Benzinga | Nov 1, 2020 09:40AM EST

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 (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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