NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

Shots: NORROY BIOSCIENCE reported that the FDA has granted Breakthrough Therapy and FTD to 68Ga-NYM096, a radiopharmaceutical imaging agent targeting CAIX for PET imaging of clear cell renal cell carcinoma (ccRCC) 68Ga-NYM096 is being developed as a non-invasive PET imaging agent to characterize indeterminate renal masses identified by CT or MRI and help differentiate ccRCC…

ByPrince GiriAugust 20, 2026

NEWS

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…

ByRidhi RastogiAugust 18, 2026

NEWS

Dizal Inks ~$1.5B Global Exclusive License Agreement with AstraZeneca for Zegfrovy

Shots: Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib) for the treatment of pts with lung cancer; closing is expected in H2’26 As per the deal, AstraZeneca will acquire worldwide rights to develop & commercialise Zegfrovy in exchange for $600M upfront, & ~$900M in development, regulatory & sales milestones, with tiered royalties…

ByRidhi RastogiJuly 14, 2026

NEWS

Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%) Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…

ByRidhi RastogiMay 29, 2026

NEWS

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…

ByRidhi RastogiFebruary 4, 2026

NEWS

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML) The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…

ByPrince GiriJanuary 14, 2026

NEWS

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Shots: The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET) Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of…

ByRidhi RastogiDecember 30, 2025

NEWS

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

Shots: The US FDA has granted BTD to zilganersen for the treatment of Alexander disease (AxD) Designation was supported by the topline P-III trial data, which assessed zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.). Zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus…

ByRidhi RastogiDecember 3, 2025

INSIGHTS+

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

NEWS

Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Shots: Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III study Across all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…

ByPrince GiriOctober 21, 2025

NORROY BIOSCIENCE Receives FDA Breakthrough Therapy and Fast Track Designations for 68Ga-NYM096 in Kidney Cancer Imaging

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Dizal Inks ~$1.5B Global Exclusive License Agreement with AstraZeneca for Zegfrovy

Merck Secures the US FDA Breakthrough Therapy Designation for Calderasib to Treat Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Praxis Precision Medicines Reports the US FDA Breakthrough Therapy Designation of Ulixacaltamide for Essential Tremor

Ionis’ Zilganersen Receives the US FDA’s Breakthrough Therapy Designation for Alexander Disease

New Drug Designations – September 2025

Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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