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March 4, 2014
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 4 at 8:00 am; not all company presentations may be webcasted. Webcast Link
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November 18, 2015
06:02 EDTMYLPerrigo upgraded to Buy from Neutral at B. Riley
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November 17, 2015
16:10 EDTBMRNBioMarin initiated with a Perform at Oppenheimer
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10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
10:11 EDTMYLOptions with decreasing implied volatility
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08:22 EDTCELGSignificant Celgene overhang removed, says JMP Securities
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07:47 EDTTEVALeerink sees M&A accelerating for central nervous system assets
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07:34 EDTMYLMylan launches Almotriptan Tablets USP in the U.S.
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November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
16:53 EDTTEVAPaulson reduced stake in Valeant
Paulson & Co. gave a quarterly update on its stakes in a filing this afternoon. NEW STAKES: Perrigo (PRGO), CIT Group (CIT), Precision Castparts (PCP), Cameron (CAM), and Altera (ALTR). INCREASED STAKES: Teva (TEVA), Post Holdings (POST), Starwood Hotels (HOT), LivaNova (LIVN), and Synergy Pharmaceuticals (SGYP). DECREASED STAKES: Valeant (VRX), Shire (SHPG), Whiting Petroleum (WLL), Computer Sciences (CSC), and Oasis Petroleum (OAS). LIQUIDATED STAKES: Houghton Mifflin Harcourt (HMHC), Broadcom (BRCM), and Sprint (S).
13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
13:08 EDTCELGCelgene defeats Bass challenege on Revlimid patent, Bloomberg reports
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11:49 EDTBLUELate-breaker ASH abstract to drive interest in bluebird, says Cowen
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11:42 EDTMYLMylan announces $1B share repurchase plan
Mylan announced that the Board of Directors of Mylan has authorized share repurchases by the company of its ordinary shares in an amount up to $1B, either in the open market through privately-negotiated transactions or in one or more self tender offers. The repurchase program does not obligate the company to acquire any particular amount of ordinary shares. The authorization expires on August 27, 2016.
11:30 EDTBLUEbluebird bio ASH late-breaker abastract data a positive, says Wedbush
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07:40 EDTMYLMylan launches generic Viramune XR ER tablets, 100mg
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07:32 EDTMYLMylan launches generic GLUCOTROL XL tablets
Mylan (MYL) announced the U.S. launch of Glipizide Extended-release Tablets, 5 mg and 10 mg, the generic version of Pfizer's (PFE) GLUCOTROL XL. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide Extended-release Tablets, 5 mg, and 10 mg, had U.S. sales of approximately $70.7 million for the 12 months ending September 30, 2015, according to IMS Health.
07:16 EDTBMRN, MYLHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
07:16 EDTBMRNFDA likely feels compelled to approve at least one DMD drug, says Leerink
Leerink analyst Joseph Schwartz says the FDA likely feels compelled to approve at least one of the exon skipping drugs to treat Duchenne muscular dystrophy in this review cycle. There is so much public attention and vocal demand in the DMD community, Schwartz tells investors in a research note. The FDA advisory panel on BioMarin's (BMRN) drisapersen is on November 24 while the panel on Sarepta's (SRPT) eteplirsen is tentatively scheduled for January 22, 2016. The greatest likelihood is that both drugs are approved, Schwartz contends. Shares of BioMarin have "significant" upside potential on a positive panel vote as many investors still doubt that drisapersen is approvable based on existing data, and approval would "greatly aid" the company's goal to reach profitability, the analyst argues. He reiterates an Outperform rating on BioMarin and a Market Perform rating on Sarepta. Jefferies analyst Eun Yang said on Friday that regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin.
07:00 EDTBMYBristol-Myers announces data from Phase 3 ALLY-3+ trial for Daklinza
Bristol-Myers announced late-breaking data from the Phase 3 ALLY-3+ trial investigating a regimen of Daklinza in combination with sofosbuvir and ribavirin in genotype 3 hepatitis C patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response rates, or cure, have proved harder to achieve. The results show that 100% of patients in the advanced fibrosis cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively.
November 15, 2015
15:37 EDTCNATConatus says emricasan abstract selected as noteworthy, sees topline data 1H18
Conatus Pharmaceuticals announced that the company's late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Diseases -- entitled "Emricasan administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension" -- was selected as one of 16 key abstracts. Conatus CEO Steven Mento remarked, "Based in part on these encouraging clinical results, we recently introduced a strategy for the initial registration of emricasan involving multiple parallel Phase 2b clinical trials, the... ENCORE trials. We expect to initiate the ENCORE trials on a staggered basis over the next 15 months and expect top-line results to be available periodically beginning in 1H18."
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