Talphera Announces Agreement with the FDA for Prior Approval Supplement Review to Reduce the Number of Patients in the NEPHRO CRRT Study [Yahoo! Finance]
Talphera, Inc. (TLPH)
Company Research
Source: Yahoo! Finance
The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif. Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study. A PAS is reviewed by the FDA within 30 days, and its approval by the agency is required before formally amending the study protocol. During this same meeting, the agency agreed to two other changes to broaden the clinical study inclusion criteria which would allow the Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours as well as heparin-tolerant patien
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TLPH
News
- Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update [Yahoo! Finance]Yahoo! Finance
- Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate UpdatePR Newswire
- Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025PR Newswire
- Talphera (NASDAQ:TLPH) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=TLPH&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> tMarketBeat
- Talphera Announces the Appointment of Joe Todisco to Board of DirectorsPR Newswire
TLPH
Earnings
- 5/14/25 - Beat
TLPH
Sec Filings
- 12/2/25 - Form 424B7
- 12/2/25 - Form EFFECT
- 11/13/25 - Form SCHEDULE
- TLPH's page on the SEC website