Shots:
The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC)
The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
Shots:
The US FDA has granted IND Clearance to initiate P-II trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in pts with advanced solid tumors
CS2009 is being evaluated in a P-II trial (currently enrolling) across Australia & China, spanning 15 cohorts to evaluate monotx. & combination regimens in 9 solid tumors, incl. NSCLC, colorectal cancer, TNBC,…
Shots:
The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma
In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…
Shots:
The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF)
The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings &…
Shots:
The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU)
The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05
NOV05 is…
Shots:
FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor
The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
Shots:
The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD)
In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…
Shots:
Insilico has entered into an exclusive out-licensing collaboration with TaiGen & its subsidiary TaiGen Biopharmaceuticals for ISM4808Â to treat CKD-related anemia
As per the deal, TaiGen will gain exclusive rights to ISM4808 & related forms for further development, commercialization & sub-licensing in Greater China, while Insilico will receive upfront payment, development & sales milestones, &…
Shots:
Lynk Pharmaceuticals has entered into an exclusive development & licensing agreement with Formation Bio, granting the latter worldwide rights to LNK01006 (excl. Greater China), a highly selective TYK2 inhibitor
LNK01006 will be developed by Formation’s new subsidiary, Bleecker Bio, following recent US FDA IND clearance, with a P-I trial planned to start in the…
Shots:
The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025
The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

