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

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HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Shots: HUTCHMED has initiated a P-III trial of HMPL-760 + R-GemOx (rituximab, gemcitabine and oxaliplatin) in r/r DLBCL Chinese pts, with first patient dosing achieved on Mar 20, 2026 Trial will evaluate efficacy, safety, & PK of HMPL-760 vs PBO, both in combination with R-GemOx in r/r DLBCL pts (n=~240) who are who are relapsed or…

ByRidhi RastogiMarch 23, 2026

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Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Shots: FDA has approved Wegovy HD (7.2mg semaglutide, QW) under CNPV along with lifestyle intervention for chronic weight management in adults with obesity; Wegovy HD will be launched as a single-dose pen by Apr 2026 Backed by STEP UP trial (~1,400 adults without T2D) & STEP UP T2D trial (~500 obese adults with T2D), based…

ByRidhi RastogiMarch 23, 2026

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Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Shots: Dizal has reported the topline P-III (WU-KONG28) trial data assessing Zegfrovy monotx. (QD, PO) vs Pt-based CT as the 1L treatment of pts with advanced NSCLC harboring EGFR exon 20 insertion mutations across Asia, EU, North America & South America The trial met its 1EP of improved PFS, assessed by BICR, plus showed superiority across…

ByRidhi RastogiMarch 23, 2026

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Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…

ByRidhi RastogiMarch 20, 2026

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

HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-cell Lymphoma in China

Novo Nordisk Reports the US FDA Approval of Wegovy HD for Weight Management

Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

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