Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Shots: Bayer has reported the P-III (FIND-CKD) trial data assessing Kerendia (finerenone; 10 or 20mg) vs PBO, both in addition to SoC, in >1,500 adults with non-diabetic chronic kidney disease Trial met its 1EP, showing a statistically significant improvement in eGFR slope, defined as the mean annual change in eGFR from baseline to Month 32; data…

ByRidhi RastogiMarch 16, 2026

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Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…

ByRidhi RastogiMarch 13, 2026

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Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Shots: Ultragenyx has reported the P-III (Enh3ance) study data assessing DTX301 AAV8 gene therapy vs PBO for the treatment of ornithine transcarbamylase (OTC) deficiency DTX301 reduced 24hr. plasma ammonia by 18% vs PBO at Wk. 36, with ammonia levels maintained in the normal range, despite a 27% mean decrease in scavenger drugs & ~13% increase…

ByRidhi RastogiMarch 13, 2026

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Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Shots: The EMA has received the Type II variation application for Tecvayli monotx. (teclistamab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Application was supported by the P-III (MajesTEC-9) trial assessing Tecvayli vs SoC of pomalidomide, bortezomib, & dexamethasone (PVd) or carfilzomib & dexamethasone (Kd) in 614…

ByRidhi RastogiMarch 12, 2026

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Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

Shots: Curatis & Neupharma have entered into an exclusive license & development agreement for Corticorelin (C‑PTBE‑01) in Japan to treat Peritumoral Brain Edema As per the deal, Neupharma will develop & commercialize corticorelin in Japan & fund a pivotal trial to support PMDA approval, in exchange of upfront & regulatory & commercial milestones totaling up…

ByRidhi RastogiMarch 11, 2026

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LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Shots: The EMA has received MAA of Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults MAA was supported by the 3 P-III (CLARITY) trials evaluating Vizz (QD) across the US, in which Vizz met all 1 & 2EPs, showing rapid near vision improvement within 30min., lasting up to 10hrs. Additionally, LENZ…

ByRidhi RastogiMarch 11, 2026

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Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The EC has approved Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone + androgen deprivation therapy (ADT) to treat adults with mHSPC & BRCA1/2 mutations Approval was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…

ByRidhi RastogiMarch 10, 2026

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BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Shots: BMS has reported the P-II/III (SUCCESSOR-2) trial data assessing mezigdomide (PO) + carfilzomib & dexamethasone vs carfilzomib & dexamethasone alone in pts with r/r multiple myeloma The P-III portion showed improved PFS (1EP), with safety consistent with the known profile of the regimen & mezigdomide. The trial will continue to follow pts for survival…

ByRidhi RastogiMarch 10, 2026

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Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China

Shots: Rapport Therapeutics has granted Tenacia exclusive rights to develop & commercialize RAP-219 in Greater China across indications, incl. focal onset seizures (FOS) & bipolar mania, with Rapport retaining rights in other territories As per the deal, Rapport will receive $20M upfront & ~$308M in development & commercialization milestones & other payments, plus mid-single digits…

ByRidhi RastogiMarch 10, 2026

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AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Shots: FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…

ByRidhi RastogiMarch 9, 2026

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Johnson & Johnson Submits Tecvayli Application to EMA for R/R Multiple Myeloma

Curatis Grants Neupharma Japan Rights to Corticorelin for Brain Edema

LENZ Therapeutics Reports EMA’s MAA Submission for Vizz to Treat Presbyopia

Johnson & Johnson Gains EC Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Rapport Therapeutics Partners with Tenacia Biotechnology to Advance RAP-219 in Greater China

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

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