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

The FDA granted emergency use authorization to Novavax Inc NVAX‘s adjuvanted COVID-19 vaccine (NVX-CoV2373) as a two-dose primary series for active immunization for individuals 18 years of age and over.

“Today’s FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine,” said Stanley Erck, Novavax’s president and CEO. 

Shares are up 1.47% at $70.98 during the premarket session.

CytomX Therapeutics Inc CTMX is restructuring its business to prioritize internal investments in its emerging pre-clinical and early clinical pipeline.

The company will cut 40% of its workforce. The changes are expected to extend the company’s cash runway into 2025.

The company said that based on the results of a three-arm Phase 2 study of Praluzatamab ravtansine in breast cancer, it would deprioritize internal investment in this program and seek a partnership to advance the asset further.

Shares are up 4.62% at $1.36 during the premarket session.

Following interim futility analysis, the Data Safety Monitoring Board recommended that ContraFect Corporation’s CFRX Phase 3 DISRUPT study of exebacase be stopped because the conditional power of the study was below the pre-specified threshold for futility.

The recommendation was based on an analysis of the clinical response rate at day 14 in 84 patients, or approximately 60% of the total planned methicillin-resistant Staphylococcus aureus population.

Further review of the data is ongoing.

Shares are slipping 77.2% at 65 cents during the premarket session.

Royalty Pharma plc RPRX agreed to acquire a royalty interest in Trelegy from Theravance Biopharma Inc TBPH and Innoviva Inc INVA for $1.31 billion upfront and up to $300 million in milestone payments.

Trelegy, marketed by GSK Plc GSK, combines an inhaled corticosteroid and two bronchodilators in a single delivery device to maintain chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma.

Click here to access Benzinga’s FDA Calendar.

Regeneron Pharmaceuticals Inc REGN and Sanofi SA’s  SNY Phase 3 trial of Dupixent (dupilumab) in children ages 1 to 11 years with eosinophilic esophagitis (EoE) met its primary endpoint of histological disease remission at 16 weeks.

68% of children on a higher dose and 58% of patients on a lower dose of Dupixent achieved histological disease remission compared to 3% of children on placebo.

The FDA has deferred action on the Biologics License Application for BeiGene Ltd’s BGNE tislelizumab as a second-line treatment of unresectable or metastatic esophageal squamous cell carcinoma. 

The FDA has been unable to conduct required inspections in China due to COVID-19-related travel restrictions. As a result, the FDA is deferring action on the application until the inspections are complete. 

Shares are slipping 6.71% at $158.35 during the premarket session.

The FDA has signed off Lantern Pharma Inc’s LTRN Phase 2 Harmonic trial for LP-300.

The 90-patient trial will evaluate LP-300 in combination with chemotherapy for never-smoker patients with advanced non-small cell lung cancer.

Shares are up 11.8% at $6.53 during the premarket session.

Marinus Pharmaceuticals Inc MRNS has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $110 million to Novo Nordisk A/S NVO.

“Upon completion, the sale of the PRV will significantly strengthen Marinus’ financial position, which we believe extends our cash runway into the fourth quarter of 2023,” said Steven Pfanstiel, CFO of Marinus.

Marinus received the voucher in March 2022 after it received approval of Ztalmy (ganaxolone) oral suspension CV for seizures associated with CDKL5 deficiency disorder, a rare form of genetic epilepsy, in patients two years of age and older.

Shares are up 5.41% at $5.85 during the premarket session.

The FDA has granted orphan drug designation to Amryt Pharma PLC AMYT‘s Mycapssa for carcinoid syndrome, the most common functional syndrome associated with neuroendocrine tumors.

Offerings

BELLUS Health Inc BLU priced its public offering of 16.5 million shares at $9.25, with gross proceeds equivalent to $153 million.

Shares are down 8.82% at $9.20 during the premarket session.

On The Radar

Earnings

Theratechnologies Inc THTX: Before the market open.

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