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

Shots: Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO At Wk. 16, mid-dose also met key 2EP…

ByRidhi RastogiMay 28, 2026

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GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Shots: GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220…

ByRidhi RastogiMay 28, 2026

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Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

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Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

Shots: Junshi Biosciences has reported the final analysis from the P-III (NEOTORCH) trial assessing toripalimab + Pt-containing doublet CT vs PBO + CT as perioperative treatment in 501 pts with resectable stage II-III NSCLC pts Trial improved EFS, with mEFS not reached vs 15.1mos. for CT alone, reducing risk of recurrence, progression, or death by 60%,…

ByRidhi RastogiMay 27, 2026

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Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

Shots: Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs…

ByRidhi RastogiMay 27, 2026

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AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer

Shots: The CHMP has recommended AZ's Camizestrant + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US & Japan Opinion was based on the P-III…

ByRidhi RastogiMay 26, 2026

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Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Shots: The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively Pyrukynd will be…

ByRidhi RastogiMay 25, 2026

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Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The US FDA has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease…

ByRidhi RastogiMay 25, 2026

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Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Shots: The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up Trial showed significant improvements in HDV RNA reduction & ALT…

ByRidhi RastogiMay 25, 2026

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Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or…

ByRidhi RastogiMay 22, 2026

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

GSK Reports the P-III (B-Well 1 and B-Well 2) Trial Data on Bepirovirsen for Chronic Hepatitis B at EASL 2026

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer

Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

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