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Arrowhead has reported topline P-III (SHASTA-3 & 4) trial results assessing plozasiran (25mg, SC, Q3M) vs PBO in sHTG pts (n=~750), where both trials met their 1EP of reduced median TGs by 79% & 81%, respectively, at 12mos. vs ~27%
Pooled analyses showed significant reductions in AP event rates & total incidence rate, with…
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Royalty Pharma will pay Neurimmune up to $425M, incl. $125M upfront, in exchange for a 3% to 4% royalty on worldwide net sales of AstraZeneca’s cliramitug
Royalty Pharma will pay Neurimmune an additional $125M in cash in Q1’27, with the remaining $175M contingent on the achievement of specified clinical & regulatory milestones
Cliramitug is…
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Repligen has entered into a definitive agreement to acquire BioLife
Repligen will acquire BioLife for an enterprise value of ~$1.5B, with BioLife stockholders receiving $11.25 per share in cash plus 0.1442 Repligen shares, representing total consideration of $31/share, comprising 64% stock & 36% cash
Acquisition is expected to fast-track Repligen’s leadership & customer solutions…
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The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor
Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor
Trial showed meaningful & durable…
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The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26
Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…
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Jupiter Neurosciences has entered into a definitive license agreement with PharmAla Biotech for perpetual exclusive US rights to ALA-002, a FDA NCE-designated, non-racemic MDMA formulation
Jupiter Neurosciences will receive perpetual exclusive US rights to ALA-002 for $3.3M upfront ($1.5M cash + $1.8M JUNS common stock), with the deal valued at up to $100M, incl.…
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IMUNON has reported preliminary data from its ongoing P-II MRD trial assessing IMNN-001 (intraperitoneally) in combination with SoC neoadj. & adj. CT (N/ACT) + Avastin, in women with newly diagnosed advanced ovarian cancer
Data from nine pts per arm reaching second-look laparoscopy showed IMNN-001 achieved deeper antitumor responses than control, with lower MRD positivity…
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Myriad Genetics has commercially launched FirstGene Multiple Prenatal Screen, combining four prenatal genetic screens in a single blood draw as early as 8wks. gestation
FirstGene covers common chromosomal conditions, 19 recessive fetal conditions, 20 maternal carrier conditions, & fetal RhD status, with >98% analytical sensitivity & >99% specificity, and results available in ~10 days;…
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Innate Pharma completed enrollment in the P-I (IPH4502-101) dose-escalation study of IPH4502, its Nectin-4 exatecan ADC, enrolling 76 pts across France & the US, incl. those with UC, NSCLC, HNSCC, breast, ovarian, gastric, esophageal, & colorectal cancers
Trial is evaluating the safety, tolerability, & preliminary antitumor activity of IPH4502 monotx. in advanced Nectin-4–expressing…
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NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC
Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…

