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NEWS

ImmunityBio Reveals P-II (QUILT-3.055) Trial Findings of Anktiva in CPI-Resistant NSCLC

Shots: ImmunityBio has reported P-II (QUILT-3.055) trial data assessing Anktiva (nogapendekin alfa inbakicept-pmln) + checkpoint inhibitor immunotherapy (CPI) in CPI-resistant advanced NSCLC Among 86 pts (51% 2L, 49% 3L+), mOS was 14.3mos. (23 alive at Dec 2025); 69/86 achieving ALC ≥1,200 had mOS of 15.8 vs 11.5mos. in non-achievers, while baseline ALC ≥1,200 & mean…
September 9, 2025

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Novartis to Acquire Tourmaline Bio for ~$1.4B, Complementing its Cardiovascular Portfolio

Shots: Novartis has entered into an agreement to acquire Tourmaline Bio, incl. its asset pacibekitug, expanding its cardiovascular portfolio As per the deal, Novartis, through its subsidiary, will acquire Tourmaline for $48/share, representing an aggregate of ~$1.4B, & will merge the subsidiary into Tourmaline upon completion, making it an indirect wholly owned unit of Novartis; closing…
September 9, 2025

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NEWS

Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease

Shots: Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025 Mosliciguat is an sGC activator that…
September 5, 2025

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Eli lilly
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The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…
September 5, 2025

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Roche
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Roche Reports the European CE Mark Approval of Contivue to Treat Neovascular Age-Related Macular Degeneration

Shots: Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
September 5, 2025

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NEWS

Argo Biopharma Inks a ~$5.3B Deal with Novartis for Multiple Cardiovascular Assets, Expanding their Existing Partnership

Shots: Argo has entered into an additional strategic collaboration with Novartis for multiple CV assets Novartis has obtained an option to license ex-China rights to two discovery-stage molecules for sHTG & mixed dyslipidemia, plus first negotiation rights to BW-00112 (ANGPTL3), a P-II asset. Deal also incl. a reciprocal P&L-sharing license for a hepatic siRNA asset…
September 4, 2025

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NEWS

IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots: IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
September 2, 2025

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