In today’s briefing:
- Mayne Pharma’s Merger with Cosette Pharmaceuticals: Navigating FDA Concerns, Shareholder Approval, and Market Reactions
- Cybin, Inc: Covering All Bases as Commercialization Preparations Continue
- DYAI: Fermbox Purchase Order
- Raqualia Pharma (4579 JP): Q1 FY12/25 flash update
- Terumo Corp (4543 JP): Mixed Performance in FY25; Revenue Growth to Decelerate in FY26
Mayne Pharma’s Merger with Cosette Pharmaceuticals: Navigating FDA Concerns, Shareholder Approval, and Market Reactions
- Mayne Pharma’s acquisition by Cosette Pharmaceuticals at A$7.40/share faces a 14% spread, with closing expected in 1.5 months.
- The FDA issued an Untitled Letter to Mayne Pharma about Nexstellis promotional materials, but it is unlikely to trigger a material adverse effect.
- Shareholder approval for the merger appears likely, with key stakeholders supporting the deal and a vote scheduled for June 18.
Cybin, Inc: Covering All Bases as Commercialization Preparations Continue
- Taking care of business in the present and future. Cybin continues to move its commercialization preparation plans forward with the announcement of another important partnership, this time with Thermo Fisher Scientific (NYSE: TMO), a leading life sciences service provider offering Contract Development and Manufacturing Organization (CDMO) services.
- To this end, Cybin has engaged Thermo to not only supply both the drug substance and drug product capsules for its ongoing Phase 3 CYB003 program in major depressive disorder (MDD), but also for the potential commercial manufacturing of CYB003 if approved.
- Tariff protection. In this agreement, CYB003 will be manufactured in Thermo’s US sites in South Carolina and Ohio and will thus be protected from tariffs should the Trump administration proceed to apply them to pharmaceutical products as it has threatened.
DYAI: Fermbox Purchase Order
- Dyadic has developed C1, its proprietary fungal expression system that can produce a variety of recombinant proteins.
- C1 has been commercialized in industrial applications and is in development for production of pharmaceutical grade proteins.
- C1 exhibits potential to economically produce recombinant proteins, biologic vaccines, virus like particles, antibodies, Fc-fusion, enzymes, AAVs and other biopharmaceuticals.
Raqualia Pharma (4579 JP): Q1 FY12/25 flash update
- Operating revenue increased by 48.8% YoY to JPY965mn, with operating profit rising 109.2% YoY to JPY93mn.
- Royalty income from four products and tegoprazan expansion resulted in JPY614mn, with other income at JPY351mn.
- RaQualia raised approximately JPY1.0bn through a third-party allotment, issuing 2,592,100 shares to HK inno.N.
Terumo Corp (4543 JP): Mixed Performance in FY25; Revenue Growth to Decelerate in FY26
- Terumo Corp (4543 JP) has reported FY25 result, with revenue and adjusted operating profit beating and operating and net profits missing guidance. TIS and GBS remained two brightest spots.
- FY26 guidance calls for a decelerated revenue growth of just 1% YoY (FY25 revenue growth rate was 12%). Foreign exchange will impact the revenue negatively.
- Implementation of the U.S. tariff poses downside risk to guidance, while better-than-expected foreign exchange rate and C&V business growth are the upside risks.
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