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Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine; PDUFA goal date is January 31 2025
NASDAQ: $AXSM Axsome Therapeutics, a leading biopharmaceutical company, has recently announced the exciting news that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. With the FDA acceptance of the NDA resubmission, Axsome Therapeutics is one step closer to…
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BIO-TECH STOCK CATALYST REPORT FOR WEEK OF DECEMBER 10-16, 2023
December 10, 2023 EVENT EVENT DATE SYMBOL PRICE POTENTIAL % (+/-) OPEN INTEREST PRICE Conference 12/10/2023 AUTL 21.1 4,281 $4.36 Conference 12/10/2023 BLUE 26.9 18,165 $2.86 Conference 12/10/2023 BMEA 43.0 49,731 $16.89 Announcement 12/11/2023 COGT 28.9 11,224 $8.64 Conference 12/11/2023 BLUE 26.9 18,165 $2.86 Conference 12/11/2023 HARP 35.3 295 $8.94 Conference 12/14/2023 BCYC 24.0 2,878…
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BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
NYSE: $BDX 1. Introduction: Overview of BD’s FDA 510(k) Clearance for Potentially Transformative Fingertip Collection Device The field of sample collection in healthcare is about to witness a significant transformation with the recent FDA 510(k) clearance obtained by BD for their groundbreaking fingertip collection device. This innovative device offers a convenient and user-friendly alternative to…
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Calliditas Therapeutics | The FDA Decision To Convert The Accelerated Approval of Calliditas Therapeutics’ Tarpeyo To Full Approval, December 20, 2023
NASDAQ: CALT 1. Introduction to Calliditas Therapeutics and Tarpeyo Calliditas Therapeutics is a renowned pharmaceutical company focused on developing innovative therapies to address unmet medical needs. One of their notable products is Tarpeyo, a drug designed to provide significant benefits to patients suffering from a specific medical condition. The accelerated approval granted by the FDA…
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Vanda Pharmaceuticals | Announces U.S. FDA Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis
NASDAQ: VNDA 1. Introduction to Vanda Pharmaceuticals’ new drug application for Tradipitant Vanda Pharmaceuticals, a leading biopharmaceutical company, has recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Tradipitant, a potential breakthrough treatment for gastroparesis. This acceptance marks a significant milestone in Vanda Pharmaceuticals’ efforts…
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BIO-TECH STOCK CATALYST REPORT FOR WEEK OF DECEMBER 3-9, 2023
December 2, 2023 EVENT EVENT DATE SYMBOL PRICE POTENTIAL % (+/-) OPEN INTEREST PRICE Conference 12/05/2023 JAGX 27.4 9,151 $0.36 Conference 12/07/2023 BMEA 43.2 25,780 $16.68 FDA Event 12/08/2023 BCLI 52.0 5,135 $0.26 Conference 12/09/2023 APTO 32.4 76 $2.66 Conference 12/09/2023 INCY 27.1 38,201 $54.02 WEEK: 12/03/2023 – 12/09/2023
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Neurocrine Biosciences | Hosting Analyst Day on December 5, 2023
NASDAQ: $NBIX Neurocrine Biosciences to Host Analyst Day on December 5, 2023 Have you heard the news? Neurocrine Biosciences, a leading biopharmaceutical company, is set to host an Analyst Day on December 5, 2023. This highly anticipated event will bring together analysts, investors, and industry experts to explore Neurocrine Biosciences’ latest developments and future prospects.…
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Carisma Therapeutics | Announces FDA Clearance of IND Application for CT-0525, a Novel HER2-Targeting CAR-Monocyte
NASDAQ: CARM Carisma Therapeutics, a leading biotechnology company committed to developing innovative cancer treatments, recently made a groundbreaking announcement. The company has successfully obtained clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This is a significant milestone for Carisma Therapeutics, as it paves the way for the…
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BrainStorm Cell Therapeutics | Announces FDA Advisory Committee Meeting to Review NurOwn® PDUFA Target Action Date Scheduled for December 8, 2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the US FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting, scheduled for December 6, 2023, will focus on plans for a Special Protocol Assessment (SPA) for a confirmatory Phase 3 trial in ALS. BrainStorm aims to…
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Arcutis Biotherapeutics | FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
NASDAQ: ARQT WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic…