Most material SEC filings — September 14, 2026

Bally's Corporation secured $560M in new financing from WhiteHawk Capital Partners ($400M closing date term loan + $160M delayed draw term loan) to fund pre-construction costs for the Bally's Bronx casino project and general corporate purposes. Financing expected to close Q3 2026, subject to regulatory approval and customary conditions.

Lipocine announced initiation of BLOOM, a Phase 3 placebo-controlled study of LPCN 1154 (oral brexanolone) for postpartum depression, enrolling approximately 120 participants with first dosing expected early Q4 2026. The prior Phase 3 trial failed its primary endpoint in full analysis but exploratory post-hoc analyses showed efficacy after excluding one high-enrolling site with data-quality issues (40% of treated participants had undetectable drug levels). Lipocine expects ~$1M monthly cash burn during study execution; as of June 30, 2026, the company had $23.3M in unrestricted cash and believes existing resources are sufficient for BLOOM.

Addentax Group Corp. entered into a private placement agreement dated September 9, 2026, to issue 520,834 shares of common stock to Chan Chun Hong (CEO/signatory) at $4.80 per share, generating approximately $2.50M in gross proceeds. Chan Chun Hong is identified as both a company officer (signatory) and the investor. The shares are unregistered, subject to a securities legend, and the transaction requires PRC governmental approval within 45–90 days post-closing. The agreement contains standard representations, warranties, and a one-year survival period (except for certain provisions surviving indefinitely).

Armata Pharmaceuticals announced FDA Breakthrough Therapy designation for AP-SA02, a bacteriophage therapeutic for complicated Staphylococcus aureus bacteremia (MRSA/MSSA). The designation is supported by Phase 1b/2a diSArm study data showing 100% clinical response maintenance at 28 days with AP-SA02 plus antibiotics versus 75% with placebo plus antibiotics, with no serious adverse events. AP-SA02 now holds Breakthrough Therapy, Fast Track, and QIDP designations; Phase 3 anticipated to initiate H2 2026, supported by $28.7M Department of War award through MTEC.

Immunocore announced full enrollment of 540 patients in TEBE-AM, a Phase 3 registrational trial testing KIMMTRAK (tebentafusp) as monotherapy and in combination with pembrolizumab versus Investigator's Choice in HLA-A*02:01-positive patients with previously treated advanced melanoma. The primary endpoint is overall survival; topline data expected end of 2026. The trial addresses an estimated 4,000-patient addressable market in the US and Europe for the post-PD1 setting.

Corbus Pharmaceuticals announced positive topline data from CANYON-1, a 254-patient Phase 1b trial of CRB-913 (oral CB1 inverse agonist) for obesity. At the 60 mg dose over 12 weeks, CRB-913 achieved 5% placebo-adjusted mean weight loss with no plateau observed; all three dose cohorts (20/40/60 mg, n=65/61/62 respectively) showed statistically significant weight loss vs. placebo (p=0.0001). Safety profile was favorable: psychiatric adverse events were mild/moderate and infrequent (1.6% depression at 60 mg), with no serious psychiatric events; GI tolerability appeared superior to published oral GLP-1 data. The company plans Phase 2 initiation in 1H 2027 and FDA engagement on development strategy.

Perspective Therapeutics and Merck announced a clinical collaboration agreement on September 14, 2026, to evaluate Perspective's [212Pb]PSV359 (targeted alpha-particle therapy) in combination with Merck's Keytruda (pembrolizumab) in an amendment to Perspective's ongoing Phase 1/2a study of FAP-α-positive solid tumors (non-small cell lung cancer and colorectal cancer). Perspective is sponsoring the study; Merck is supplying pembrolizumab at no cost. The study has completed enrollment in the first three monotherapy dose cohorts and will now proceed to combination dosing.

Q32 Bio announced the appointment of Jos Trevejo, M.D., Ph.D. as Chief Medical Officer and Ellie Hershberger, Pharm.D. as Chief Development Officer on September 14, 2026. Both executives bring 20+ and 30+ years of late-stage clinical development experience respectively. The appointments support Q32 Bio's transition toward a registration-directed program for bempikibart in severe alopecia areata, anticipated in H1 2027, with potential expansion to additional indications.