Nabriva Therapeutics (NBRV) is a commercial-stage biopharmaceutical company with locations in the United States, Austria, and Ireland, home of their corporate headquarters *Nabriva Therapeutics is committed to developing new antibiotics to treat infectious diseases *Nabriva currently have three products; one that is currently marketed and one other that is in current on-going clinical trials The current marketed product is called XENLETA (Lefamulin) The product in on-going trials are called: Contepo.
XENLETA (Lefamulin) – Was FDA Approved for CABP August 2019 It is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganism. They believe XENLETA will present fewer potential complications as than current therapies. Based on their research, we also believe that the availability of both IV and oral formulations of XENLETA, and an option to switch to oral treatment, could reduce the length of a patient’s hospital stay and the overall cost of care achieved early and effective clinical response against common CABP pathogens in as short as 5 total days of therapy. Lefamulin was OK’d in canada https://seekingalpha.com/news/3591418-nabrivas-lefamulin-okd-in-canada-for-community-acquired-pneumonia. Offical pr has not been released yet, which will act as another catalyst when released.
Contepo – it is an investigational, first-in-class intravenous (IV) epoxide antibiotic with a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR strains that threaten hospitalized patients. Contepo utilizes a new dosing approach, to optimize the compound’s pharmacokinetics and pharmacodynamics. Contepo is to be used as a first-line treatment for complicated urinary tract infections (cUTI) suspected to be caused by MDR pathogens non-clinical data have shown that Contepo acts synergistically with certain other antibiotics to improve bacterial killing and restore susceptibility to agents otherwise demonstrating resistance. In December 2019, Nabriva resubmitted its New Drug Application (NDA) to the FDA for Contepo for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis. FDA approval delayed due to Covid-19 travel restricitions. (medication is fine. However, FDA could not get employees to inspect them due to travel restrictions). Nabriva scheduled an emergency meeting with the FDA for next steps. Other than that, no news yet.
Nabriva Therapeutics (NBRV) Catalysts
- Merck collab: https://www.globenewswire.com/news-release/2020/07/15/2062852/0/en/Nabriva-Therapeutics-Enters-into-Exclusive-Agreement-to-Promote-and-Distribute-SIVEXTRO-tedizolid-phosphate-in-the-U-S.html Announced after hours yesterday
- For comparison: Surface Oncology (SURF) announced a collaboration with Merck on May 20. Price hovered around $2.3 and jumped to a high of $7.66 at this time. That’s over 100% on this collaboration news alone with Merck. So plenty of upside left for NBRV
- An EMA (Europe) approval for this same medicine (Lefamulin). Deadline this month. So news sometime this month.
- Any positive news about their FDA approval for Contepo.
Nabriva Therapeutics (NBRV) Risk
At the end of the month (29th of July) there will be voted for a reverse split, which might decline the prices. However, I think this is to prevent delisting from stock exchange. This will be unnecessary if the stock finishes 10 days in a row above 1, which is highly possible with this Merck collab news. I expect this to be cancelled before the vote, if not, the vote will be overwhelmingly no. this rs was scheduled way before the Merck partnership was announced.
