Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

Shots: Kaigene has granted Celltrion exclusive global rights to develop & commercialize KG006 (excl. Greater China & Japan) & KG002 As per the deal, Kaigene will receive $8M upfront, & ~$736M in milestone payments, incl. $11M in near-term milestones through the initiation of P-I trials, along with net sales-based tiered royalties KG006 is an FcRn…

ByRidhi RastogiNovember 4, 2025

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UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings planned Approval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

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Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases

Shots: Manifold has entered into a strategic research collaboration & licensing deal with Roche to develop multiple next-gen blood-brain barrier (BBB) shuttles for neurological & neurodegenerative diseases, leveraging Manifold’s shuttle portfolio & mDesign AI-driven in vivo discovery platform As per the deal, Manifold will lead research & discovery of BBB shuttles for Roche’s therapeutic payloads,…

ByRidhi RastogiNovember 4, 2025

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TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors

Shots: TransThera Sciences has entered into a royalty-bearing patent assignment & research collaboration deal with Neurocrine Biosciences to develop preclinical NLRP3 inhibitors for multiple diseases As per the deal, Neurocrine will gain exclusive ex-Greater China rights to develop, manufacture & commercialize NLRP3 inhibitors from TransThera’s NLRP3 portfolio, while TransThera will retain Greater China rights (Mainland,…

ByRidhi RastogiNovember 4, 2025

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Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

Shots: The US FDA has granted ODD to CAL101 for the treatment of idiopathic pulmonary fibrosis (IPF) CAL101 (IV, QM for 7mos.) is being investigated in a P-II (AURORA) trial against PBO in 150 IPF pts, with enrolment open in the sites across US, UK, EU, Turkey, & South Korea, evaluating lung function per forced vital…

ByRidhi RastogiNovember 3, 2025

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UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Shots: UCB has reported 3yr. BE HEARD trials data where 2 P-III (BE HEARD I & II) trials assessed Bimzelx (320mg; Q2W till Wk. 16, then Q4W) vs PBO in 1,014 adults with mod. to sev. HS; 556 pts completing Wk. 48 entered the OLE (BE HEARD EXT) study Among pts with ≥1 draining tunnel…

ByRidhi RastogiNovember 3, 2025

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Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Shots: Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…

ByRidhi RastogiNovember 3, 2025

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Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Shots: The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found,…

ByRidhi RastogiNovember 3, 2025

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Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease

Shots: The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan,…

ByRidhi RastogiNovember 3, 2025

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Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLC Trial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…

ByRidhi RastogiNovember 3, 2025

Ridhi Rastogi

Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases

TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors

Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)

UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa

Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)

Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)

Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC

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