Shots:
The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors
Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…
Shots:
GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer
As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…
Shots:
J&J has entered into a definitive agreement to acquire Firefly Bio, incl. its Firelink degrader antibody conjugate (DAC) platform, expanding its oncology pipeline
As per the deal, J&J will acquire Firefly Bio for $1B in cash, with closing expected later this year
The Firelink DAC platform is a targeted protein degradation tech that selectively…
Shots:
Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders
As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones
Acquisition will expand Incyte’s hematology portfolio with…
Shots:
Engitix & GSK have entered a strategic research collaboration & option agreement to identify & validate novel therapeutic targets that drive liver fibrosis regression using Engitix’s human extracellular matrix (ECM) platform & multi-omics datasets
As per the deal, Engitix will receive ~£44.5M (~$59.3M) upfront & near-term payments, along with ~£118M (~$157.3M) per target in…
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The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease
BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…
Shots:
In TRIUMPH-1 trial & nested studies in knee osteoarthritis pain & OSA, retatrutide met all 1EPs at 80wks., with weight loss of 25.9% (9mg) & 28.3% (12mg). At 12mg, 65.3% pts achieved a BMI <30 & 33.3% reached BMI <25, while those with BMI ≥35 lost ~85 lbs through 104wks. It also reduced WOMAC…
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Nurix has entered a global collaboration with Roche to develop & commercialize bexobrutideg (PO), a BTK targeted protein degrader, which is under P-II/III trial for chronic lymphocytic leukemia
Nurix will receive $700M upfront & ~$2.3B in milestones. Development costs will be shared (40% Nurix & 60% Roche), with both co-commercializing the drug & equally…
Shots:
AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression
Trial showed a 46.6% reduction in 24-hr. UPCR from baseline at 34wks. vs 5.6% with PBO, as early as Wk. 10 & sustained through 34wks. The results were consistent…
Shots:
Kashiv BioSciences has reported that Health Canada has validated and accepted the MAA for ADL-018, a biosimilar version of Xolair (omalizumab)
Omalizumab is approved for multiple allergic & inflammatory conditions, incl. mod. to sev. persistent asthma (≥6yrs.), CRSwNP (≥18yrs.), chronic spontaneous urticaria (≥12 yrs.), & IgE-mediated food allergy (>1yr.)
Additionally, Alvotech & Kashiv BioSciences have…

