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Pfizer Touts Positive Data From Global Maternal Immunization Trial For Its Bivalent RSV Vaccine Candidate

Pfizer Inc (NYSE:PFE) announced topline data from the Phase 3 MATISSE trial investigating its bivalent RSV prefusion vaccine candidate administered to…
byVandana Singh
November 1, 2022
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  • Pfizer Inc (NYSE:PFE) announced topline data from the Phase 3 MATISSE trial investigating its bivalent RSV prefusion vaccine candidate administered to pregnant participants to help protect their infants from RSV disease after birth.
  • The study enrolled approximately 7,400 pregnant individuals. 
  • If approved, Pfizer’s RSV vaccine candidate could be the first maternal vaccine to help prevent RSV illness in young infants.
  • The pre-planned interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints. 
  • Vaccine efficacy of 81.8% was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life, with high efficacy of 69.4% demonstrated through the first six months of life.
  • Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% in infants from birth through the first 90 days of life. 
  • Efficacy for MA-LRTI of 51.3% was observed over the six-month follow-up period.
  • At the recommendation of the DMC and in consultation with the FDA, Pfizer has stopped enrollment in the study. 
  • Pfizer plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022 for the vaccine candidate, followed by other regulatory authorities in the coming months.
  • In August, Pfizer reported positive data from bivalent RSV prefusion F vaccine candidate in adults 60 years or older.
  • Price Action: PFE shares are up 2.53% at $47.73 on the last check Tuesday.
 
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Heritage Cannabis’ Stock Plunges On Announcing Creditor Protection, Looks To Pursue Restructuring And Sales Process

By Jelena Martinovic
April 3, 3:06 PM
Heritage Cannabis Holdings Corp. announced on Tuesday that alongside its subsidiaries it sought and obtained an order for creditor protection from the Ontario Superior Court of Justice under the Companies Creditors Arrangement Act. "The difficult but necessary decision to commence CCAA proceedings was made after careful consideration of the Company's financial position while evaluating all available alternatives and engaging in significant consultation with legal and financial advisors," the company said in a press release. The Toronto-based cannabis producer also said that BJK Holdings Ltd., its senior secured lender, made a demand to the company for payment in full of certain indebtedness owing by the Heritage Group to the lender totaling $8,421,088.87. Heritage has entered into binding agreements to sell its real estate properties in Ontario and British Columbia to BJK Developments Ltd. for a net purchase price of $9,714,475 and lease the Ontario and BC Property back from the purchaser in October. The company said at the time the purchase would be used to set off the amount owing by the company to its lender, BJK Holdings Ltd., a related entity of the purchaser, reducing the company's remaining term debt by roughly 64% to $5,256,379. The remaining term financing, as amended within a third amending agreement, has been extended through to Jan. 31, 2025. Additionally, the company said it retains its revolving line of credit of up to $5 million with BJK, which has also been extended until the same date.

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