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The P-III (ARISE) trial assessed Cobenfy (xanomeline & trospium chloride) vs PBO as an adj. therapy to atypical antipsychotics in adults with inadequately controlled schizophrenia symptoms; eligible pts could enter a 52wk. OLE study
At Wk. 6, trial showed a PANSS score change (1EP) of -14.3 vs -12.2, which was not statistically significant, &…
NEWS
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FUJIFILM Diosynth Biotechnologies & Regeneron have entered into a 10-year manufacturing supply agreement, under which FUJIFILM will provide US-based manufacturing services for Regeneron
As per the deal, FUJIFILM will receive ~$3B to manufacture biopharmaceuticals for Regeneron at its Holly Springs, North Carolina facility, which will begin operations in late 2025
Holly Springs site is…
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China’s NMPA has accepted IND application for RN1871 for hypertension, with Rona planning to advance it in P-I trial to assess its safety, PK, & preliminary efficacy in humans
Preclinical studies have demonstrated AGT suppression & sustained blood pressure control, with reduced dosing frequency of RN1871
RN1871 is engineered to suppress AGT mRNA expression in the…
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HUTCHMED has completed pts enrollment in P-II trial assessing savolitinib for G/GEJ adenocarcinoma pts (n=64) with MET amplification to evaluate ORR per IRC (1EP) & 2EPs incl. PFS & AE incidence; HUTCHMED plans to file for potential NMPA’s Approval in late 2025
Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…
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Alumis and ACELYRIN have amended their 2025 merger agreement, which originally granted ACELYRIN stockholders 0.4274 Alumis shares/share, giving them a 45% stake in the combined company
As per the amendment, ACELYRIN stockholders will receive 0.4814 Alumis shares/share, allowing them to own 48% of the combined entity on a fully diluted basis; closing expected in Q2'25…
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The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10)
Trial showed improved PFS (1EP); OS (2EP) was immature but showed…
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Exact Sciences has launched Oncodetect to detect MRD across multiple solid tumors, with its efficacy supported by strong clinical validation, incl. ~5yrs. of follow-up data from the Alpha-CORRECT study
Addiitonally, clinical & analytical validation studies across multiple solid tumors are underway, supported by strategic partnerships for multi-cancer evidence generation
Oncodetect test provides clear “Detected”…
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Novocure has reported CE Mark approval of Optune Lua for mNSCLC adults progressed on Pt-based regimen based on P-III (LUNAR) trial assessing the treatment vs PD-1/PD-L1 inhibitors/docetaxel alone; launch in Germany is expected in coming wks.
Trial showed improved OS (1EP), with an mOS of 13.2 vs 9.9mos. with treatment vs PD-1/PD-L1 inhibitors/docetaxel, 18.5…
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China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
Preclinical studies of K1, K2, & their combination showed…
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DAAN Biotherapeutics & GC Cell have entered into an exclusive technology transfer agreement for tumor antigen-specific antibody sequence
As per the agreement, DAAN has granted GC Cell exclusive rights to use its antibody sequence, which targets a protein highly overexpressed in major solid tumors, for research & development of CAR-T & CAR-NK therapies
Financial terms of…

