The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

The FDA is set to rule on Spectrum Pharmaceuticals, Inc. (SPPI)'s BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is October 24.

Clinical Readouts

  • Pfizer Inc. is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.
  • Alnylam Pharmaceuticals, Inc. (ALNY) will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.
  • Omeros Corporation (OMER) is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for October 22.
  • Mustang Bio Inc. (MBIO), founded by Fortress Biotech (FBIO), is scheduled to present at the Prostate Cancer Foundation's annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for October 23.

EORTC-NCI-AACR Symposium Presentations

  • Cyclacel Pharmaceuticals Inc. (CYCC): Phase 1 safety, pharmacokinetic and pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent kinase inhibitor, in patients with advanced cancer. The presentation is being held October 24.
  • Revolution Medicines Inc. (RVMD): interim data from the Phase 1b/2 clinical trial evaluating the combination of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic mutations. The presentation is being held October 24.
  • Aileron Therapeutics Inc. (ALRN): proof-of-concept data from the Phase 1b study of ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced toxicities, such as severe anemia, neutropenia, and thrombocytopenia, in patients with p53-mutated small cell lung cancer, who are being treated with the chemotherapy topotecan. The presentation is being held October 24.
  • Turning Point Therapeutics Inc. (TPTX): First-in-human safety, pharmacokinetics, and preliminary efficacy of TPX-0022 in patients with advanced solid tumors harboring genetic alterations in MET. The presentation is being held October 24.
  • Syros Pharmaceuticals Inc. (SYRS): initial data from the ongoing dose escalation portion of its Phase 1 clinical trial of SY-5609, its highly selective and potent oral CDK7 inhibitor, in patients with select solid tumors. The presentation is being held October 24.
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