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3 month PPS objective in your opinion? tia
Another green day a comin?
7:08AM Myriad Genetics announces a research collaboration with BioMarin (BMRN) that will use Myriad's novel HRD (MYGN) 27.59 : Co announces a research collaboration with BioMarin (BRMN) that will use Myriad's novel HRD (Homologous Recombination Deficiency) test to identify tumor types that may be sensitive to BioMarin's investigational product candidate, BMN-673. Specific terms of the deal were not disclosed.
7:08AM Myriad Genetics announces Myriad myRisk Hereditary Cancer test is 'highly accurate' in key validation study; five studies to be presented at the American Society of Human Genetics Annual Meeting (MYGN) 25.39 : Co announced it will present data this week at the American Society of Human Genetics (ASHG) annual meeting in Boston showing that the Myriad myRisk Hereditary Cancer test meets rigorous quality standards and provides clinical sequencing results equivalent to 99.99 percent accuracy. Myriad myRisk Hereditary Cancer is a new diagnostic test that provides patients with information about their hereditary risk for eight major cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric cancers and melanoma. We've invested three years of research to optimize our Myriad myRisk Hereditary Cancer test, and the validation data show that Myriad myRisk Hereditary Cancer offers 99.99 specificity and sensitivity which means it provides unprecedented quality and accuracy equal to the gold standard Sanger sequencing."
7:05AM Myriad Genetics announces results from a verification study showed the Myriad myPath Melanoma test effectively differentiated malignant melanoma from benign skin lesions (MYGN) 22.77 : Co announced that results from a verification study showed the Myriad myPath Melanoma test effectively differentiated malignant melanoma from benign skin lesions. Co presented these data at the American Society of Dermatopathology Annual Meeting on Oct. 13, 2013. The verification study evaluated a 23-gene panel designed to differentiate malignant melanoma from benign skin lesions. The study analyzed 464 skin biopsy samples including 254 samples representing melanomas from all major subtypes including superficial spreading, lentigo maligna melanoma, acral, nodular and desmoplastic lesions. Using this set of patient samples, the myPath Melanoma test demonstrated high sensitivity of 89% and specificity of 93% at differentiating malignant melanoma from benign skin lesions.
7:08AM Myriad Genetics Study Highlights Importance of myRisk Hereditary Cancer Testing; Data to be Presented at the National Society of Genetic Counselors Annual Meeting (MYGN) 24.25 : Co announces it will present data showing the high prevalence and overlap between hereditary colon cancer and hereditary breast and ovarian cancer in patients previously diagnosed with endometrial and ovarian cancer. The presentations will take place Oct 11.
Prevalence of Lynch Syndrome and HBOC among Patients with Primary Endometrial and Primary Ovarian Cancers
Results showed that among 1,529 patients evaluated 11.2% had a deleterious mutation with 73.3% of the mutations in hereditary colon cancer genes and 26.7% in hereditary breast cancer genes. Although the prevalence of hereditary colon cancer was higher than hereditary breast cancer in patients with endometrial and ovarian cancers, these patients showed a strong family history overlap between the two syndromes. The findings suggest these patients would be appropriate candidates for testing with a hereditary cancer panel to prevent a missed diagnosis of hereditary cancer.
7:06AM Myriad Genetics' myRisk Hereditary Cancer test improves colon cancer testing by 60% (MYGN) 25.11 : Co announced new clinical data from a study with myRisk Hereditary Cancer, a 25-gene hereditary cancer panel, that showed a 60% increase in mutations detected in cancer predisposition genes in patients with a prior history of colon cancer and/or polyps. Myriad is presenting this clinical study and data from four other studies this week at the Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) Annual Meeting in Anaheim, Calif.
Germline Mutations Identified by a 25-Gene Panel in Patients Undergoing Lynch Syndrome Testing
This study evaluated the mutation prevalence among cases referred for Lynch Syndrome (LS), the most common genetic cause of colon cancer, using the myRisk Hereditary Cancer test, a 25-gene hereditary cancer panel. The study presents data from two cohorts representing a total of 1,133 patients diagnosed with colon cancer or colorectal polyps. The results demonstrated that 10% of patients had deleterious mutations in the traditional hereditary colon cancer genes, but an additional 6% had deleterious mutations in other genes. This represents a 60% increase in the number of patients detected with deleterious mutations in cancer predisposing genes.
Overlap between Lynch Syndrome and Hereditary Breast and Ovarian Cancer Syndrome among Family Histories in Patients Tested for Hereditary Cancer Syndromes
This study investigated the overlap of personal and family histories in hereditary breast and ovarian cancer (HBOC) and hereditary colon cancer in 9,000 patients. Results showed that among patients tested for HBOC, 6.9% also had family histories that meet the National Comprehensive Cancer Network criteria for hereditary colon cancer. In addition, 30% of patients tested for hereditary colon cancer also met NCCN criteria for HBOC. This analysis demonstrates the overlap among patients with a family history of hereditary breast cancer and those with a family history of colon cancer, suggesting that patients may benefit from multi-gene panels to better improve the diagnosis of hereditary cancer syndromes.
7:03AM Myriad Genetics myPlan Lung Cancer test meets primary clinical endpoint (MYGN) 25.08 : Co announced new data published in Clinical Cancer Research that showed the myPlan Lung Cancer test is a significant predictor of lung cancer death in patients with early-stage, resectable lung adenocarcinoma and may be a valuable tool for selecting which early-stage patients should be considered for additional post-surgical chemotherapy. The myPlan Lung Cancer test measured mRNA expression levels of 31 cell cycle proliferation genes and 15 housekeeping genes in stage I and II tumor samples from a total of 841 patients. The results showed that myPlan Lung Cancer consistently was the strongest independent predictor of 5-year disease survival and remained the dominant prognostic marker in the presence of conventional clinical variables.
I sold part of my holdings today.
Most importantly I am ahead after being way down.
Sure hope some of you cashed in when stock was at absurd bargain price of $25.
I sure hope everyone has made some money during this nice runup when all of the fools were selling.
I would be very much surprised if the stock price doesn't at least stabilze here and then move forward provided of course there isn't a big overall drop in the market.
I agree. After this initial shock, MYGN will stair climb back to it's 52 wk highs again in no time. Earnings report last May 7 were above expectations (revenue up 21%, earnings up 34%), and the company raised 2013 revenue guidance again, from $575-585M to $595-600M, and EPS guidance from $1.55-1.58 to $1.65-1.67. IMO, sellers the past 2 trading days will start re-investing again very soon. In fact, Myriad Genetics was upgraded to Outperform from Market Perform at JMP Securities, citing valuation and said the Supreme Court decision removes an overhang.
I added to my position also yesterday and today-for me this is a temporary blip and thats it.
Best of luck to you and all longs.
MYGN. Bought at $27.20 today. IMO, this will be back to $30's next week.
Here are some thoughts from analysts on the stock:
From Credit Suisse Analyst V. Divan (Neutral rating, $28 target price):
“A mixed ruling by the Supreme Court … What was surprising to us, however, was the speed with which competitors announced that they would be entering the BRCA testing market, in spite of [the Supreme Court] upholding that cDNA is patent eligible. While the near-term Myriad story is still solid, the longer-term concerns that we have had around the name are now accelerated as these competitors will likely cause MYGN to face pricing pressure and/or market share losses over time. … Myriad may challenge the legality of competing tests but we believe this will be tough to do on a case-by-case basis and the overhang will remain in place for many months (years?) … We are lowering our FY14/15 EPS estimates to $1.82/$1.98 (from $1.83/$1.99) respectively.”
Leerink Swann Analysts Dan Leonard and Julian Cochran (Market Perform, $39 target price):
“Following the Supreme Court’s mixed ruling on gene patents, we believe focus on Myriad’s stock will shift to its long-term competitive positioning in the hereditary cancer testing market, in which we think its share has nowhere to go but down, and pricing could compress over time. While we believe MYGN’s long-term positioning remains strong … [the ruling] has mixed implications …The patents at issue expired in Dec. 2015 anyway, and the larger debate on Myriad is what its business looks like long-term regarding pricing and share of hereditary cancer testing. Also, we expect the fall of the isolated DNA patents could be enough to accelerate competitive entry (BRLI, University of Washington, and Ambry Genetics have already announced plans to launch), and we would be surprised if Myriad is successful obtaining an injunction against oncoming competitors. … meaningful upside to MYGN’s intraday price … requires more aggressive assumptions on price and share maintenance long-term than we are comfortable with, and thus downgrade the stock to Market Perform.”
Mizuho Securities USA analysts Peter Lawson and Eric Criscuolo (Buy rating, $43 target price):
“The decision is positive for Myriad and removes a significant overhang for the stock, allowing greater focus onto strong earnings performance and significant new product cycle. … Myriad is converting its single gene hereditary tests (BRACAnalysis, COLARIS, Melaris, Panexia) into a single product, the myRisk panel, which will launch in the fall of 2013. Management expects to convert its entire hereditary business to the myRisk panel by Summer 2015. Myriad is also increasing its focus on pharma collaborations and companion diagnostic development. … With the patent overhang removed, we are increasing our 12-month price target from $38 to $43, based on 24x our FY14 EPS estimate of $1.80, a premium to peers due to Myriad’s growth, margin profile and product cycle.”
Cantor Fitzgerald Analyst Sung Ji Nam (Buy rating, $41 price target):
“Bio-Reference Laboratories and Quest Diagnostics plan to offer BRCA1/2 testing by year-end, which we find somewhat surprising given the risk/reward associated with potential legal proceedings. … We believe that Myriad’s intellectual property (IP) around BRACAnalysis remains strong through 2018, given four of the nine patent claims adjudicated by the Supreme Court have been essentially upheld and Myriad’s large majority of the patents and claims … remain unchallenged, and as such, we think Myriad will aggressively defend its IP going forward. Based on our adjusted estimates (competition still entering in FY:14, higher SG&A from legal expenses, slightly slower share erosion vs. our prior estimates), we reiterate our BUY rating and raise our price target to $41 from $40.”
http://blogs.barrons.com/stockstowatchtoday/2013/06/14/myriad-cancer-gene-test-survives-but-stock-sinks-13/?mod=yahoobarrons
1:33AM Myriad Genetics announces AstraZeneca (AZN) advances PARP inhibitor into Phase 3 Trial With BRACAnalysis (MYGN) 32.10 : Myriad Genetics announces that AstraZeneca (AZN) will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption with the FDA for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States.
7:06AM Myriad Genetics to present PROLARIS data at ASCO 2013, continuing its commitment to cancer research says 'clinical data show that prolaris predicts prostate cancer outcome in multiple patient cohorts and in diverse clinical settings' (MYGN) 31.67 : "Clinical data show that PROLARIS predicts prostate cancer outcome in multiple patient cohorts and in diverse clinical settings," said Professor Cuzick. "PROLARIS provides independent information beyond clinicopathologic variables and accurately differentiates aggressive prostate cancer from indolent cancer based on real oncologic outcomes." Key clinical characteristics of PROLARIS include: The PROLARIS Score is the dominant variable at diagnosis in predicting risk of prostate cancer progression, as determined by the gold standard oncologic endpoints such as biochemical recurrence, metastasis and prostate cancer specific mortality.
Myriad Retained at Outperform
By Zacks Equity Research | Zacks – Fri, Mar 8, 2013 9:18 AM EST..
On Mar 5, 2013, we reaffirmed our long-term Outperform recommendation on Myriad Genetics Inc. (MYGN) following its strong second-quarter fiscal 2013 results and upward revision in the fiscal outlook.
Why the Reiteration?
On Feb 5, Myriad reported another positive earnings surprise when its second-quarter earnings per share rose 27% on a year-over-year basis to 42 cents, reflecting a beat of 10.5% over the Zacks Consensus Estimate. Revenues climbed 21% to $149.1 million, surpassing the Zacks Consensus Estimate. The quarter showed sign of balanced growth as Myriad’s mainstay franchise of molecular diagnostic test was supported by the relatively minor companion diagnostic segment.
While Bracanalysis test remains Myriad’s flagship product, the BART (Bracanalysis Rearrangement Technology) test continues to gain traction. The positive momentum of the BART test is reflected in the massive five time increase of its revenues to $15.8 million.
Apart from these, Myriad has a gamut of other tests to drive growth. The company’s strong pipeline, with certain tests that will serve a billion-dollar market, is another upside.
On the other hand, Myriad’s focus on the companion diagnostic market is encouraging. The company’s agreements with several pharmaceutical companies like Sanofi (SNY) is likely to boost revenues for the companion diagnostic franchise going forward.
Myriad’s new share buyback program should provide earnings upside in the coming quarters. Meanwhile, the company has made commendable progress with respect to its expansion in Europe.
Although there is no dearth of growth catalysts for Myriad, margin pressure and reimbursement price cuts for its tests might sour its momentum. We also remain watchful of the patent litigation (to decide whether isolated human genes can be patented), which might affect Myriad’s patent landscape for its flagship product. The decision is anticipated in Jun 2013.
Myriad Stymies Cancer Answers by Impeding Data Sharing
By Robert Langreth - Dec 28, 2012 12:01 AM ET
Tory Galloway thought her negative result on a widely-used test sold by Myriad Genetics Inc. (MYGN) cleared her DNA as a cause for her fallopian tube cancer.
She happily advised her four sisters that the disease didn’t result from a family trait. The relief from the December 2010 test, though, was short lived. In October, after getting results from a broader scan at the University of Washington that included dozens of genes, she learned the truth: Her cancer was caused by a mutation that wasn’t included in the Myriad product.
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Tory Galloway, a landscape designer in Indianola, Washington, thought her negative result on a widely-used test sold by Myriad Genetics Inc. cleared her DNA as a cause for her fallopian tube cancer. Source: Family Photo via Bloomberg
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Tory Galloway, center, poses with her sisters, from left, Jody, Laura, Wendy and Liz. After a test at the University of Washington that included dozens of genes, Tory Galloway learned that her cancer was caused by a mutation that wasn’t included in the Myriad Genetics test. Family Photo via Bloomberg
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The Myriad Genetics Inc. corporate campus in Salt Lake City. Source: Continuum Health Communications via Bloomberg
Mary-Claire King, a geneticist now at the University of Washington, stunned the scientific world in 1990 by proving that a single gene can raise the risk of breast cancer. Backed by venture capital money, Myriad beat King and her academic colleagues to pinpoint the location of the cancer gene and patenting it. Source: University of Washington via Bloomberg
“It makes me nuts to even think about it,” said Galloway, a landscape designer in Indianola, Washington.
The broader test, created by University of Washington researchers, uses technology to identify as many cancer risks as possible. There’s one problem: Such a test can’t include the BRCA1 and BRCA2 genes that are the most common inherited causes for breast and ovarian cancer because Myriad owns the patents on them. This prevents other U.S. laboratories from using them in a commercial test.
In the mid-1990s, Myriad helped kick-start the gene-testing revolution by pinpointing the two BRCA genes. Now, the world’s biggest genetic testing company for breast cancer, with a market value of $2.2 billion, is under attack by researchers, genetic counselors, doctors, and their patients.
Besides stifling competitors from offering combination tests including the BRCA genes, critics also said the company won’t share data from decades of testing that could aid research into how best to interpret screening. They said Myriad doesn’t adequately respond when other researchers find added BRCA mutations that address risks their current tests don’t cover.
At Stake
“What is at stake is the way we want our health-care system to work,” said Robert Cook-Deegan, a professor of public policy, biology, and medicine at Duke University in Durham, North Carolina, who supports limits on gene patents. “The testing has been set up by Myriad to optimize this business model. It is not set up to optimize public health outcomes.”
The dispute, which has grown in intensity as more and more cancer-causing mutations are found, has spilled out of the laboratories and clinics into the U.S. Supreme Court. A ruling next year in a case challenging Myriad’s hold on the BRCA patents could either support the company’s profit-driven motives or redefine a nascent industry in a way that affects millions of dollars in revenue.
Myriad officials reject the criticisms, saying they offer faster, more accurate testing for harmful mutations in breast cancer genes than any other laboratory in the world, and its patents haven’t hindered research or patient care.
Life Saver
“Myriad has never done anything to harm patients,” said Peter Meldrum, Myriad’s chief executive officer, during an interview at his company’s headquarters in Salt Lake City, near the Wasatch Mountain foothills. “We have the most accurate results, we give the fastest results.” There has never been a reported case in which Myriad wrongly told that a woman she had a cancer-causing mutation, he said.
Carol Mackoff, 70, a Chicago-based managing director for Rice Financial Products Co., says Myriad “saved my life.”
Mackoff tested positive on a Myriad test for a BRCA1 mutation in 2002 after visiting an ovarian cancer prevention program at Northwestern Memorial Hospital in Chicago, she said in a telephone interview. Within weeks, she had her ovaries removed to prevent ovarian cancer, and later in 2009 had a prophylactic double mastectomy.
Without the Myriad test, “I would have had cancer,” she said. “The fact that they developed these tests and gave me a tool to work with to allow me to prevent getting cancer, I owe them everything.”
Breast Cancer
Faster, cheaper DNA testing is revolutionizing medical care. Nowhere has the impact been felt more strongly than in breast cancer. A woman who tests positive using Myriad’s tests carries as much as an 80 percent chance that she will get breast cancer in her lifetime. Testing helps women take charge of their medical future, providing options that can include preventative surgery and more extensive monitoring.
Widespread use of the tests has made Myriad an unabashed financial success. The company’s testing business, led by its flagship $3,340 BRCA product, carries an 87 percent gross profit margin that in fiscal 2012 generated $496 million in sales, according to Myriad.
That’s helped boost the company’s shares 30 percent this year.
Meldrum and Utah researcher Mark Skolnick founded Myriad in May 1991, about a year after Mary-Claire King, a geneticist now at the University of Washington, stunned the scientific world by proving that a single gene can raise the risk of breast cancer. Skolnick is retired from the company.
Venture Backed
Backed by venture capital money, Myriad beat King and her academic colleagues to pinpoint the location of the BRCA1 cancer gene and patent it. They won a similar race to find another gene linked to increased risk -- BRCA2. Myriad filed a patent application for that cancer gene just days before a British-led team published a scientific paper announcing they had found it.
Sales have soared, fueled by patents which give Myriad a virtual monopoly on genetic testing for hereditary breast cancer in the U.S. About 227,000 American women are diagnosed with breast cancer every year and about 5 to 10 percent carry the mutant genes.
“Nobody else has built a half a billion-dollar business around tests for single genes,” Peter Lawson, a New York based analyst for Mizuho Securities USA, said in a telephone interview. “They are the dominant player in the industry.”
Myriad is also “far and away the most conspicuous and controversial” testing company relying on gene patents, said Duke’s Cook-Deegan.
Research Stifled
While Myriad provides accurate testing for mutations in BRCA1 and BRCA2, its exclusive right to test those genes limits laboratories and researchers in developing new tests, said King, the University of Washington geneticist.
In 2006, after it became clear that Myriad’s main test missed some BRCA mutations, Myriad angered geneticists and genetic counselors when it didn’t modify its main test to include those mutations.
Instead, it came out with a separate test, now priced at $700, to detect the additional BRCA mutations missed by the main test. Insurance companies didn’t cover the second test for years, and most women didn’t get it until recently, genetic counselors said. Some women who tested negative on the main test may wrongly think they don’t have a cancer-causing gene.
Standard Practice
Kathleen Maxian thought she wasn’t at high risk for inherited ovarian cancer, because her sister, who’d had breast cancer, had undergone Myriad’s main test and was cleared.
She was wrong. When Maxian developed ovarian cancer in 2009, she was shocked to find out that her sister had undergone only one of Myriad’s available tests. If her sister had gotten the second part of the two-part test, Maxian would have known that she was also vulnerable to ovarian cancer as well as breast cancer.
“It was absolutely devastating,” said Maxian, who said she would have gotten her ovaries removed and her cancer likely would have been prevented. “There are a lot of women out there like my sister and I ... we are time bombs.”
It is standard practice to split up tests, and insurers’ refusal to pay for the second test put Myriad in a no-win position, said Mark Capone, president of Myriad’s testing unit. The company has provided the second test free to patients who meet certain family and personal history criteria.
Patent Constraint
In 2010, King and her colleague, Tom Walsh, devised a new test that looks at dozens of breast and ovarian cancer genes, including the BRCA genes. When the University of Washington introduced a commercial version of the test this summer including 40 genes, it had to remove the BRCA genes because of Myriad’s patents, she said.
Use of the broader screens would eliminate delays and confusion caused by having to take as many as three rounds of tests that need to be passed by insurance, and may involve sending different blood samples to multiple labs, said Ellen Matloff, who heads cancer genetic counseling at Yale Cancer Center in New Haven, Connecticut, and is a plaintiff in the case.
“Every time a woman dies of breast or ovarian cancer who turns out to have a mutation in BRCA1 or BRCA2, or any of the 20 or so sister genes, I feel in a way that it’s on us,” King said in an interview. King is outgoing president of the American Society of Human Genetics, which has joined in amicus briefs with other organizations against gene patents. King recused herself from the discussions, she said.
Sharing Data
Myriad is working actively on its own product to scan multiple cancer-risk genes at once, said Meldrum, the CEO. While the new technology used for such tests is rapidly improving, it still is “not accurate enough now for clinical purposes,” potentially leading to errors if used before it is perfected, he said.
Myriad also refuses to share genetic data collected from many thousands of women tested since 2004, eight years after the BRCA test was first marketed.
Scientists worldwide are moving to place mutation data into public databases to improve interpretation of genetic tests and reduce the number of women left in limbo with ambiguous results, said James Evans, a geneticist at the University of North Carolina at Chapel Hill. Even in well-known genes, there are thousands of possible mutations in different ethnic groups, and it’s not always obvious whether a mutation is harmful.
Working Together
In one effort, 48 U.S. companies and university genetics labs have agreed to work together to put mutations into a government-run database, said Heidi Rehm, a geneticist at Harvard Medical School in Cambridge, Massachusetts, who is heading the project. Myriad hasn’t yet agreed to participate, she said in an e-mail.
Myriad’s reasoning for the secrecy is straightforward. Sharing “doesn’t make a lot of business sense,” Meldrum said.
Myriad “is holding clinical testing back,” said Evans, a board member for the American College of Medical Genetics and Genomics, a plaintiff in the Supreme Court case against Myriad. “There’s no medical, or rational, logic here.”
Runi Limary, 36, of Austin, Texas, found a cancerous lump in her right breast in 2005 when she was 28. She had that breast removed, followed by 14 months of chemotherapy and antibody therapy. She put off getting Myriad’s test because her insurance didn’t cover it until she changed jobs in 2007.
The gene test was less helpful than she had hoped.
In Limbo
She had a mutation in BRCA1 that Myriad had only seen in two other patients, she said, which meant that the company wasn’t sure whether it was harmful or not.
As a result, Limary is in limbo. She faces an agonizing decision soon, whether to get her ovaries surgically removed to prevent ovarian cancer, she said.
If Myriad’s database was public, and if there were more competitors doing the test, she might have received a definitive answer sooner on whether her tumor was due to a bad gene, she said. She is a plaintiff in the patent case against Myriad.
There are simply too many questions left about genetic testing to allow Myriad to control results affecting millions of women, Limary said. “It is very disheartening,” she said.
Myriad is now gearing up for what may be its biggest challenge -- defending its patents before the U.S. Supreme Court, which agreed on Nov. 30 to hear the case.
Natural Products
In that suit, the justices are being asked to decide whether BRCA or other human genes that have been removed from the body are products of nature, and thus ineligible for protection, or whether isolating and purifying the genes from the body creates a patentable invention.
The 20 plaintiffs include patients, scientists and genetic counselors, professional groups representing more than 100,000 pathologists, geneticists and lab workers, and the consumer health organizations Breast Cancer Action and Our Bodies Ourselves.
The plaintiffs won the first round in the case in March 2010, when a federal judge invalidated parts of seven patents. An appeals court partially overturned that decision this past August, setting the stage for the Supreme Court to take the case.
The high court is expected to decide the Myriad case by next summer.
If the patents are upheld, they will remain in force until 2015, Meldrum said. The company also has an additional 17 patents on its BRCA testing that, so far, are unaffected by that lawsuit. They provide strong protection until 2018, and by then Myriad will have introduced a new test that combines BRCA with the other cancer risk genes, he said.
“As a pioneer you will take arrows,” said Capone, the president of Myriad’s testing unit. “We have put the patient at the center of focus of the entire organization.”
The case is Association for Molecular Pathology v. Myriad Genetics, 12-00398, U.S. Supreme Court (Washington)
To contact the reporters on this story: Robert Langreth in New York at rlangreth@bloomberg.net
To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net; Jonathan Kaufman at jkaufman17@bloomberg.net
4:18PM Myriad Genetics' HRD score detects loss of DNA repair function in ovarian cancer (MYGN) 27.03 +0.01 : Co announced that a study published in the British Journal of Cancer demonstrated the ability of the Company's Homologous Recombination Deficiency (HRD) Assay to detect loss of DNA repair in ovarian tumors. The study, entitled, "Patterns of Genomic Loss of Heterozygosity Predict Homologous Recombination Repair Defects in Epithelial Ovarian Cancer," confirmed, with highly statistically significant results, the relationship between Myriad's HRD score and tumors deficient in DNA repair.
1-Oct-12 WallachBeth Initiated Buy
Myriad Beats, Raises Guidance
By Zacks Equity Research | Zacks – Wed, May 2, 2012 2:45 PM EDT
Myriad Genetics (MYGN) reported earnings per share ("EPS") of 34 cents for the third quarter of fiscal 2012, beating both the Zacks Consensus Estimate of 32 cents and the year-ago quarter’s EPS of 31 cents. Revenues were $129.8 million, up 27% year over year and higher than the Zacks Consensus Estimate of $119 million.
Myriad’s two businesses – Molecular diagnostic testing and Companion diagnostic services – recorded revenues of $123.3 million (up 20% year over year) and $6.5 million, respectively. The company acquired the Companion diagnostic business following the acquisition of Rules-Based Medicine in May 2011 which now accounts for 5% of total revenues. Molecular diagnostic testing revenue is derived from both Oncology (up 19% to $86.6 million) and Women’s Health (up 25% to $36.7 million).
While Myriad markets several molecular diagnostic products, the company's flagship product is Bracanalysis (representing 81% of total revenues during the quarter), which studies BRCA1 and BRCA2 genes for assessing a woman's risk of developing hereditary breast and ovarian cancers. This test recorded a 17% jump in revenues to $105.9 million. Moreover, revenues derived from Colaris and Colaris AP, which assess a patient's risk of developing hereditary colorectal and uterine cancers, increased 51% to $11.2 million.
Gross profit increased 23.3% year over year to $112.5 million. Gross margin, however, declined 240 basis points (bps) to 86.7%. Operating expenses increased 34.5% during the quarter to $66.4 million due to a 27.9% rise in selling, general and administrative expenses ($54.7 million) and a 76.3% increase in research and development (R&D) expenses ($11.7 million). Consequently, operating margin declined 530 bps to 35.5%.
Myriad exited the quarter with cash, cash equivalents and marketable securities of $466.7 million, down from $417.3 million at the end of fiscal 2011. The company repurchased 502,008 million shares during the quarter. The consistent share buyback program had a favorable impact on the company’s bottom line as shares outstanding declined 4.1% year over year.
Guidance Raised
Myriad upgraded its guidance for fiscal 2012 after raising it at the end of the second quarter. The company now expects to report revenues of $492–$496 million (previous guidance of $465–$475 million) resulting in an EPS of $1.29–$1.31 ($1.24–$1.28). The revised guidance is more optimistic than the current Zacks Consensus Estimates of $474 million in revenues and EPS of $1.26. The lift in guidance was due to an improvement in outlook on the Molecular diagnostic testing business, sales estimates of which have been upped to $467–$471 million (previous guidance of $440–$450 million). The outlook for Companion diagnostic services remained unchanged at $24–$26 million.
Recommendation
We consider Myriad’s Bracanalysis as a valuable asset for top-line growth as it has the potential to tap a widely unexplored market. We are encouraged by the company’s various initiatives to achieve this objective. During the quarter, the company had entered into an agreement with Cephalon, a subsidiary of Teva Pharmaceutical (TEVA), to conduct BRCA1 and BRCA2 mutations testing on patients to be enrolled in a Phase 1/II clinical trial. Moreover, with a strong cash balance, the company is well placed to expand its product portfolio and target new territories. The stock retains a Zacks #2 Rank (“Buy”) in the short term.
However, operating expenses are on rise due to the company’s focus on international expansion and product development. As a result, the company’s margin remains under pressure, although the bottom line should benefit from the repurchase program. The company also faces stiff competition from players such as Genomic Health (GHDX) and Qiagen (QGEN) among others. We currently have a Neutral recommendation on Myriad.
7:45AM Myriad Genetics Prolaris test shown to predict prostate cancer outcome in needle biopsy tissue (MYGN) 23.97 : Co announced that a study published in the British Journal of Cancer demonstrated the prognostic ability of the co's Prolaris test in needle biopsy material. The study highlighted the ability of the test to significantly and accurately predict prostate cancer aggressiveness and consequent death from the disease.
~ $MYGN ~ Earnings posted, pending or coming soon! In Charts and Links Below!
~ $MYGN ~ Earnings expected on Tuesday *
This Week In Earnings: Earnings are coming or are already posted! This is what the charts look like! If you play the earnings these posts can be very helpful to you!
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~ Investorshub Board Search: http://investorshub.advfn.com/boards/getboards.aspx?searchstr=MYGN
~ Investorshub PostStream Search: http://investorshub.advfn.com/boards/poststream.aspx?ticker=MYGN
~ Investorshub Goodies Search: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18582&srchyr=2011&SearchStr=MYGN
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~ MarketWatch: http://www.marketwatch.com/investing/stock/MYGN/profile
~ E-Zone Chart: http://www.windchart.com/ezone/signals/?symbol=MYGN
~ 5-Min Wind: http://www.windchart.com/stockta/analysis?symbol=MYGN
~ 10-Min Wind: http://www.windchart.com/stockta/analysis?symbol=MYGN&size=l&frequency=10&color=g
~ 30-Min Wind: http://www.windchart.com/stockta/analysis?symbol=MYGN&size=l&frequency=30&color=g
~ 60-Min Wind: http://www.windchart.com/stockta/analysis?symbol=MYGN&size=l&frequency=60&color=g
http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916
*If the earnings date is in error please ignore error. I do my best.
Myriad Genetics gets rights to cancer-linked gene
Myriad Genetics gets rights to a gene linked to greater risk of breast and ovarian cancer
Associated PressAssociated Press – Wed, Jan 18, 2012 4:57 PM EST
SALT LAKE CITY (AP) -- Myriad Genetics Inc. said Wednesday that it has acquired the rights to a gene that, when mutated, is associated with increased risk for hereditary breast and ovarian cancer.
The company said it will develop a test for the gene, which is called RAD51C. Mutations on the gene are associated with greater risk for those cancers. Myriad said it will have an exclusive license to provide commercial testing for mutations on the gene in most countries. In Germany it shares the license with the German Consortium for Hereditary Breast and Ovarian Cancers, which helped establish the link between RAD51C and cancer.
Myriad also makes the BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Mutations on that are associated with much greater risks of breast and ovarian cancer.
Shares of Myriad Genetics rose 38 cents to $21.33 on Wednesday.
Myriad Genetics MYGN Auriga Hold » Buy $21 » $24
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1Xk6bsNcI
Myriad Genetics secures option to buy Crescendo
Myriad Genetics secures option to buy Crescendo Biosciences
On Thursday September 8, 2011, 7:20 pm EDT
NEW YORK (AP) -- Diagnostic testing company Myriad Genetics Inc. said Thursday that it loaned $25 million to Crescendo Bioscience Inc. as part of a deal that includes an exclusive three-year option for Myriad to buy Crescendo.
Myriad said that acquisition could expand its portfolio of molecular diagnostic products to cover autoimmune disorders such as rheumatoid arthritis. Myriad currently specializes in oncology, preventative care, urology, dermatology and neuroscience products.
It said Crescendo has developed a diagnostic test for rheumatoid arthritis that satisfies and unmet need.
The exact terms of the deal weren't disclosed, but Myriad said it can exercise its option if Crescendo Bioscience, based in South San Francisco, attains a minimum revenue level during the three-year term. The purchase price in that scenario would be determined by a formula based on Crescendo's revenue growth.
If Crescendo Bioscience doesn't attain the minimum revenue, Myriad would have a one-time right to exercise the option for a fixed price. In either case, the purchase would be all in cash.
Myriad said its $25 million loan to Crescendo Bioscience is for six years at an interest rate of 6 percent.
Shares Myriad closed down 23 cents at $18.96.
MYGN $19 Myriad Genetics made a $25 mln strategic debt investment in Crescendo Bioscience and secured an exclusive, three-year option to acquire the co (MYGN) 18.96 -0.23 : Co announced that it has made a $25 million strategic debt investment in Crescendo Bioscience and secured an exclusive, three-year option to acquire the company. The potential acquisition of Crescendo Bioscience would expand Myriad's already strong portfolio of transformative molecular diagnostic products to include products for autoimmune disorders, such as rheumatoid arthritis. Additionally, if the option is exercised, the acquisition of Crescendo Bioscience would add a sixth disease specialty, Rheumatology, to Myriad's current strategic focus which includes Oncology, Preventative Care, Urology, Dermatology, and Neuroscience.
Myriad Genetics MYGN Auriga Buy » Hold $27 » $25
Read more: http://www.briefing.com/investor/calendars/upgrades-downgrades/#ixzz1PLXuiI15
Myriad Genetics MYGN Auriga U.S.A Buy $27
http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm
Myriad Genetics (MYGN): The stock gets moved to Neutral from Buy at Global Hunter. For more on this sector, see Vertex Proves Telaprevir Could Be First, Best for Hep C.
Ahead of the Bell: Myriad Genetics shares slide
Myriad Genetics stock slides after outlook, fiscal 3rd-qtr profit fall short of expectations
The Associated Press, On Wednesday May 5, 2010, 8:39 am EDT
Shares of Myriad Genetics Inc. slid in premarket trading Wednesday, a day after the molecular diagnostics company reported a fiscal third-quarter profit and gave a full-year forecast that fell short of Wall Street expectations.
The Salt Lake City company earned $33.3 million, or 33 cents per share, in the three months that ended March 31. That was up from net income of $25.3 million, or 27 cents per share, a year earlier, when Myriad had a charge of nearly $13 million for discontinued operations. Revenue rose 5 percent to $90.8 million.
Analysts surveyed by Thomson Reuters had expected net income of 39 cents per share on revenue of $97.8 million.
In a note to clients, Jefferies & Co. analyst Bruce Cranna said testing volumes dropped from the previous quarter due to a decline in patient office visits.
Cranna lowered his price target on the stock to $17 from $24.
"We continue to view (Myriad) as an attractive property but remain cautious as to how long the struggling economy will depress BRCA testing volumes and slow growth in the asymptomatic patient population," he wrote.
Myriad Genetics sells a test for mutations on the breast cancer predisposition gene, or BRCA.
Cranna also noted that Myriad expects after-tax earnings per share for 2010 in the range of $1.30 to $1.35.
Analysts expect about $1.49 per share.
Myriad shares fell 23 percent to $18.35 before the market opened Wednesday. That's down from Tuesday's closing price of $24.08.
4:08PM Myriad Genetics to repurchase $100 mln of common stock (MYGN) 24.08 -0.35 :
End of Gene Patents Will Help Patients, Force Companies to Change
By Brandon Keim April 1, 2010
When you went to sleep last Sunday night, 20 percent of your genome belonged to a researcher or company. One day later, following federal district court judge Robert Sweet’s ruling, it belonged to you. Some activists cheered the landmark decision on general principle, but for others, it was a business and medical matter. They say the end of gene patents could be a boon for patients, who will benefit from gene-testing companies competing for their business.
“They’ll have to deliver products to the marketplace faster, better and cheaper. There’s all sorts of ways to make money,” said Dan Ravicher, executive director of the Public Patent Foundation and a plaintiff in the lawsuit, which pitted civil rights activists and patient groups against Myriad Genetics, a Utah provider of tests on its patented breast-cancer-risk genes. “I’m a strong conservative. I believe companies are good and competition is good.”
Myriad and its supporters, including the Biotechnology Industry Organization, had argued that gene patents were necessary. They made commercial profits possible, and potential financial rewards drove research. Ravicher’s foundation, the American Civil Liberties Union, and their supporters — including the American Medical Association, American Society of Human Genetics and March of Dimes — said this simply wasn’t true.
Beyond the absurdity of gene patents — imagine patenting gold, the human arm, or gravity — they said that patents had hurt patients, stifled business and stunted research. Myriad’s monopoly prevented women from getting second opinions on their breast-cancer gene tests. More broadly, existing gene patents dissuaded researchers from studying sections of the genome that were already claimed, and high licensing fees discouraged would-be entrepreneurs.
In a public statement, Myriad Genetics said it would appeal the decision. “My hope is that this ruling stands and companies will need to actually innovate and create new advances based on genetic findings, not dependent on sole access to them,” wrote Linda Avey, CEO of personalized genomics company 23andMe, in a comment on the Genetic Future blog. “Rather than relying on obscure patent language and legal strategies, companies will need to develop products that are competitively positioned.”
One area of competition will be in the interpretation of gene mutations. Gene testers don’t just plug a DNA sequence into a computer and wait for the result. They use an arsenal of interpretive techniques, and must update their approaches with new research. “There are a lot of algorithms that each of us uses. Some are more right than others. There are differences in how you study mutations, weight them, and interpret the data,” said Wendy Chung, a Columbia University breast cancer researcher and plaintiff in the lawsuit.
Chung said that Myriad’s tests are well-regarded, but they’ve lagged in interpreting rare gene variants that each person has, but because they’re so unique, have not been ascribed a clinical significance. “On the academic side, there are a lot of people trying to computationally guess what the functions of these variants will be. Myriad has been conservative in saying, if we don’t know what it is, then we won’t make guesses,” said Chung.
Gene-testing companies will also compete to do the best job explaining often-ambiguous genetic results to their customers. Business relationships with insurance companies and health care providers will become even more important. And companies will still be able to patent tools used to interpret genes. “Companies can compete on quality, speed and taking the burden off hospitals,” said Robert Cook-Deegan, a Duke University gene policy expert. The decision “does threaten some business models but it opens the gate for others.”
http://www.wired.com/wiredscience/2010/04/gene-testing-future/
I honestly don't know...
But I do know this: Charging $3k for a simple test just because you've secured the 'right' to do so may be the American Way...but it's definitely not the way I do business. Yes, health care is a business...but ripping people off for excessive profit is nothing more than medical terrorism.
If this patent ruling holds up on appeal, you've noted how it may be damaging to MYGN. I'm wondering -- are there patents now held by others that may then be marketed by MYGN? If so, could this evolution of patents in this area become a positive for MYGN?
...About time, too.
Bye bye MYGN. LOL!...
Judge Nullifies Gene Patents
A federal judge on Monday nullified patents associated with human genes known to detect early signs of breast and ovarian cancer.
It was the first time a federal court has invalidated a patent on genes. The American Civil Liberties Union, which brought the case, said the New York federal court decision “calls into question the validity of patents now held on approximately 2,000 genes.”
U.S. District Judge Robert Sweet agreed with the civil rights group that the patents were invalid because they covered the most basic element of every person’s individuality. “Products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product,” Sweet wrote in a 152-page opinion.
The lawsuit claimed the patents were so broad they barred scientists from examining and comparing the BRCA1 and BRCA2 genes at the center of the dispute. The patents issued more than a decade ago covered any new scientific methods of looking at these human genes that might be developed by others.
The patents gave Myriad Genetics a virtual monopoly on such predictive testing for breast and ovarian cancer. Women who fear they may be at an increased risk are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder, which charges about $3,000 for a test.
About 10 percent of women with breast cancer are likely to have a mutation inherited from their parents in the genes at issue, according to the suit.
Patents for exclusive genetic testing have also been issued for a host of genes, including those related to cystic fibrosis, heart arrhythmias and hemochromatosis.
The Patent and Trademark Office first issued a patent for a human gene in 1982 to the Regents of the University of California in connection to a hormone promoting breast development during pregnancy.
Myriad did not immediately respond for comment.
4:07PM Myriad study reveals patients receive suboptimal dosing with chemotherapy regimens of FOLFOX6 and FOLFOX6 plus avastin (MYGN) 22.37 -0.42 : Co announced that a presentation entitled: "Extensive 5-FU Inter-Patient Pharmacokinetic Variability May Result in Suboptimal 5-FU Dosing of Metastatic and Adjuvant Colon Cancer Patients on FOLFOX Regimens," was presented on Sunday, January 24th, 2010, at the Seventh Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. 5-fluorouracil (5-FU) is a backbone of many chemotherapy regimens, including FOLFOX (folinic acid, fluorouracil and oxaliplatin), FOLFOX6, and FOLFIRI (folinic acid, fluorouracil and irinotecan), and is used extensively in the treatment of colorectal, metastatic breast, and head and neck cancers. +
"Stakes rise in gene-patenting lawsuit"
http://www.sltrib.com/portlet/article/html/fragments/print_article.jsp?articleId=13446720&siteId=297
MYGN @ $26.96. High pole warning 9/23/09 on P & F chart.
http://stockcharts.com/charts/gallery.html?MYGN
High pole warning 9/23/09 on P & F chart, "The high pole warning is given when a chart rises above a previous high by at least 3 boxes but then reverses to give back at least 50% of the rise. The reversal implies that the demand that was making the prices rise has given way to supply pressure. The pattern is a warning that lower prices could be seen in the future." from "chartschool" on stockcharts. com
On regular stockcharts. com chart, RSI @ 35, not in oversold territory yet; MACD rolling over but still in positive territory and Full STO <20, so that is "oversold," but it does not mean that MYGN could not still go lower. MA(50) $27.89, which it has crossed today, which is negative.
$30.63 (Q2-09 low)
$28.22 (pre move high)
$28.04
Resistance:
@ $26.52:
Support
$25.88 (which was the price before MYGN popped to $30.89),
$25.04 and
$24.36, which as of this time is the Q3-2009 low.
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