Oculis Holding AG

Oculis Reports Q3 2026 Financial Results and Builds Momentum Toward Multiple Upcoming Pipeline Catalysts

Oculis reported Q3 2026 results with $252.0 million in cash and short-term investments, providing runway into 2H 2029 as it advances two late-stage programs. Patient randomization is complete in the PREDICT-1 registrational trial of Licaminlimab in TNFR1-mediated dry eye disease (176 patients), with topline data expected around year-end 2026 — a potential first precision medicine in ophthalmology. Privosegtor's PIONEER-1 trial in optic neuritis is advancing, with IND clearance for acute MS relapses expected in Q4 2026 and new biomarker data supporting its neuroprotective potential. The company also completed the asset purchase from Accure Therapeutics for Privosegtor and ACT-02, and hired Prof. Björn Tackenberg (from Roche) as CSO and Aaron Tansy as VP Neurology to build the neurology franchise. Financially, Q3 R&D expense was $18.5M (vs $17.6M) and G&A rose to $10.6M (vs $8.0M); nine-month net loss narrowed to CHF 57.1 million from CHF 75.4 million, largely on warrant fair-value and FX gains.

•5d ago

REG-Oculis Reports Q3 2026 Financial Results and Builds Momentum Toward Multiple Upcoming Pipeline Catalysts

Oculis reported Q3 2026 results with $252.0 million in cash and short-term investments, providing runway into 2H 2029, and no revenue as a clinical-stage biotech. PREDICT-1 randomization is complete with 176 patients enrolled; topline data for Licaminlimab in TNFR1-mediated dry eye disease are expected around year-end 2026, and IND clearance for Privosegtor in acute MS relapses is expected in Q4 2026. Q3 R&D expense rose to $18.5 million (from $17.6 million) and G&A to $10.6 million (from $8.0 million); nine-month net loss narrowed to $71.7 million from $89.7 million, helped by warrant fair-value gains and FX. The company completed its asset purchase from Accure Therapeutics for Privosegtor rights and hired Prof. Björn Tackenberg (ex-Roche) as CSO to build the neurology franchise.

•5d ago

REG-Oculis Appoints Experienced Life Sciences Leader Björn Tackenberg, M.D., Ph.D., as Chief Scientific Officer to Advance Neurology Innovation

Oculis appointed Prof. Björn Tackenberg, M.D., Ph.D., as Chief Scientific Officer, joining from Roche where he led Integrative Neuroscience & Medical Practice. He will lead global scientific strategy and advance lead asset Privosegtor through the PIONEER registrational program, including evaluating its potential in acute multiple sclerosis relapses and other neurological indications. Aaron Tansy, M.D., was also appointed VP, Development Franchise Head, Neurology, bringing Phase 1-3 development experience from PTC Therapeutics, Ovid Therapeutics and Teva. Privosegtor holds FDA Breakthrough Therapy and EMA PRIME designations for optic neuritis and remains investigational with no regulatory approval to date.

•6d ago

Oculis Appoints Experienced Life Sciences Leader Björn Tackenberg, M.D., Ph.D., as Chief Scientific Officer to Advance Neurology Innovation

Oculis appointed Professor Björn Tackenberg, M.D., Ph.D., formerly Head of Integrative Neuroscience & Medical Practice at Roche, as its new Chief Scientific Officer. He will lead the global scientific strategy for Privosegtor, advancing it through the PIONEER registrational program and exploring potential in acute MS relapses and other neurological indications. Aaron Tansy, M.D., was also appointed VP, Development Franchise Head, Neurology, bringing Phase 1-3 development experience from PTC Therapeutics, Ovid Therapeutics and Teva.

•7d ago

REG-Oculis to Feature Privosegtor’s Neuroprotective Potential and Ongoing PIONEER Program at APOIS Congress and CNS Summit

Oculis will present Phase 2 ACUITY data and an overview of the Privosegtor PIONEER registrational program at the APOIS Congress in Seoul and the CNS Summit in Boston. ACUITY showed improvements in visual function, retinal preservation, and reduced blood neurofilament levels in acute optic neuritis, supporting Breakthrough Therapy and PRIME designations for Privosegtor. Privosegtor could become the first neuroprotective therapy for optic neuritis; Oculis also anticipates IND clearance for acute MS relapses in Q4 2026.

•10d ago

Oculis Reports New Phase 2 ACUITY Biomarker Data Further Supporting Privosegtor’s Neuroprotective Potential in Optic Neuritis

Oculis reported new biomarker data from the Phase 2 ACUITY trial showing Privosegtor reduced post-onset increases in plasma NfL and GFAP versus placebo in optic neuritis patients. The biomarker findings corroborate previously reported functional results, including +18-letter low-contrast visual acuity gains at Month 3 and preserved retinal structure. The data support advancing Privosegtor in the PIONEER registrational program and a planned IND for acute MS relapses; the drug holds FDA Breakthrough Therapy, EMA PRIME, and Or Drug designations but is not yet approved.

•18d ago

REG-Oculis Reports New Phase 2 ACUITY Biomarker Data  Further Supporting Privosegtor’s Neuroprotective Potential in Optic Neuritis

Oculis reported new Phase 2 ACUITY biomarker data showing Privosegtor reduced post-onset increases in plasma NfL and GFAP versus placebo in acute optic neuritis. Lower NfL and GFAP levels provide biological evidence of reduced neuroaxonal injury, complementing previously reported +18-letter low-contrast visual acuity gains and preserved retinal structure at Month 3. The data were presented at the ACTRIMS-ECTRIMS meeting and strengthen the case for the ongoing PIONEER registrational program, with an IND planned for acute MS relapses.

•18d ago

Oculis to Present Late-Breaking Phase 2 ACUITY Biomarker Analyses of Privosegtor in Optic Neuritis at the 10th Joint ACTRIMS-ECTRIMS Meeting

Oculis will present late-breaking Phase 2 ACUITY biomarker analyses of Privosegtor at the joint ACTRIMS-ECTRIMS meeting in Toronto on October 22, 2026. The new translational data evaluate plasma NfL and GFAP as biomarkers of neuroaxonal injury and neuroinflammation in acute optic neuritis, presented by principal investigator Professor Céline Louapre. Privosegtor holds FDA Breakthrough Therapy and EMA PRIME designations, with two registrational PIONEER trials ongoing and an IND planned for acute MS relapses. The release is a conference-presentation notice without new headline results; investors will get a broader pipeline update at the December 8 R&D Day.

•20d ago

Oculis Completes Randomization in PREDICT-1 Registrational Trial of Licaminlimab for TNFR1-Mediated Dry Eye Disease

Oculis completed randomization of 176 patients in PREDICT-1, its genotype-based registrational trial of Licaminlimab for TNFR1-mediated dry eye disease. Two-thirds of enrolled patients carry the target TNFR1 genetic variant previously linked to enhanced response in Phase 2, and topline data are expected around year-end 2026. If successful, Licaminlimab would be a first-in-class precision medicine for an estimated 1.5+ million U.S. patients with moderate-to-severe TNFR1-mediated DED; the result remains a binary clinical readout.

•21d ago

REG-Oculis lýkur slembiröðun í PREDICT-1 skráningarrannsókninni á Licaminlimab við TNFR1-miðluðum augnþurrki

Oculis Holding AG completed randomization in PREDICT-1, its first genotype-based registration trial of Licaminlimab for TNFR1-mediated dry eye disease, enrolling 176 patients. Two-thirds of enrolled patients carry the TNFR1 genetic variant previously associated with stronger clinical response in Phase 2 studies, and topline results are expected around year-end 2026. If successful, Licaminlimab could become the first precision-medicine therapy for the estimated 1.3-1.9 million US patients with moderate-to-severe TNFR1-mediated dry eye disease, an area of significant unmet need.

•21d ago

First Patient Treated in PIONEER-1 Registrational Trial of Privosegtor for Optic Neuritis

Oculis has dosed the first patient in the PIONEER-1 registrational trial evaluating Privosegtor for the treatment of optic neuritis. The trial design is supported by a FDA Special Protocol Assessment (SPA) and targets clinically meaningful functional endpoints, with Privosegtor already holding Breakthrough Therapy and PRIME designations. Building on the Phase 2 ACUITY data, Oculis plans to submit an IND for Privosegtor to treat acute multiple sclerosis relapses in Q4 2026.

•2mo ago

REG-First Patient Treated in PIONEER-1 Registrational Trial of Privosegtor for Optic Neuritis

Oculis has treated the first patient in the PIONEER-1 registrational trial evaluating Privosegtor for optic neuritis, a pivotal study backed by a FDA Special Protocol Assessment. Privosegtor holds Breakthrough Therapy and PRIME designations, with the potential to become the first neuroprotective therapy for this condition, and Oculis plans to submit an IND for acute MS relapses in Q4 2026. The study targets a clinically meaningful 15-letter gain in visual acuity, leveraging a multidisciplinary network to optimize patient screening and enrollment.

•2mo ago

Oculis Signs Asset Purchase Agreement with Accure Therapeutics for Lead Candidate, Privosegtor, Fortifying Oculis’ Position as an Emerging Leading Neuro-Ophthalmology Company

Oculis Holding AG signed an asset purchase agreement with Accure Therapeutics to acquire worldwide rights to Privosegtor (ACT-01) and ACT-02, eliminating existing milestone and royalty obligations. Total consideration is $3.8 million in upfront cash and up to 2,050,000 Oculis ordinary shares, with closings expected by February and March 2027 respectively. Privosegtor is currently in registrational trials for optic neuritis and acute MS relapses, holding FDA Breakthrough Therapy and EMA PRIME designations.

•2mo ago

REG-Oculis Signs Asset Purchase Agreement with Accure Therapeutics for Lead Candidate, Privosegtor, Fortifying Oculis’ Position as an Emerging Leading Neuro-Ophthalmology Company

Oculis signed an asset purchase agreement to acquire worldwide development and commercial rights to its lead candidate Privosegtor and early-stage asset ACT-02 from Accure Therapeutics. Total consideration includes a $3.8 million upfront cash payment and the issuance of up to 2,050,000 Oculis ordinary shares, effectively terminating the legacy license agreement and associated royalty obligations to Accure. Privosegtor is currently in the registrational PIONEER-1 trial for optic neuritis and holds FDA Breakthrough Therapy designation; the transaction closings are expected by February and March 2027, respectively.

•2mo ago

Oculis Reports Q2 2026 Financial Results and Provides Company Update

Oculis reported Q2 financial results with cash, cash equivalents, and short-term investments of $282.3 million, extending the company's cash runway into the second half of 2029. The company announced positive FDA pre-IND feedback for Privosegtor in acute MS relapses, eliminating the need for additional preclinical studies and supporting an IND submission in Q4 2026, while the PREDICT-1 trial for Licaminlimab is over 45% enrolled. Following a review of topline data, Oculis decided not to pursue an FDA regulatory filing for OCS-01 in DME, focusing resources instead on the Privosegtor neuroprotection franchise and the Licaminlimab precision medicine program.

•3mo ago

REG-Oculis Reports Q2 2026 Financial Results and Provides Company Update

Oculis reported Q2 2026 financial results with cash, cash equivalents, and short-term investments totaling $282.3 million, which provides a cash runway into the second half of 2029. The company announced positive FDA pre-IND feedback for Privosegtor in acute MS relapses, supporting an IND submission in Q4 2026, while the Licaminlimab PREDICT-1 trial remains on track with over 45% of patients randomized. Management decided not to pursue an FDA regulatory filing for OCS-01 in DME following topline results, opting instead to focus resources on its neuro-ophthalmology pipeline.

•3mo ago

Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses

Oculis announced positive FDA pre-IND feedback for Privosegtor, supporting a regulatory pathway for acute multiple sclerosis relapses. The feedback confirms existing data can be cross-referenced for a new IND submission planned for Q4 2026, eliminating the need for additional preclinical studies. The proposed strategy includes a primary endpoint at 3 months using a 3mg/kg daily dose for 5 days.

•3mo ago

REG-Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses

Oculis received positive pre-IND feedback from the FDA for Privosegtor, supporting a regulatory pathway for the treatment of acute multiple sclerosis relapses. The agency confirmed that existing data can be cross-referenced for a new IND submission, which is now planned for the fourth quarter of 2026 without the need for additional preclinical studies. The proposed clinical strategy includes a primary endpoint as early as 3 months using the same 3mg/kg dose regimen currently in the PIONEER program.

•3mo ago