Cytokinetics Announces Receipt of FDA Feedback Regarding Reldesemtiv in Patients With SMA
Cytokinetics, Incorporated (CYTK)
Last cytokinetics, incorporated earnings: 3/3 04:00 pm
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Jan. 22, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that the Six Minute Walk Test (6MWT) is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atrophy (SMA) who have maintained ambulatory function. The FDA also recommended adding a global function scale as a secondary endpoint, such as the Hammersmith Functional Motor Scale – Expanded (HFMSE). In collaboration with Astellas, Cytokinetics is developing reldesemtiv as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The companies are discussing potential next steps regarding the ongoing development program for reldesemtiv in this patient population. Results from a Phase 2 clinical study of reldesemtiv in patient
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CYTK
News
- Cytokinetics, Incorporated (NASDAQ: CYTK) had its price target lowered by analysts at JMP Securities from $110.00 to $106.00. They now have a "market outperform" rating on the stock.MarketBeat
- Cytokinetics, Incorporated (NASDAQ: CYTK) had its price target lowered by analysts at Oppenheimer Holdings Inc. from $107.00 to $106.00. They now have an "outperform" rating on the stock.MarketBeat
- Cytokinetics, Incorporated (NASDAQ:CYTK) Q1 2024 Earnings Call Transcript [Yahoo! Finance]Yahoo! Finance
- Cytokinetics, Incorporated (NASDAQ: CYTK) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $108.00 price target on the stock.MarketBeat
- Cytokinetics (CYTK) Reports Q1 Loss, Lags Revenue Estimates [Yahoo! Finance]Yahoo! Finance
CYTK
Earnings
- 5/8/24 - Miss
CYTK
Sec Filings
- 5/10/24 - Form 10-Q
- 5/8/24 - Form 8-K
- 5/8/24 - Form 8-K
- CYTK's page on the SEC website