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Ionis
NEWS

Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome

Shots:The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndromeDesignation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorableAdditionally, ION582 is being investigated in…
September 12, 2025

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NEWS

Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

Shots:Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in ChinaAdditionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
September 12, 2025

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NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots:The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026)NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safetyAdditionally, relacorilant (GR antagonist)…
September 11, 2025

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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 NSCLCAmong 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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NEWS

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 portfolioAs 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 2025Mosliciguat is an sGC activator that…
September 5, 2025

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Eli lilly
NEWS

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
NEWS

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 reviewApproval 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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