In today’s briefing:
- Santen Pharmaceutical (4536 JP): Subdued H1 Performance; FY25 Guidance Reiterated; Robust Pipeline
- COCP: Multiple Upcoming Catalysts
- Cybin, Inc. – CYB003 Demonstrates Exceptional Durable Treatment Benefits for Depression
- D. Western Therapeutics Institute (4576 JP) – News Flash – November 19, 2024
- ABEO: FDA Accepts BLA Re-Submission for Pz-cel PDUFA Date of April 29
- Pharmaessentia Corp (6446 TT): Third Consecutive Quarters for Operating Profit; Pipeline Raises Hope
- RVPH: Year-End OLE Update
- LGMK: New Freedom Alert Mini & Freedom Alert Max Expand Product Suite
Santen Pharmaceutical (4536 JP): Subdued H1 Performance; FY25 Guidance Reiterated; Robust Pipeline
- Santen Pharmaceutical (4536 JP) witnessed flat revenues while core operating profit and net profit declined in H1FY25. Overseas business grew 6% YoY and remained the main driver.
- Santen reiterated FY25 guidance as overseas markets are performing well, reviewed impact of generics in Japan, and continued progress in company-wide cost optimizations.
- Santen signed collaboration agreement for ARVN001 suprachoroidal injectable suspension, a treatment for uveitic macular oedema, for exclusive commercialization rights in China, excluding Hong Kong, Macau, and Taiwan.
COCP: Multiple Upcoming Catalysts
- On November 13, 2024, Cocrystal Pharma, Inc. (COCP) announced financial results for the third quarter of 2024 and provided a business update.
- Over the next few months, we anticipate multiple important catalysts for the company, including topline results from the Phase 2a trial of CC-42344 before the end of 2024, filing of an Investigational New Drug (IND) application in 2025 to conduct the next study of CC-42344 in the U.S., and topline results for the multiple-ascending dose (SAD) portion of the Phase 1 trial of CDI-988 in late 2024 or early 2025.
- The company exited the third quarter of 2024 with unrestricted cash of approximately $13.0 million, which is enough to fund operations for at least the next 12 months.
Cybin, Inc. – CYB003 Demonstrates Exceptional Durable Treatment Benefits for Depression
- CYB003’s Phase 2 data demonstrate impressive long-term safety and efficacy data.
- Cybin’s release of its highly anticipated 12-month safety and efficacy data for CYB003, its proprietary deuterated psilocin program for the potential adjunctive treatment of major depressive disorder, did not disappoint.
- The outcomes demonstrated durable and robust efficacy from its Phase 2 study of CYB003.
D. Western Therapeutics Institute (4576 JP) – News Flash – November 19, 2024
- DWTI announced topline results from its Phase 2B clinical trial of its H-1337 Ophthalmic Solution, for the treatment of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
- This study was a double-masked, active- controlled, dose-response study in 201 subjects with primary open-angle glaucoma or ocular hypertension, where subjects were dosed for 28 days during the period from August 2023 – August 2024.
- The study was designed to evaluate the ocular safety and hypotensive efficacy of three doses of multi-kinase inhibitor H-1337 Ophthalmic Solution: 0.6% twice-daily, 1.0% twice daily, and 1.0% once-daily.
ABEO: FDA Accepts BLA Re-Submission for Pz-cel PDUFA Date of April 29
- On November 14, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the third quarter of 2024 and provided a business update.
- The company recently announced that the U.S. FDA has accepted the re-submission of the Biologics License Application (BLA) for pz-cel and set a PDUFA target action date of April 29, 2025.
- The acceptance of the BLA by the FDA indicates that the resubmission includes all the necessary information that was found to be deficient in the original BLA filing and we are confident that the company has addressed all the issues identified in the CRL and the pre-license inspection.
Pharmaessentia Corp (6446 TT): Third Consecutive Quarters for Operating Profit; Pipeline Raises Hope
- Pharmaessentia Corp (6446 TT) reported 66% QoQ increase in operating profit in 3Q24. Scale expansion coupled with tight control over expenses led to such strong performance.
- 3Q24 marks the six consecutive quarters of sequential revenue increase. Revenue for the first three quarters of 2024 already exceeded full-year 2023 revenue.
- Geography expansion of the sole marketed drug Besremi, indication expansion, and pipeline progress will remain the main growth engines. Pharmaessentia is eyeing on Besremi’s indication expansion in US by 2026.
RVPH: Year-End OLE Update
- Reviva is a research and development pharmaceutical company with two portfolio compounds targeting nine indications.
- The candidates address multiple related mental disorders, rare diseases & other categories of un met need.
- Reviva’s lead indication in schizophrenia with brilaroxazine (RP5063) completed its 1st Phase III trial & expects to begin its 2nd in 2025.
LGMK: New Freedom Alert Mini & Freedom Alert Max Expand Product Suite
- As LGMK creates and launches new products, the goal is to expand the target addressable market beyond its traditional target demo and concurrently broaden its penetration within the traditional market with new hardware such as the Freedom Alert Mini and Max and new features such as advanced fall detection and solutions leveraging AI/ML technologies, among other features.
- The company also expects opportunities to license its technology to third parties and thereby boost recurring high-margin revenue, and continues to expands its patent position to support potential licensing opportunities and protect its IP.
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