The Week Ahead In Biotech (Dec. 6-Dec. 11): Daré FDA Decision, Adcom Tryst For Reata, Multiple Conference Presentations And More

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. VBIV and Merck & Co., Inc. MRK 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. BYSI 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. CTIC myelofibrosis treatment was extended by three months.

With omicron concerns raging, Pfizer, Inc. PFE-BioNTech SE BNTX, and Moderna, Inc. MRNA announced new vaccine supply deals with the U.K. government.

Here are the key catalysts that a biotech investor should be focusing on in the unfolding week:



American Epilepsy Society, or AES, 2021 Annual Meeting: Dec. 3-7, in Illinois, Chicago

2021 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

63rd American Society of Hematology, or ASH, Annual Meeting & Exposition: Dec.11-14, in Atlanta, Georgia



The Food and Drug Administration is scheduled to rule on Daré Bioscience, Inc.'s DARE 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 am to 5 pm, to discuss Reata Pharmaceuticals, Inc.'s RETA 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 MGTX 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.

IDEAYA Biosciences, Inc. IDYA has scheduled a conference call on Tuesday, at 8:30 am, to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib and crizotinib combination in patients with metastatic uveal melanoma.


ESMO Immuno-Oncology Conference Presentations

Bolt Biotherapeutics, Inc. BOLT: Preliminary results from a phase 1/2 study of BDC-1001 in patients with advanced HER2-expressing solid tumors (Monday)

Nektar Therapeutics NKTR: 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. MRUS: data from the Phase 1 Dose Escalation Study of MCLA-145, a bispecific Antibody in solid tumors (Monday)

Surface Oncology, Inc. SURF: Phase 1 trial data for SRF617 as monotherapy or in combination, in patients with advanced solid tumors (Monday)

Innate Pharma S.A. IPHA: 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. BGNE: 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)

IMV Inc. IMV: Phase 2 for maveropepimut-S in advanced ovarian cancer patients (Thursday)

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates


SABCS Presentations

Gilead Sciences, Inc. GILD: Phase 3 data from the ASCENT study of Sacituzumab Govitecan in metastatic triple-negative breast cancer, or TNBC

OncoSec Medical Incorporated ONCS: 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. INFI: Updated safety and efficacy data from the Phase 2 study evaluating eganelisib in a novel triple combination with Roche Holding AG's RHHBY Tecentriq and Abraxane in unresectable locally advanced or metastatic TNBC

Context Therapeutics Inc. CNTX: preliminary results from ONA-XR in postmenopausal women with PR+/HER2- early breast cancer

Zymeworks Inc. ZYME: new clinical data for zanidatamab, in combination with chemotherapy in heavily pretreated patients with HER2-positive breast cancer

Other companies presenting at the conference include Ambrx Biopharma Inc. AMAM, Incyte Corporation INCY, Oncolytics Biotech Inc. ONCY, Jaguar Health, Inc. JAGX, Puma Biotechnology, Inc. PBYI, BeiGene and Arvinas, Inc. ARVN.


ALS/MND Symposium Presentations

Cytokinetics, Incorporated CYTK: Updated data from the Phase 3 study of Reldesemtiv in ALS patients (Tuesday)


SEUD Congress Presentations

ObsEva SA OBSV: 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 NVS: 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 disease

ADC Therapeutics SA ADCT: interim analysis of a Phase 2 Study of Loncastuximab Tesirine Plus ibrutinib in patients with advanced diffuse large B-cell lymphoma

Imago BioSciences, Inc. IMGO: 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. REGN: 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 ALNY cemdisiran (in healthy volunteers

AbbVie Inc. ABBV: 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. ATNM, NexImmune, Inc. NEXI, ImmunoGen, Inc. IMGN, Epizyme, Inc. EPZM, Mereo BioPharma Group plc MREO, Forma Therapeutics Holdings, Inc. FMTX, Bio-Path Holdings, Inc. BPTH, Cellectis S.A. CLLS, Karyopharm Therapeutics Inc. KPTI, Protagonist Therapeutics, Inc. PTGX, Global Blood Therapeutics, Inc. GBT, MorphoSys AG MOR, Agios Pharmaceuticals, Inc. AGIO, AlloVir, Inc. ALVR, Kura Oncology, Inc. KURA, Aprea Therapeutics, Inc. APRE, CASI Pharmaceuticals, Inc. CASI, Atossa Therapeutics, Inc. ATOS, Keros Therapeutics, Inc. KROS and Precision BioSciences, Inc. DTIL.



Applied DNA Sciences, Inc. APDN (Thursday, after the close)


IPO Quiet Period Expiry

Bluejay Diagnostics, Inc. BJDX, Vaxxinity, Inc. VAXX, Tivity Health, Inc. TVTY, and Journey Medical Corporation DERM

Related Link: Arbutus Shares Are Soaring As Moderna Loses Appeal Of Board Ruling On COVID-19 Vaccine Delivery Technology Patent

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