Tag:

Droxidopa

Latest Headlines

Latest Headlines

FDA notes 'technical deficiencies' in Chelsea's drug filing

In another setback for Chelsea Therapeutics, drug regulators have identified certain technical deficiencies for the biotech's lead investigational therapeutic Northera (droxidopa) in a review of the company's resubmitted New Drug Application.

Chelsea rebounds after FDA agrees to take a look at new Northera data

Last summer Chelsea Therapeutics did some painful belt tightening after its stock price plunged following the FDA's decision to reject its application for Northera (droxidopa), saying the biotech would have to pull off another study of its experimental drug before it could win an OK.

Struggling Chelsea jettisons staffers, plots survival strategy

Struggling to find a way forward for droxidopa (Northera) after the FDA rejected its application for the lead program, Chelsea Therapeutics ($CHTP) today broadly outlined some big changes at the little biotech.

More bad news on Northera app blights Chelsea shares

Chelsea Therapeutics' stock ($CHTP) took yet another drubbing today after the biotech spread the word that the FDA wants to see results from another clinical trial before it can approve Northera, or droxidopa, to prevent dizziness and fainting among patients with disorders of the nervous system. Shares plunged 47% on the release.

UPDATED: FDA rejects Chelsea's Northera, demands additional study data

After the markets closed on Wednesday, Chelsea Therapeutics ($CHTP) put out the word that the FDA had rejected Northera.

Conflicting signals cloud Chelsea's chances on D-Day for Northera

It's D-Day for Chelsea Therapeutics and its rare disease drug Northera.

Chelsea Therapeutics reports positive efficacy results in PhII fibromyalgia study

Chelsea Therapeutics ($CHTP) has racked up some more positive efficacy data for its lead drug droxidopa, which is now up for review at the FDA. Investigators reported the drug spurred a statistically

Chelsea shares rocket up after lead drug clears PhIII

Almost a year after its lead therapy stunned investors by failing a critical late-stage study, Chelsea Therapeutics (CHTP) is reporting that its hypotension drug cleared the Phase III hurdle on its

Chelsea's plan to change endpoint raises fresh doubts

A few weeks ago, Chelsea Therapeutics shares cratered after a late-stage study of its orthostatic hypotension therapy droxidopa--long considered a sure thing by many analysts--failed to hit its

In a stunner, Chelsea's hypotension drug flunks Phase III

Chelsea Therapeutics stunned analysts and investors this morning, reporting that a late-stage trial of its experimental neurological disorder drug Droxidopa failed to hit its primary endpoint. The