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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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February 12, 2016
08:04 EDTPTCTPTC Therapeutics announces second annual Strive grant award program for DMD
PTC Therapeutics announced the second annual STRIVE grant award program for Duchenne muscular dystrophy, or DMD. STRIVE provides funds to patient advocacy organizations to develop unique and collaborative programs that will make meaningful contributions to the rare disease community by increasing awareness, diagnosis, education or fostering development of future patient advocates. The program is aimed at improving the diagnosis and treatment of DMD patients. One-year awards of up to $30,000 will be given to the most creative, feasible and sustainable proposals identified by a panel of judges. The deadline for submission of proposals is May 31 and awards will be announced on World Duchenne Awareness Day, on Sept. 7.
February 8, 2016
10:17 EDTPTCTSarepta approval seen as 'long shot' as FDA pushes back decision
Shares of drugmaker Sarepta Therapeutics (SRPT) took a dive in morning trading after the company said the U.S. Food and Drug Administration delayed a decision on eteplirsen for the treatment of Duchenne muscular dystrophy. WHAT'S NEW: Sarepta announced that the FDA has pushed out the the Prescription Drug User Fee Act, or PDUFA, date for eteplirsen for the treatment of Duchenne muscular dystrophy to May 26. The previous PDUFA date for the eteplirsen new drug application, or NDA, was originally set for late February. FDA POSTPONEMENT: The FDA notified Sarepta that it's submission of 4-year clinical data, including additional six minute walk test and loss of ambulation data compared to historical control, was designated as a "major amendment" to the NDA and that the PDUFA goal date was extended to allow for a full review of the submission. The FDA previously granted eteplirsen Priority Review status, as well as Rare Pediatric Disease Designation, Orphan Drug Designation and Fast Track Status to eteplirsen. WHAT'S NOTABLE: In late January, the FDA postponed a meeting of its advisory committee to review the Sarepta drug due to an inclement weather forecast for Washington D.C. LONG SHOT: Piper Jaffray analyst Edward Tenthoff told investors in a note that the FDA's PDUFA date postponement for eteplirsen is "not surprising" following the delay of the January 22 AdCom due to weather. Tenthoff also noted that a new AdCom has yet to be scheduled. The analyst continues to see eteplirsen accelerated approval by the new PDUFA date as a "long shot." He believes that the panel discussion will be a "plea from the community" to approve something for DMD and that members will not be asked to vote on drug approval. Tenthoff has a Neutral rating and $15 price target on Sarepta. OTHERS TO WATCH: Other companies developing treatments for Duchenne muscular dystrophy include BioMarin (BMRN) and PTC Therapeutics (PTCT). PRICE ACTION: Sarepta is down 9.5% in morning trading to $11.06.
06:28 EDTRHHBYPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 3, 2016
14:32 EDTRHHBYPacific Biosciences deal with Roche may take time to get done, says Cantor
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February 2, 2016
16:23 EDTRHHBYOn The Fly: Top stock stories for Tuesday
Stocks began the session in negative territory and remained there throughout the entire session. The early weakness was attributed to oil prices, which were down early and never recovered during the day. The losses of more than 5% brings the loss over the past two days to more than 10%, pushing WTI crude back below $30 a barrel and squashing equities in the process. Any hope that oil prices would de-couple from stock prices will have to wait another day as the two continue to move in lockstep with each other. Even a solid earnings report from tech bellwether Alphabet (GOOG) could not help the market. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet. In Europe, statistics agency Eurostat reported that unemployment across the eurozone decreased by 49,000 to a total of 16.75M in December dropping the unemployment rate to its lowest since September 2011 at 10.4%. In central bank news, the Reserve Bank of Australia and Reserve Bank of India both held their benchmark interest rates steady, as expected. COMPANY NEWS: Class A shares of Alphabet (GOOGL) advanced 1.3% to $780.91 after its better than expected quarterly results were followed by analysts around Wall Street hiking their price targets for shares, including Deutsche Bank analyst Ross Sandler, who raised his target on the parent of Google to $1,080 from $900... Exxon Mobil (XOM) reported better than expected revenue and profits in the fourth quarter, but its shares slid 2.2% to $74.61 amid the renewed weakness in oil prices. Shares of fellow oil major BP (BP) plunged 8.5% to $29.02 in New York trading after reporting a steep quarterly loss, largely due to $2.6B in charges related to impairments of Upstream assets as well as restructuring... Ford (F) shares fell 4.6% after the company reporting that its U.S. sales declined 3% last month versus a year ago. Peer General Motors (GM) slid 1.5% after reporting that its U.S. sales grew 0.5% in January... Dow Chemical (DOW) jumped 5.75% to $45.03 after posting better than expected earnings and revenue. Of note, Dow CEO Andrew Liveris said he plans to transition out of the company when it completes its planned merger with DuPont (DD). MAJOR MOVERS: Among the notable gainers were Michael Kors (KORS) and Mattel (MAT), which rose nearly 24% and almost 14%, respectively, following their earnings reports. Also higher was Pacific Biosciences (PACB), which jumped 24% to $12.67 after Reuters said Roche (RHHBY) has recently approached the company to discuss a potential acquisition. Among the noteworthy losers following earnings were Integrated Device (IDTI), which fell 26.8%, ADT (ADT), which dropped 15.7%, and Royal Caribbean (RCL), which declined 15.2%. INDEXES: The Dow fell 295.64, or 1.8%, to 16,153.54, the Nasdaq lost 103.42, or 2.24%, to 4,516.95, and the S&P 500 declined 36.35, or 1.87%, to 1,903.03.
15:12 EDTRHHBYRoche approached Pacific Biosciences about possible acquisition, Reuters says
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15:10 EDTRHHBYRoche approached Pacific Biosciences about possible acquisition, Reuters says
08:36 EDTRHHBYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
11:02 EDTRHHBYRoche: Updated cervical cancer screening guidelines support use of cobas test
Roche announced that recently updated cervical cancer screening guidelines from the American College of Obstetricians and Gynecologists support the use of its cobas HPV Test for primary cervical cancer screening as an alternative to current cytology-based cancer screening methods in women 25 and older. The College's revised Practice Bulletin 157, published in the January issue of Obstetrics & Gynecology, reinforces similar guidance issued in 2015 by the Society for Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. The cobas HPV Test was approved by the FDA in 2011 for use in screening women 21 and older with unclear Pap test results and for co-testing with a Pap test in women 30 and older. The FDA approved it for first-line primary cervical cancer screening for women 25 and older in April 2014 following a unanimous recommendation from the independent Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee. Currently utilized by more than 250 labs in the U.S., the cobas HPV Test is the only test approved in the U.S. for all three HPV testing options now supported by three major medical societies.
January 31, 2016
16:13 EDTRHHBYGenentech receives orphan designation for Avastin in mesothelioma
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