Aldeyra Therapeutics, Inc. ALDX

Aldeyra Therapeutics Inc is a biotechnology company engaged in developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated and metabolic diseases. The company's product candidate, Reproxalap, is a treatment in late-stage development for dry eye disease and allergic conjunctivitis. In addition, it also has additional product candidates in development for proliferative vitreoretinopathy, primary vitreoretinal lymphoma, and other retinal diseases, autoimmune disease, and cancer. Company products includes ADX248, ADX743, ADX631, ADX246, ADX629, ADX2191.

• Zacks Investment Research 29 sept

  Acadia's Daybue Patent Allowance Extends U.S. Protection to March 2041

  Acadia Pharmaceuticals received a Notice of Allowance from the USPTO that extends patent protection for trofinetide (Daybue) to March 2041, adding nearly five years to existing coverage. Daybue sales grew 25% to $226 million in H1 2026, and the drug received EU approval in August 2026, becoming the first and only approved treatment for Rett syndrome in Europe.

  

• Zacks Investment Research 23 sept

  Vertex Posts Positive Phase II Data on Kidney Disease Drug

  Vertex Pharmaceuticals reported positive results from its phase IIb AMPLIFIED study, showing that inaxaplin reduced UACR by 42.7% in AMKD patients with modest proteinuria and 17.3% in those with AMKD and type II diabetes. The company has completed enrollment in the phase II/III AMPLITUDE pivotal study, with interim data expected in early 2027. Inaxaplin was well-tolerated with no serious adverse events reported.

  

• Zacks Investment Research 18 sept

  XENE Files NDA for Epilepsy Drug, Falls on Depression Studies' Setback

  Xenon Pharmaceuticals submitted an FDA application for azetukalner to treat focal onset seizures, supported by positive phase IIb and phase III epilepsy studies showing significant seizure reductions. However, the company temporarily paused enrollment in depression studies due to neuropsychiatric adverse events, causing a 27% stock decline in premarket trading. The X-NOVA2 depression study is 80% enrolled with top-line data expected in Q1 2027.

  

• Zacks Investment Research 15 sept

  Definium Reports Second Phase III Success in Anxiety Disorder Program

  Definium Therapeutics announced positive Phase III results for DT120 ODT in generalized anxiety disorder, with the Panorama study meeting primary and key secondary endpoints. The treatment showed a 5.1-point placebo-adjusted benefit in HAM-A scores at Week 12 with rapid effects by day 2. The company plans an FDA pre-NDA meeting in Q4 2026 and NDA filing in H1 2027, with DT120 also advancing in major depressive disorder and posttraumatic stress disorder trials.

  

• Zacks Investment Research 14 sept

  GSK Presents Jideytro Data for Potential Use in First-Line NSCLC

  GSK announced positive data from the ARROS-1 study showing Jideytro (zidesamtinib) achieved a 94% response rate in first-line ROS1-positive NSCLC patients, with 90% remaining progression-free at 12 months and 70% of patients with brain metastases achieving complete tumor clearance. The drug was acquired through GSK's purchase of Nuvalent and is expected to support a supplemental FDA application for first-line use expansion.