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Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
10 mars 2025 08h30 HE
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Biodexa Pharmaceuticals PLC
March 10, 2025 Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP Clears the way to finalize Phase 3 protocol and recruit sites for U.S....
Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025
04 mars 2025 09h00 HE
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Cingulate Inc.
Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY,...
Neurona Unveils Phase 3 EPIC Study for NRTX-1001 Cell Therapy in Epilepsy
20 févr. 2025 12h00 HE
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Neurona Therapeutics
Neurona Unveils Phase 3 EPIC Study for NRTX-1001 Cell Therapy in Epilepsy
Chemomab Completes Successful End-of-Phase 2 Meeting and Aligns with FDA on Clear and Efficient Path to Potential Regulatory Approval for Nebokitug (CM-101) in Primary Sclerosing Cholangitis
19 févr. 2025 07h00 HE
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Chemomab Therapeutics
After End-of-Phase 2 meeting, Chemomab and FDA aligned on a clear pathway to regulatory approval—a single pivotal Phase 3 study for the treatment of PSC.
AB2 Bio signs U.S. option and licensing agreement with Nippon Shinyaku for Tadekinig alfa for an ultra-rare autoimmune disease
27 janv. 2025 02h30 HE
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AB2 Bio Ltd
Agreement grants Nippon Shinyaku an option to acquire exclusive U.S. rights to commercialize AB2 Bio’s Tadekinig alfa to treat Primary Monogenic IL-18 driven Hyperinflammatory Syndrome in patients...
MoonLake initiates three new clinical trials and further expands the portfolio of indications for the Nanobody® sonelokimab
08 janv. 2025 07h00 HE
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MoonLake Immunotherapeutics AG
New trials in three new indications have been initiated with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar...
Cambium Bio Successfully Closes A$3.0M Financing Round
04 déc. 2024 22h58 HE
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Cambium Bio Limited
Cambium Bio Successfully Closes A$3.0M Financing Round
Curium Completes Enrollment Early of Phase 3 SOLAR-RECUR Prostate Cancer Trial
19 nov. 2024 03h30 HE
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Curium
ST. LOUIS, Mo., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that it has completed enrollment of its Phase 3 SOLAR-RECUR clinical trial. The trial is a...
MoonLake Immunotherapeutics starts Phase 3 IZAR program of the Nanobody® sonelokimab in patients with active psoriatic arthritis
13 nov. 2024 08h00 HE
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MoonLake Immunotherapeutics AG
MoonLake Immunotherapeutics starts Phase 3 IZAR program of the Nanobody® sonelokimab in patients with active psoriatic arthritis Two trials for active psoriatic arthritis (PsA) with one focusing on...
Cingulate Initiates Final Study for Lead ADHD Asset CTx-1301
12 sept. 2024 08h30 HE
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Cingulate Inc.
KANSAS CITY, Kan., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform...