Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

Shots: Abcuro has reported the P-II/III (MUSCLE) trial data assessing ulviprubart (ABC008; Q8W) in 272 IBM pts randomized to either 0.5mg/kg (n=94, Low Dose), 2mg/kg (n=92, High Dose), or PBO (n=86) Across all pts, the 1EP showed a trend toward slower IBMFRS decline at Wk. 76, with a 1.7-point decrease in the low-dose group vs…

ByRidhi RastogiMarch 27, 2026

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Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported P-III (VISIONARY) trial data evaluating Voyxact (sibeprenlimab-szsi; 400mg, SC, Q4W) vs PBO in IgAN pts at risk for disease progression Trial showed 82.5% vs 52.6% pts achieved negative microscopic hematuria (0–5/HPF; exploratory EP) at 48wks., with a median time to achieve 0–5/HPF was 9 vs 24wks.; data were presented at…

ByRidhi RastogiMarch 26, 2026

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Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has approved Lifyorli (relacorilant) + nab-paclitaxel for the treatment of adults with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic therapies, ≥1 of which included Avastin NDA was supported by P-III (ROSELLA) assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) with no…

ByRidhi RastogiMarch 26, 2026

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Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was…

ByRidhi RastogiMarch 25, 2026

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Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Shots: The US FDA has accepted NDA & granted priority review to zilganersen for the treatment of Alexander disease (AxD), with PDUFA target action date of Sep 22, 2026 NDA was backed by the P-III trial assessing zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open label…

ByRidhi RastogiMarch 25, 2026

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Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Shots: The P-III (SENTRY) trial assessed Selinexor (60mg, QW) + ruxolitinib vs PBO + ruxolitinib in 353 pts with frontline myelofibrosis; FDA discussions on SENTRY data & its sNDA strategy is underway, with potential compendia inclusion in H2’26 As of Feb 20, 2026, trial met its first co-1EP, with 50% vs 28% achieving SVR35 at…

ByRidhi RastogiMarch 25, 2026

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Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

ByRidhi RastogiMarch 24, 2026

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Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Shots: Apogee has reported maintenance data from Part A of the P-II (APEX) trial assessing zumilokibart (APG777; 360mg at Q3M or Q6M) in pts with mod. to sev. atopic dermatitis Trial showed 75% (Q3M) & 85% (Q6M) of Wk. 16 zumilokibart-responders maintained EASI-75, while 86% (Q3M) & 78% (Q6M) sustained vIGA 0/1, with continued deepening…

ByRidhi RastogiMarch 24, 2026

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Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots: Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…

ByRidhi RastogiMarch 24, 2026

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IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

Shots: The US FDA has received sNDA of Aqneursa (levacetylleucine) for the treatment of Ataxia-Telangiectasia (A-T) sNDA was backed by the P-III trial assessing Aqneursa in adult and pediatric pts with A-T, which met its 1 & key 2EPs & showed that Aqneursa has a favorable safety profile Aqneursa was previously approved by both the…

ByRidhi RastogiMarch 23, 2026

Abcuro Presents the P-II/III (MUSCLE) Study Data on Ulviprubart for Inclusion Body Myositis at GCOM 2026

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Corcept Therapeutics Reports the US FDA Approval of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Ionis’ Zilganersen Receives US FDA Priority Review for Alexander Disease

Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Apogee Therapeutics Reports Part A P-II (APEX) Maintenance Data on Zumilokibart in Atopic Dermatitis

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia

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