|Bid||3.3000 x 800|
|Ask||3.3800 x 800|
|Day's Range||3.2250 - 3.4300|
|52 Week Range||1.8700 - 31.9900|
|Beta (3Y Monthly)||1.72|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
Replacement demand for agricultural equipment and strong demand in construction likely to be conducive to Deere's (DE) third-quarter fiscal 2019 results.
Akin to the previous quarters, net new business and the steady uptake of Maintenance Choice programs are likely to bolster CVS Health's (CVS) PBM business in Q2.
Newton startup Acer Therapeutics is slashing its staff by more than half and halting work on its lead drug candidate for a tissue disorder after the FDA rejected an early application for it late last month.
The FDA went overdrive in the month of June, deciding on several regulatory applications before the July 4 holiday. There were favorable outcomes as well as disappointments. Acer Therapeutics Inc (NASDAQ: ...
Acer Therapeutics Inc. (ACER) receives a Complete Response Letter from the FDA regarding its new drug application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks hitting 52-week highs on June 25) ArQule, Inc. (NASDAQ: ARQL ) Zai Lab Ltd (NASDAQ: ZLAB ...
plummeted by nearly 80% toward a record low after the pharmaceutical company said the Food and Drug Administration declined to approve its treatment for a genetic disorder that can cause blood vessels to fatally rupture. The treatment, Edsivo (celiprolol), was developed to treat patients with vascular Ehlers-Danlos syndrome (vEDS), a rare but severe hereditary disorder of the connective tissue. In its response letter, the FDA has asked the company to conduct an "adequate and well-controlled trial" to determine whether Edsivo reduces the risk of clinical events in patients with vEDS.
The FDA rejected Acer's application this week, tasking the company with conducting new trials of the drug, called edsivo, before re-submitting it approval.
Acer Therapeutics Inc. said Tuesday it received a complete response letter (CRL) from the U.S. Food and Drug Administration regarding its new drug application (NDA) for Edsivo, a treatment of vascular Ehlers-Danlos syndrome (vEDS). After resuming trade following a halt for news, the stock plummeted 81% toward a record low in premarket trading. Volume of over 140,000 shares was already more than the full-day average of about 97,000 shares. The CRL says Acer will have to conduct an adequate and well-controlled trial to determine whether Edsivo (celiprolol) lowers the risk of clinical events in patients with vEDS. "We remain committed to working closely with the FDA to fully understand its response," Acer Chief Executive Chris Schelling said in a statement. "We expect to respond to the FDA in the third quarter of this year." The stock has lost 4.2% year to date through Monday, while the Dow Jones Industrial Average has gained 14.6%.
The treatment, Edsivo, aims to treat vascular Ehlers-Danlos syndrome (vEDS)- the most severe type of a hereditary disorder of the connective tissue. FDA, in its complete response letter, has asked Acer to conduct further trials to determine the efficiency of Edsivo in treating patients with vEDS, Acer said. "We expect to respond to the FDA in the third quarter of this year," Acer Chief Executive Officer Chris Schelling said.
Acer Therapeutics Inc said on Tuesday the U.S. Food and Drug Administration declined to approve its treatment for a severe, rare genetic disorder that can cause blood vessels to fatally rupture, sending its shares plunging as much as 78%. The treatment, Edsivo, aims to treat vascular Ehlers-Danlos syndrome (vEDS)- the most severe type of a hereditary disorder of the connective tissue. The agency, in its complete response letter, has asked Acer to conduct a clinical trial to determine the efficiency of Edsivo in treating patients with vEDS, Acer said.
The PDUFA date for a potential FDA approval of Edsivo for the treatment of Vascular Ehlers-Danlos Syndrome (vEDS) patients is scheduled for June 25, Chico said in the note. Regarding investor concern around whether the data supporting Edsivo’s filing was too limited for an FDA approval, Chico said that it is consistent with the filings of recently approved orphan indications.
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Acer Therapeutics jumped Wednesday after the FDA accepted its application for a drug to treat a connective-tissue disorder. The drug, Edsivo, would treat patients with a genetic mutation.
A look at the shareholders of Acer Therapeutics Inc (NASDAQ:ACER) can tell us which group is most powerful. Institutions will often hold stock in bigger companies, and we expect to Read More...