PhaseBio Explodes 82% After-Hours On FDA Nod For Covid-19 Clinical Trial

Shares in PhaseBio Pharmaceuticals (PHAS) surged 82% in after-hours trading on Wednesday, after the company announced clearance of its investigational new drug (IND) application by the FDA under its Coronavirus Treatment Acceleration Program (CTAP).

PhaseBio’s “VANGARD” trial will assess the efficacy and safety of its PB1046 in hospitalized COVID-19 patients at high risk for rapid clinical deterioration and acute respiratory distress syndrome. Approximately 210 patients will be targeted to be enrolled at approximately 20 sites across the US. The primary endpoint will measure days alive and free of respiratory failure.

The patients will be treated with PB1046, a novel, once-weekly, subcutaneously-injected vasoactive intestinal peptide (VIP) receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems. VIP is a neurohormone known to have anti-inflammatory effects, and importantly, has also been observed to have potent bronchodilatory and immunomodulatory effects in the respiratory system.

PhaseBio now expects to begin dosing patients by the end of June and is targeting to report trial results late in the fourth quarter of 2020. Based on feedback from the FDA, PhaseBio believes that positive, clearly interpretable and clinically meaningful results from this trial may enable PhaseBio to submit a Biologics License Application.

“Physicians are in desperate need of new options to treat COVID-19 patients facing rapid deterioration of lung function and before progressing to a ventilator,” said John Lee, CMO at PhaseBio. “Early mitigation by PB1046 of the effects of inflammatory cytokines that can cause acute lung injury, is a promising strategy that could prevent patients from declining to the point where they require mechanical ventilation and help alleviate the strain on critical care infrastructure that we’re witnessing.”

Indeed, analysts have a firmly bullish outlook on PHAS with 4 recent buy ratings, no holds and no sells, giving it a Strong Buy consensus. The average analyst price target stands at $12.75 (188% upside potential). (See PhaseBio stock analysis on TipRanks).

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