Impact of Oral Sebetralstat on Anxiety Associated With Hereditary Angioedema Attacks scientiasalut.gencat.cat/handle/11351... #ScientiaVH
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scientiasalut.gencat.cat
September 1, 2026 at 11:39 AM
Impact of Oral Sebetralstat on Anxiety Associated With Hereditary Angioedema Attacks scientiasalut.gencat.cat/handle/11351... #ScientiaVH
$KALV -1.9% [KalVista denies reported FDA rejection request for sebetralstat (HAE). JonesResearch expects approval, sees sell-off unjustified. Buy/$30.] endpoints.news/sources-fda-...
Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say
FDA Commissioner Marty Makary reportedly attempted to reject KalVista Pharmaceuticals' drug application, sources said. An HHS spokesperson calls the claim 'totally false.'
endpoints.news
June 24, 2025 at 8:48 PM
$KALV -1.9% [KalVista denies reported FDA rejection request for sebetralstat (HAE). JonesResearch expects approval, sees sell-off unjustified. Buy/$30.] endpoints.news/sources-fda-...
$KALV -1% [The FDA has delayed its decision on KalVista's sebetralstat NDA for HAE, missing the June 17, 2025 PDUFA goal date by four weeks due to workload. The FDA has not requested additional data or raised safety/efficacy concerns.] ir.kalvista.com/news-release...
ir.kalvista.com
June 13, 2025 at 8:28 PM
$KALV -1% [The FDA has delayed its decision on KalVista's sebetralstat NDA for HAE, missing the June 17, 2025 PDUFA goal date by four weeks due to workload. The FDA has not requested additional data or raised safety/efficacy concerns.] ir.kalvista.com/news-release...
KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada -Sebetralstat has potential to become first oral on-demand treatment for HAE...
#Business #Wire #News #Releases #PMN #Press #Releases #BW
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KalVista Pharmaceuticals Enters into Licensing Agreement with Pendopharm to Commercialize Sebetralstat for HAE in Canada
-Sebetralstat has potential to become first oral on-demand treatment for HAE in Canada-
financialpost.com
June 26, 2025 at 11:49 AM
Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension scientiasalut.gencat.cat/handle/11351... #ScientiaVH
Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension
scientiasalut.gencat.cat
May 20, 2026 at 7:09 AM
Long-Term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension scientiasalut.gencat.cat/handle/11351... #ScientiaVH
Impact of Oral Sebetralstat on Anxiety Associated With Hereditary #Angioedema Attacks onlinelibrary.wiley.com/doi/10.1111/... #hvhebron #al [Text complet]
Impact of Oral Sebetralstat on Anxiety Associated With Hereditary Angioedema Attacks
In the phase 3 KONFIDENT trial of oral sebetralstat for on-demand treatment of hereditary angioedema attacks, many attacks induced moderate-to-extreme anxiety. Sebetralstat reduced anxiety versus pla....
onlinelibrary.wiley.com
March 12, 2026 at 12:07 PM
Impact of Oral Sebetralstat on Anxiety Associated With Hereditary #Angioedema Attacks onlinelibrary.wiley.com/doi/10.1111/... #hvhebron #al [Text complet]
Long-term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension www.sciencedirect.com/science/arti... #hvhebron #al [Text complet]
Long-term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension
Poor compliance with hereditary angioedema guidelines for on-demand treatment is common due to challenges with parenteral administration. Sebetralstat…
www.sciencedirect.com
September 4, 2025 at 12:35 PM
Long-term Safety and Effectiveness of Sebetralstat: Interim Analysis of KONFIDENT-S Open-label Extension www.sciencedirect.com/science/arti... #hvhebron #al [Text complet]
Sebetralstat (Ekterly) for Treatment of Hereditary Angioedema Attacks https://medicalletter.org/sebet748c
February 9, 2026 at 3:29 PM
Sebetralstat (Ekterly) for Treatment of Hereditary Angioedema Attacks https://medicalletter.org/sebet748c
Advance Release Article: Sebetralstat (Ekterly) for Treatment of Hereditary Angioedema Attacks bit.ly/4nimiLd
October 20, 2025 at 4:13 PM
Advance Release Article: Sebetralstat (Ekterly) for Treatment of Hereditary Angioedema Attacks bit.ly/4nimiLd
$KALV KalVista Pharmaceuticals shares are trading higher after the company announced new data and findings for sebetralstat.
June 2, 2025 at 4:56 PM
$KALV KalVista Pharmaceuticals shares are trading higher after the company announced new data and findings for sebetralstat.
#KalVistaPharma has finally received FDA approval for its oral kallikrein inhibitor #sebetralstat, becoming the first treatment in the US that can provide oral, on-demand treatment of hereditary angioedema (#HAE) attacks.
pharmaphorum.com/news/kalvist...
pharmaphorum.com/news/kalvist...
KalVista bags FDA approval for delayed oral HAE drug
KalVista has brought the first oral, on-demand treatment for hereditary angioedema attacks to the US market.
pharmaphorum.com
July 7, 2025 at 4:41 PM
#KalVistaPharma has finally received FDA approval for its oral kallikrein inhibitor #sebetralstat, becoming the first treatment in the US that can provide oral, on-demand treatment of hereditary angioedema (#HAE) attacks.
pharmaphorum.com/news/kalvist...
pharmaphorum.com/news/kalvist...
54 novel drugs await FDA review through mid-2025, including tabelecleucel for EBV-related disorders and zanidatamab for cancer. Highlights: subcutaneous therapies reducing infusion times, oral options like sebetralstat for angioedema, and rare disease advances. #FDA #PharmaNews
54 Novel Drugs Await FDA Review
An analysis published in the American Journal of Health-System Pharmacy provides an overview of the potential next wave of pharmaceuticals.
conexiant.com
December 12, 2024 at 2:50 PM
54 novel drugs await FDA review through mid-2025, including tabelecleucel for EBV-related disorders and zanidatamab for cancer. Highlights: subcutaneous therapies reducing infusion times, oral options like sebetralstat for angioedema, and rare disease advances. #FDA #PharmaNews
Despite delay, KalVista wins FDA approval after Makary's short-lived attempt to intervene
endpoints.news/fda-approves...
endpoints.news/fda-approves...
Despite delay, KalVista wins FDA approval after Makary's short-lived attempt to intervene
FDA approves KalVista Pharmaceuticals' sebetralstat for hereditary angioedema after controversy involving FDA Commissioner Makary's attempted intervention in review process
endpoints.news
July 7, 2025 at 12:01 PM
Despite delay, KalVista wins FDA approval after Makary's short-lived attempt to intervene
endpoints.news/fda-approves...
endpoints.news/fda-approves...
Feed: "google-discover"
By: Lisa Rapaport on Wednesday, July 16, 2025
By: Lisa Rapaport on Wednesday, July 16, 2025
Hereditary Angioedema (HAE) Attacks Can Now Be Treated With a Pill
HAE attacks can now be treated with a pill, Ekterly (sebetralstat), instead by injection or infusion. That could translate to faster symptom relief.
www.everydayhealth.com
July 17, 2025 at 9:04 AM
Feed: "google-discover"
By: Lisa Rapaport on Wednesday, July 16, 2025
By: Lisa Rapaport on Wednesday, July 16, 2025
Feed: "PharmaTimes"
By: John Pinching on Tuesday, July 15, 2025
By: John Pinching on Tuesday, July 15, 2025
MHRA approves first oral treatment for hereditary angioedema attacks
Sebetralstat offers injection-free relief for patients aged 12 and over
pharmatimes.com
July 15, 2025 at 10:27 PM
Feed: "PharmaTimes"
By: John Pinching on Tuesday, July 15, 2025
By: John Pinching on Tuesday, July 15, 2025
Feed: "Endpoints News"
By: Jaimy Lee on Friday, June 13, 2025
By: Jaimy Lee on Friday, June 13, 2025
KalVista says FDA delayed decision on HAE drug, citing ‘heavy workload’
FDA delays decision on KalVista's sebetralstat oral drug for hereditary angioedema by 4 weeks due to workload, disappointing CEO Ben Palleiko.
endpoints.news
June 14, 2025 at 9:35 AM
Feed: "Endpoints News"
By: Jaimy Lee on Friday, June 13, 2025
By: Jaimy Lee on Friday, June 13, 2025
DOGE cuts force FDA to extend review of an oral drug for a hereditary disease that causes tissue swelling. www.businesswire.com/news/home/20...
KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet...
www.businesswire.com
June 15, 2025 at 10:19 PM
DOGE cuts force FDA to extend review of an oral drug for a hereditary disease that causes tissue swelling. www.businesswire.com/news/home/20...
Breaking: KalVista wins FDA approval for HAE drug after Makary's short-lived attempt to intervene.
endpoints.news/fda-approves...
endpoints.news/fda-approves...
Despite delay, KalVista wins FDA approval after Makary's short-lived attempt to intervene
FDA approves KalVista Pharmaceuticals' sebetralstat for hereditary angioedema after controversy involving FDA Commissioner Makary's attempted intervention in review process
endpoints.news
July 7, 2025 at 11:15 AM
Breaking: KalVista wins FDA approval for HAE drug after Makary's short-lived attempt to intervene.
endpoints.news/fda-approves...
endpoints.news/fda-approves...