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NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…
June 27, 2025

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NEWS

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots: Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapy Trial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…
June 6, 2025

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Remegen
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RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…
May 27, 2025

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Viridian
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Viridian Therapeutics Releases the Long-Term Durability Data Evaluating Veligrotug in P-III (THRIVE) Study in Active TED 

Shots: Viridian reported positive long-term durability data from the P-III (THRIVE) study evaluating 5 infusions of veligrotug (veli) or PBO (Q3W), with primary topline analysis at 15wks and follow-up to 52wks, in active thyroid eye disease (TED) pts. (N=30) Study demonstrated that 70% (21/30) were proptosis responders at 15wks. and maintained at least a 2…
May 21, 2025

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Teva and Alvotech
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Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025 Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…
May 6, 2025

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Akesobio
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Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…
April 25, 2025

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Intellia Therapeutics
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Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN

Shots: Intellia has reported the first pts dosing in its P-III (MAGNITUDE-2) trial assessing nexiguran ziclumeran (nex-z) for hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN); BLA submission is expected in 2028 Trial will assess nex-z (55mg infusion) vs PBO in ~50 ATTRv-PN pts to evaluate modified neuropathy impairment score & change in serum TTR levels as…
April 7, 2025

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