Shots:
TRIUMpH program consists of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE) & non-erosive reflux disease (NERD); EE’s maintenance phase to end by Q3’25, with FDA’s NDA filing for both EE & NERD planned in Q4’25
EE study (vs lansoprazole) in 1250 pts (incl. 463 with LA Grade C/D)…
Shots:
Mosaic has in-licensed ASTX029 & ASTX295 from Astex (Otsuka Pharmaceutical’s subsidiary) to develop combination therapies using these assets, with the 1st combination study expected to begin in 2026
As per the deal, Astex granted Mosaic exclusive rights to develop combination products for pts with limited therapy options, receiving a 19% equity stake upfront &…
Shots:
Health Canada has approved Keytruda + pemetrexed + Pt-based CT as 1L treatment of unresectable advanced or metastatic MPM based on P-II/III (IND.227/KEYNOTE-483) trial led by CCTG in collaboration with NCIN & IFCT
Trial assessed the regimen in MPM pts (n=440) who received either Keytruda (200mg, IV) + pemetrexed (500mg/m^2) & Pt-based CT on Day…
Shots:
BI & Tessellate Bio have entered into a research collaboration & global license agreement to develop oral therapies for ALT-positive tumors
As per the terms, Tessellate Bio will receive near term payments incl. an upfront license fee, research funding & technical milestones along with downstream success-based milestones, making it an aggregate of ~$573M (~€500M)…
Shots:
VERAXA to reverse merge with Voyager, where the combined entity- "VERAXA Biotech” will be listed on Nasdaq under VERX ticker; closing expected in Q4’25
As per the deal, VERAXA will have access to ~$253M cash from Voyager’s trust at closing & contribute ~$1.3B in equity for ~130M shares, with all shareholders rolling over 100%…
Shots:
Veravas has launched VeraBIND Tau to detect both symptomatic & pre-symptomatic pts with Alzheimer's disease (AD) or other tau-related neurodegenerative disorders (tauopathies)
In an analytical verification study, VeraBIND Tau showed 96% sensitivity, 90% specificity, & 92% agreement with tau PET imaging, detecting Alzheimer’s-related tau & offering VeraBIND Tau score, a semi-quantitative measure of pathologically…
Shots:
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, &…
Shots:
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…
Shots:
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…

