FDA Decisions For Pfizer, Eli Lilly And Bluebird Bio, Bristol-Meyers Squibb, Plus New Data And Earnings

Biotech stocks reversed course in the week ended March 19 amid mixed news flow on data readouts and lackluster broader market performance.

Rubius Therapeutics, Inc. RUBY was among the biggest gainers of the week after the biopharma reported positive Phase 1/2 data for its RTX-240 in solid tumors.

Marker Therapeutics, Inc. MRKR had a volatile ride amid an announcement concerning common stock offering and insider buying.

The Muscular Dystrophy Association and the Society of Gynecologic Oncology meetings scheduled for the week provided platforms for multiple presentations by companies. Some of the presentations moved stocks in a big way.

The week also witnessed listings by four biopharma companies, which raised a cumulative $678.84 million in gross proceeds through initial public offerings.

Here are the key catalysts for the unfolding week:


The Endocrine Society's ENDO 2021: March 20-23


The Food and Drug Administration is likely to rule on Pacira Biosciences Inc's PCRX supplemental new drug application for Exparel as a single-dose postsurgical pain relief treatment for children, aged six and over. The drug has already received clearance from the Food and Drug Administration for the same indication in adults.

Zealand Pharma A/S ADR ZEAL awaits an FDA nod for its new drug application for dasiglucagon as a rescue medication for low blood sugar levels in diabetic patients. The PDUFA date is scheduled for Saturday.

The FDA will also announce by Saturday its decision on the BLA submitted by bluebird bio Inc BLUE and Bristol-Myers Squibb Co BMY for idecabtagene vicleucel, or ide-cel/bb2121, in multiple myeloma. Ide-cel is being developed as part of a co-development and profit-sharing agreement between Bristol Myers Squibb and bluebird bio.

Adcom Meetings

An osteoarthritis drug from Pfizer Inc. PFE will be up for discussion at joint meeting of the FDA's Arthritis Advisory and Drug Safety and Risk Management Advisory committees, March 24-25. This is over a biologic license application for a tanezumab injection aimed at relieving osteoarthritis pain in adults. Tanezumab is being jointly developed by Pfizer and Eli Lilly and Company LLY.

Clinical Readouts

BioCryst Pharmaceuticals, Inc. BCRX will present new Phase 1 clinical trial data on BCX9930, a drug for PNH patients. PNH — paroxysmal nocturnal hemoglobinuria — is a rare blood disorder that causes red blood cells to break apart. The presentation will take place on Monday during the company's virtual R&D meeting.

ProQR Therapeutics N.V. PRQR is due to present on Wednesday results from its Phase 1/2 Stellar trial of QR-421a in adults with Usher syndrome and non-syndromic retinitis pigmentosa. Usher syndrome is a rare genetic disorder that affects both hearing and vision.

Related Link: I-Mab Poised To Capitalize On Growing Oncology Sector, Needham Says In Bullish Initiation



VolitionRx Limited VNRX (after the market close)
BioLife Solutions, Inc. BLFS (after the market close)


aTyr Pharma, Inc. LIFE (after the market close)
Bionano Genomics, Inc. BNGO (after the market close)


Forte Biosciences, Inc. FBRX (before the market open)
Aptinyx Inc. APTX (after the close)
TELA Bio, Inc. TELA (after the close)
Navidea Biopharmaceuticals, Inc. NAVB (after the close)
STRATA Skin Sciences, Inc. SSKN (after the close)


Vascular Biogenics Ltd. VBLT (before the market open)
Genetron Holdings Limited GTH (before the market open)
Synlogic, Inc. SYBX (before the market open)
NovaBay Pharmaceuticals, Inc. NBY (after the close)
Neoleukin Therapeutics, Inc. NLTX (after the close)
OpGen, Inc. OPGN (after the close)
Eyenovia, Inc. EYEN (after the close)
HTG Molecular Diagnostics, Inc. HTGM (after the close)
CymaBay Therapeutics, Inc. CBAY (after the close)
BIOLASE, Inc. BIOL (after the close)
ADMA Biologics, Inc. ADMA (after the close)
Athersys, Inc. ATHX (after the close)

Other Events

On Monday, CytoDyn Inc. CYDY will update shareholders on its recent COVID-19-related filings for conditional emergency use authorization with the FDA in the U.S., an interim order in Canada, and an accelerated rolling review in the U.K., as well as potential similar filings in Brazil and the Philippines. It will also provide updates on its active trials for COVID-19, non-alcoholic steatohepatitis and cancer treatments, along with expected timelines for BLA submissions for HIV in the U.S., Canada and the U.K.


Dutch biotechnology Lava Therapeutics B.V. has filed to offer 6.7 million shares in an initial public offering to be priced between $14 and $16. The company has applied for listing on the Nasdaq under the ticker symbol LVTX. Lava develops biospecific antibodies engineered to induce immunity against tumor cells.

Related Link: Novavax Stock Down 32% From Recent Highs: Is The COVID-19 Play A Buy Ahead of Key Readouts?

(Story updated to reflect correct CytoDyn event day.)

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