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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