The Week Ahead In Biotech: The Vaccine Updates, Drug Presentations, And FDA Decisions That Will Move The Markets

Biotech stocks advanced in the week ended Nov. 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 Nov. 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, 2nd 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 to rule on Alkermes Plc's ALKS NDA for ALKS 3831 in schizophrenia and bipolar I disorder. (Sunday)

Also on Sunday, the fate of Adamis Pharmaceuticals Corp's ADMP Zimhi, an investigational treatment for opioid overdose, is to be decided by the FDA.

Mylan NV MYL awaits the FDA's nod for its ANDA for dimethyl fumarate, a generic version of one made by Biogen Inc BIIB to treat a relapsing form of multiple sclerosis. (Monday)

The FDA has set a PDUFA date of Nov. 16 for Bristol-Myers Squibb Co's BMY BLA for liso-cel as a treatment option for patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies. (Monday)

Eiger BioPharmaceuticals Inc EIGR awaits a decisive moment with the FDA on Nov. 20 with respect to its NDA for Lonfarnib in progeria and progeroid laminopathies. (Friday)

Clinical Readout/Data Presentations

AAO Meeting Presentations

Lineage Cell Therapeutics Inc LCTX: updated interim results from the ongoing Phase 1/2a study of its lead product candidate OpRegen in dry age-related macular degeneration. (Sunday); 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 (Sunday)

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 (Sunday)

Akero Therapeutics Inc AKRO: additional data analysis from the Phase 2a BALANCED study of efruxifermin in non-alcoholic steatohepatitis (Sunday)

Dicerna Pharmaceuticals Inc DRNA: Updated Phase 1 data for RG6346 in HBV infection (Monday)

CymaBay Therapeutics Inc CBAY: a late-breaking presentation highlighting results from the ENHANCE Phase 3 study of seladelpar in patients with primary biliary cholangitis (Monday)

Related Link: 7 Stocks That Could Benefit From Pfizer's COVID-19 Vaccine That Requires Cold Chain Storage

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 (Thursday)

Kintara Therapeutics Inc KTRA: update on Phase 2 studies of VAL-083 in MGMT-unmethylated Recurrent Glioblastoma Multiforme (Thursday)

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 (Thursday)

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 (before the market open)
Jaguar Health Inc JAGX (before the market open)
Celsion Corporation CLSN (before the market open)

Tuesday

Trinity Biotech plc TRIB (before the market open)
PAVmed Inc PAVM

Wednesday

Edap Tms SA EDAP (after the close)

Thursday

Precipio Inc PRPO (after the close)

Friday

Burning Rock Biotech Ltd BNR (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