The Daily Biotech Pulse: Adcom Recommends Additional Trials For Lilly's Partnered Cancer Drug, Novavax Touts Pediatric Vaccine Data, TC Biopharm IPO

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Adcom Rules That Lilly May Have To Conduct Additional Studies For Co-Developed Oncology Drug

Eli Lilly And Company LLY said the U.S. Food and Drug Administration's Oncology Drug Advisory Committee, which reviewed the biologic license application filed for sintilimab, voted that additional clinical trial(s) should be required to demonstrate applicability to the U.S. population and U.S. medical practice prior to a final regulatory decision.

Sintilimab is a novel PD-1 inhibitor being developed and commercialized under a collaboration agreement between Innovent and Lilly.
It has been approved in China as a first-line treatment of people with non-squamous non-small cell lung cancer.

Separately, Lilly announced an agreement with the U.S. government to supply up to 600,000 doses of the investigational drug bebtelovimab for at least $720 million. The U.S. government will accept the doses of bebtelovimab if it is granted an emergency use authorization by the FDA.

Novavax Announces Positive COVID Vaccine Data In Pediatric Trial

Novavax, Inc. NVAX announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the delta variant was the predominant circulating strain in the U.S.

The stock was rising 1.7% to $89.50 in premarket trading.

Related Link: The Week Ahead In Biotech (Feb. 6-12): Pfizer, AstraZeneca Earnings, Conference Presentations, IPOs And More

ProQR Gains On Disclosure Of Fund Stake

ProQR Therapeutics N.V. PRQR said in a filing with the SEC that Adage Capital Partners held a 6.63% stake in the company. The stock was adding 6.38% to $6 in premarket trading.

Click here to access Benzinga's FDA calendar.

Earnings

Bio-Rad Laboratories, Inc. BIO said its fourth-quarter net sales fell 7.2% to $732.8 million. On a non-GAAP basis, net income per share declined from $4.01 to $3.21, which however, was ahead of the consensus estimate of $2.85.

For 2022, the company anticipates non-GAAP currency-neutral revenue growth of approximately 1%-2%.

The stock moving down 0.77% to $630 in premarket trading.

DexCom, Inc.'s DXCM fourth-quarter revenues climbed 23% year-over-year to $698.2 million, while non-GAAP net income per share fell from 91 cents to 68 cents. Analysts, on average, estimated EPS of 85 cents. The company reiterated its fiscal year 2022 revenue guidance of $2.82 billion to $2.94 billion, which is below the consensus estimate of $2.95 billion.

The stock was slipping 4.05% to $424.38 in premarket trading.

Illumina, Inc. ILMN said its fourth-quarter revenues rose 26% year-over-year to $1.198 million and non-GAAP net income fell from $1.22 per share to 75 cents per share. The EPS, however, was better than the 40 cents per share consensus estimate. For 2022, the company expects revenues growth of 14%-16% and non-GAAP earnings per share of $4-$4.20. Analysts, on average, estimate 10.7% revenue growth and non-GAAP EPS of $4.20.

The stock was retreating 1.11% to $354.10 in premarket trading.

On The Radar

Clinical Readouts/Presentations

Angiogenesis, Exudation, And Degeneration Meeting Presentations

Graybug Vision, Inc. GRAY: full-data analysis and highlight patient cases from the 18-month Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration.

IVERIC bio, Inc. ISEE: new post-hoc analyses from the GATHER1 Zimura Phase 3 clinical trial for the treatment of geographic atrophy, secondary to age-related macular degeneration.

WORLDSymposium Presentations

Freeline Therapeutics Holdings plc FRLN: Phase 1/2 safety and efficacy data for FLT190 for the treatment of patients with Fabry disease

Passage Bio, Inc. PASG: Safety, biomarker and preliminary efficacy results following ICM administration of PBGM01 in children with late onset infantile GM1-gangliosidosis.

Earnings

Neurocrine Biosciences, Inc. NBIX (before the market close)

IPOs

TC Biopharm (Holdings) PLC TCBP, a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, priced its initial public offering of 4.118 million ADSs and warrants to purchase up to 8.235 million ADSs, for aggregate gross proceeds of approximately $17.5 million. Each ADS represents one ordinary share, and each warrant represents the right to purchase one ADS.

The company has received approval for listing its ADSs and warrants on the Nasdaq, with its ADSs trading under the symbol "TCBP" and the warrants trading under the symbol "TCBPW."

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates