Monopar Therapeutics Inc

Monopar Therapeutics reported a wider second-quarter net loss and said it has begun a rolling New Drug Application submission for its lead candidate ALXN1840 in Wilson disease. The net loss widened to $5.3 million, or $0.62 per share, from $2.5 million, or $0.35 per share, a year earlier. Cash, cash equivalents and investments totaled $134.3 million as of June 30, 2026, expected to fund operations through at least December 31, 2027. The FDA granted Rare Pediatric Disease designation to ALXN1840 on June 30, and the company initiated the rolling NDA submission on July 22, anticipating completion within the next few months.

Several biotech stocks reached 52-week highs on August 7, 2026, driven by quarterly results and clinical advancements. Delcath Systems surged over 22% to $15.62 after reporting second-quarter net revenues of $29.1 million, up from $24.2 million a year earlier, with HEPZATO product revenue growing about 30% to $27.1 million across roughly 31 active treatment centers. Alto Neuroscience rose to a 52-week high of $29.48 following last month's registered direct offering that raised an estimated $100 million to advance its lead candidate ALTO-207 toward a Phase 3 trial. Hemab Therapeutics hit $53.60 after positive Phase 2 data showed Sutacimig reduced the mean annualized treated bleeding rate by 84% in Glanzmann thrombasthenia and Factor VIII deficiency, alongside encouraging interim Phase 2 results for HMB-002 in Von Willebrand's disease. Monopar Therapeutics reached $124.31 on the back of positive Phase 3 results for ALXN1840 in Wilson disease, which earned a Rare Pediatric Disease voucher from the FDA, with an NDA submission planned by mid-2026. Nurix Therapeutics climbed to $25.49 after receiving a $10 million milestone payment from Sanofi for the Phase 1 initiation of NX-3911 and announcing with Roche the first patient enrolled in the Phase 3 DAYBreak CLL-306 trial evaluating Bexobrutideg in relapsed/refractory chronic lymphocytic leukemia.

Several biotech stocks reached 52-week highs on July 20, 2026, driven by upcoming clinical trial launches and data readouts. Xencor Inc. hit $20.26, closing up 7%, as it advances XmAb942 in a Phase 2b ulcerative colitis trial with interim results expected by year-end 2026, and two bispecific antibodies in Phase 1 with data due in the second half of 2026. Hemab Therapeutics Holdings Inc. reached $52.15 after reporting positive Phase 2 data for Sutacimig in Glanzmann thrombasthenia and Factor VIII deficiency, showing an 84% reduction in mean annualized treated bleeding rate, along with positive interim Phase 2 results for HMB-002 in Von Willebrand's disease and the launch of HMB-003 for heavy menstrual bleeding. Monopar Therapeutics Inc. hit $115 following positive Phase 3 results for ALXN1840 in Wilson disease, for which it received a Rare Pediatric Disease voucher and plans an NDA submission by mid-2026, while also advancing MNPR-101 in Phase 1 for solid tumors. SOPHiA GENETICS SA rose over 7% to a 52-week high of $6.50, reporting first-quarter revenue of $21.7 million, up 22% year-over-year, and guiding for full-year 2026 revenue of $92 million to $94 million, representing 20% to 22% growth. Aclaris Therapeutics Inc. is advancing Bosakitug in a Phase 2 atopic dermatitis trial with topline results expected in the fourth quarter of 2026, ATI-052 in a Phase 1b for atopic dermatitis and a Phase 2b asthma program starting in the fourth quarter, and ATI-2138 in a planned Phase 2 basket study for lichen planus in the second half of 2026.

Monopar Therapeutics announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation to ALXN1840, its late-stage candidate for the treatment of Wilson disease. The designation is for therapies intended to treat serious or life-threatening diseases primarily affecting children from birth to 18 years of age. It provides Monopar with the potential to receive a pediatric Priority Review Voucher upon NDA approval, which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. Priority review can reduce the FDA's target review time by several months.

Monopar Therapeutics announced new analyses from the Phase 3 FoCus trial of ALXN1840 showing greater neurologic and global clinical improvement versus standard of care in Wilson disease patients with neurologic symptoms at baseline. In the subset of 207 patients, ALXN1840 demonstrated significant and continued neurologic improvement on the Unified Wilson Disease Rating Scale Part III, while standard of care did not. Global clinical improvement at Week 48 was significantly greater with ALXN1840, and a higher proportion of patients achieved neurologic improvement across multiple thresholds. ALXN1840 also showed similar or better outcomes on psychiatric and hepatic measures, with a favorable safety profile across 266 patients and a median treatment duration of 2.58 years. These findings support Monopar’s planned New Drug Application submission to the U.S. Food and Drug Administration in mid-2026.

Several biotech stocks surged on Tuesday, led by Boundless Bio which agreed to an all-stock merger with privately held Serapha Bio. Boundless Bio expects to declare a cash dividend to pre-merger stockholders before the deal closes in the fourth quarter of 2026, after which the combined company will operate as Serapha Bio and trade on Nasdaq under the ticker AATD. Monopar Therapeutics rose over 19% with its New Drug Application for ALXN1840 in Wilson disease on track for mid-2026 submission to the FDA. Galectin Therapeutics gained over 11% after reaching an agreement with the FDA on key elements of its planned Phase 3 program for Belapectin in MASH cirrhosis with portal hypertension, with the final protocol expected in the third quarter of 2026. Other notable movers included Jade Biosciences, up nearly 13% amid progress in its autoimmune pipeline, and Treace Medical Concepts, up almost 12% following the first surgical use of its HyperPlate XM implant.