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The Week Ahead In Biotech (Nov. 1-7): Adcom Test For Biogen's Aducanumab, Alzheimer's Conference, SMID-cap Earnings

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The Week Ahead In Biotech Nov. 1-7: Adcom Test For Biogen's Aducanumab, Alzheimer's Conference, SMID-cap Earnings

Biotech stocks continued to sway to the tunes of the broader market in the week ended Oct. 30, which succumbed to geopolitical and macroeconomic concerns.

Several big-name pharma companies, including Merck & Co. Inc. (NYSE: MRK) and Pfizer Inc. (NYSE: PFE), reported earnings during the week. The earnings news flow was broadly mixed.

Catabasis Pharmaceuticals Inc (NASDAQ: CATB) was among the biggest decliners, as it halted a late-stage trial of its Duchenne muscular dystrophy drug.

On the other hand, Scholar Rock Holding Corp. (NASDAQ: SRRK) was up about over 175% during the week, reacting to positive mid-stage results for spinal muscular atrophy drug.

On the COVID-19 front, Regeneron Pharmaceuticals Inc. said it is (NASDAQ: REGN) halting the Phase 3 trial of its antibody cocktail in patients with severe COVID-19, citing safety issue.

Kala Pharmaceuticals Inc. (NASDAQ: KALA) announced FDA approval for its dry eye disease drug, while Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) communicated a delay in the decision for its treatment option for chemotherapy-induced neutropenia, as the FDA could not inspect a plant in South Korea due to COVID-19.

Here're the key catalysts for the unfolding week:

 

Conferences

 

  • International Cytokine and Interferon Society's Cytokines, or, ICIS, 2020 Conference – Nov. 1–5
  • 13th Clinical Trials on Alzheimer's Disease, or CTAD: Nov. 4-7

 

Adcom Calendar

 

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss Friday Biogen Inc's (NASDAQ: BIIB) BLA for its Alzheimer's treatment candidate aducanumab. On Nov. 4, the FDA will release briefing document that has the potential to move the stock.

Outperformance of Biogen hinges on a positive regulatory verdict for aducanumab, according to SVB Leerink analyst Marc Goodman.

 

Clinical Readouts/Presentations

 

Surface Oncology Inc. (NASDAQ: SURF) is scheduled to present at the ICIS congress, preclinical data on SRF388, a first in class IL-27 blocking antibody, in clinical trials for patients with cancer. (Sunday. 5:30 pm-7:30 pm)

vTv Therapeutics Inc. (NASDAQ: VTVT) will make an oral presentation at the CTAD, providing a general study update and data on the baseline characteristics of patients enrolled in the ongoing phase 2 Elevage Study of azeliragon as a potential treatment for mild-probable Alzheimer's disease in adult patients who also have type 2 diabetes. (Wednesday, 1am)

Bellerophon Therapeutics Inc. (NASDAQ: BLPH) will present at the American Thoracic Society Interstitial Lung Disease Mini Symposia as well as the 2020 Pulmonary Fibrosis Foundation Meeting, data from its Phase 2 study of INOpulse for the treatment of fibrotic interstitial lung disease patients at risk for pulmonary hypertension. (Thursday)

Cassava Sciences Inc. (NASDAQ: SAVA) is due to present at the CTAD conference, results of its Phase 2b study of sumifilam in Alzheimer's disease. (Saturday, 11:10 am)

 

Earnings

 

Monday

  • IVERIC bio Inc. (NASDAQ: ISEE) (before the market open)
  • Eagle Pharmaceuticals Inc. (NASDAQ: EGRX) (before the market open)
  • Intersect ENT Inc (NASDAQ: XENT) (before the market open)
  • Horizon Therapeutics PLC (NASDAQ: HZNP) (before the market open)
  • Minerva Neurosciences Inc (NASDAQ: NERV) (before the market open)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the close)
  • Neuronetics Inc (NASDAQ: STIM) (before the market open)
  • Inspire Medical Systems Inc (NYSE: INSP) (before the market open)
  • Veracyte Inc (NASDAQ: VCYT) (before the market open)
  • Syndax Pharmaceuticals Inc. (NASDAQ: SNDX) (before the market open)
  • Halozyme Therapeutics Inc. (NASDAQ: HALO) (before the market open)
  • Esperion Therapeutics Inc. (NASDAQ: ESPR) (before the market open)
  • Urovant Sciences Ltd. (NASDAQ: UROV) (before the market open)
  • DURECT Corporation (NASDAQ: DRRX) (before the market open)
  • SI-Bone Inc (NASDAQ: SIBN) (before the market open)
  • Karyopharm Therapeutics (Inc NASDAQ: KPTI)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)

Tuesday

  • Oxford Immunotec Global PLC (NASDAQ: OXFD) (before the market open)
  • Catalent Inc (NYSE: CTLT) (before the market open)
  • Avanos Medical Inc. (NYSE: AVNS) (before the market open)
  • Acorda Therapeutics Inc. (NASDAQ: ACOR) (after the close)
  • Five Prime Therapeutics Inc. (NASDAQ: FPRX) (after the close)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)
  • Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) (after the close)

Related Link: Aldeyra Has 'Catalayst-Rich' 12 Months Ahead, Jefferies Says In Bullish Initiation

Wednesday

  • Haemonetics Corp. (NYSE: HAE) (before the market open)
  • Aquestive Therapeutics Inc. (NASDAQ: AQST) (after the close)
  • Anika Therapeutics Inc. (NASDAQ: ANIK) (after the close)
  • Axonics Modulation Technologies Inc. (NASDAQ: AXNX) (after the close)
  • ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the close)
  • T2 Biosystems Inc. (NASDAQ: TTOO) (after the close)
  • OraSure Technologies, Inc. (NASDAQ: OSUR) (after the close)
  • Hologic Inc. (NASDAQ: HOLX) (after the close)
  • Otonomy Inc. (NASDAQ: OTIC) (after the close)
  • SurModics Inc. (NASDAQ: SRDX) (after the close)
  • Sangamo Therapeutics Inc. (NASDAQ: SGMO) (after the close)
  • PRA Health Sciences Inc. (NASDAQ: PRAH) (after the close)
  • Cytosorbents Corp. (NASDAQ: CTSO) (after the close)
  • Lineage Cell Therapeutics Inc. (NYSE: LCTX) (after the close)
  • Insulet Corp. (NASDAQ: PODD) (after the close)
  • Cytokinetics Inc. (NASDAQ: CYTK) (after the close)
  • MannKind Corp. (NASDAQ: MNKD) (after the close)
  • Flexion Therapeutics Inc. (NASDAQ: FLXN) (after the close)
  • DiaMedica Therapeutics Inc. (NASDAQ: DMAC) (after the close)
  • Orthopediatrics Corp. (NASDAQ: KIDS))
  • Ionis Pharmaceuticals Inc. (NASDAQ: IONS)
  • G1 Therapeutics Inc. (NASDAQ: GTHX)
  • Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI)

Thursday

  • Kura Oncology Inc. (NASDAQ: KURA) (before the market open)
  • Synlogic Inc. (NASDAQ: SYBX) (before the market open)
  • Regeneron (before the market open)
  • Bristol-Myers Squibb Co. (NYSE: BMY) (before the market open)
  • Arbutus Biopharma Corp. (NASDAQ: ABUS) (before the market open)
  • Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY) (before the market open)
  • Athenex Inc (NASDAQ: ATNX) (before the market open)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) (before the market open)
  • ANI Pharmaceuticals Inc Common Stock (NASDAQ: ANIP) (before the market open)
  • Antares Pharma Inc. (NASDAQ: ATRS) (before the market open)
  • Agios Pharmaceuticals Inc. (NASDAQ: AGIO) (before the market open)
  • X4 Pharmaceuticals Inc. (NASDAQ: XFOR) (before the market open)
  • SAGE Therapeutics Inc. (NASDAQ: SAGE) (before the market open)
  • Intellia Therapeutics Inc. (NASDAQ: NTLA) (before the market open)
  • Kala Pharmaceuticals Inc. (NASDAQ: KALA) (before the market open)
  • OptiNose Inc. (NASDAQ: OPTN) (before the market open)
  • Orthofix Medical Inc. (NASDAQ: OFIX) (before the market open)
  • Radius Health Inc (NASDAQ: RDUS) (before the market open)
  • Repligen Corp. (NASDAQ: RGEN) (before the market open)
  • Incyte Corp. (NASDAQ: INCY) (before the market open)
  • Eyepoint Pharmaceuticals Inc. (NASDAQ: EYPT) (before the market open)
  • Concert Pharmaceuticals Inc. (NASDAQ: CNCE) (before the market open)
  • Clovis Oncology Inc. (NASDAQ: CLVS) (before the market open)
  • Vericel Corp. (NASDAQ: VCEL) (before the market open)
  • Provention Bio Inc. (NASDAQ: PRVB) (before the market open)
  • Harvard Bioscience Inc. (NASDAQ: HBIO) (before the market open)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
  • BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (before the market open)
  • Amarin Corporation plc (NASDAQ: AMRN) (before the market open)
  • Y-mAbs Therapeutics Inc. (NASDAQ: YMAB) (after the close)
  • AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) (after the close)
  • Aerie Pharmaceuticals Inc. (NASDAQ: AERI) (after the close)
  • Adamas Pharmaceuticals Inc. (NASDAQ: ADMS) (after the close)
  • Transenterix Inc. (NYSE: TRXC) (after the close)
  • Paratek Pharmaceuticals Inc. (NASDAQ: PRTK) (after the close)
  • Nektar Therapeutics (NASDAQ: NKTR) (after the close)
  • Spero Therapeutics Inc. (NASDAQ: SPRO) (after the close)
  • Misonix Inc. (NASDAQ: MSON) (after the close)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP) (after the close)
  • Xencor Inc (NASDAQ: XNCR) (after the close)
  • Oyster Point Pharma Inc. (NASDAQ: OYST) (after the close)
  • Sarepta Therapeutics Inc. (NASDAQ: SRPT) (after the close)
  • Natera Inc. (NASDAQ: NTRA) (after the close)
  • ICU Medical Inc. (NASDAQ: ICUI) (after the close)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close)
  • Guardant Health Inc (NASDAQ: GH) (after the close)
  • Retrophin Inc (NASDAQ: RTRX) (after the close)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the close)
  • Chembio Diagnostics Inc (NASDAQ: CEMI) (after the close)
  • Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) (after the close)
  • Exelixis, Inc. (NASDAQ: EXEL) (after the close)
  • Endo International PLC (NASDAQ: ENDP) (after the close)
  • FibroGen Inc (NASDAQ: FGEN) (after the close)
  • Fluidigm Corporation (NASDAQ: FLDM) (after the close)
  • Nevro Corp (NYSE: NVRO) (after the close)
  • CytomX Therapeutics Inc (NASDAQ: CTMX) (after the close)
  • Dynavax Technologies Corporation (NASDAQ: DVAX) (after the close)
  • Geron Corporation (NASDAQ: GERN) (after the close)
  • CorMedix Inc. (NYSE: CRMD) (after the close)
  • Celcuity Inc (NASDAQ: CELC) (after the close)
  • BioLife Solutions Inc (NASDAQ: BLFS) (after the close)
  • Caladrius Biosciences Inc (NASDAQ: CLBS) (after the close)
  • Theravance Biopharma Inc (NASDAQ: TBPH) (after the close)
  • Global Blood Therapeutics Inc (NASDAQ: GBT) (after the close)
  • Coherus Biosciences Inc (NASDAQ: CHRS) (after the close)
  • Iovance Biotherapeutics Inc (NASDAQ: IOVA)
  • AtriCure Inc. (NASDAQ: ATRC)
  • Acceleron Pharma Inc (NASDAQ: XLRN)
  • ADMA Biologics Inc (NASDAQ: ADMA)
  • Ocular Therapeutix Inc (NASDAQ: OCUL)
  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
  • Syros Pharmaceuticals Inc (NASDAQ: SYRS)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
  • Sensus Healthcare Inc (NASDAQ: SRTS)
  • Deciphera Pharmaceuticals Inc (NASDAQ: DCPH)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)
  • Chiasma Inc (NASDAQ: CHMA)
  • Emergent Biosolutions Inc (NYSE: EBS)
  • INmune Bio Inc (NASDAQ: INMB)
  • Calithera Biosciences Inc (NASDAQ: CALA)

Friday

  • Mylan NV (NASDAQ: MYL) (before the market open)
  • Amphastar Pharmaceuticals Inc (NASDAQ: AMPH) (before the market open)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
  • Elanco Animal Health Inc (NYSE: ELAN) (before the market open)
  • Matinas BioPharma Holdings Inc (NYSE: MTNB) (before the market open)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)

 

IPO Analysts' Quiet Period Expiry

 

  • Aziyo Biologics Inc (NASDAQ: AZYO)
  • Kronos Bio Inc (NASDAQ: KRON)
  • Spruce Biosciences Inc (NASDAQ: SPRB)

Related Link: Moderna Bull, Bear On Q3 Report, Coronavirus Vaccine Timeline

 

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