Biotech stocks had a rather uneventful week, as the sector was seen mostly flatlining amid light trading volume ahead of the Thanksgiving holiday.

However, Christmas came early for Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) as the FDA greenlighted its Oxlumo product as the first treatment for primary hyperoxaluria type 1, a rare genetic disorder.

Merck & Co., Inc. (NYSE:MRK) went shopping this week by agreeing to buy privately-held OncoImmune, a company that has a late-stage COVID-19 treatment candidate, for $425 million in cash.

Here are the key catalysts for the coming week.

Conferences

Piper Sandler 32nd Annual Virtual Healthcare Conference: Nov. 30-Dec. 3
3rd Annual Evercore ISI 2020 Virtual HealthCONx Conference: Dec. 1-2
American Epilepsy Society, or AES, Annual Meeting (virtual event): Dec. 4-8
62nd American Society of Hematology, or ASH, Annual Meeting and Exposition (virtual event): Dec. 5-8

PDUFA Dates

The FDA is scheduled to rule on Y-mAbs Therapeutics, Inc's (NASDAQ:YMAB) BLA for naxitamab, which is being evaluated for
relapsed/refractory high-risk neuroblastoma. The NDA has a PDUFA action date of Nov. 30.

The regulatory agency will also decide by Dec. 1 Vanda Pharmaceuticals Inc.'s (NASDAQ:VNDA) sNDA for Hetlioz capsules and its NDA for the liquid formulation of Hetlioz for the treatment of Smith-Magenis Syndrome.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) awaits an FDA nod for the NDA for oral, once-daily berotralstat for the prevention of hereditary angioedema attack, with the application having a PDUFA action date of Dec. 3.

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Clinical Readouts

Standalone Releases

Imv Inc (NASDAQ:IMV) is scheduled to hold a KOL (key opinion leader) event at 8 a.m. on Dec. 3, wherein it will provide an update on the Phase 2 trial of its T cell therapy in patients with advanced ovarian cancer.

Sutro Biopharma Inc (NASDAQ:STRO) will provide at a KOL meeting scheduled for 5 p.m. , Dec. 3, a clinical update from the dose escalation Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with ovarian cancer. The data will be based on a new data cut-off date of Oct. 30.

AES Meeting Presentations:

Xenon Pharmaceuticals Inc (NASDAQ:XENE): interim data from the Phase 2 proof-of-concept study evaluating XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy

Ovid Therapeutics Inc (NASDAQ:OVID) and Takeda Pharmaceutical Co Ltd (NYSE:TAK): abstracts from the TAK-935/OV935 clinical development program in Dravet syndrome or Lennox-Gastaut syndrome and Phase 2 data from the OV101 clinical development program in Angelman syndrome

ASH Meeting Presentations (Dec. 5)

Syros Pharmaceuticals Inc (NASDAQ:SYRS): new clinical data from the Phase 2 trial of SY-1425 in acute myeloid leukemia, or AML, and Myelodysplastic Syndrome, MDS

Celyad ADR Representing Ord Shs (NASDAQ:CYAD): results from the Phase I study of CYAD-01 in relapsed or refractory AML and MDS patients; first results from the dose escalation segment of the Phase 1 study of CYAD-02 in relapsed or refractory AML and MDS patients (Saturday, 10 a.m. to 6:30 a.m.)

Trillium Therapeutics Inc (NASDAQ:TRIL): update from the first-in-human dose escalation study of TTI-622 in patients with advanced relapsed or refractory lymphoma (Saturday from 10 a.m. onwards)

Allogene Therapeutics Inc (NASDAQ:ALLO): initial data from the Phase 1 UNIVERSAL trial of ALLO-715 in relapsed/refractory multiple myeloma patients

Legend Biotech Corp (NASDAQ:LEGN): latest data from the Phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel, that is being studied for the treatment of patients with relapsed or refractory multiple myeloma

Actinium Pharmaceuticals Inc (NYSE:ATNM): Phase 3 data for antibody Radiation Conjugate Iomab-B in AML

Beyondspring Inc (NASDAQ:BYSI): data from the confirmatory trial to demonstrate superiority of the Plinabulin+Pegfilgrastim combo versus standard-of-care Pegfilgrastim for the prevention of chemotherapy-induced neutropenia in breast cancer patients

Gamida Cell Ltd (NASDAQ:GMDA): updated data from the Phase 1 study of GDA-201, an investigational, natural killer cell-based cancer immunotherapy, for the treatment of patients with non-Hodgkin lymphoma; new data from the ongoing Phase 1/2 study of omidubicel in patients with severe aplastic anemia

Cellectis SA (NASDAQ:CLLS): Preliminary results from the Phase 1 study of of BALLI-01 in adult patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia; Phase 1 study of AMELI-01 in AML

Autolus Therapeutics PLC (NASDAQ:AUTL): Updated Phase 1 data for AUTO1 in acute lymphoblastic leukemia; updated Phase 2 data for AUTO3 in relapsed or refractory diffuse large B-cell lymphoma

Corvus Pharmaceuticals Inc (NASDAQ:CRVS): Updated Phase 1 data for CPI-818 in patients with advanced peripheral T cell lymphoma

Constellation Pharmaceuticals Inc (NASDAQ:CNST): clinical and translational data from MANIFEST Phase 2 study of CPI-0610, including 24-week data from 50 – 60 first-line and 90 –100 second-line myelofibrosis patients

Fortress Biotech (NASDAQ:FBIO) and Mustang Bio Inc (NASDAQ:MBIO): interim Phase 1/2 data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphoma

Agios Pharmaceuticals Inc (NASDAQ:AGIO): Phase 2 data for AG-348 in sickle cell disease

Pluristem Therapeutics Inc. (NASDAQ:PSTI): first clinical results from the Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation

Kura Oncology Inc (NASDAQ:KURA): Preliminary data on a Phase 1/2a study of KO-539 in patients with relapsed or refractory AML

IGM Biosciences Inc (NASDAQ:IGMS): Results of the Phase 1 dose escalation study of bispecific antibody IGM-2323 in patients with advanced B-cell malignancies

Hutchison China MediTech ADR Representing 5 Ord Shs (NASDAQ:HCM): Results from a Phase 1 dose escalation study of HMPL-689 in Chinese patients with relapsed/refractory lymphoma

Beigene Ltd (NASDAQ:BGNE): efficacy and safety of zanubrutinib in patients with treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma with del(17p)

Keros Therapeutics Inc (NASDAQ:KROS): Phase 1 data for KER-047 in anemia

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