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News Breaks
August 7, 2014
14:05 EDTRHHBY, PTCTPTC Therapeutics reports publication of preclinical study results in SMA models
PTC Therapeutics (PTCT) announced that he journal Science published results of a preclinical study demonstrating that treatment with orally available RNA splicing modifiers of the SMN2 gene starting early after birth is preventing deficits in mouse models of Spinal Muscular Atrophy or SMA. Stuart Peltz, CEO of PTC Therapeutics, said, "Using the experience and expertise in RNA biology we have gained at PTC over the last 16 years, we used our alternative splicing technology to identify and subsequently optimize investigational compounds that target the SMN2 splicing to produce the SMN protein. Our unique partnership with Roche and the SMA Foundation has allowed this project to rapidly move into clinical development." Luca Santarelli, Head of Neuroscience, Ophthalmology and Rare Diseases at Roche (RHHBY), said, "Although still preclinical, these results demonstrate how SMN2 splicing modifiers could correct the molecular deficit that causes SMA. This study represents an important step towards developing a potential therapeutic option for this devastating and currently untreatable condition. Early clinical trials are currently underway to determine the safety and tolerability of this approach."
News For PTCT;RHHBY From The Last 14 Days
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April 23, 2015
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
05:27 EDTRHHBYRoche sees FY15 core EPS to grow ahead of sales at constant exchange rates
Expects FY15 sales to grow low- to mid-single digit, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:27 EDTRHHBYRoche reports Q1 group sales CHF 11.83B vs. CHF 11.50B
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April 21, 2015
07:06 EDTRHHBYBina Tech, AstraZeneca announce collaborative agreement for GMS
Bina Technologies, a member of the Roche Group (RHHBY), and AstraZeneca (AZN) announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Program and to further develop the Bina Genomic Management Solution. AstraZeneca will utilize the Bina GMS as an enterprise platform to support its development work across three main therapeutic areas: oncology, cardiovascular and metabolic disease, and respiratory, inflammation and autoimmunity. Bina’s proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximize the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support enterprise genomic data analysis and management. Bina in turn will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.
05:33 EDTRHHBYInovio, Roche initiate clinical trial for DNA immunotherapy to treat HCB
Inovio Pharmaceuticals (INO) announced that it has initiated a Phase I trial to evaluate Inovio's DNA immunotherapy in patients who are chronically infected with hepatitis B. In 2013, Roche (RHHBY) and Inovio entered into a partnership to co-develop and commercialize Inovio's hepatitis B immunotherapy. This trial initiation triggers a $3M milestone payment from Roche to Inovio. This phase I, randomized, open-label, active-controlled, dose escalation study will evaluate the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator. This international study will enroll patients in the United States and Asia Pacific region with a primary endpoint of safety and tolerability of the therapy. The secondary endpoints will evaluate the cellular and humoral immune response to INO-1800 and investigate the therapy's effect on several viral and antiviral parameters. All trial subjects are also medicated with standard-of-care antiviral therapies.
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.
April 17, 2015
05:32 EDTRHHBYAccelerate Diagnostics appoints Pete Bantock to Chief Culture Officer
Accelerate Diagnostics (AXDX) appointed Pete Bantock to the newly created position of Chief Culture Officer and Head of Human Resources. Bantock was most recently the SVP and Head of commercial Operations for the Americas. He will be replaced by Ron Price, who joins the company from Roche (RHHBY) where he held the position of VP of Point of Care and Commercial Operations.
April 16, 2015
10:00 EDTPTCTOn The Fly: Analyst Upgrade Summary
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08:04 EDTRHHBYRoche granted orphan status for lymphoma treatment
The FDA granted Roche's Genentech unit orphan status for Gazyva, its treatment of follicular lymphoma.
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 14, 2015
06:30 EDTRHHBYRoche to seek to have cancer drug tested in 11 trials in 2015, Reuters says
Roche said it would seek to have its immunotherapy cancer drug, MPDL3280A, in 11 late stage trials by the end of 2015, aaccording to Reuters. The drug is being tested in melanoma, as well as lung, bladder, kidney, bowel and blood cancers, the news service noted. Reference Link
April 13, 2015
10:01 EDTRHHBYRoche acquires CAPP Medical
Roche announced it has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and industry veterans, to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA in blood.

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