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Stock Market & Financial Investment News

News Breaks
June 23, 2014
04:55 EDTACRX, ACRX, BLRX, BLRX, CRIS, CRIS, NEO, NEO, PRTA, PRTA, PTCT, PTCT, LGND, LGND, GALE, GALE, IPCI, IPCIRoth Capital to hold a conference
ROTH Healthcare Corporate Access Day to be held in London, England on June 23-24.
News For ACRX;BLRX;CRIS;NEO;PRTA;PTCT;LGND;GALE;IPCI From The Last 14 Days
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April 23, 2015
16:14 EDTLGNDLigand names Melanie Herman Interim CFO
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09:18 EDTPTCTOn The Fly: Pre-market Movers
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07:51 EDTPTCTPTC Therapeutics price target raised to $155 from $135 at Oppenheimer
Oppenheimer increased its price target on PTC after the company, along with Roche (RHHBY), presented data on its RG7800 drug that the firm believes showed proof-of-mechanism in health subjects. The firm recommends owning PTC ahead of two events: the scheduled October 2015 P3 read-out of Translarna in DMD, and an update on the MOONFISH trial of RG7800 slated to occur in early 2016. The firm keeps an Outperform rating on the shares.
April 22, 2015
12:01 EDTLGNDLigand earns milestone payment from Sage Therapeutics for SAGE-547
Ligand (LGND) announced that it has earned a $500,000 milestone payment from SAGE Therapeutics (SAGE) relating to the treatment of the first patient in SAGEs Phase 3 open-label expanded access protocol, designated Study 302. Study 302 is designed to offer SAGE-547 to patients affected by super-refractory status epilepticus and to evaluate the safety of SAGE-547 in patients with SRSE. SAGE has reported that the results from this clinical trial, along with results from SAGE's planned Phase 3 placebo-controlled clinical trial - called the STATUS Trial and other clinical data obtained from the SAGE-547 development program are intended to form the basis of a New Drug Application submission.
April 21, 2015
16:40 EDTNEONeoGenomics appoints Steven Brodie as Chief Scientific Officer
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09:34 EDTGALEGalena sent FDA warning letter following site inspection
A warning letter published by the FDA, dated April 3, states that the agency's inspection of Galena Biopharma's site in Portland, Oregon, conducted between November 17 and 21, 2014, revealed "serious violations" of FDAs PADE reporting requirements. Reference Link
09:16 EDTLGNDTG Therapeutics data positive, says Roth Capital
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April 20, 2015
08:19 EDTPTCTPTC Therapeutics to present Phase 1 clinical data from SMA program
PTC Therapeutics announced that Phase 1 clinical data from the company's joint development program with Roche and the SMA Foundation in spinal muscular atrophy, or SMA, will be presented at the 2015 American Academy of Neurology 67th Annual Meeting. As previously disclosed, findings from the Phase 1 study indicated that RG7800, an investigational oral therapy for SMA, showed a favorable safety profile and was well tolerated at all dose levels studied. In addition, proof of mechanism was demonstrated by a dose-dependent effect on Survival Motor Neuron 2, or SMN2, splicing towards the production of full length SMN2 mRNA. The Phase 1 study was a single ascending dose, placebo-controlled, double-blind study in 48 healthy volunteers testing single oral doses from 0.5 to 90 mg.
07:59 EDTPTCTJPMorgan sees range-bound as best case for PTC shares
JPMorgan believes the many triple-digit price targets for shares of PTC Therapeutics factor in unrealistic expectations for the company's pipeline in the absence of positive phase 3 data. The firm expects shares to be range bound in a best case with volatility likely amid continued takeover speculation. JPMorgan thinks a potential buyer is unlikely to pay "significantly" higher than current shares levels, particularly with the Phase 3 trial of ataluren in Duchenne muscular dystrophy in Q4. The firm raised its price target for PTC shares to $77 from $65 to reflect the MPS 1 opportunity for Translarna. It reiterates a Neutral rating on the stock.
07:41 EDTLGNDLigand partner TG Therapeutics presents pre-clinical data on IRAK4 compounds
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April 19, 2015
15:37 EDTCRISCuris, Aurigene to present data on IRAK-4 inhibitor program
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April 17, 2015
16:04 EDTCRISCuris files to sell 17.12M shares of common stock for holders
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April 16, 2015
10:00 EDTPTCTOn The Fly: Analyst Upgrade Summary
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07:58 EDTPTCTPTC Therapeutics upgraded to Outperform at Cowen
As previously reported, Cowen upgraded PTC Therapeutics to Outperform from Market Perform ahead of its upcoming ACT-DMD data in the fourth quarter. The firm expects positive Phase 3 data after Phase 2 data established proof of concept. Cowen raised its price target to $120 from $70 on PTC Therapeutics to reflect the chance of success of Translarna in DMD.
07:55 EDTPTCTPTC Therapeutics upgraded to Outperform from Market Perform at Cowen
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April 15, 2015
07:41 EDTLGNDEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
08:07 EDTIPCIIntellipharmaceutics reports Q1 EPS (4c), consensus (7c)
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07:26 EDTGALEGalena completes over-enrollment of NeuVax Phase 3 PRESENT clinical trial
Galena Biopharma announced the completion of enrollment in the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat, or ITT, population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment, or SPA, called for 700 patients; and, the company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events occur, whichever comes later.

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