Nabriva Therapeutics (NBRV) Stock Up On FDA Approval

Nabriva Therapeutics NBRV Stock News

Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) is up in the market this morning, trading on early gains of more than 7% after the company announced that it has received FDA approval. Here’s what’s going on:

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NBRV Stock Heads Up On FDA Approval

In a press release issued early this morning, Nabriva Therapeutics announced that the FDA has approved its New Drug Application for the oral and IV forms of XENLETA. Xenleta has been indicated for the treatment of community-acquired bacterial pneumonia, or CABP, in adults.

As a result of the FDA approval, oral XENLETA is approved in a 600 mg dose every 12 hours. The FDA also approved IV XENLETA in a 150 mg dose every 12 hours. Both IV and oral XENLETA will be given to patients over a five to seven day course of therapy.

In a statement, Ted Schroeder, CEO at NBRV, had the following to offer:

Today’s approval of XENLETA is a significant breakthrough in the collective fight against the growing threat of antimicrobial resistance and provides a desperately needed IV and oral empiric monotherapy treatment option for adults with CABP.

We are especially proud of this approval because XENLETA was discovered in our labs over a decade ago and the entire development program was designed and executed by our dedicated and passionate team. We are indebted to the patients and researchers who collaborated with us and are excited to bring to patients and healthcare providers a novel, short course, empiric monotherapy treatment option for CABP.

XENLETA has a mechanism of action that is different than other approved antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with the beta-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes. XENLETA has a targeted in vitro spectrum of activity against the most common causative Gram-positive, Gram-negative and atypical pathogens associated with CABP, which aligns with the principles of antimicrobial stewardship.

Why This Is Significant News

There’s no doubt that the news released today is significant for NBRV. First and foremost, with the FDA approval, XENLETA will move into commercial stages, generating revenue for the company. However, the significance of this approval goes far further than that.

This is the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in almost 2 decades. Moreover, the approval of this treatment may give patients an option to avoid hospitalization and for those that are hospitalized, expedite discharge.

That’s a big deal considering that the median length of stay for patients with CABP is three to four days. Nabriva Therapeutics pointed out that as a result of these extended hospital stays, in the United States, a $17 billion dollor hospital costs burden is created annually.

Also, at Acumen Research, experts expect that the antibiotic resistant CABP market will grow to be worth more than $12 billion annually by 2026. This is going to be the sweet spot for XENLETA, an area of the market that could lead to blockbuster sales. Considering that NBRV has a market cap of about $175 million, the potential provided by this FDA approval is incredible.

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