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Stock Market & Financial Investment News

News Breaks
January 10, 2014
10:20 EDTSHPG, CHTPChelsea falls after FDA staff call droxidopa approval decision 'complex'
Shares of Chelsea Therapeutics (CHTP) are sharply lower in early trading after the FDA posted briefing documents related to a review of a resubmission for the company's droxidopa drug. The documents are related to a cardiovascular and renal drug advisory committee meeting scheduled for January 14. WHAT'S NEW: Chelsea Therapeutics is seeking approval of droxidopa for “the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, which includes Parkinson’s Disease, Multiple System Atrophy and Pure Autonomic Failure, as well as to treat two other conditions. In the document, FDA staff wrote that the decision whether or not to approve droxidopa is "complex," noting that strong evidence from one clinical trial indicates that droxidopa confers "at least one week of symptomatic benefit," but also that there has been no durable effect, i.e., more than 1 week, demonstrated for droxidopa. The document also notes that Shire (SHPG), the sponsor of midodrine, an approved drug for symptomatic orthostatic hypotension, is currently being tasked with completing 2 adequate and well controlled trials to demonstrate that drug’s symptomatic benefit. The document also states that there were "numerous concerning safety findings" related to droxidopa. PRICE ACTION: In morning trading, shares of Chelsea Therapeutics are down over 29% to $2.50. Reference Link
News For CHTP;SHPG From The Last 14 Days
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April 23, 2015
09:20 EDTSHPGCelgene patent latest to be challenged by Hayman Capital's Bass
The Coalition For Affordable Drugs, a group linked to Hayman Capital's Kyle Bass, has requested an Inter Partes Review of Claims 1–10 of U.S. Patent No. 6,045,501 held by Celgene (CELG), according to a USPTO filing. The ’501 patent claims methods for delivering a drug, including a teratogenic drug, to a patient while preventing the exposure of a fetus or other contraindicated individuals to the drug. The patent is related to the company's Revlimid drug. BACKGROUND: Previously, the same coalition requested an Inter Partes Review of patents held by Pharmacyclics (PCYC), Acorda Therapeutics (ACOR), Shire (SHPG) and Jazz Pharmaceuticals (JAZZ). On January 7, Reuters reported that Bass planned to take "around 15 pharmaceutical companies with a combined market capitalization of $450B" into an Inter Partes Review for extending patents in questionable ways, citing a presentation made by Bass in Oslo. PRICE ACTION: Shares of Celgene are down 0.5% to $114.92 in pre-market trading.
April 22, 2015
07:07 EDTSHPGEuropean Association for the Study of the Liver to hold annual meeting
50th Annual Meeting of EASL will be held in Vienna, Austria on April 22-26.
April 20, 2015
14:32 EDTSHPGPharmacyclics patent for Imbruvica challenged by Hayman Capital's Bass
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April 13, 2015
07:20 EDTSHPGShire price target raised to $288 from $267 at JPMorgan
JPMorgan raised its price target for Shire to $288 after lifting its estimates for Lifitegrast in dry eye following the FDA's Priority Review designation. The firm believes the FDA is very likely to approve the application in October of this year, without waiting for the third Phase III study late 2015. It upped its 2020 Lifitegrast forecasts by $600M to $900M and reiterates an Overweight rating on Shire.

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