AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Shots: The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+…

ByRidhi RastogiOctober 1, 2025

NEWS

Genmab to Acquire Merus for ~$8B

Shots: Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned model As per the deal, Genmab will acquire Merus for $97 per share in an all-cash transaction, representing the deal value of ~$8B, with closing expected in the…

ByRidhi RastogiSeptember 29, 2025

NEWS

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots: The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26 Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…

ByRidhi RastogiSeptember 26, 2025

NEWS

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots: The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC) Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…

ByRidhi RastogiSeptember 25, 2025

NEWS

Solid Biosciences & Kinea Bio Partner to Advance KNA-155 Using AAV-SLB101 for Dysferlin-Related Limb-Girdle Muscular Dystrophy

Shots: Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsid As per the deal, Kinea Bio will receive a non-exclusive global license to utilize AAV-SLB101 for the delivery of KNA-155, which will enter IND-enabling studies…

ByRidhi RastogiSeptember 24, 2025

NEWS

Pfizer Expands into Obesity Treatments with ~$7.3B Metsera Acquisition

Shots: Pfizer has entered into a definitive agreement to acquire Metsera, expanding to obesity & cardiometabolic market As per the deal, Metsera will receive $47.5/share, representing an enterprise value of ~$4.9B, plus a non-transferable CVR of ~$22.50/share tied to milestones: $5 on P-III start of MET-097i + MET-233i, $7 on FDA approval for MET-097i monotx.,…

ByRidhi RastogiSeptember 23, 2025

NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…

ByRidhi RastogiSeptember 18, 2025

NEWS

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…

ByRidhi RastogiSeptember 16, 2025

NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…

ByRidhi RastogiSeptember 15, 2025

NEWS

MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC

Shots: MAIA Biotechnology has reported P-II (THIO-101) trial data assessing ateganosine followed by Libtayo (cemiplimab) in pts with advanced NSCLC who progressed after ≥2 SoC therapy regimens As of Jun 30, 2025, ateganosine (180mg) showed mPFS of 5.6 vs 2.5mos. & mOS of 17.8mos., plus 2 pts completed 33 cycles across pts of all treatment lines,…

ByRidhi RastogiSeptember 15, 2025

AbbVie Reports the US FDA’s BLA Submission of Pivekimab Sunirine to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm

Genmab to Acquire Merus for ~$8B

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Solid Biosciences & Kinea Bio Partner to Advance KNA-155 Using AAV-SLB101 for Dysferlin-Related Limb-Girdle Muscular Dystrophy

Pfizer Expands into Obesity Treatments with ~$7.3B Metsera Acquisition

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC

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