EYEG: Building towards FDA filings

EYEG: OBG-PRK Pivotal Data Upcoming, 2020 Launch Feasible. OBG-PE Pre-Pivotal Study Moving Quick, Pivotal in 2020?

EyeGate Pharmaceuticals - OBG pivotal study recruitment on schedule

EyeGate’s Ocular Bandage Gel (OBG) is progressing in its ongoing pivotal study in corneal wound healing following photorefractive keratectomy (PRK) surgery. The firm recently met its 75% recruitment target (planned n=260 patients) and data are expected by YE19. If positive, it should lead to a market approval filing in H120. EyeGate will shortly begin a follow-on pilot study in punctate epitheliopathies (PE), a much larger indication that is related to dry eye disease (DED). Prior OBG PRK studies showed improved wound healing and a prior PE pilot trial showed improvement in patient symptoms,...

discoverIE Group - FY24 EPS in line; good margin progress

discoverIE anticipates reporting FY24 underlying EPS in line with board expectations. After a period in mid-FY24 of working down inventory, customers appear to be reverting to normal ordering patterns, with Q424 organic revenue growth of 2% y-o-y and 11% q-o-q and a strong pipeline of design wins at year-end. We have revised our forecasts to reflect lower revenue, partly due to a disposal, but maintain our profit forecasts, which results in operating margin expansion in FY24 and FY25.

Ultimovacs - Steadfast commitment to UV1 progression

Despite the recent setback with the INITIUM trial (first-line treatment of patients with unresectable or metastatic malignant melanoma), Ultimovacs has reinstated its commitment to press on with its clinical development of its cancer vaccine, UV1, across other target indications. The principal near-term focus will be on the anticipated results of Phase II FOCUS (head and neck cancer) and DOVACC (ovarian cancer) trials in Q324 and H125, respectively, and will inform its subsequent strategic direction. To remain funded to these milestones, the company has enforced stringent cost control measures...

OSE Immunotherapeutics - AbbVie deal clears antitrust hurdle

OSE has announced that its licence agreement with AbbVie has cleared antitrust review and has become effective. As previously noted, this is expected to support OSE’s runway extension into 2026, past key milestones and readouts for in-house assets Tedopi (non-small cell lung cancer, US Phase III trials expected to commence in Q224) and Lusvertikimab (ulcerative colitis, Phase II readouts expected in mid-2024). Following the Federal Communications Commission (FCC) mandatory waiting period, OSE is expected to receive the negotiated US$48m upfront payment from AbbVie imminently, as part of its gl...