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Novo Nordisk Enters ~$2.1B Deal with Omeros to Advance Zaltenibart for Rare Blood & Kidney Disorders

Shots: Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains certain rights to other preclinical MASP-3 programs, incl. small-molecule MASP-3 inhibitors for select indications As per the deal, Novo will receive exclusive global rights to develop…

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Corcept Therapeutics Reports the EMA’s MAA Submission of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancer MAA 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 & showed favorable safety Relacorilant (PO) is a GR antagonist that is…

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BioCryst to Acquire Astria Therapeutics in ~$700M Cash-and-Stock Transaction

Shots: BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolio As per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…

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Pfizer New

Pfizer Reports Topline P-III (HER2CLIMB-05) Trial Data of Tukysa (Tucatinib) in Metastatic Breast Cancer (MBC)

Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…

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Boehringer Ingelheim and Click Therapeutics Report P-III (CONVOKE) Trial Data on CT-155 for Schizophrenia

Shots: The P-III (CONVOKE) trial assessed CT-155 (BI 3972080) vs a digital control app as an adjunct to SoC antipsychotic therapy in pts (≥18yrs.) with experiential negative symptoms of schizophrenia Trial met its 1EP with 6.8 vs 4.2-point improvement in negative symptom severity on the CAINS-MAP at 16wks., achieving a Cohen’s D of -0.36; most…

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SystImmune Doses First Patient in P-II/III (IZABRIGHT-Breast01) Trial of Iza-Bren to Treat Triple Negative Breast Cancer (TNBC)

Shots: SystImmune has dosed the first patient with izalontamab brengitecan (iza-bren) in the global P-II/III (IZABRIGHT-Breast01) study for previously untreated TNBC ineligible for anti-PD-(L)1 drugs First patient dosing triggered $250M milestone payment to SystImmune under its 2023 deal with BMS, where SystImmune is further eligible to receive additional ~$250M in contingent near-term payments & ~$7.1B…

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BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots: The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…

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Hutchmed

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots: HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC  As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…

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Novo Nordisk to Acquire Akero Therapeutics for ~$5.2B, Expanding its MASH Portfolio

Shots: Novo Nordisk will acquire Akero Therapeutics, incl. its lead asset efruxifermin (EFX), to expand its metabolic dysfunction-associated steatohepatitis (MASH) portfolio As per the deal, Novo Nordisk will acquire Akero for $54/share in an all-cash transaction totaling ~$4.7B, along with one non-tradeable CVR of $6/share (~$0.5B) tied to EFX’s US FDA approval for compensated cirrhosis due…

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