FDA

145922793

Is This the Sunesis Resurrection?

In early October, Sunesis Pharmaceuticals Inc. (NASDAQ: SNSS) announced that its Phase 3 clinical trial of vosaroxin and cytarabine failed to meet the primary endpoint of the study, which ultimately ...
Read Full Story »
biotech

What Licensing Imetelstat Will Mean for Geron

Geron Corp. (NASDAQ: GERN) has announced that it entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech to develop and commercialize imetelstat. What investors need to keep ...
Read Full Story »
fda_logo

Is Geron Back From the Dead?

The U.S. Food and Drug Administration (FDA) gave Geron Corp. (NASDAQ: GERN) some good news Monday morning when it removed the clinical hold on the company’s investigational new drug application ...
Read Full Story »
152498601

Pain Therapeutics and Durect Stung by Pfizer Move

Pain Therapeutics Inc. (NASDAQ: PTIE) shares dropped significantly in Monday’s trading on news that Pfizer Inc. (NYSE: PFE) had discontinued its agreement to develop and commercialize Pain’s Remoxy extended release ...
Read Full Story »
fda_logo

Sarepta Faces Major Hurdle, and Not From Ebola

In non-Ebola related news, Sarepta Therapeutics Inc. (NASDAQ: SRPT) shares took a big hit on Monday morning as disappointing news started its week out on the wrong foot. The stock ...
Read Full Story »
fda_logo

Alcobra Loses Focus in ADHD Trial for FDA Approval

Cognitive disorders, specifically Attention Deficit Hyperactivity Disorder (ADHD), are prevalent within the United States and affect 5% of children. Around half of these children will continue to have ADHD as ...
Read Full Story »
DNA

Chimerix Wants Its Piece of the Ebola Pie

Chimerix Inc. (NASDAQ: CMRX) has become the latest company to get an Ebola announcement out. With scares rising in America after last week's disclosure of a confirmed Ebola case in Dallas, ...
Read Full Story »
biotech

What Else Is Under the Hood for Catalyst Pharma?

Catalyst Pharmaceutical Partners Inc. (NASDAQ: CPRX) announced positive topline results from its Phase 3 clinical trial of Firdapse for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome, or LEMS. In the ...
Read Full Story »
Pills

Will Analysts Start Following Alimera After Its FDA Approval?

Alimera Sciences Inc. (NASDAQ: ALIM) traded up big on Monday on news that the company received U.S. Food and Drug Administration (FDA) approval for its drug Iluvien. The company stated ...
Read Full Story »
152498601

Flexion Therapeutics Stumbles on Clinical Hold

In the after-hours on Wednesday, Flexion Therapeutics Inc. (NASDAQ: FLXN) made a hard fall on the news of a clinical hold. Usually clinical holds result in some serious fall out ...
Read Full Story »
research

NPS Pharma Enters Cautionary Phase of the FDA Approval Process

NPS Pharmaceuticals Inc. (NASDAQ: NPSP) is trading lower on what sounded like good news. The problem is that headlines often do not reveal the underlying story. After its shares were ...
Read Full Story »
145922793

Does New Data Make or Break NPS Pharmaceuticals?

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) is up huge in regular trading on Wednesday, due to positive preliminary results of a clinical trial. The FDA has posted the briefing materials prior to ...
Read Full Story »
research

Huntington’s Disease Orphan Drug Designation Could Rescue Prana

Prana Biotechnology Ltd. (NASDAQ: PRAN) saw its shares surge on Friday. This movement is on the heels of the U.S. Food and Drug Administration (FDA) granting an orphan drug designation to ...
Read Full Story »
DNA

What This Skin Cancer Drug Approval Really Means to Merck

Merck & Co. Inc. (NYSE: MRK) has received approval from the FDA to bring its new drug to market. The drug is called Keytruda and it is designed to treat ...
Read Full Story »
health care

ELIQUIS Approved for Deep Vein Thrombosis and Pulmonary Embolisms

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) had approved the drug ELIQUIS, as a treatment for Deep Vein Thrombosis and Pulmonary ...
Read Full Story »