29.86 /

+0.14 (+0.47%)

HUM Humana
$449.06 /

+2.66 (+0.60%)

GOOGL Alphabet Class A
$2,290.20 /

-19.4 (-0.84%)

GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

GD General Dynamics
$185.95 /

+0.74 (+0.40%)

EAT Brinker
$65.58 /

+0.21 (+0.32%)

DISCA Discovery
$39.03 /

+0.21 (+0.54%)

CALT Calliditas Therapeutics
$29.04 /

+0.14 (+0.48%)

BSX Boston Scientific
$42.37 /

+0.11 (+0.26%)

BA Boeing
$242.28 /

+0.89 (+0.37%)

ADP ADP
$195.89 /

+0.77 (+0.39%)

ADMA ADMA Biologics
$1.90 /

+0.04 (+2.16%)

CALT Calliditas Therapeutics
$29.04 /

+0.14 (+0.48%)

02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
07/01/20 Citi
Calliditas Therapeutics initiated with a Buy at Citi
06/30/20 Jefferies
Calliditas Therapeutics initiated with a Buy at Jefferies
ADMA ADMA Biologics
$1.90 /

+0.04 (+2.16%)

10/01/20 Raymond James
ADMA Biologics price target raised to $9 from $7 at Raymond James
09/30/20 Jefferies
ADMA Biologics shares 'in arbitrage territory,' says Jefferies
05/26/20 Maxim
ADMA Biologics' use of plasma is 'oldest trick in pandemic playbook', says Maxim
05/07/20 Oppenheimer
ADMA Biologics price target lowered to $7 from $14 at Oppenheimer
SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

04/23/21 Baird
Shopify price target lowered to $1550 from $1600 at Baird
04/21/21 Citi
Shopify price target raised to $1,475 from $1,315 at Citi
04/05/21 Evercore ISI
Shopify initiated with an In Line at Evercore ISI
04/05/21 Credit Suisse
Shopify assumed with a Neutral at Credit Suisse
BSX Boston Scientific
$42.37 /

+0.11 (+0.26%)

04/15/21 Atlantic Equities
Atlantic Equities starts Boston Scientific at Overweight
04/15/21 Atlantic Equities
Boston Scientific initiated with an Overweight at Atlantic Equities
04/05/21 Citi
Citi opens positive catalyst watches on four medical supply stocks
03/03/21 Piper Sandler
Piper Sandler still positively inclined on Boston Scientific after Lumenis deal
HUM Humana
$449.06 /

+2.66 (+0.60%)

04/16/21 Stephens
Humana named a new Best Idea for 2021 at Stephens
04/08/21 Gordon Haskett
Gordon Haskett highlights Encompass Health's 'interesting' Rhode Island trip
01/13/21 Deutsche Bank
DaVita price target raised to $150 from $105 at Deutsche Bank
01/06/21 Argus
Humana price target raised to $450 from $430 at Argus
GD General Dynamics
$185.95 /

+0.74 (+0.40%)

04/08/21 Wolfe Research
General Dynamics downgraded to Underperform from Outperform at Wolfe Research
03/29/21 Cowen
General Dynamics price target raised to $210 from $183 at Cowen
03/25/21 Citi
General Dynamics price target raised to $200 from $160 at Citi
01/29/21 Susquehanna
General Dynamics price target raised to $180 from $162 at Susquehanna
SWK Stanley Black & Decker
$207.74 /

+1.45 (+0.70%)

04/13/21 Deutsche Bank
Stanley Black & Decker price target raised to $221 from $215 at Deutsche Bank
04/07/21 JPMorgan
Stanley Black & Decker price target raised to $206 from $200 at JPMorgan
04/06/21 Barclays
Stanley Black & Decker price target raised to $219 from $214 at Barclays
03/12/21
Fly Intel: Top five analyst upgrades
IPG Interpublic Group
$29.86 /

+0.14 (+0.47%)

04/22/21 BMO Capital
Interpublic Group downgraded to Market Perform from Outperform at BMO Capital
02/19/21 BMO Capital
Interpublic Group price target raised to $28 from $23 at BMO Capital
12/15/20 Citi
Interpublic Group price target raised to $29 from $24 at Citi
12/11/20 Barclays
Interpublic Group initiated with an Overweight at Barclays
EAT Brinker
$65.58 /

+0.21 (+0.32%)

04/15/21 Wells Fargo
Brinker price target raised to $76 from $62 at Wells Fargo
04/12/21 JPMorgan
Brinker price target raised to $78 from $72 at JPMorgan
04/09/21 Deutsche Bank
Brinker price target raised to $72 from $63 at Deutsche Bank
04/01/21 MKM Partners
Brinker price target raised to $82 from $75 at MKM Partners
GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

04/28/21 Oppenheimer
Alphabet price target raised to $2,510 from $2,350 at Oppenheimer
04/28/21 Credit Suisse
Alphabet price target raised to $2,755 from $2,500 at Credit Suisse
04/28/21 Morgan Stanley
Morgan Stanley says Alphabet Search results a positive read for Facebook, Amazon
04/28/21 Monness Crespi
Alphabet price target raised to $3,000 from $2,500 at Monness Crespi
GOOGL Alphabet Class A
$2,290.20 /

-19.4 (-0.84%)

04/28/21 BMO Capital
Alphabet price target raised to $2,700 from $2,600 at BMO Capital
04/28/21 Truist
Alphabet price target raised to $2,500 from $2,200 at Truist
BA Boeing
$242.28 /

+0.89 (+0.37%)

04/15/21 Credit Suisse
Boeing price target raised to $233 from $193 at Credit Suisse
04/14/21 JPMorgan
Boeing price target raised to $260 from $230 at JPMorgan
04/09/21 Baird
Baird says add to Boeing on any weakness due to 'tiny fix' needed for MAX jets
03/29/21 Goldman Sachs
Boeing resuming 787 deliveries removes overhang, says Goldman Sachs
ADP ADP
$195.89 /

+0.77 (+0.39%)

03/24/21 Jefferies
ADP price target raised to $200 from $197 at Jefferies
02/10/21 Mizuho
ADP initiated with a Buy at Mizuho
02/01/21 Barclays
ADP price target raised to $197 from $180 at Barclays
01/29/21
Fly Intel: Top five analyst upgrades Spire
SPOT Spotify
$293.22 /

-4.905 (-1.65%)

04/22/21 Jefferies
Jefferies starts Spotify at Buy, sees 'more platform than streaming service'
04/22/21 Jefferies
Spotify initiated with a Buy at Jefferies
04/21/21 Atlantic Equities
Apple making push to fight Spotify for podcast creators, says Atlantic Equities
04/05/21 Evercore ISI
Spotify assumed with an Outperform at Evercore ISI
SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

02/03/21 Citi
Tax sharing agreement 'very bullish' for Liberty SiriusXM, says Citi
01/28/21
Fly Intel: Top five analyst downgrades
01/28/21 Credit Suisse
Sirius XM downgraded to Neutral after rally at Credit Suisse
01/27/21 Credit Suisse
Sirius XM downgraded to Neutral from Outperform at Credit Suisse
DISCA Discovery
$39.03 /

+0.21 (+0.54%)

04/07/21 Deutsche Bank
Discovery price target raised to $60 from $35 at Deutsche Bank
03/26/21
Fly Intel: Top five analyst downgrades
03/26/21 Wells Fargo
Discovery downgraded to Equal Weight from Overweight at Wells Fargo
03/26/21 Wells Fargo
Discovery downgraded to Equal Weight from Overweight at Wells Fargo
MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

04/28/21 Morgan Stanley
Microsoft price target raised to $300 from $290 at Morgan Stanley
04/28/21 Credit Suisse
Microsoft price target raised to $300 from $265 at Credit Suisse
04/28/21 BMO Capital
Microsoft price target raised to $290 from $280 at BMO Capital
04/28/21 Cowen
Microsoft price target raised to $295 from $280 at Cowen
PLX Protalix
$5.84 /

-0.28 (-4.58%)

12/31/20 H.C. Wainwright
Protalix data underscore value proposition for PRX-102, says H.C. Wainwright
SWK Stanley Black & Decker
$207.74 /

+1.45 (+0.70%)

SPOT Spotify
$293.22 /

-4.905 (-1.65%)

SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

IPG Interpublic Group
$29.86 /

+0.14 (+0.47%)

HUM Humana
$449.06 /

+2.66 (+0.60%)

GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

GD General Dynamics
$185.95 /

+0.74 (+0.40%)

EAT Brinker
$65.58 /

+0.21 (+0.32%)

DISCA Discovery
$39.03 /

+0.21 (+0.54%)

BSX Boston Scientific
$42.37 /

+0.11 (+0.26%)

BA Boeing
$242.28 /

+0.89 (+0.37%)

ADP ADP
$195.89 /

+0.77 (+0.39%)

ADMA ADMA Biologics
$1.90 /

+0.04 (+2.16%)

  • 14
    Apr
  • 23
    Feb
  • 12
    Feb
  • 29
    Jan
  • 16
    Sep
  • 05
    Jun
  • 22
    May
  • 08
    May
  • 07
    May
SPOT Spotify
$293.22 /

-4.905 (-1.65%)

SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

IPG Interpublic Group
$29.86 /

+0.14 (+0.47%)

HUM Humana
$449.06 /

+2.66 (+0.60%)

GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

GD General Dynamics
$185.95 /

+0.74 (+0.40%)

DISCA Discovery
$39.03 /

+0.21 (+0.54%)

BA Boeing
$242.28 /

+0.89 (+0.37%)

SPOT Spotify
$293.22 /

-4.905 (-1.65%)

SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

PLX Protalix
$5.84 /

-0.28 (-4.58%)

MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

HUM Humana
$449.06 /

+2.66 (+0.60%)

GOOGL Alphabet Class A
$2,290.20 /

-19.4 (-0.84%)

GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

GD General Dynamics
$185.95 /

+0.74 (+0.40%)

EAT Brinker
$65.58 /

+0.21 (+0.32%)

DISCA Discovery
$39.03 /

+0.21 (+0.54%)

BSX Boston Scientific
$42.37 /

+0.11 (+0.26%)

BA Boeing
$242.28 /

+0.89 (+0.37%)

SWK Stanley Black & Decker
$207.74 /

+1.45 (+0.70%)

SPOT Spotify
$293.22 /

-4.905 (-1.65%)

SIRI Sirius XM
$6.28 /

-0.075 (-1.18%)

SHOP Shopify
$1,157.17 /

-7.43 (-0.64%)

MSFT Microsoft
$262.19 /

+0.61 (+0.23%)

GOOGL Alphabet Class A
$2,290.20 /

-19.4 (-0.84%)

GOOG Alphabet
$2,307.58 /

-18.91 (-0.81%)

EAT Brinker
$65.58 /

+0.21 (+0.32%)

DISCA Discovery
$39.03 /

+0.21 (+0.54%)

BSX Boston Scientific
$42.37 /

+0.11 (+0.26%)

BA Boeing
$242.28 /

+0.89 (+0.37%)

ADP ADP
$195.89 /

+0.77 (+0.39%)

ADMA ADMA Biologics
$1.90 /

+0.04 (+2.16%)

Hot Stocks
Calliditas Therapeutics receives priority review for Nefecon NDA from FDA » 05:12
04/28/21
04/28
05:12
04/28/21
05:12
CALT

Calliditas Therapeutics

$29.04 /

+0.14 (+0.48%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that the FDA has accepted the submission and granted priority review for the new drug application, or NDA, for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy, or IgAN. The FDA has set a Prescription Drug User Fee Act goal date of September 15.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$29.04 /

+0.14 (+0.48%)

CALT Calliditas Therapeutics
$29.04 /

+0.14 (+0.48%)

02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
07/01/20 Citi
Calliditas Therapeutics initiated with a Buy at Citi
06/30/20 Jefferies
Calliditas Therapeutics initiated with a Buy at Jefferies
  • 29
    Jan
  • 05
    Jun
Hot Stocks
Calliditas receives accelerated assessment procedure for Nefecon from EMA » 05:28
04/23/21
04/23
05:28
04/23/21
05:28
CALT

Calliditas Therapeutics

$27.00 /

+0.36 (+1.35%)

Calliditas Therapeutics…

Calliditas Therapeutics announced that its lead product candidate Nefecon has been granted accelerated assessment procedure by the European Medicine Agency's, or EMA, Committee for Human Medicinal Products, or CHMP. Accelerated assessment, which may be granted when the CHMP concludes that the product is of major public health interest and major therapeutic innovation pursuant to Article 14 of Regulation No 726/2004, reduces the timeframe for the EMA to review a marketing authorization application, or MAA. Calliditas expects to submit an MAA to the EMA in Q2 of 2021.

ShowHide Related Items >><<
CALT Calliditas Therapeutics
$27.00 /

+0.36 (+1.35%)

CALT Calliditas Therapeutics
$27.00 /

+0.36 (+1.35%)

02/26/21
Fly Intel: Top five analyst initiations
02/26/21 H.C. Wainwright
Calliditas Therapeutics initiated with a Buy at H.C. Wainwright
07/01/20 Citi
Calliditas Therapeutics initiated with a Buy at Citi
06/30/20 Jefferies
Calliditas Therapeutics initiated with a Buy at Jefferies
  • 29
    Jan
  • 05
    Jun

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.