FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

Summary of SoftOx Solutions Investor Update Call Company Overview - **Company**: SoftOx Solutions AS - **Industry**: Pharmaceutical, specifically focusing on inhaled antimicrobial therapies Key Points and Arguments 1. **Technological Potential**: The company believes its technology can significantly change the treatment of lung infections, particularly through the SoftOx Inhalation Solution, which utilizes hypochlorous acid to combat various pathogens [2][10][12] 2. **Clinical Adoption and Commercial Value**: Emphasis on the need for clinical adoption at scale to achieve commercial value and shareholder rewards [3][6] 3. **Proof-of-Concept Study**: The company is initiating its first proof-of-concept study targeting cystic fibrosis patients, which is seen as a critical step in demonstrating the efficacy of their technology [3][12][35] 4. **Market Potential**: The addressable market for cystic fibrosis is estimated at around $600 million, with potential annual turnover of approximately $90 million if the company captures a 15% market share [28][29] 5. **Broader Applications**: The technology may also be applicable to other chronic lung infections, such as non-cystic fibrosis bronchiectasis, which presents a larger market opportunity [15][29][36] 6. **Antibiotic Resistance**: The SoftOx Inhalation Solution is positioned as a solution to the growing problem of antibiotic resistance, with the ability to target dormant bacteria and biofilms [11][12][18] 7. **Clinical Trial Design**: The upcoming trial will involve higher dosages and a more homogeneous patient population, which is expected to yield robust data on bacterial load reduction [19][20][21] 8. **Funding and Financial Strategy**: The company has established an equity placement facility to raise up to NOK 50 million, with the option to extend to NOK 80 million, providing financial security and strategic flexibility [43][44] Additional Important Information 1. **Regulatory Engagement**: The company has been in contact with EMA and FDA for scientific advice regarding clinical trials and orphan drug designation [39][40] 2. **Partnership Strategy**: SoftOx is open to partnerships for commercialization but will focus on generating proof-of-concept data first before engaging in formal discussions [49][50] 3. **Equity and Dilution Concerns**: The company acknowledges the need for equity issuance to fund operations, which may lead to dilution, but emphasizes the importance of this funding for advancing their clinical trials [51][52] 4. **Long-term Vision**: The management team is optimistic about the future, believing that successful clinical data will attract interest from global pharmaceutical companies for partnerships by 2027 [36][55] This summary encapsulates the key insights from the investor update call, highlighting the company's strategic direction, market potential, and the importance of upcoming clinical trials in validating their technology.