Author: Vitaliy Dadalyan

Pfizer, BioNTech Score Fast Track Status For Covid-19 Vaccine Candidates

Pfizer Inc (PFE) and BioNTech SE (BNTX) have announced that two of the companies’ four investigational Covid-19 vaccine candidates from their BNT162 mRNA-based vaccine program have received Fast Track designation from the U.S. Food and Drug Administration (FDA).Shares in Pfizer are up 3% in Monday’s pre-market trading, while BioNTech has soared 9%.The two candidates, BNT162b1 and BNT162b2, are the most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines to treat or prevent serious conditions with an unmet medical need.This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.The BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format...

Pfizer, BioNTech's coronavirus vaccine candidates get FDA's 'fast track' status

The candidates, BNT162b1 and BNT162b2, are the most advanced of the at least four vaccines being assessed by the companies in ongoing trials in the United States and Germany. Pfizer's shares were up about 2% and U.S.-listed shares of BioNTech were up about 6% before the bell. Earlier this month, the companies said BNT162b1 showed potential against the virus and was found to be well tolerated in early-stage human trials....

Disney World Cautiously Reopens; Analyst Optimistic On Outlook

Walt Disney Co. (DIS) reopened its popular theme park, Disney World on July 10 after closing nearly four months ago as a result of the COVID-19 outbreak.The theme park reported attendance for its two areas, Magic Kingdom and Animal Kingdom with a combined 16,000 visitors for the reopening. This falls well below the pre-COVID average of nearly 100,000 people per day. Disney plans to reopen the remainder of its park on July 15.Disney’s stock was up 2% at market close on July 10 at $119.32 per share.Disney is requiring everyone in the park to wear a mask except for swimming as well as eating and drinking. A limited number of restaurants and hotels are back in business and more are planning to open in the coming months.J.P. Morgan analyst Alexia Quadrani was optimistic on July 10 regarding Disney World saying that the “reopening of the parks globally is a critical sign of...

Equillium Explodes 260% On Positive Covid-19 Results; India Approval

Shares in biotech Equillium (EQ) have almost tripled in Monday’s pre-market trading after the company announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.Equillium is currently developing itolizumab to treat severe autoimmune and inflammatory disorders. The stock is currently trading up 260% in the pre-market.Biocon also announced that the Drugs Controller General of India (DCGI) has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.Based on the encouraging topline results and DCGI approval, Equillium revealed that it is now planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to...