Talphera (NASDAQ:TLPH) Issues Earnings Results

Talphera (NASDAQ:TLPH) issued its quarterly earnings data on Thursday. The company reported ($0.05) earnings per share for the quarter, hitting the consensus estimate of ($0.05), FiscalAI reports.

Here are the key takeaways from Talphera’s conference call:

• Talphera asked the FDA to allow the NEPHRO-CRRT study to stop enrolling by December 31, 2026, with the patients enrolled by then; the company says the study is already more than 80% powered for its primary endpoint. FDA feedback is expected by year-end, and top-line results are expected four to six weeks after enrollment closes.
• Enrollment has slowed sharply, with consented and enrolled patients down 85%–90% versus the same period in 2025, though the company did not identify a specific cause. If the FDA does not agree to early closure, Talphera says it will continue toward its original 70-patient target, which could push completion into the first quarter.
• The company raised its estimate of Niyad’s potential peak annual U.S. CRRT sales to more than $200 million, based on physician market research. Talphera also cited updated KDIGO draft guidelines recognizing nafamostat as an alternative and evidence it believes could support broader CRRT use; the sales opportunity remains contingent on approval.
• Talphera reported $14.2 million in cash at September 30 and said it expects cash plus two conditional financing tranches totaling about $16 million to fund operations through a potential 2027 Niyad PMA approval. The financing depends on meeting conditions, while quarterly cash operating expenses increased to $3.8 million from $3.3 million a year earlier.

Talphera Trading Down 1.4%

TLPH stock opened at $1.03 on Friday. The business’s 50-day moving average price is $1.12 and its two-hundred day moving average price is $1.01. Talphera has a 1-year low of $0.69 and a 1-year high of $1.57. The firm has a market cap of $53.73 million, a PE ratio of -3.83 and a beta of 0.77.

Wall Street Analysts Forecast Growth

A number of research analysts have recently issued reports on TLPH shares. Wall Street Zen upgraded shares of Talphera to a “hold” rating in a research note on Saturday, August 8th. HC Wainwright restated a “buy” rating and set a $3.00 price target on shares of Talphera in a research report on Thursday, August 13th. Finally, Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Talphera in a report on Thursday, October 15th. Two research analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat, the stock presently has a consensus rating of “Hold” and a consensus price target of $3.00.

About Talphera

Talphera, formerly known as AcelRx Pharmaceuticals, is a specialty pharmaceutical company focused on developing and commercializing therapies for acute pain. The company’s lead product is DSUVIA, a sublingual tablet containing sufentanil, an opioid analgesic designed to provide rapid relief for adults experiencing acute pain severe enough to require an opioid. DSUVIA is intended for use in medically supervised settings, including hospitals, surgical centers and other certified health-care environments.