Iterum Therapeutics (ITRM) FDA approval can push the stock higher

Iterum Therapeutics (ITRM) is a company that is creating a groundbreaking antibody (sulopenem) that has the potential to be the one and only version of itself. This antibody/antibiotic is going to be the only oral and intravenous branded penem available to the public. 

This is convenient for doctors because they do not have to prescribe multiple things to their patients but in return only prescribe one. This will fight multi drug resistant pathogens in the patient. The antibiotic will be available in oral and IV forms.

Sulopenem is the first oral and IV penem antibiotic demonstrating a potent spectrum of activity against multi-drug resistant gram-negative infections in both the hospital and community settings.

ITRM’s fair value is shown at around $2.56, and the stock is trading under $2, almost a full dollar under its fair value. The offering was announced at $2, and for the stock to be trading under that shows the oversold sentiment on the stock.

Iterum has submitted its NDA to the FDA, which has been accepted for priority review, with a decision date set for late July. Management are eyeing a potential $6.5bn market, and peak sales ~$1bn, but successful antibiotics treatments typically make sales ~$300m. Iterum stock has been on a recent bull run to ~$2.4, from $1.23, and if Sulopenem is approved, the share price ought to challenge May 20 highs of ~$4.2. Based on the positive endpoint from the SURE 1 trial of superiority to Cipro in patients with a quinolone non-susceptible pathogen, Iterum management filed a New Drug Application in November last year for that indication, which was accepted by the FDA in late January for priority review, with a decision date set for July 25 – less than six months away.

Management has experience developing and launching new antibiotic therapies with CEO Corey Fishman and Board Member Michael Dunne having developed Dalbavancin – a treatment for acute bacterial skin and skin structure infections (“ABSSSI”) at Durata Therapeutics, before selling the company to Actavis in a $675m deal in 2014.

ITRM has a lot of upside potential. All it really needs is a small catalyst to send the stock up. Its current catalyst is the approval that is scheduled to happen in July which would have $ITRM retest previous high of $4 from May 2020.

ITRM was close to testing this in February when it reached highs of around $3.25. Iterum is ran by a phenomenal CEO who has over 25 years of experience in the Therapeutics/Pharmaceutical industries. Corey Fishman is an intelligent CEO who knows his company’s industry, and knows how to thrive in it.

The breakthrough technology being presented by Iterum’s Sulopenem will create convenience not only to hospitals and doctors, but patients all around the world. $ITRM has a great “dip buy opportunity” as it is currently under its fair value presented by Morningstar Investment Research Center and it is trading under its $2 offering price.

As for my consensus, I believe that $ITRM has great upside potential and will most likely surpass the $2 resistance mark within the coming days/weeks and squeeze shorts into sending this stock back to highs BEFORE the approval catalyst.