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)

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