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Biotech stocks advanced in the week ended November 13 amid a vaccine news flow-induced rally that also lifted the broader market. The week started with positive tidings from Pfizer Inc. (PFE) and its German partner BioNTech SE – ADR (BNTX), which reported positive interim Phase 3 data for their jointly developed mRNA vaccine against the COVID-19 coronavirus.

An update from rival vaccine developer Moderna Inc. (MRNA) on reaching the mandated number of cases for its first interim analysis also generated optimism. Five Prime Therapeutics Inc. (FPRX) rallied over 300% during the week, with the upside primarily due to a positive mid-stage readout for its investigational drug in a stomach cancer study. Supernus Pharmaceuticals Inc. (SUPN), meanwhile, came under pressure after the FDA rejected its ADHD drug.

Earnings news flow continued, but the week was silent on the IPO front. Multiple conferences got underway during the week, giving biopharma companies a chance to show new data on products they're investigating. Here are the key catalysts for the week from November 13.

Conferences

• American Academy of Ophthalmology, or AAO, 2020 Virtual meeting: Nov. 13-15.
• American Association for the Study of Liver Diseases, or AASLD, The Liver Meeting, Digital Experience: Nov. 13-16.
• Guggenheim Healthcare Talks, Idea Forum, Second Annual Neuro/Immunology Day: Nov. 16.
• Stifel 2020 Virtual Healthcare Conference: Nov. 16-18.
• Jefferies Virtual London Healthcare Conference: Nov. 17-19.
• Wolfe Research Virtual Healthcare Conference: Nov. 18-19.
• Connective Tissue Oncology Society, or CTOS, Virtual Annual Meeting: Nov. 18-21.
• SVB Leerink Oncology Day: Nov. 19.
• 2020 Society for Neuro-Oncology, or SNO, Virtual Meeting: Nov. 19-21.

PDUFA Dates

• The FDA is set for Sunday, November 22 to rule on Alkermes Plc. (ALKS)’s NDA for ALKS 3831 in schizophrenia and bipolar I disorder. Also on Sunday, the fate of Adamis Pharmaceuticals Corp. (ADMP)’s Zimhi, an investigational treatment for opioid overdose, is to be decided by the FDA.
• Mylan NV (MYL) awaits the FDA's nod on Monday, November 16, for its ANDA for dimethyl fumarate, a generic version of one made by Biogen Inc. (BIIB) to treat a relapsing form of multiple sclerosis.
• The FDA has set a PDUFA date of Monday, November 16 for Bristol-Myers Squibb Co. (BMY)’s BLA for liso-cel as a treatment option for patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
• Eiger BioPharmaceuticals Inc. (EIGR) awaits a decisive moment with the FDA on Friday, November 20 with respect to its NDA for Lonfarnib in progeria and progeroid laminopathies.

Clinical Readout/Data Presentations - AAO Meeting Presentations

Lineage Cell Therapeutics Inc. (LCTX): Sunday, November 22, updated interim results will be presented from the ongoing Phase 1/2a study of its lead product candidate OpRegen in dry age-related macular degeneration. The company has also scheduled a call with key opinion leaders Tuesday, 4 pm ET, to discuss the data.

AASLD Presentations

• Albireo Pharma Inc. (ALBO): new data from a Phase 3 study of odevixibat in progressive familial intrahepatic cholestasis to be presented Sunday, November 22.
• Inventiva ADR Representing Ord Shs (IVA): new data from the NATIVE Phase 2b clinical trial evaluating lanifibranor for NASH, focusing on the efficacy of lanifibranor in type-2 diabetic patients and its positive effect on key plasma biomarkers to be presented Sunday, November 22.
• Akero Therapeutics Inc. (AKRO): additional data analysis from the Phase 2a BALANCED study of efruxifermin in non-alcoholic steatohepatitis to be presented Sunday, November 22.
• Dicerna Pharmaceuticals Inc. (DRNA): Updated Phase 1 data for RG6346 in HBV infection to be presented Monday, November 16.
• CymaBay Therapeutics Inc. (CBAY): a late-breaking presentation highlighting results from the ENHANCE Phase 3 study of seladelpar in patients with primary biliary cholangitis to be presented Monday, November 16.

SNO Meeting Presentations

• VBI Vaccines Inc. (VBIV): data from Part B of the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma to be presented Thursday, November 19.
• Kintara Therapeutics Inc. (KTRA): update on Phase 2 studies of VAL-083 in MGMT-unmethylated Recurrent Glioblastoma Multiforme to be presented Thursday, November 19.
• Plus Therapeutics Inc. (PSTV): new interim data from the ongoing NIH-sponsored ReSPECT Phase 1 clinical trial evaluating its lead investigational asset, Rhenium NanoLiposome, in patients with recurrent glioblastoma to be presented Thursday, November 19.

CTOS Presentations

• Karyopharm Therapeutics Inc. (KPTI): data from the Phase 3 portion of the SEAL study of Xpovio in advanced dedifferentiated liposarcoma.
• Cogent Biosciences Inc. (COGT): final clinical data from its Phase 1/2 study of PLX9486 in gastrointestinal stromal tumors.

Standalone Data Readouts

Avrobio Inc. (AVRO) will announce at its Virtual R&D Day scheduled for Tuesday additional details on its new Hunter syndrome program while also sharing new data on its three clinical programs, including initial clinical data from its Gaucher disease program.

Pfizer and BioNTech expect safety data milestone to be achieved in the third week of November and plan for emergency use authorization shortly after. Moderna could release interim Phase 3 readout for its coronavirus vaccine candidate, given it has said it has reached the mandated number of cases for analysis.

Earnings

Monday:

• Vascular Biogenics Ltd. (VBLT) to report before the market open.
• Jaguar Health Inc. (JAGX) to report before the market open.
• Celsion Corporation (CLSN) to report before the market open.

Tuesday:

• Trinity Biotech plc. (TRIB) to report before the market open.
• PAVmed Inc. (PAVM).

Wednesday:

• Edap Tms SA (EDAP) to report after the market close.

Thursday:

• Precipio Inc. (PRPO) to report after the market close.

Friday:

• Burning Rock Biotech Ltd. (BNR) to report before the market open.

IPOs

San Diego, California-based Maravai Lifsciences Holding, Inc. is planning to sell in an initial public offering 50 million shares of its common stock at a price range of $24-$27.

The company, which provides critical products to enable the development of drug therapies, diagnostics, novel vaccines, and support research on human diseases, said its shares will be listed on the Nasdaq under the ticker symbol MRVI.

Sotera Health Company, a sterilization, lab testing, and advisory services company, has filed a prospectus with the SEC to offer 46.6 million shares of its common stock, which are to be priced between $20 and $23. The Broadview Heights, Ohio-based company has applied for listing its shares on the Nasdaq under the ticker symbol SHC.

IPO Quiet Period Expiry

• Foghorn Therapeutics Inc. (FHTX).