ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots:The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1)ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) studyATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

ByRidhi Rastogi1 day ago

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BioAtla and GATC Health Announce $40M SPV Transaction to Advance Ozuriftamab Vedotin into P-III Study for 2L+ OPSCC

Shots:BioAtla and GATC Health announce into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC)Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…

ByDipanshu DixitJanuary 2, 2026

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Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Shots:The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosisDesignation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvementTrial showed that HMI-115…

ByRidhi RastogiDecember 5, 2025

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Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

Shots:The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG)Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at…

ByRidhi RastogiNovember 27, 2025

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New Drug Designations – September 2025   

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …

ByRidhi RastogiOctober 28, 2025

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Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Shots:The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS)ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EUADCE-D01 is an ADC targeting uPARAP & conjugated to the…

ByRidhi RastogiOctober 10, 2025

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Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots:The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC)Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…

ByRidhi RastogiSeptember 25, 2025

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The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots:The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitorDesignation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

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The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots:The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic strokeDesignation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onsetAdditionally, Revalesio is planning…

ByRidhi RastogiAugust 4, 2025

INSIGHTS+

New Drug Designations – May 2025  

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA  The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others  …

ByDipanshu DixitJune 24, 2025

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

BioAtla and GATC Health Announce $40M SPV Transaction to Advance Ozuriftamab Vedotin into P-III Study for 2L+ OPSCC

Hope Medicine’s HMI-115 Receives the US FDA Fast Track Designation for Endometriosis-Associated Pain Relief

Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma

New Drug Designations – September 2025

Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

New Drug Designations – May 2025

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