New to The โคStreetโ Highlights FDA Approval for NRxโฃ Pharmaceuticals’ Ketamine Initiative
NEW YORK, NY – [Date of Release] – โข New to The Street, aโค leading financial news and corporateโค profiling โขtelevision brand, isโข spotlighting aโข significant milestone achieved by its โฃclient, NRx pharmaceuticals, Inc. (NASDAQ: NRXP). The FDA has approved NRx’s Suitability Petition, paving theโค way for theโ company toโ re-file an Abbreviated New Drug Request โ(ANDA) for its proposed preservative-free formulation of ketamine, KETAFREEโข.
This approval represents โa crucial step forward forโฃ NRx Pharmaceuticals, which is developing KETAFREEโขโข for a market currently estimated at $750 million. Beyond this commercial opportunity, NRx is also pursuing approval of itsโ non-generic ketamine formulation, NRX-100, as a novel treatment for โคsuicidal depression and PTSD through a New Drug Application (NDA).the company has also applied for the Commissioner’s National Priority Voucherโ Program for NRX-100.
“NRx Pharmaceuticals is breaking new ground in mental health and patient safetyโ with its preservative-free ketamine initiative,” stated vince Caruso, โCo-Founder and CEO of New to theโฃ street.”This FDA approval of their Suitability Petition is โa pivotal โฃmilestone, and we are proud to showcase their journey across our national broadcast platforms. their work exemplifies the type of innovationโฃ and impact that resonates โwith investors, business leaders, and patients alike.”
nrx Pharmaceuticals’ Chairmanโ and CEO, Jonathan C.โ Javitt, MD,โ MPH, expressed appreciation for the โFDA’s responsiveness and stated the company looks forward to bringing the โฃpreservative-free โคketamine presentation to the US market “at the earliestโ possible moment.”โข Heโค also noted NRx’s recent participation in a listening session hosted โฃby the FDA โขCommissioner โคfor biotechnology CEOs.
NRxโ Pharmaceuticals is focused on developing therapeutics for central nervous system โฃdisorders, leveraging its NMDAโ platform. The company’s NRX-100 hasโค received Fast โคTrack โคdesignation for suicidal ideation in depression, including bipolar depression, while โคNRX-101 (oral D-cycloserine/lurasidone) has been awarded Breakthrough Therapy โขDesignation โขfor the treatment of suicidal bipolar depression.
New to The Street, broadcasting weekly on Fox Business and Bloomberg, delivers itsโฃ signature “Opportunities To Considerโข” segments to โขa broad โaudience of investors and business leaders. With a substantial online presence including over 3.5 million YouTube โsubscribers and prominent Times Square billboards, the platform โprovides significant exposure for companies like NRx Pharmaceuticals.
Source: New To The Street – [link to original press release: https://www.accessnewswire.com/newsroom/en/publishing-and-media/new-to-the-streets-prestigious-client-nrx-pharmaceuticals-inc.-nasdaq-nrxp-rec-1077512]**