Update for July 26, 2022

Regulatory Update
 
The FDA designated gedatolisib a Breakthrough Therapy for the treatment of HR+/HER2- metastatic breast cancer that has progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor.
 
Acadia submitted an NDA for trofinetide for the treatment of Rett syndrome.
 
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) supports an expedited review of sabizabulin for the treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS).

The EMA approved teclistamab for the treatment of relapsed and refractory multiple myeloma.
 
The EMA approved eladocagene exuparvovec for the treatment of aromatic l-amino acid decarboxylase (AADC) deficiency.
 
Announced Research Updates
 
VBL Therapeutic announced that in the 409 patient, Phase III OVAL trial, adding ofranergene obadenovec to paclitaxel did not improve overall survival or progression-free survival compared to paclitaxel monotherapy in patients with platinum-resistant ovarian cancer.
 
VistaGen announced that in the Phase III PALISADE-1 trial, treatment with PH94B did not decrease the Subjective Units of Distress Scale (SUDS) compared to placebo in patients with social anxiety experiencing acute anxiety.
 
Published Research Updates
 
The 639 patient Phase III, INTELLANCE-1 trial was discontinued after an interim analysis failed to demonstrate an improvement in overall survival with depatuxizumab in combination with radiation and temozolomide in the treatment of EGFR-amplified glioblastoma.
 
In the 52-week, 346 patient, Phase III, ACOUSTICS trial, the annual exacerbation rate was decreased by 51% with lebrikizumab 125 mg and 40% with 37.5 mg compared to placebo in adolescents (aged 12-17 years) with uncontrolled asthma.
 
In the 20-week, 276 patient, Phase II METEORIC-HF trial, treatment with omecamtiv mecarbi did not improve peak oxygen uptake during cardiopulmonary exercise testing compared to placebo in patients with HFrEF.
 
In the six-week, 166 patient, Phase III FLASH trial, 16% of patients treated with one cycle of light activated topical hypericin had at least a 50% reduction in lesions compared to 4% with placebo in patients with early-stage cutaneous T-cell lymphoma. In the open-label extension of the trial, 40% of patients that received two cycles and 49% that received three cycles achieved a 50% reduction.
 
In a 12-week, 40 patient, Phase II trial, treatment with palovarotene did not reduce heterotopic ossification flare-ups compared to placebo in patients with fibrodysplasia ossificans progressiva (FOP).
 
In a 402 patient, Phase III trial, treatment with the oral combination of paclitaxel and encequidar resulted in an overall response rate of 36% compared to 23% with IV paclitaxel in patients with metastatic breast cancer.
 
In the induction phase of the 50-week, 219 patient, Phase III ultraVIOLET trial, oteseconazole was non-inferior to fluconazole (93.2% vs 95.8%) in resolving an acute vulvovaginal candidiasis (VVC) infection in female patients with recurrent VVC. 185 patients entered the maintenance phase and were treated with oteseconazole or fluconazole for 11 weeks and then followed for 37 weeks. At the end of 48-weeks, 5.1% of oteseconazole patients experienced a culture-verified acute infection compared to 42.2% with fluconazole.