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Stock Market & Financial Investment News

News Breaks
January 31, 2014
11:36 EDTMYGN, CWH, JNJ, BMRNOptions with increasing implied volatility: BMRN CWH MYGN JNJ
News For BMRN;CWH;MYGN;JNJ From The Last 14 Days
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May 20, 2015
11:46 EDTBMRNBioMarin sees self as buyer, not acquisition candidate, dealReporter says
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10:26 EDTJNJJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
10:22 EDTBMRNSarepta soars after FDA agrees to accept DMD drug submission
The shares of Sarepta Therapeutics (SRPT) are rallying after the company announced that, following meetings with the FDA, it would submit its eteplirsen drug for the agency's approval. Last October, the FDA said the company would have to submit more data on the drug before the agency would consider approving the treatment. WHAT'S NEW: Sarepta announced last night that it would submit its eteplirsen to the FDA for approval. The submission will be done on a rolling basis, with various components of the application being submitted separately. Eteplirsen is a treatment for Duchenne muscular dystrophy or DMD. ANALYST REACTION: Roth Capital analyst Debjit Chattopadhyay responded to the news by more than doubling his price target on Sarepta to $45 from $22. The analyst is upbeat on Sarepta's approach of seeking to address DMD patients' lack of dystrophin, which he calls the patients' primary biochemical defect. He predicts that both eteplirsen and another DMD treatment, BioMarin's (BMRN) drisapersen, will be recommended for approval at a joint panel meeting in the second half of 2015. While both drugs are likely to be approved, BioMarin's decision to not yet initiate new studies on its DMD treatment has placed Sarepta in the pole position, Chattopadhyay believes. BioMarin will have to run additional studies and if both drugs are approved, BioMarin will find it difficult to recruit patients due to drisapersen's safety profile, according to the analyst. Chattopadhyay continues to believe that Sarepta's PMO platform will be the winner in DMD and he kept a Buy rating on the stock. More upbeat on BioMarin was Jefferies analyst Eun Yang. After meeting with BioMarin's management, the analyst reported that the company's confidence has increased following its pre-submission discussions with the FDA. If the FDA approves drisapersen on a non-accelerated basis, BioMarin may not be required to conduct any additional studies, the analyst stated. Yang sees a 60% chance of the drug being approved and believes that the stock would rise more than 25% if approval is granted. The analyst kept a $135 price target and Buy rating on BioMarin shares. PRICE ACTION: In early trading Sarepta climbed 45% to $23.81 and BioMarin was little changed at $125 per share.
09:10 EDTBMRNSarepta price target raised to $43 from $34 at William Blair
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09:07 EDTJNJJohnson & Johnson says exploring eight new indications for Imbruvica
Imbruvica is jointly developed and commercialized by Pharmacyclics (PCYC) and Johnson & Johnson (JNJ) subsidiary Janssen Biotech. AbbVie (ABBV) is in the process of acquiring Pharmacyclics.
09:05 EDTBMRNSarepta price target raised to $45 from $22 at Roth Capital
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08:49 EDTJNJJohnson & Johnson: Priorities for free cash flow include dividends, repurchases
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08:30 EDTJNJAchillion price target lowered to $16 from $25 at Leerink
Leerink says Achillion's deal with Johnson & Johnson (JNJ) increases the probability that it will be a competitive commercial-stage player in hepatitis C. The firm believes the collaboration limits share downside as well as upside by making the "home-run scenario of great combo data leading to an acquisition less likely." It lowered its price target for Achillion shares to $16 and keeps an Outperform rating on the name.
08:15 EDTJNJJohnson & Johnson CEO Alex Gorsky says won't pursue pure-play strategy
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08:02 EDTJNJJohnson & Johnson to hold a meeting
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07:51 EDTJNJAchillion shares remain undervalued after HCV pact with J&J, says Cowen
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07:48 EDTBMRNBioMarin has a conference call hosted by JPMorgan
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07:33 EDTJNJJ&J to file more than 10 new '$1B potenital' products by 2019
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07:30 EDTJNJAchillion downgraded on valuation at JMP Securities
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07:17 EDTBMRNBioMarin can rally over 25% on drisapersen approval, says Jefferies
Jefferies analyst Eun Yang sees greater than 25% upside in shares of BioMarin should the FDA approve drisapersen for Duchenne muscular dystrophy. After hosting an investor dinner with management, Yang says BioMarin's confidence in drisapersen approvability has increased. The analyst's model, which includes a price target for shares of $135 and a Buy rating, assumes 60% probability of approval for drisapersen. Shares of BioMarin closed yesterday down $1.03 to $124.99.
06:17 EDTJNJAchillion downgraded to Neutral from Buy at UBS
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May 19, 2015
16:10 EDTJNJAchillion enters into collaboration for HCV with Janssen
Achillion (ACHN) announced that it has entered into a worldwide license and collaboration arrangement with Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to develop and commercialize one or more of Achillion's lead hepatitis C virus, or HCV, assets which include ACH-3102, ACH-3422, and sovaprevir. Under the terms of the agreement, Achillion will grant Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets. Achillion is eligible to receive a number of payments based upon achievement of specified development, regulatory and sales milestones. Achillion is also eligible to receive tiered royalty percentages between mid-teens and low-twenties based upon future worldwide sales. Janssen will be responsible for all of the development costs within the collaboration and all subsequent costs related to commercialization of the HCV assets. A key objective of the collaboration will be to develop a short-duration, highly effective, pan-genotypic, oral regimen for the treatment of HCV. An initial regimen that will be explored will feature Achillion's ACH-3102, a second-generation NS5A inhibitor currently in Phase 2 clinical studies that has been granted Fast Track designation by the U.S. Food and Drug Administration, in combination with an NS3/4A HCV protease inhibitor plus an NS5B HCV polymerase inhibitor from the collaboration. Additionally, in an equity transaction separate to the exclusive license and collaboration arrangement, Johnson & Johnson Innovation JJDC, Inc. will invest $225M in Achillion and, in return, receive approximately 18.4M newly issued, unregistered shares of Achillion at a price of $12.25 per share. The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. Transitional clinical development and technology transfer activities under the collaboration are expected to take place over the next several months.
May 15, 2015
10:28 EDTMYGNMAC updates positive for NanoString, Myriad, Invitae, QIAGEN, says Leerink
Leerink said that coverage updates posted yesterday by Medicare Administrative Contractors were favorable for NanoString (NSTG), Myriad Genetics (MYGN), Invitae (NVTA) and QIAGEN (QGEN). The firm has Outperform ratings on NanoString and Invitae and Market Perform rating on the other two stocks listed.
07:35 EDTJNJMedivation price target raised to $148 from $128 at Leerink
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07:09 EDTMYGNMyriad Genetics presents clinical data for Prolaris test
Myriad Genetics presented clinical data for its Prolaris test at the 2015 American Urological Association, or AUA, Annual Meeting being held May 15-19 in New Orleans, La. The results highlighted and underscored the significant ability of the Prolaris test to help physicians improve care for men diagnosed with prostate cancer. In this pioneering study, Myriad presented important new clinical validation data that establishes an active surveillance, or AS, threshold for men with localized prostate cancer. Specifically, the AS threshold is a composite of the Prolaris test score and clinicopathologic features. In the validation data featured at AUA, the pre-defined AS threshold was evaluated in 765 conservatively managed men, and the clinical endpoint was 10-year risk of prostate cancer mortality. The results showed that at the AS threshold, the predicted 10-year survival rate of prostate cancer patients was 97%. Conversely, there was a three percent risk of 10-year, prostate-specific mortality. Importantly, however, there were no observed prostate cancer-specific deaths over 10 years among men whose scores fell below the AS threshold. Additionally, a separate analysis of 4,218 patients was performed to determine what percentage of patients who were clinically tested with Prolaris would be candidates for active surveillance based on the validated AS threshold. Of this commercial cohort, 36% qualified for active surveillance based on their clinical features alone. However, when the Prolaris test was added to the clinical risk assessment, 60% of these patients fell below the AS threshold, representing a significant increase in the total number of candidates who may be eligible for active surveillance.
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