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WILMINGTON, Del. - NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a $51 million market cap biotech company whose stock has gained nearly 20% year-to-date, announced Wednesday that the U.S. Food and Drug Administration has granted Fast Track designation for its NRX-100 (preservative-free ketamine) in treating suicidal ideation in patients with depression, including bipolar depression. According to InvestingPro analysis, the stock appears fairly valued based on its proprietary Fair Value model.
The company is now making NRX-100 available on an expanded access basis for patients with serious or life-threatening suicidal depression who haven’t responded to currently available treatments.
In granting the Fast Track designation, the FDA determined that NRX-100 has potential to address an unmet medical need based on preliminary data submitted in the application.
According to the Centers for Disease Control and Prevention, approximately 13 million adults seriously consider suicide each year, with one American dying from suicide every 11 minutes.
Patients may be eligible for expanded access if they have a serious or life-threatening condition that hasn’t responded to approved treatments, and if a benefit-risk analysis supports making the investigational drug available.
"We at NRx recognize the urgent need to make NRX-100 available to patients with suicidal depression for whom approved therapies are not tolerated or effective," said Jonathan C. Javitt, Chairman and CEO of NRx Pharmaceuticals.
NRx Pharmaceuticals has recently filed an Abbreviated New Drug Application and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for treating suicidal depression.
Physicians wishing to request NRX-100 for eligible patients under the FDA Expanded Access Program can contact the company directly.
The information in this article is based on a company press release statement.
In other recent news, NRx Pharmaceuticals reported its financial results for the second quarter of 2025, revealing a larger-than-expected loss. The company posted an earnings per share (EPS) of -$0.98, which fell short of the anticipated -$0.53, marking an EPS surprise of 84.91%. This financial disclosure was part of a recent earnings call where strategic developments were also discussed. In another development, D. Boral Capital raised its price target for NRx Pharmaceuticals from $31.00 to $34.00, maintaining a Buy rating on the stock. The revised target is based on an updated model that increases the likelihood of success for the company’s ketamine-based therapy, NRX-100, from 70% to 80%. These updates reflect the latest developments surrounding NRx Pharmaceuticals.
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