- The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) increased by 90.74% this past month. This is why it happened.
The stock price of Iterum Therapeutics PLC (NASDAQ: ITRM) increased by 90.74% this past month as it went from $1.08 per share on May 17 to $2.06 as of the closing of the market today. There were a few catalysts that drove the stock price up this month.
Q1 2021 Financial Results
On May 14, 2021, the company reported financial results for the first quarter ended March 31, 2021. In the quarterly results, Iterum revealed it had cash, cash equivalents and short-term investments of $100.5 million. And based on its current operating plan, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into the first half of 2023.
In the quarterly earnings announcement, Iterum Therapeutics CEO Corey Fishman said that the FDA continues its review of the company’s new drug application (NDA) for oral sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible organism and has not advised them of any change to the current PDUFA goal date of July 25, 2021
“With an FDA decision on oral sulopenem expected in the second half of 2021 and a strong cash position, we are preparing for a launch of oral sulopenem into the community in the fourth quarter of 2021, if approved,” said Fishman.
NDA Review Update
On May 27, Iterum Therapeutics announced that they participated in a late-cycle meeting with the U.S. Food and Drug Administration (FDA) yesterday. And during the meeting, the FDA shared issues still under review regarding the company’s new drug application (NDA) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. And so Iterum Therapeutics responded to the issues. The FDA had determined that an Advisory Committee meeting is not currently necessary. And the review of the NDA is ongoing and the company was informed that the FDA continues to work toward the PDUFA goal date of July 25, 2021.
Crestone Joined The Antimicrobials Working Group
On June 8, the Antimicrobials Working Group (AWG) announced the addition of Crestone to its coalition of companies with a mission to combat drug resistant infections and spur life-saving innovations. This addition brought AWG’s membership to 12 antimicrobial drug companies.
The AWG was founded in 2012 with a goal of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today the AWG is comprised of 12 antimicrobials companies: Cidara Therapeutics, Crestone, Entasis Therapeutics, Iterum Therapeutics Ltd, Melinta Therapeutics, Nabriva Therapeutics US, Paratek Pharmaceuticals, Qpex Biopharma, SCYNEXIS, Summit Therapeutics plc, UTILITY therapeutics, and Venatorx Pharmaceuticals.
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