Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

Shots: Pharvaris has reported the P-III (CHAPTER-3) trial (N=85) assessing deucrictibant XR tablet (40mg, QD, PO; n=55) vs PBO (n=30) for the prevention of attacks in adolescents & adults with HAE Trial met all 1 & 2EPs, reducing monthly mean HAE attack rates by 83% overall & 87% in Type 1 or 2 HAE (n=80),…

ByRidhi RastogiSeptember 9, 2026

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Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Shots: Amgen & AZ have reported the P-III (DeLLphi-305) trial data assessing Imfinzi + Imdelltra vs Imfinzi as the 1L maintenance treatment for pts (n=563) with ES-SCLC who have not progressed following induction treatment with Imfinzi + PT-based CT & etoposide Trial showed improved OS (1EP) & demonstrated benefits across 2EPs, incl. PFS & ORR;…

ByRidhi RastogiSeptember 9, 2026

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Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

Shots: Novo Nordisk has reported the P-III (STEP Young) trial data assessing semaglutide (1.7 or 2.4mg based on weight at start of trial; QW, SC) vs PBO in 165 children (6 to <12yrs.) with obesity, both in combination with a reduced-calorie diet & increased physical activity Trial met its 1EP of superior BMI reduction at…

ByRidhi RastogiSeptember 7, 2026

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Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

Shots: Novartis has reported the topline P-III (Lp(a)HORIZON) trial data assessing pelacarsen vs PBO on the incidence of 4-point major adverse CV events (MACE) in 8,323 pts with elevated Lp(a) & established CVD Pelacarsen did not meet its 1EP of reducing major CV events, despite lowering Lp(a) levels in pts receiving guideline-directed lipid-lowering & antihypertensive…

ByRidhi RastogiSeptember 7, 2026

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AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…

ByRidhi RastogiSeptember 7, 2026

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AbbVie Reports the Topline P-III (CERVINO) Trial Data on Etentamig for R/R Multiple Myeloma

Shots: AbbVie has reported the P-III (CERVINO) trial assessing etentamig (Q4W) vs standard available therapies in pts with R/R MM who have received ≥2 prior lines of therapy, incl. exposure to a proteasome inhibitor, an immunomodulatory drug & an anti-CD38 mAb At the mFU of 11.4mos. (n=393 pts; median 3 prior lines), trial met its dual 1EPs…

ByRidhi RastogiSeptember 4, 2026

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Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

Shots: FDA has approved Zanvastro (50mg, Q3M, intrathecal injection) for the treatment of AxD in pediatric & adult pts, with launch expected in the coming wks. FDA also granted Ionis a Rare Pediatric Disease PRV Approval was backed by the Phase I-III trial assessing Zanvastro (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for…

ByRidhi RastogiSeptember 4, 2026

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Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Shots: Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…

ByRidhi RastogiSeptember 3, 2026

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HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Shots: The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…

ByRidhi RastogiSeptember 1, 2026

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PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…

ByRidhi RastogiSeptember 1, 2026

Pharvaris Reports the P-III (CHAPTER-3) Trial Data on Deucrictibant XR for Hereditary Angioedema (HAE)

Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

AbbVie Reports the Topline P-III (CERVINO) Trial Data on Etentamig for R/R Multiple Myeloma

Ionis’ Zanvastro (Zilganersen) Receives US FDA Approval for Alexander Disease (AxD)

Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

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