MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag [Yahoo! Finance]
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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Source: Yahoo! Finance
The FDA grants breakthrough therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that therapy may provide substantial improvements over available treatments. Simultaneously, the company announced that the phase IIb MMED008 study, which evaluated a single oral dose of MM120 (100 µg) in GAD, met its key secondary endpoint by demonstrating clinically and statistically significant durability of activity seen through week 12 of treatment. MNMD stock surged 51.5% on Mar 7 following the announcement of the news. MindMed previously announced that treatment with a single dose of MM120 demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) versus placebo at week four of treatment—the primary endpoint of the MMED008 study. The latest secondary endpoint data showed that MM12 maintained a clinically and statistical
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ADMA
Earnings
- 2/28/24 - Miss
ADMA
Sec Filings
- 4/15/24 - Form ARS
- 4/15/24 - Form DEFA14A
- 4/15/24 - Form DEF
- ADMA's page on the SEC website