Vertex Pharmaceuticals Inc. on Friday said the European Medicines
Agency’s Committee for Medicinal Products for Human Use recommended
expanded approval of Kalydeco to include the treatment of children and
adolescents with the most common cystic fibrosis genetic mutation.
The European Commission, which generally follows the CHMP’s
recommendations, will now review the positive opinion, which covers
patients ages six months and older who have the R117H mutation in the
cystic fibrosis transmembrane conductance regulator gene, the Boston
drug maker said.
Vertex said Kalydeco, if approved, will be the first and only
medicine in Europe to treat the underlying cause of cystic fibrosis in
patients with the R117H mutation, the most common residual function
mutation in the progressive, genetic disease that causes persistent lung
infections.
Kalydeco is already approved in Europe for adults with the R117H mutation and for children with several other mutations.
https://www.marketscreener.com/VERTEX-PHARMACEUTICALS-11321/news/Vertex-Pharmaceuticals-Gets-European-CHMP-Positive-Opinion-for-Kalydeco-Expanded-Pediatric-Use-30510612/
Friday, May 1, 2020
For small business loan program, forgiveness may be the hardest part
The U.S. government’s $660 billion small business rescue program has
stumbled on missing paperwork, technology failure, and the misdirection
of funds to big corporations. Now, it is lurching toward another hurdle:
forgiving those hastily arranged loans.
The second round of the Small Business Administration’s Paycheck Protection Program launched on Monday, allowing lenders to issue forgivable, government-guaranteed loans to small businesses shuttered by the novel coronavirus outbreak.
Smoothing the forgiveness process is critical for the program to succeed, but a lack of government guidance on the related calculations and necessary documentation could land borrowers and banks alike with billions in unexpected debts.
“Probably every PPP borrower expects their loan to be forgiven, but it is not that simple,” said Paul Merski, an executive at the Independent Community Bankers of America.
“There are rules and regulation to consider. So the borrower best have their information and paperwork in order.”
In principle, the forgiveness terms are straightforward: borrowers must spend 75% of the loan on payroll costs, such as salaries, tips, leave, severance pay and health insurance, within the first two months. The remaining 25% can be spent on other running costs, such as rent and utilities. Money spent on non-qualifying expenses must be repaid at an annual rate of 1% within two years.
But in reality, it is going to be very tricky calculating partial forgiveness sums for borrowers who have not met the 75% threshold, said bankers. They point to potential areas of confusion such as when employees must be rehired and what happens if borrowers do not use the funds as promised.
“I do think it could become a little bit complex, because with every answer there’s another question,” said Chris Giamo, head of the commercial bank at TD Bank in New York.
That has created uncertainty for borrowers like Josh Mason, founder of Maryland catering company Vittles Catering. He said his bank only gave him instructions on how to maximize his eligibility for forgiveness on April 24, two days after he received the funds. Those instructions warned clients that the forgiveness process was “not yet clear.”
While a 1% interest rate is very low, the two-year repayment term could see companies that fail to qualify for full forgiveness landed with chunky monthly payments.
“I have read all the guidelines, but I wouldn’t be able to say exactly how much will be forgiven and not forgiven. I think that ambiguity is going to create a little bit of a mess when all of this comes to a close,” said Mason.
Given the many potential calculation variables, banking groups are pushing the SBA and the Treasury Department to issue a standard forgiveness form for borrowers and to create a calculator so every bank gets the same outcome when using the same data, said executives at three bank groups.
They are also seeking clarity on which documents are necessary to prove borrowers’ expenditures, and how closely banks are expected to scrutinize that paperwork.
Spokespeople for the Treasury and SBA did not respond to requests for comment, but the agencies are aware of the issues said David Pommerehn, general counsel of the Consumer Bankers Association.
“From a banking perspective, we are really acting as a middleman here. We don’t want to carry these loans on our books,” he said. “We see this as potentially a bigger mess than the funding process.”
https://www.marketscreener.com/news/For-small-business-loan-program-forgiveness-may-be-the-hardest-part–30510947/?countview=0
The second round of the Small Business Administration’s Paycheck Protection Program launched on Monday, allowing lenders to issue forgivable, government-guaranteed loans to small businesses shuttered by the novel coronavirus outbreak.
Smoothing the forgiveness process is critical for the program to succeed, but a lack of government guidance on the related calculations and necessary documentation could land borrowers and banks alike with billions in unexpected debts.
“Probably every PPP borrower expects their loan to be forgiven, but it is not that simple,” said Paul Merski, an executive at the Independent Community Bankers of America.
“There are rules and regulation to consider. So the borrower best have their information and paperwork in order.”
In principle, the forgiveness terms are straightforward: borrowers must spend 75% of the loan on payroll costs, such as salaries, tips, leave, severance pay and health insurance, within the first two months. The remaining 25% can be spent on other running costs, such as rent and utilities. Money spent on non-qualifying expenses must be repaid at an annual rate of 1% within two years.
But in reality, it is going to be very tricky calculating partial forgiveness sums for borrowers who have not met the 75% threshold, said bankers. They point to potential areas of confusion such as when employees must be rehired and what happens if borrowers do not use the funds as promised.
“I do think it could become a little bit complex, because with every answer there’s another question,” said Chris Giamo, head of the commercial bank at TD Bank in New York.
That has created uncertainty for borrowers like Josh Mason, founder of Maryland catering company Vittles Catering. He said his bank only gave him instructions on how to maximize his eligibility for forgiveness on April 24, two days after he received the funds. Those instructions warned clients that the forgiveness process was “not yet clear.”
While a 1% interest rate is very low, the two-year repayment term could see companies that fail to qualify for full forgiveness landed with chunky monthly payments.
“I have read all the guidelines, but I wouldn’t be able to say exactly how much will be forgiven and not forgiven. I think that ambiguity is going to create a little bit of a mess when all of this comes to a close,” said Mason.
Given the many potential calculation variables, banking groups are pushing the SBA and the Treasury Department to issue a standard forgiveness form for borrowers and to create a calculator so every bank gets the same outcome when using the same data, said executives at three bank groups.
They are also seeking clarity on which documents are necessary to prove borrowers’ expenditures, and how closely banks are expected to scrutinize that paperwork.
Spokespeople for the Treasury and SBA did not respond to requests for comment, but the agencies are aware of the issues said David Pommerehn, general counsel of the Consumer Bankers Association.
“From a banking perspective, we are really acting as a middleman here. We don’t want to carry these loans on our books,” he said. “We see this as potentially a bigger mess than the funding process.”
https://www.marketscreener.com/news/For-small-business-loan-program-forgiveness-may-be-the-hardest-part–30510947/?countview=0
Athersys advances MultiStem study in COVID-19
Athersys (NASDAQ:ATHX) and University Hospitals Cleveland Medical Center (UH Cleveland) announce
that latter is now open as the first clinical site for the MACOVIA
(MultiStem Administration for COVID-19 Induced Acute Respiratory
Distress Syndrome) trial.
UH Cleveland has commenced enrollment and is now screening COVID-19 induced ARDS patients for inclusion in the trial.
The MACOVIA trial aims to confirm the safety and
efficacy of MultiStem therapy as a treatment for patients with moderate
to severe ARDS due to COVID-19.
The primary efficacy endpoint will be number of
ventilator-free days through day 28 as compared to placebo, and the
secondary objectives are to evaluate time in the intensive care unit,
pulmonary function, all-cause mortality and quality of life among
survivors.
The study is designed to enroll ~400 subjects.
https://seekingalpha.com/news/3567504-athersys-advances-multistem-study-in-covidminus-19-shares-up-14-premarket
Co-Diagnostics up on COVID-19 test data
Co-Diagnostics (NASDAQ:CODX) perks up 10% premarket on light volume on the heels of performance data on its LogixSmart real-time PCR test that detects RNA from the SARS-CoV-2 virus in lower respiratory tract fluids.
Tests performed in Australia (n=207), India (n=45)
and Mexico (n not provided) showed 100% sensitivity and 100%
specificity with no cross-reactivity with other viruses.
It also says that the test detected more low-level
positives than the CDC assay while testing at the Minnesota Department
of Health showed 100% concordance with another (unnamed) assay.
https://seekingalpha.com/news/3567516-co-diagnostics-up-10-premarket-on-covidminus-19-test-dataImmunoGen Q1 top-line up 55%; guidance affirmed
ImmunoGen (IMGN) Q1 results:
Revenues: $13.3M (+54.7%).
Net loss: ($29.1M) (+33.6%); loss/share: ($0.17) (+43.3%); Quick Assets: $247.3M (+40.4%).
2020 Guidance: Revenues: $60M – 65M (unch).
The company initiated SORAYA trial for mirvetuximab soravtansine in platinum-resistant ovarian cancer.
Anticipated 2020 events: Present updated data from
the FORWARD II platinum-sensitive triplet cohort evaluating
mirvetuximab in combination with carboplatin and bevacizumab in the
fall.
Continue enrollment in IMGN632 monotherapy and combination cohorts.
File IND for IMGC936 at the end of Q2.
Transition IMGN151 into pre-clinical development.
Shares are up 6% premarket.
Previously: ImmunoGen EPS misses by $0.02, misses on revenue (May 1)
https://seekingalpha.com/news/3567533-immunogen-q1-top-line-up-55-guidance-affirmedMedigus up 71% premarket on first order for COVID-19 blood test
Nano cap Medigus Ltd. (NASDAQ:MDGS) announces the receipt of its first order, 10K units from a medical equipment distributor in Mexico, for its COVID-19 blood test kit.
The kits are sourced in China through collaboration partner L-1 Systems Ltd.
Shares up 71% premarket on robust volume.
https://seekingalpha.com/news/3567538-medigus-up-71-premarket-on-first-order-for-covidminus-19-blood-testCerner sidelined on valuation after rally
With shares trading up 27% from a March low, SunTrust Robinson Humphrey cuts Cerner (NASDAQ:CERN) from Buy to Hold.
Analyst Sandy Draper thinks the current valuation
“fairly reflects the company’s growth” with near-term demand “paused” by
the pandemic.
The timing of the rebound isn’t certain, but Draper doesn’t expect a V-shaped recovery.
SunTrust raises its Cerner target from $66 to $72, a 4% upside.
Related: Earlier this week, CERN reported a mixed Q1 with a revenue miss and said it expects to feel the largest coronavirus impact in Q2.
https://seekingalpha.com/news/3567599-cerner-sidelined-on-valuation-after-rally
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