The Week Ahead In Biotech (Jan 24-30): J&J, Lilly to Kickstart Big Pharma Earnings, Amgen FDA Decision and More

Biopharma stocks advanced yet again in the week ended Jan. 22, with the change of guard at the White House generating broader market strength.

Eli Lilly And Co LLY was the standout biopharma stock of the week, as it set fresh 52-week highs in all four sessions of the truncated week, the catalysts being an oncology licensing deal with Merus NV MRUS, an analyst upgrade and a positive readout for its COVID-19 antibody treatment candidate.

News flow on licensing deals and follow-on offerings abounded.

The Food and Drug Administration approved two key drugs during the week — Merck & Co., Inc.'s MRK heart failure drug and a long-acting, injectable combo treatment option for HIV from ViiV Healthcare, a venture established by GlaxoSmithKline plc GSK and Pfizer Inc. PFE.

Aurinia Pharmaceuticals Inc's AUPH voclosporin in combination with a background immunosuppressive therapy regimen was also approved by the agency to treat adult patients with active lupus nephritis.

Here are the key catalysts for the unfolding week:

Conferences:

The International Association for the study of Lung Cancer, or IASLC, World Conference on Lung Cancer (virtual event): Jan. 28-31

PDUFA Dates:

The FDA is scheduled to rule on Amgen, Inc.'s AMGN sBLA for Nplate, a protein that raises and sustains platelet counts, as a treatment option for hematopoietic subsyndrome of acute radiation syndrome. The decision is due Thursday, Jan. 28.

Related Link: The Gilead, Galapagos Pipeline Opportunities That Are Turning Morgan Stanley Bullish

Regulatory Filings:

Axsome Therapeutics Inc AXSM expects to file this month a new drug application for its AXS-05 treatment of mild depressive disorder.

Clinical Readouts:

Rhythm Pharmaceuticals Inc RYTM is scheduled to host a virtual event on Tuesday, Jan. 26, from 8 a.m. to 10 a.m. to provide an update on its ongoing exploratory Phase 2 study and genetic sequencing efforts. The company will present data for setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene, as well as SRC1 and SH2B1 deficiency obesities. It will also provide an update on data from its sequencing efforts, which now includes samples from about 37,500 people with severe obesity.

Zymeworks Inc ZYME is due to present a clinical progress update for ZW49, which is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers. The presentation is scheduled for Wednesday, Jan. 27, at 4:30 p.m.

January Readouts

Johnson & Johnson JNJ: interim results of a Phase 3 clinical trial of its experimental COVID-19 vaccine, JNJ-78436735

GlaxoSmithKline plc GSK/Vir Biotechnology Inc VIR: initial results from the Phase 3 trial of COVID-19 antibody treatment candidate VIR-7831

IASLC World Conference on Lung Cancer Presentations

Amgen: Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib in patients with KRAS G12C-mutated advanced non-small cell lung cancer, or NSCLC, (Friday, Jan. 2), and an oral presentation of updated Phase 1 data from AMG 757 in small cell lung cancer

Earnings:

Tuesday

Johnson & Johnson JNJ (before the market open)
Varian Medical Systems, Inc. VAR (after the close)

Wednesday

Abbott Laboratories ABT (before the market open)
Edwards Lifesciences Corp EW(after the close)
Hologic, Inc. HOLX (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)

Thursday

ABIOMED, Inc. ABMD (before the market open)
ResMed Inc. RMD (after the close)

Friday

Lilly (before the market open)

IPOs

 

Raritan, New Jersey-based Ortho Clinical Diagnostics Holdings plc has filed to offer 70 million shares in an initial public offering, expected to be priced between $20 and $23. The pure-play in vitro diagnostics company has applied for listing the shares on the Nasdaq under the ticker symbol OCDX.

Related Link: Pfizer-BioNTech Vaccine Found Effective Against New Coronavirus Strain In Lab Study