FDA

clinical trials

Why Sarepta’s PDUFA Delay Is a Good Thing

Sarepta Therapeutics Inc. (NASDAQ: SRPT) shares saw a handy gain on Wednesday following an analyst upgrade. Janney Montgomery Scott has a Neutral rating on Sarepta but increased its fair value estimate to ...
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Theravance Gets FDA Nod on Vibativ

Theravance Biopharma Inc. (NASDAQ: TBPH) saw its share take a slight tick up on Monday morning following a U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA ...
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4 Major FDA Decisions Expected by June

Pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a great amount ...
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3 Big Pharma Stocks With Credible Threats to Their Blockbusters

A pharmaceutical company could face a threat to one of its products for a number of reasons, ranging from an improved formulation, a new drug approval to simply a patent expiry and the ...
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Why This Isn’t the End of Catalyst Pharmaceuticals

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) saw its shares get halved just Tuesday morning alone, following a business update regarding its Lambert-Eaton myasthenic syndrome (LEMS) treatment. The company provided an update ...
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4 Companies That Have Destroyed Shareholders

As earnings season is underway, some analysts are expecting earnings disappointments going forward, as S&P Global Market Intelligence expects earnings for the S&P 500 to shrink by about 8% in ...
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Why TransEnterix Shares Are in Free Fall

TransEnterix Inc. (NYSEMKT: TRXC) watched its shares in free fall on Thursday morning following a devastating judgment by the U.S. Food and Drug Administration (FDA). The company announced after the markets ...
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Can BioMarin Make Treating Hemophilia More Affordable?

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) is ready to break above the $1 billion revenue barrier in 2016. This is a feat that marks a major hurdle for many biotech and emerging ...
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Are Analysts Realistic on Clovis Oncology Now?

Clovis Oncology Inc. (NASDAQ: CLVS) was down about 5% Tuesday and was down even more Wednesday after the Oncologic Drugs Advisory Committee voted against its lung cancer drug. The committee ...
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clinical trials

Is PTC Therapeutics on the Road to Recovery?

PTC Therapeutics Inc. (NASDAQ: PTCT) saw its shares jump late Friday morning on positive news on its nonsense mutation Duchenne muscular dystrophy (nmDMD) treatment. The company announced that the National Institute for ...
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inVentiv Files for IPO

inVentiv Group Holdings has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were mentioned in the filing, but ...
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clinical trials

Regeneron Rises on Positive Top-Line Results

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), in conjunction with Sanofi, released top-line results for its most recent late-stage study. The companies announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab ...
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Opko Health Stumbles Over FDA Letter

Opko Health Inc. (NYSE: OPK) saw its shares slide in Wednesday’s regular trading session following the release of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). ...
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Acadia Posts Big Win With FDA Approval

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) saw its shares on the rise again this week following an incredibly positive U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) vote. ...
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SEC Charges Aveo With Misleading Investors

The U.S. Securities and Exchange Commission (SEC) has just announced fraud charges against Aveo Pharmaceuticals Inc. (NASDAQ: AVEO) and three former executives for misleading investors concerning the company’s efforts to ...
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