Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…

ByRidhi RastogiJuly 28, 2025

NEWS

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Shots: The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25 Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

ByRidhi RastogiJuly 28, 2025

NEWS

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025 Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…

ByRidhi RastogiJuly 28, 2025

NEWS

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…

ByRidhi RastogiJuly 28, 2025

NEWS

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The EC has approved Cabometyx for inoperable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts, who progressed on ≥1 prior systemic therapy other than somatostatin analogues in all 30 EEA states Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts, which were…

ByRidhi RastogiJuly 25, 2025

NEWS

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

Shots: The EC has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy. Review ongoing in the US (PDUFA: Oct 23, 2025) & China (priority review for DREAMM-7) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade…

ByRidhi RastogiJuly 25, 2025

NEWS

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

ByRidhi RastogiJuly 24, 2025

NEWS

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

ByRidhi RastogiJuly 24, 2025

NEWS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

ByDipanshu DixitJuly 24, 2025

NEWS

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

Shots: AstraZeneca has reported P-III (PREVAIL) trial assessing gefurulimab vs PBO in 260 gMG adults for 26wks. across North America, EU, & APAC region; eligible pts could then enter an ongoing OLE study Trial met its 1EP & all 2EPs, showing significant improvement in MG-ADL total score from baseline at 26wks. in adults with AChR…

ByRidhi RastogiJuly 24, 2025

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

GSK’s Blenrep (Belantamab Mafodotin) Regimens Receive the EC’s Approval to Treat R/R Multiple Myeloma

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

AstraZeneca Reports P-III (PREVAIL) Trial Data of Gefurulimab for Generalised Myasthenia Gravis (gMG)

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