Biotech stocks headed higher in the week ended Dec. 5 as broader market optimism pervaded into the sector. The sector also continued to get support from vaccine-related positive news flow.

The biggest headline of the week was the first-ever emergency-use authorization of a coronavirus vaccine candidate. The U.K. became the first country to conditionally approve a vaccine, as the nation's regulator gave its nod to Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) for their mRNA vaccine, BNT162b2. The timeline for authorizations elsewhere has also been set.

Moderna Inc (NASDAQ: MRNA) reported at the start of the week positive primary efficacy and safety data, and also filed for emergency use authorization with the U.S. Food and Drug Administration.

Meanwhile, Novavax, Inc. (Nasdaq: NVAX) hinted at a delay in the U.S. leg of the Phase 3 study of its vaccine candidate. And Inovio Pharmaceuticals Inc (NASDAQ: INO), which also is working on a vaccine, added a new contract development and manufacturing organization (CDMO) to its consortium of partners.

The two FDA decisions slated for the week led to positive results, with the agency approving Vanda Pharmaceuticals Inc.'s (NASDAQ: VNDA) sleep disorder drug and BioCryst Pharmaceuticals, Inc.'s (NASDAQ: BCRX) treatment for hereditary angioedema.

The week also witnessed multiple presentations at the virtual American Society of Hematology annual meeting.

Four biotechs made their Wall Street debuts this week, raising a combined $782.5 billion in gross proceeds from initial public offerings.

Here are the key catalysts for the upcoming week:

FDA Meeting On Pfizer-BioNTech Vaccine

The FDA's Vaccines and Related Biological Products Advisory Committee will meet Dec. 10 (Thursday) in an open session to discuss emergency use authorization of the vaccine developed by Pfizer and BioNTech. This is one of the most highly anticipated points in the timeline of this unfolding COVID-19 vaccine saga. It could determine whether some Americans start getting vaccines as soon as the next day. Vaccinations are set to begin in the U.K. on Tuesday.

Conferences

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
San Antonio Breast Cancer Symposium, or SABCS, being held virtually: December 8-11
ESMO Immuno-oncology Virtual Congress: Dec. 9-12

Clinical Readouts/Presentations

Sarepta Therapeutics Inc (NASDAQ: SRPT) will present on Monday interim data from the MOMENTUM study, a multiple-ascending dose clinical trial of SRP-5051, for the treatment of Duchenne muscular dystrophy.

ASH Conference Presentations

Sunday

Erytech Pharma SA (NASDAQ: ERYP): results of Phase 2 trial of eryaspase in acute lymphoblastic leukemia patients

Imara Inc (NASDAQ: IMRA): data from the ongoing IMR-687 Phase 2a open label extension clinical trial in adult patients with sickle cell disease

Blueprint Medicines Corp (NASDAQ: BPMC): Overall survival data in patients with advanced systemic mastocytosis receiving avapritinib in the Phase I EXPLORER study

Protagonist Therapeutics Inc (NASDAQ: PTGX): updated results from the Phase 2 proof-of-concept study of PTG-300 in polycythemia vera

Xencor Inc (NASDAQ: XNCR): Updated results from Phase 1 studies of vibecotamab in acute myeloid leukemia

Rocket Pharmaceuticals Inc (NASDAQ: RCKT): Phase 1 study of lentiviral mediated gene therapy for pyruvate kinase deficiency

Beigene Ltd (NASDAQ: BGNE): initial results from the MAGNOLIA Phase 2 trial of zanubrutinib in patients with relapsed/refractory marginal zone lymphoma

MacroGenics Inc (NASDAQ: MGNX): Phase 1/2 data for flotetuzumab in primary induction failure and early relapse acute myeloid leukemia

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) & Crispr Therapeutics AG (NASDAQ: CRSP): results from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9 gene-editing therapy CTX001 in patients with sickle cell disease and beta thalassemia.

ADC Therapeutics SA (NYSE: ADCT): preliminary results of a Phase 2 study of camidanlumab tesirine (Cami), an antibody-drug conjugate, in patients with relapsed or refractory Hodgkin lymphoma; interim results of loncastuximab tesirine combined with ibrutinib in relapsed/refractory diffuse large B-cell lymphoma

Syndax Pharmaceuticals Inc (NASDAQ: SNDX): updated data from the Phase 1 trial of axatilimab, its anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease

CTI BioPharma Corp (NASDAQ: CTIC): results from the Phase 1/2 study of pacritinib in graft-versus-host disease

Aptose Biosciences Inc (NASDAQ: APTO): data from the Phase 1a/b dose escalation study of CG-806 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or Non-Hodgkin's Lymphomas

Johnson & Johnson (NYSE: JNJ) & Halozyme Therapeutics, Inc. (NASDAQ: HALO): primary data from the Phase 3 APOLLO study of subcutaneous daratumumab in combination with pomalidomide and dexamethasone in patients with multiple myeloma who have received one or more prior lines of therapy

Humanigen Inc (NASDAQ: HGEN): results from the Phase 1/2 multi-center study of lenzilumab and axicabtagene ciloleucel in patients with relapsed or refractory large B cell lymphoma

Imv Inc (NASDAQ: IMV): updated data from phase 2 SPiReL study evaluating IMV's T cell therapy - DPX-Survivac - in combination with Merck & Co., Inc.'s (NYSE: MRK) Keytruda in patients with relapsed / refractory diffuse large B cell lymphoma

Related Link: What Pfizer, BioNTech Investors Need To Know About COVID-19 Vaccine With Conditional UK Approval

Monday

Bluebird bio Inc (NASDAQ: BLUE): updated results from patients in Group C of the Phase 1/2 HGB-206 study of lentiGlobin for sickle cell disease gene therapy

Rocket Pharmaceuticals: Phase 1/2 study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I and updated results from global clinical studies of RP-L102 in Fanconi anemia

Beigene: data from the Phase 2 study of zanubrutinib in patients with Waldenström macroglobulinemia as well as Phase 2 study of zanubrutinib in patients with relapsed/refractory B-cell malignancies

Sutro Biopharma Inc (NASDAQ: STRO): additional Phase 1 dose-escalation data for STRO-001 in patients with B-cell non-Hodgkin lymphoma

Precigen Inc (NASDAQ: PGEN): initial Phase 1 data for PRGN-3006 in myelodysplastic syndromes and acute myeloid leukemia

Forma Therapeutics Holdings Inc (NASDAQ: FMTX): data from the Phase 1 study of FT-4202 in patients with Sickle Cell Disease

Autolus Therapeutics PLC (NASDAQ: AUTL): longer term follow-up data for AUTO1 in acute lymphoblastic leukemia, and updated Phase 2 data and longer-term follow up data for AUTO3 in diffuse large B cell lymphoma

Curis, Inc. (NASDAQ: CRIS): results (pharmacokinetics and activity) from the Phase 1 study of CA-4948 in patient with relapsed or refractory hematologic malignancies, and results from the Phase 1 open-label dose escalation trial evaluating CA-4948 in patients with acute myelogenous leukemia or myelodysplastic syndrome

TG Therapeutics Inc common stock (NASDAQ: TGTX): results from the Phase 3 UNITY-CLL study of umbralisib plus ublituximab in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia, and results from the Phase 2 global UNITY-NHL trial that is evaluating umbralisib in patients with relapsed or refractory indolent non-Hodgkin's lymphoma

Agios Pharmaceuticals Inc (NASDAQ: AGIO): Phase 1 multiple ascending dose study data for mitapivat in subjects with sickle cell disease

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX): data from the first patient treated in the proof-of-concept study of OTL-201, an investigational ex vivo autologous hematopoietic stem cell gene therapy being studied for the treatment of mucopolysaccharidosis type IIIA

Trillium Therapeutics Inc (NASDAQ: TRIL): updates from Phase 1 dose escalation and expansion study of TTI-621, a biologic targeting CD47, in patients with relapsed or refractory hematologic malignancies

Allovir Inc (NASDAQ: ALVR): results from a Phase 2 study of ALVR106 for treating severe, drug-refractory viral infections in patients following hematopoietic stem cell transplantation

GlycoMimetics Inc (NASDAQ: GLYC) and Pfizer: Phase 3 data for rivipansel in vaso-occlusive crisis of sickle cell disease

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) and Fortress Biotech (NASDAQ: FBIO): Phase 2 dose selection study data for CAEL-101 in patients with AL amyloidosis

Oncternal Therapeutics Inc (NASDAQ: ONCT): data update for patients with mantle cell lymphoma and chronic lymphocytic leukemia, treated with cirmtuzumab plus ibrutinib in a Phase 1/2 study

Tuesday

Uniqure NV (NASDAQ: QURE): first data from the Phase 3 HOPE-B gene therapy trial evaluating efficacy and safety of Etranacogene Dezaparvovec, a AAV5-Padua hFIX variant and codenamed AMT-061, in adults with severe or moderate-severe hemophilia B treated irrespective of pre-existing anti-capsid neutralizing antibodies (11:45 am ET)

SABCS Presentations

Infinity Pharmaceuticals Inc. (NASDAQ: INFI) and Arcus Biosciences Inc (NYSE: RCUS): Efficacy and safety of Arcus' etrumadenant + pegylated liposomal doxorubicin ± Infinity's eganelisib in participants with metastatic ovarian and triple negative breast cancer (Wednesday, 2 a.m. ET)

Infinity Pharma: Poster presentation on initial Phase 2 data from the study evaluating a triple combo of Infinity's eganelisib, Roche Holdings AG's Basel ADR Common Stock (OTC: RHHBY) Tecentriq and Bristol-Myers Squibb Co (NYSE: BMY) chemotherapy medication Arabaxane as first-line therapy for locally advanced or metastatic triple-negative breast cancer (Wednesday, 2 a.m. ET)

Evelo Biosciences Inc (NASDAQ: EVLO): Poster presentation of additional data from Phase 1/2 trial of EDP1503 in triple-negative breast cancer

Athenex Inc (NASDAQ: ATNX): Phase 2 data for oral Paclitaxel and Encequidar in the treatment of cutaneous angiosarcoma, the breast angiosarcoma group

Incyte Corporation (NASDAQ: INCY) & Oncolytics Biotech, Inc. (NASDAQ: ONCY): poster presentation of phase 2 data for Incyte's retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer (Wednesday, 9 a.m. ET)

Oncolytics Biotech: Phase 2 study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel

G1 Therapeutics Inc (NASDAQ: GTHX): final analysis of Phase 2 data for trilaciclib in combination of gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer (Wednesday, 10 a.m. to 11:15 a.m.)

Puma Biotechnology Inc (NASDAQ: PBYI): Latest findings from the breast cancer cohort in the SUMMIT Phase 2 study of 'basket' trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, HR-positive, metastatic breast cancer; Final overall survival analysis from the phase 3 study of neratinib in patients with HER2-positive early-stage breast cancer (both on Wednesday)

ESMO Presentations

Innate Pharma SA (NASDAQ: IPHA): updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (Wednesday)

Earnings

Veru Inc (NASDAQ: VERU) (Wednesday, before the market open)
Enzo Biochem, Inc. (NYSE: ENZ) (Wednesday, after the close)

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

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