Revenue of $292.69M (+20.9% Y/Y) beats by $9.3M.
Tuesday, November 12, 2019
Evotec SE reports Q3 results
Evotec SE (OTCPK:EVTCY): Q3 GAAP EPS of €0.08.
Revenue of €114.2M (+15.1% Y/Y)
Kodiak Sciences EPS in-line
Kodiak Sciences (NASDAQ:KOD): Q3 GAAP EPS of -$0.33 in-line.
Cash, cash equivalents and marketable securities of $60.6M.
Monday, November 11, 2019
CRIPSR could be used to detect disease
New research has uncovered a potential new purpose for CRISPR, the controversial but revolutionary gene-editing tool. In a paper published this September in German Journal, Angewandte Chemie, researchers explain how CRISPR could be used to establish new diagnostic blood tests for detecting disease by identifying viral nucleic acids, such as Parvo or HPV.
The findings are exciting because it could mean a robust, accurate, and cost-effective method entering the market to enable a faster diagnosis to an extended cohort of patients.
A new application for the revolutionary gene-editing tool
There has been no shortage of news articles surrounding the gene-editing tool, CRISPR, in recent years. Headlines have claimed it to be both a panacea for disease, as well as being a tool that will enable a dystopian future of tailor-made babies.
There has been excitement surrounding the potential disease curing capabilities as well as debates on the ethics surrounding its use have been commonplace in the scientific community.
Reports have claimed that the technique could play a fundamental role in the establishment of new and better methods for not only treating but eradicating illnesses such as cancer, sickle-cell anemia and other conditions with a genetic basis. Earlier this year, it was used in its first human trials in an attempt to develop a cure for an inherited form of blindness.
However, it was also claimed to have been used to genetical modify a set of twins in utero to make them resistance to contracting HIV in a study that generated a major ethical discussion.
The technology relies on a piece of genetic material known as guide RNA to lead the Cas9 enzyme to the desired part of the DNA sequence in order to cut it at the targeted section. This gives scientists the ability to remove genes, repair faulty ones, or add in new genes.
A new potential method for disease detection
Researchers at Case Western Reserve University have uncovered a new role for the CRISPR technique. They have suggested a new “universal biosensing” medical device that will not be dissimilar to the already available commercial blood-glucose sensor.
However, this device will accurately and rapidly detect the presence of viruses that play a key role in diseases, such as the human papillomavirus (HPV) or parvovirus (parvo). The first being a common virus that has been linked with the development of six kinds of cancer. The latter being responsible for fifth disease, a mild rash illness that mostly affects children.
To develop their new assay, the research team used the precision of the CRISPR technique in its ability to accurately locate and identify a target to recognize the biomarkers of those viruses. The method, known as E-CRISPR, utilizes a CRISPR‐Cas12a (cpf1) based electrochemical biosensor, which detects viral nucleic acids through optimizing its in vitro trans‐cleavage activity.
It is believed that this method could be further developed to create a new point-of-care device for detecting various viruses and diseases. The potential system is important because it would deliver a high level of accuracy, as well as being cost-effective, portable, fast, and would only require a drop of blood.
Currently, systems that detect HPV and Parvo take days to process, whereas the E-CRISPR could generate reliable results within the hour.
Future applications of CRISPR
The potential future development of a CRISPR based disease detection device is just one of many potential future applications for the gene-editing method.
Scientists are currently considering the development of the technique in creating allergy-free foods, in developing DNA ‘tape recorders’, producing biofuels, eradicating pests, raising the nutrient value of fish, and even bringing animals back from extinction.
Journal reference:
Dai et al. (2019). Exploring the Trans‐Cleavage Activity of CRISPR‐Cas12a (cpf1) for the Development of a Universal Electrochemical Biosensor. A Journal of the German Chemical Society. DOI: 10.1002/anie.201910772
Omeros Q3 2019 Earnings Preview
Omeros (NASDAQ:OMER) is scheduled to announce Q3 earnings results on Tuesday, November 12th, after market close.
The consensus EPS Estimate is -$0.41 (+42.3% Y/Y) and the consensus Revenue Estimate is $27.19M (+489.8% Y/Y).
Over the last 2 years, omer has beaten EPS estimates 50% of the time and has beaten revenue estimates 38% of the time.
Over the last 3 months, EPS estimates have seen 1 upward revision and 1 downward. Revenue estimates have seen 2 upward revisions and 2 downward.
FDA to revoke orphan designation for opioid addiction drug Sublocade
The FDA said Thursday that it has decided to revoke the orphan designation granted to Indivior’s opioid use disorder (OUD) treatment Sublocade (buprenorphine extended-release injection).
Approved as a sublingual tablet in 2002 and known as Subutex (buprenorphine), the drug received orphan designation and seven years of exclusivity thorough 2009. In 2017, the FDA approved Indivior’s extended release injection of buprenorphine, known as Sublocade.
The company said in its FY 2018 report it’s targeting $1 billion-plus of peak annual net revenue from Sublocade, although it had net revenue of $12 million in FY 2018.
In December 2018, the FDA tentatively approved Braeburn’s buprenorphine extended-release injection drug Brixadi, though the company is unable to market the drug until November 2020. If Sublocade receives orphan drug exclusivity as well, Braeburn said in its petition seeking to revoke the exclusivity that the company would be barred from marketing Brixadi until 2024.
In December 2018, the FDA tentatively approved Braeburn’s buprenorphine extended-release injection drug Brixadi, though the company is unable to market the drug until November 2020. If Sublocade receives orphan drug exclusivity as well, Braeburn said in its petition seeking to revoke the exclusivity that the company would be barred from marketing Brixadi until 2024.
Petition Granted
In revoking Sublocade’s orphan designation, the FDA’s Lowell Schiller, principal associate commissioner for policy, explains in a letter to the Indivior competitor Braeburn’s lawyer that the Subutex orphan designation in 1993 should not have been granted initially because Indivior failed to establish that it would not recover the costs of developing its buprenorphine drug from the drug’s sales.
In revoking Sublocade’s orphan designation, the FDA’s Lowell Schiller, principal associate commissioner for policy, explains in a letter to the Indivior competitor Braeburn’s lawyer that the Subutex orphan designation in 1993 should not have been granted initially because Indivior failed to establish that it would not recover the costs of developing its buprenorphine drug from the drug’s sales.
The FDA also says it was not reasonable of Indivior to assume that the market size would remain constant for the first seven years of Sublocade’s marketing.
Schiller further explains how Indivior’s assertions and arguments for keeping the orphan designation do not change the FDA’s conclusion. And the agency says that slight changes to Indivior’s initial assumptions, such as its assumption that 104,000 people would use buprenorphine or that the number of treatment facilities would not increase, would have resulted in the company making a profit off the drug.
The FDA, which estimates the total prevalence of OUD to be between 1 million and 1.5 million, also explains how other initial assumptions were wrong and how Indivior failed to provide information about what other buprenorphine products could be developed.
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