The Week Ahead In Biotech (April 17-April 23): J&J, Abbott Earnings, Adcom Test For TG Therapeutics And More

Zinger Key Points
  • Shares of Kaleido Biosciences plunged after disclosing in a filing that it is shuttering operations.
  • Regeneron Pharmaceuticals says the FDA decided to delay granting full approval of its antibody cocktail REGEN-COV.

Biotech stocks retreated in the week ending April 14, lock-stepping with the broader market. The news flow was light during the holiday-shortened week and ahead of the imminent first-quarter reporting season.

Lyra Therapeutics, Inc. LYRA was among the biggest gainers of the week following the completion of a $100.5 million private placement. Sierra Oncology, Inc. SRRA also advanced strongly after it announced a deal to be acquired by GlaxoSmithKline plc GSK for $1.9 billion.

Meanwhile, Kaleido Biosciences, Inc. KLDO plunged after disclosing in a filing that it is shuttering operations. The microbiome therapeutic-focused biopharma was facing a cash crunch and clinical setbacks.

Regeneron Pharmaceuticals, Inc.'s REGN communicated the Food and Drug Administration's decision to delay granting full approval of its antibody cocktail REGEN-COV as a prophylactic treatment for COVID-19.

Here are the key catalysts that could impact trading in biotech stocks in the unfolding week:

Conferences

2022 American Society of Cataract and Refractive Surgery, or ASCRS, Annual Meeting: April 23-26, in Washington, D.C.

2022 Tandem Meetings – Transplantation & Cellular Therapy Meetings Of American Society for Transplantation and Cellular Therapy, or ASTCT, and Center for International Blood and Marrow Transplant Research, or CIBMTR: April 23-26, in Salt Lake City, Utah

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Adcom Calendar

FDA's Oncologic Drugs Advisory Committee is scheduled to meet on Friday, April 22 to discuss TG Therapeutics, Inc.'s TGTX sNDA for Ukoniq (umbralisib) tablets, and BLA for ublituximab injection. The proposed indication for these two products is in combination for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The committee will also discuss the existing umbralisib indications in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma approved under accelerated approval regulations.

Clinical Readouts/Presentations

ASCRS Meeting Presentation(s)

Ocular Therapeutix, Inc. OCUL: Phase 2 data for OTX-DED, an intracanalicular dexamethasone Insert, for the treatment of episodic dry eye disease (Saturday, 3:30-3:35 pm ET)

Earnings

Johnson & Johnson JNJ (Tuesday, before the market open)
Abbott Laboratories ABT (Wednesday, before the market open)
Plus Therapeutics, Inc. PSTV (Thursday, after the close)
Intuitive Surgical, Inc. ISRG (Thursday, after the close)

IPOs

IPO Quiet Period Expiry

AN2 Therapeutics, Inc. ANTX

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

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