$Aquestive Therapeutics(AQST.US)$ NEWS Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Positive Successful completion of Phase 3 study for Anaphylm in Q1 2024 Received FDA approval for Libervant for patients ages two to five Extended cash runway into 2026 through underwritten public offering Progressed clinical studies for AQST-108 in dermatology conditions Increase in total revenues from $11.1 million in Q1 2023 to $12.1 million in Q1 2024 Negati...
$Aquestive Therapeutics(AQST.US)$📣 FDA Approves Libervant™ (Diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 ⇨ 🥇 1st and only FDA approved orally administered rescue product ⇨ for Tx of seizure clusters (ages 2-5)
Breakthrough in Pediatric Epilepsy Treatment: FDA Approves Libervant™ for Seizure Clusters in Young Children. Aquestive Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Libervant™ (diazepam) Buccal Film. This innovative treatment is designed for the acute management of seizure clusters in pediatric patients aged 2 to 5 years with epilepsy. This milestone marks Liber...
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NEWS
Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
Positive
Successful completion of Phase 3 study for Anaphylm in Q1 2024
Received FDA approval for Libervant for patients ages two to five
Extended cash runway into 2026 through underwritten public offering
Progressed clinical studies for AQST-108 in dermatology conditions
Increase in total revenues from $11.1 million in Q1 2023 to $12.1 million in Q1 2024
Negati...
📣 4 PDUFAs upcoming in May:
$德納維製藥(DVAX.US)$ : 🤔
⇒ Heplisav-B
‣ vaccination of adults on hemodialysis
‣ PDUFA date: 5/13/24 (sBLA)
$Ascendis Pharma A/S(ASND.US)$ : 🤔
⇒ YORVIPATH®
‣ hypoparathyroidism
‣ PDUFA date: 5/14/24 (NDA)
$施貴寶(BMY.US)$ : 🤔
⇒ Breyanzi®
‣ PDUFA dates: (sBLAs)
‣‣ 5/23/24 (r/r follicular lymphoma)
‣‣ 5/31/24 (r/r mantle cell lymphoma)
🗓️ Last week’s PDUFAs:
$X4製藥(XFOR.US)$ : Approved 4/29 🎉
⇨ XOLREMDI (mavorixafor)
‣ WHI...
🗓️ Last week’s PDUFAs:
$輝瑞(PFE.US)$ : Approved 4/26 🎉
⇨ BEQVEZ (fidanacogene elaparvovec-dzkt)
▹ Hemophilia B
▹ BLA
▹ PDUFA date: Q2 2024
$Day One Biopharmaceuticals(DAWN.US)$ : Approved 4/23 🎉
⇨ OJEMDA (tovorafenib)
▹ Pediatric low-grade glioma
▹ NDA
▹ PDUFA date: 4/30/24
$ImmunityBio(IBRX.US)$ : Approved 4/22 🎉
⇨ Anktiva + BCG
▹ Bladder cancer
▹ resubmitted BLA
▹ PDUFA date: 4/23/24
$Abeona Therapeutics(ABEO.US)$ : CRL 4/22 🙁
⚠...
in Pediatric Patients Ages 2 to 5
⇨ 🥇 1st and only FDA approved orally administered rescue product
⇨ for Tx of seizure clusters (ages 2-5)
Aquestive Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Libervant™ (diazepam) Buccal Film. This innovative treatment is designed for the acute management of seizure clusters in pediatric patients aged 2 to 5 years with epilepsy. This milestone marks Liber...
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