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Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal
Shots: Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties Miudella was approved by the US FDA in Feb 2025, for…
February 24, 2026
Immedica Pharma Receives the US FDA Accelerated Approval for Loargys to Treat Hyperargininemia in Patients with ARG1-D
Shots: The US FDA has granted accelerated approval to Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in pts (≥2yrs.) with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction, with commercial availability expected in Apr 2026 Approval was based on the P-III (PEACE) trial assessing Loargys vs PBO, which showed reduced plasma arginine from…
February 24, 2026
Astellas Partners with Vir Biotechnology for VIR-5500 in ~$1.7B Deal
Shots: Astellas has partnered with Vir Biotechnology to advance VIR-5500, a PRO-XTEN dual-masked CD3 T-cell engager targeting PSMA, for the treatment of prostate cancer As per the deal, Astellas will fund 60% & Vir 40% of global development costs; Vir will continue the P-I trial until transition, after which Astellas will assume development. Also, Vir will…
February 24, 2026
Gilead Sciences to Acquire Arcellx for $7.8B
Shots: Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…
February 23, 2026
Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC
Shots: Partner Therapeutics has reported post-hoc analysis from the eNRGy study assessing zenocutuzumab (marketed as Bizengri in the US) in pts with advanced NRG1+ NSCLC In 27 pts with NRG1+ NSCLC treated with zenocutuzumab (≥3 doses) beyond radiographic progression, 81% had oligoprogression & 19% diffuse progression, extending median exposure to ~10 vs ~7mos. pre-progression. Additionally,…
February 23, 2026
Lupin and Sandoz Receive the EC approval for Ranluspec (Biosimilar, Lucentis) 
Shots:  The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)    Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization  Sandoz and Lupin Limited partnered in August 2025 to develop and…
February 23, 2026
Vanda Pharmaceuticals
Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Shots: FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26 In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full…
February 23, 2026
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