Helus Pharma Appoints Michael Halstead CEO, Completes Enrollment in Phase 3 APPROACH Study of HLP003 and Reports Q2 2026 Results

• Outlook Therapeutics reported a $20.3 million loss for the third quarter, coinciding with the FDA approval of its intravitreal treatment, LYTENAVA. • Management projects that LYTENAVA could generate over $500 million in annual U.S. sales by 2030 due to its direct-to-retina delivery method.

• Eli Lilly and Company is urging online platforms, payment processors, and regulators to dismantle the illegal black market for retatrutide. • Retatrutide is currently an investigational molecule in Phase 3 clinical trials for obesity and type 2 diabetes and has not been approved for human use by any global regulatory agency.

• Thousands of people were sickened by Cyclospora after the parasite evaded U.S. food safety systems, highlighting critical gaps in contamination tracking. • The FDA cut a specific program for tracking Cyclospora outbreaks and delayed a rule that would have forced companies to provide supply chain records more quickly during investigations.

• Researchers are testing a novel approach to treating depression by using anti-inflammatory drugs to calm the immune system rather than targeting brain chemicals. • Early results from a small clinical trial indicate that this immune-focused strategy shows promise in alleviating depressive symptoms.

• The Medicines and Healthcare products Regulatory Agency (MHRA) is proposing a shake-up of the UK's medicines approval process to accelerate the development of treatments for rare diseases. • With approximately 10,000 rare diseases existing, the vast majority currently lack effective therapies, creating significant gaps in patient care.

• UCLA researchers have developed a new blood test designed to identify multiple types of cancer at an early stage by acting as a "health radar" for the body. • The method works by removing large quantities of normal blood-cell DNA, allowing the test to detect rare signals from tumors or damaged organs that are typically overwhelmed.

• Helus Pharma reported its financial results for the first quarter of fiscal 2027, ending June 30, 2026, alongside key business updates. • The company appointed former Intra-Cellular Therapies President Michael Halstead as CEO to oversee late-stage development and future commercialization efforts.

• The FDA has approved mFLUSIVA, a new mRNA-based flu vaccine designed to provide enhanced protection for older adults. • Clinical trials demonstrated the vaccine is highly effective in preventing serious illness for adults aged 50 to 64, with accelerated approval granted for those 65 and older.

• A new executive order regarding childhood vaccines has been issued, alongside the appointment of a permanent director for the CDC to fill a year-long vacancy. • The FDA has approved the first mRNA-based flu vaccine, while the American Academy of Pediatrics (AAP) released its official recommendations for the upcoming flu season.

• A new study published June 2, 2026, reveals that the type of dietary fat consumed significantly impacts pancreatic cancer progression. • Researchers discovered that oleic acid, primarily found in olive oil, helped reduce the disease by half, while other fats promoted tumor growth.

• Associate Professor Damali Campbell-Oparali of Rutgers New Jersey Medical School is addressing the systemic drivers behind maternal health disparities affecting Black mothers. • The discussion focuses on the specific challenges Black women navigate during pregnancy and the postpartum period to identify gaps in care.