The pharmaceutical industry is one of the biggest in the world, with reliably growing demand for its products. But central to all pharmaceutical operations is R&D and Iterum Therapeutics (NASDAQ: ITRM) appears set for a breakthrough thanks to its efforts as a clinical-stage pharmaceutical company. Dedicated to finding effective oral treatments to antibiotic resistant infections, ITRM stock is turning heads following an announced meeting with the FDA which caused a 23% spike between September 28th and 29th.
After submitting their New Drug Application (NDA) in May, ITRM experienced a procedural hiccup which caused a massive selloff in July. After receiving a Complete Response Letter (CRL) from the FDA requesting additional information regarding its oral treatment for uncomplicated urinary tract infections, ITRM shares dropped 37.99% on July 2nd. Its stock fell again on July 26th, losing $.49 per share by market close.
Things had died down for the company until ITRM’s announcement on September 28th regarding a Type A meeting with the FDA. Currently, ITRM is working to re-submit their NDA and met with the FDA during Q3 to discuss how best to meet the additional data requirements outlined by the FDA. According to ITRM’s CEO, Corey Fishman, the company is “evaluating the optimal design for an additional Phase 3 uUTI (uncomplicated urinary tract infection) study to be conducted prior to the potential resubmission of the NDA”. This could be a good sign for the company as it works to improve its treatment with more data.
ITRM’s product already has a market niche given that quinolone-resistant bacteria are prevalent in urinary tract infections and physicians have exhausted effective and safe oral options to treat such uUTIs. Rates of resistance in the U.S. range from from 20-40% by community but given that new oral antibiotics for uUTIs have not been approved in over 20 years – ITRM’s product could develop a lucrative hold over this market.
As multiple drug resistant bacteria become an increasing issue for health professionals to address, ITRM’s sulopenem product has the potential to be a compelling treatment alternative for patients with quinolone-resistant uUTIs. The company estimates there are 9 to 10 million annual infections due to quinolone-resistant bacteria and once approved, sulopenem could be a comparably inexpensive treatment option that keeps patients out of costly hospitals and infusion clinics.
ITRM has already strategized a “resource-efficient model” for commercialization with plans to target prescribers like PCPs, OB/GYNs, urologists, and ER physicians in areas with high rates of quinolone-resistance. The company expects “minimal branded
competition” given its competitive edge and believes that with “modest field organization” it could generate substantial revenue given its competitive edge in areas with high rates of quinolone resistance.
Despite its product’s potential, ITRM has become caught up in a class action lawsuit filed by Klein Law Firm on behalf of ITRM stockholders. The firm argues that ITRM violated federal securities laws by downplaying the severity of issues and deficiencies associated with its sulopenem NDA. Pomerantz LLP recently released a reminder to shareholders regarding the class action lawsuit saying that they have until October 4th “to ask the Court to appoint you as Lead Plaintiff for the class”.
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Currently trading at $.60, ITRM stock has a resistance point at .6835 with an immediate support at .59 and a secondary support near .577. The MACD is poised for a bearish crossover on the upside as its RSI settles at 51.6. Meanwhile its accumulation has dropped significantly since September 28th.
Should You Buy?
Although ITRM stock lost considerable value in July, bullish investors are anticipating a trend reversal soon. Pharmaceutical companies are notorious for binary catalysts and ITRM could see another spike as its NDA is resubmitted to the FDA, in which case buying in at a dip price may prove to be a beneficial investment. But even long-term investors should be wary given the current class action lawsuit affecting ITRM’s operations and public image.
Given the disappointment of ITRM’s last NDA, its second attempt is not a guaranteed success. But if ITRM breaks through its current resistance level, its next breaking point would be near $.72 – offering an opportunity for investors to take some gains.
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