NRx Pharmaceuticals (NRXP) - NOV 10 is the GDUFA date! Yesterday they announced receipt of a letter from the FDA stating that only a product labeling correction is needed. Great news! NRXP is on track for approval and their drug is now as highly derisked as you can get.
NRXP is set to receive FDA approval by Nov 10 with only minor labeling corrections needed. The company will launch the only preservative-free, US-manufactured ketamine (KETAFREE) into a $3B market facing supply shortages, with 4-5M vials ready to ship immediately and capacity for 1M vials/month. High short interest and recent price decline create a potential squeeze setup.
At post $2.60·Now $2.74+5.4% since postedas of Oct 13, 12:31 PM ET
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NRx Pharmaceuticals (NRXP) - Two September Catalysts Upon Us
NRx Pharmaceuticals has two major catalysts expected by end-2026: ANDA approval for preservative-free IV ketamine (anytime through Sep 2026) and NDA submission for NRX-100 (psychiatric indication). The company has exclusive market access, domestic supply, and 1M vial/month production capacity. Analyst price targets range $25-$45, with near-term price support of $10-12 on ANDA approval alone.
At post $3.44·Now $2.74-20.4% since postedas of Oct 13, 12:31 PM ET
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NRx Pharmaceuticals (NRXP) - Awaiting ANDA (generic drug) approval for no-preservative Intravenous (IV) ketamine for analgesia (pain control) and anesthesia ... which will happen in the near term.
NRx Pharmaceuticals is positioned for near-term FDA approval of KETAFREE (preservative-free ketamine), addressing critical supply chain and safety issues while solving strategic FDA goals. The company has resolved the only outstanding FDA concern (luer lock vial attestation) and has significant pre-launch commercialization momentum, with share price expected to respond positively to ANDA approval and subsequent NDA filings.
At post $3.56·Now $2.74-23.0% since postedas of Oct 13, 12:31 PM ET
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NRx Pharmaceuticals (NRXP) - Imminent Catalyst - 8-K dropped today (follow-up to yesterday's post - I encourage you to check it out). The stock is up nicely this morning, as a result! One of my favorite companies to hold. This company is a winner ... now ... and longer term.
NRx's KETAFREE ANDA is near approval with only a manufacturing certification hurdle remaining; the FDA has committed to expedited review due to ketamine shortage and first commercial sales are expected in 2026. The company is well-capitalized and positioned to supply preservative-free ketamine to a market currently facing supply constraints.
At post $3.58·Now $2.74-23.5% since postedas of Oct 13, 12:31 PM ET
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NRX Pharmaceuticals (NRXP) - Imminent Catalyst and other statuses! This company is on the move and gaining traction. Price targets are multiples of the current share price.
NRX Pharmaceuticals has multiple imminent catalysts: KETAFREE (preservative-free IV ketamine) FDA ANDA decision expected imminently following no major deficiencies, NRX-100 NDA submission in final stages, and NRX-101 (combination therapy) in pivotal trials with BTD status. The company has built manufacturing capacity, raised capital, and positioned itself in a large market for depression and PTSD treatment, with price targets noted as multiples of current share price.
At post $3.09·Now $2.74-11.3% since postedas of Oct 13, 12:31 PM ET
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