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Innovent
Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Shots: The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL Trial…
4 hours ago
Gyre Therapeutics to Acquire Cullgen for ~$300M
Shots: Gyre has entered into an agreement to acquire Cullgen in an all-stock transaction valued at ~$300M, making it a wholly owned subsidiary upon deal completion in Q2’26 Following the acquisition’s close, the combined company will operate as a fully integrated biopharma organization with US & China capabilities across discovery, manufacturing, & commercialization, addressing inflammatory…
7 hours ago
Zymeworks Raises $250M from Royalty Pharma Backed by Ziihera Royalties
Shots: Zymeworks secured $250M from Royalty Pharma via a non-recourse royalty-backed note, repayable from 30% of worldwide tiered royalties on Ziihera owed by Jazz Pharmaceuticals and BeOne Medicines Royalty will receive payments until it achieves 1.65x of the note by Dec 31, 2033, or 1.925x thereafter; Zymeworks retains 70% of royalties during repayment, with full…
1 day ago
Pfizer, Merck and Astellas Report P-III (KEYNOTE-B15) Trial Findings on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)
Shots: The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…
1 day ago
Ascendis’ Yuviwel (Navepegritide) Receives the US FDA Accelerated Approval for Achondroplasia
Shots: FDA granted accelerated approval to Yuviwel (navepegritide, QW) to increase linear growth in children (≥2yrs.) with achondroplasia & open epiphyses; commercially available by Q2’26 Approval was based on extensive clinical data, incl. 3 PBO-controlled trials plus up to 3yrs. of OLE data, with the pivotal ApproaCH results published in JAMA Pediatrics Continued approval may…
1 day ago
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