In AstraZeneca’s third trip to Asia this year, the pharma secured ex-China rights to a dual inhibitor of PDE3 and PDE4, which in a Phase 2b study significantly improved lung function and lowered symptom burden in patients with chronic obstructive pulmonary disorder. AstraZeneca has gone on another excursion to Asia, this time enlisting Sino Biopharmaceutical for a global licensing deal to address a chronic respiratory disorder. The pharma is paying $200 million upfront and offering up to $1.9

Additional capital brings total raised to $150 million in a Series C financing Funds support pivotal-stage development of Soficabtagene Geleucel, an off-the-shelf CAR-T cell therapy being evaluated in relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) New Allotera name reflects the company’s focus on advancing allogeneic cell therapies for patients with aggressive blood cancers Allotera Therapeutics, Inc. (formerly Wugen, Inc.), a clinic

July 8, 2026 -- Keenova Therapeutics plc announced today positive results from its Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic medical condition that causes nodules composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. The pivotal trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in pain versus placeb

July 8, 2026 -- Grünenthal announced today that its investigational compound tegacorat (GRM-01) received Orphan Drug and Rare Pediatric Disease Designations from the US Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). Tegacorat, a non-steroidal Selective Glucocorticoid Receptor Agonist and Modulator (SEGRAM), is an orally available investigational compound being developed to provide an alternative to glucocorticoid-based treatments such as prednisone, t

PDUFA target action date set for April 28, 2027 Varegacestat could provide a meaningful new oral treatment option for adults with desmoid tumors if approved Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted its New Drug Application (NDA) for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor (GSI

– Comprehensive updates to be presented at Barth Syndrome Foundation conference – July 8, 2026 -- Mighty Therapeutics (the "Company" or "Mighty"), a commercial-stage biotechnology company pioneering a new class of medicines that directly target mitochondrial dysfunction in rare and age-related diseases, today announced that the first patient has been dosed in 4TAZPower, its global Phase 4 study to confirm the efficacy, safety, and pharmacokinetics of once-daily elamipretide in individuals at le

Enpatoran could address a significant unmet need in lupus, specifically targeting cutaneous manifestations of the disease, which currently have no approved therapies FDA's decision was supported by Phase 2 WILLOW study results, which demonstrated meaningful symptoms improvement, particularly among patients with active cutaneous manifestations Enpatoran's potential to go beyond current treatment standards in lupus prompted FDA's breakthrough designation, which is designed to expedite drug develop

FDA clearance enables initiation of a planned Phase 1 clinical study evaluating local intravesical administration of UGN-501, with patient enrollment expected to begin in Q4 2026 UGN-501 is a differentiated investigational next-generation oncolytic virus designed to combine direct tumor cell destruction with anti-tumor immune activation July 08, 2026 -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial an

MeiraGTx has secured an investment of up to $400 million from Oberland Capital to help get its late-stage gene therapies across the commercialization finish line. Earlier this year, MeiraGTx bought back botaretigene sparoparvovec (bota-vec) from Johnson & Johnson, despite the therapy failing to improve vision-guided mobility in patients with X-linked retinitis pigmentosa (XLRP) in a phase 3 trial . Despite the trial miss, the company touted “clinically meaningful benefit” seen in the data and s

Existing data supports direct path to resubmission following constructive FDA engagement July 7, 2026 -- Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for SL1009, sodium dichloroacetate (DCA), for the treatment of pyruvate dehydrogenase complex deficiency (PDCD), a rare, life-threatening mitochondrial disease with no FDA-approved therapies. The resubmi