The Omicron variant concerns were front and center in the markets in the week ended Dec. 3, and biotech stocks did not escape the brunt of selling in the wake of the negative development. The sector recorded weekly losses, reversing course from the previous week’s advance.
Regulatory decisions scheduled for the week turned in mixed outcomes. VBI Vaccines Inc. and Merck & Co. Inc. received greenlights from the FDA, the former for its PreHevbrio, a preventative treatment for hepatitis B virus infection, and latter for an expanded label for its cancer drug Keytruda.
On the other hand, BeyondSpring Inc. faced an outright rejection for its Plinabulin, in combination with granulocyte colony-stimulating factor, for the prevention of chemotherapy-induced neutropenia. The review period for CTI BioPharma Corp. myelofibrosis treatment was extended by three months.
With Omicron concerns raging, Pfizer Inc.-BioNTech SE, and Moderna Inc. announced new vaccine supply deals with the UK government.
Conferences
American Epilepsy Society, or AES, 2021 Annual Meeting: Dec. 3–7, in Illinois, Chicago2021 San Antonio Breast Cancer Symposium, SABCS: Dec. 7–10 in San Antonio, Texas
32nd International Symposium On Amyotrophic Lateral Sclerosis, or ALS/Motor Neurone Disease, or MND, (held virtually): Dec. 7–10
Stifel GMP 2nd Annual Future of Healthcare Conference: Dec. 8
European Society For Medical Oncology, or ESMO, Immuno-Oncology Online Congress: Dec. 8–11
77th Society Of Endometriosis And Uterine Disorders, SEUD, Congress: Dec. 9–11, in Stockholm, Sweden
PDUFA Dates
The Food and Drug Administration is scheduled to rule on Daré Bioscience Inc.’s new drug application for Dare-BV1, an investigational treatment for bacterial vaginosis. The PDUFA goal date is scheduled for Tuesday, Dec. 7.Adcom Meeting
FDA’s Cardiovascular And Renal Drugs Advisory Committee is scheduled to meet on Dec. 8, 9:30 a.m. to 5 p.m., to discuss Reata Pharmaceuticals Inc.’s NDA for bardoxolone methyl capsules for the proposed indication of slowing the progression of chronic kidney disease caused by Alport syndrome in patients 12 years of age and older.Clinical Readouts/Presentations
Standalone Releases
MeiraGTx Holdings plc. will host a conference call and webcast to provide an update Tuesday, at 8 am, on its AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia.ESMO Immuno-Oncology Conference Presentations
Bolt Biotherapeutics Inc.: Preliminary results from a phase 1/2 study of BDC-1001 in patients with advanced HER2-expressing solid tumors (Monday)Nektar Therapeutics: Preliminary results from a phase 1/2 study of bempegaldesleukin plus Merck’s Keytruda, with or without chemotherapy in patients with metastatic non-small cell lung cancer (Monday)
Merus N.V.: data from the Phase 1 Dose Escalation Study of MCLA-145, a bispecific Antibody in solid tumors (Monday)
Surface Oncology Inc.: Phase 1 trial data for SRF617 as monotherapy or in combination, in patients with advanced solid tumors (Monday)
Innate Pharma S.A.: Phase 2 data for monalizumab, cetuximab, and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (Thursday)
BeiGene Ltd.: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with PD-(L)1-refractory/ resistant unresectable or metastatic melanoma from a Phase 1b study (Thursday)
SABCS Presentations
Gilead Sciences Inc.: Phase 3 data from the ASCENT study of Sacituzumab Govitecan in metastatic triple-negative breast cancer, or TNBCOncoSec Medical Incorporated: updated Phase 2 data for Tavo from the KEYNOTE-890 clinical trial in combination with Keytruda with or without chemotherapy in patients with inoperable locally advanced or metastatic TNBC
Infinity Pharmaceuticals Inc.: Updated safety and efficacy data from the Phase 2 study evaluating eganelisib in a novel triple combination with Roche Holding AG’s (PNK: RHHBY) Tecentriq and Abraxane in unresectable locally advanced or metastatic TNBC
Context Therapeutics Inc.: preliminary results from ONA-XR in postmenopausal women with PR+/HER2- early breast cancer
Zymeworks Inc.: new clinical data for zanidatamab, in combination with chemotherapy in heavily pretreated patients with HER2-positive breast cancer
ALS/MND Symposium Presentations
Cytokinetics, Incorporated: Updated data from the Phase 3 study of Reldesemtiv in ALS patients (Tuesday)SEUD Congress Presentations
ObsEva SA: results from a Phase 2b dose-ranging trial of linzagolix in endometriosis and Phase 3 data for linzagolix in uterine fibroids (Friday)ASH Meeting Presentations
Novartis AG: new longer-term data from pivotal Phase 3 ASCEMBL study for recently U.S.-approved Scemblix in patients with PH+ chronic myeloid leukemia, final analysis from Phase 1b study evaluating sabatolimab in combination with HMAs in patients with very high/high-risk myelodysplastic syndrome and acute myeloid leukemia and first analysis of Phase 2 SOLACE-kids data on Adakveo in pediatric patients aged 12–17 years old with sickle cell diseaseADC Therapeutics SA: interim analysis of a Phase 2 Study of Loncastuximab Tesirine Plus ibrutinib in patients with advanced diffuse large B-cell lymphoma
Imago BioSciences Inc.: Phase 2 data for IMG-7289 in advanced myelofibrosis and essential thrombocythemia
Roche: Phase 3 data for Polivy and chemo combo in diffuse large B-cell lymphoma, pivotal results from the Phase 1/2 study of mosunetuzumab with relapsed or refractory follicular lymphoma, and interim data from the Phase 3 study of Hemlibra in people with moderate or mild hemophilia A without factor VIII inhibitors
Regeneron Pharmaceuticals Inc.: new data for REGN5458 in patients with heavily pretreated multiple myeloma and first data evaluating a combination therapy approach with pozelimab and Alnylam Pharmaceuticals Inc.’s cemdisiran (in healthy volunteers
AbbVie Inc.: final overall survival results from the Phase 3 study of Venetoclax or placebo in combination with Bortezomib and dexamethasone in multiple myeloma
Other ASH presenters for the week include Actinium Pharmaceuticals Inc., NexImmune Inc., ImmunoGen Inc., Epizyme Inc., Mereo BioPharma Group plc., Forma Therapeutics Holdings Inc., Bio-Path Holdings Inc. , Cellectis S.A. , Karyopharm Therapeutics Inc., Protagonist Therapeutics Inc., Global Blood Therapeutics Inc., MorphoSys AG, Agios Pharmaceuticals Inc., AlloVir Inc., Kura Oncology Inc., Aprea Therapeutics Inc., CASI Pharmaceuticals Inc., Atossa Therapeutics Inc., Keros Therapeutics Inc., and Precision BioSciences Inc.
