Announcement • 10h
F2G Ltd and Shionogi Announces Positive Topline Results from Global Phase 3 Oasis Study Evaluating Oral Olorofim Versus Ambisome Followed by Standard of Care in Patients with Invasive Aspergillosis F2G Ltd. and Shionogi & Co., Ltd. announced positive topline results from the global Phase 3 OASIS study (NCT05101187), comparing the investigational oral antifungal drug olorofim versus AmBisome (liposomal amphotericin B for injection) followed by standard of care in patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome followed by standard of care (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). No new safety findings were observed for olorofim; the rate of drug-related treatment-emergent adverse events (TEAEs) was 35.8% for olorofim and 63.9% for AmBisome followed by standard of care, with the difference mainly driven by the higher rate of renal events in the AmBisome arm. These results expand on the previous Phase 2b study data that led to olorofim’s Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA), reinforcing olorofim’s potential as a treatment for patients with invasive aspergillosis. F2G and Shionogi plan to present pivotal results from the study at a future medical congress. These data will be submitted to regulatory authorities in the U.S. by F2G and in Europe and Asia by Shionogi. Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients and is associated with substantial morbidity and mortality. Treatment options are limited for patients who cannot be treated with available azole antifungal therapies. F2G and Shionogi are collaborating to develop and commercialize olorofim and bring this novel antifungal therapy to patients with invasive fungal infections. F2G has commercial responsibility for olorofim in North America and non-Shionogi territories, and Shionogi has commercial responsibility for olorofim in Europe and Asia. The Phase 3 OASIS (Olorofim Aspergillus Infection Study) trial (NCT05101187) was a global, randomized study that evaluated the efficacy and safety of olorofim versus AmBisome followed by standard of care in adult patients with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy. OASIS was designed as a non-inferiority study using a non-inferiority margin of 20% comparing outcomes in 225 subjects randomized 2:1 to olorofim or AmBisome-based standard of care. Invasive aspergillosis is a life-threatening fungal infection with limited treatment options due to rising drug resistance and toxicity concerns. The study’s primary endpoint was all-cause mortality at Day 42, with additional measures of clinical response, safety, and quality of life. Olorofim (formerly, F901318) is F2G's leading candidate from the orotomide class and has been studied in a recently completed global Phase 3 trial ("OASIS", NCT05101187). Olorofim is a first-in-class antifungal with a novel mechanism of action, oral dosing, and activity against a wide range of Aspergillus species, including strains that are resistant to currently approved agents. If approved based on the Phase 3 OASIS data, olorofim will be the first novel mechanism agent for invasive aspergillosis in more than 20 years. In the U.S., olorofim has received orphan drug status from the FDA for the treatment of invasive aspergillosis, scedosporiosis, invasive scopulariopsis, and coccidioidomycosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for several invasive fungal infections, including invasive aspergillosis and coccidioidomycosis. Additionally, olorofim has also received two Breakthrough Therapy designations (BTD) from the FDA. The first BTD was for the treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium and Scopulariopsis species. The second BTD was for the treatment of central nervous system (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy. In Europe, olorofim has been granted orphan designation from the European Medicines Agency for the treatment of invasive aspergillosis, scedosporiosis, and invasive scopulariopsis. Olorofim is an investigational therapy and has not been approved by any regulatory authorities. 4507
Live News • Jun 12
Shionogi Trades at Discount Despite First US Approval for XOCOVA COVID-19 Prophylaxis XOCOVA (ensitrelvir) has received U.S. FDA approval as an oral post-exposure prophylaxis for COVID-19 in adults and adolescents, described as the first approved drug of its kind globally.
Shionogi’s share price return has fallen 17.82% over the past 90 days despite the FDA approval and recent product launches.
The stock is trading at a lower P/E ratio compared with peers, suggesting it may be undervalued relative to its current earnings.
The key tension here is that Shionogi has secured a new U.S. approval for a differentiated COVID-19 product while the stock has recently declined and now trades on a lower earnings multiple than similar companies.
For investors following Shionogi, the combination of new product catalysts and a discounted P/E versus peers makes valuation metrics, regulatory developments and early market adoption of XOCOVA important areas to monitor. Announcement • Jun 03
Shionogi & Co., Ltd. Announces US FDA's Approval of the Anti-Coronavirus (SARS-CoV-2) Drug Encitrelvir Fumarate for Post-Exposure Prevention of Covid-19 Shionogi & Co. Ltd. announced that its U.S. group company, Shionogi Inc., has received approval from the U.S. Food and Drug Administration (FDA) for the post-exposure prevention of COVID-19 disease in relation to the anti-SARS-CoV-2 drug encitrelvir fumarate (product name in Japan: Zocova; hereinafter referred to as "ensitrelvir"). The target date for completion of review (PDUFA) was June 16, 2026 .Disclaimer: The Above Content is Auto-Translated. This approval is based on the positive results of the global Phase 3 post-exposure prevention trial (SCORPIO-PEP *2 trial). The primary endpoint of this trial was "post-exposure prevention in cohabitants or family members of patients who developed COVID-19," and encitrelvir was the first oral antiviral drug in the world to demonstrate efficacy. In the encitrelvir group, the risk of developing COVID-19 up to day 10 after administration was statistically significantly reduced by 67% compared to the placebo group. Furthermore, encitrelvir was well-tolerated, and the incidence of adverse events was similar in both groups. The results of this trial were published in The New England Journal of Medicine on May 14, 2026 . With this approval, encitrelvir becomes the first oral antiviral drug in the United States to receive approval for post-exposure prevention of COVID-19. 
