The Week Ahead In Biotech (Jan 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More
Biotech stocks pulled back yet again during the week ending Jan. 21, with the sector retreating along with the broader market. The news flow tapered off following the frenetic pace of the week that encompassed the JPM Healthcare conference.
On the M&A front, rare disease biopharma Zogenix, Inc. (NASDAQ:ZGNX) agreed to be acquired by Belgium's UCB SA (OTC:UCBJY) for about $1.8 billion.
Here are the key catalytic events biotech investors can look forward to in the unfolding week:
Conferences
B. Riley Virtual Oncology Conference: Jan. 27-28
PDUFA Dates
The Food and Drug Administration is scheduled to announce by Saturday, Jan. 29, its verdict on Azurity's new drug application for zonisamide oral suspension for the treatment of partial seizures in patients with epilepsy. Azurity had purchased zonisamide oral suspension from Eton Pharmaceuticals, Inc.(NASDAQ:ETON).
Roche Holding AG (PNK: RHHBY) awaits approval for its biologic license application for faricimab as a treatment option for wet age-related macular degeneration and diabetic macular edema. The decision is expected by late January.
Clinical Readouts/Presentations
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) will present at the American Society of Clinical Oncology Plenary Series Session on Tuesday, results of the Phase 3 INTRIGUE study of Qinlock in second-line gastrointestinal stromal tumor. Zai Lab Limited (NASDAQ:ZLAB) has in-licensed the investigational asset for the Greater China region.
Cue Biopharma, Inc. (NASDAQ:CUE) will provide on Wednesday an update from its ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma.
Related Link: 23andMe Pivoting To Clinical Research: Could That Lead To A Turnaround For The Stock?
Earnings
Johnson & Johnson (NYSE:JNJ) (Tuesday, before the market open)
Abbott Laboratories (NYSE:ABT) (Wednesday, before the market open)
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) (Wednesday, after the close)
Edwards Lifesciences Corporation (NYSE:EW) (Wednesday, after the close)
ResMed Inc. (NYSE:RMD) (Thursday, after the close)
IPOs
IPO Pricing
New Jersey-based Samsara Vision, Inc. (NASDAQ:SMSA) has filed a preliminary prospectus with the SEC related to its proposed initial public offering of 4.17 million shares. The medical device that focuses on treatments for late-stage conditions of the retina expects the shares to be priced between $5 and $7. It has applied for listing its common stock on the Nasdaq under the ticker symbol SMSA.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates