Target $49
Tuesday, March 7, 2023
AstraZeneca, Ionis application for nerve damage therapy OKd by FDA
35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group
Eplontersen previously granted Orphan Drug Designation for transthyretin-mediated amyloidosis
FDA assigns PDUFA action date of Dec. 22, 2023
Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The application has been given a Prescription Drug User Fee Act (PDUFA) action date of Dec. 22, 2023.
https://finance.yahoo.com/news/ionis-announces-fda-acceptance-drug-120500628.html
SoFi Bank Files Federal Lawsuit To End Student Loan Payment Pause
In another setback for the administration’s student loan relief program, and just a week after the Supreme Court heard oral arguments in the case, SoFi Bank filed a federal lawsuit to end the payment pause. SoFi argues the eighth extension of the moratorium is “not in accordance with the law, is without observance of procedure required by law, is arbitrary and capricious and is invalid,” according to court filings.
SoFi, a private lender, further contends in the lawsuit filed in the U.S. District Court for the District of Columbia on March 3 that the moratorium on the student payment has “substantially injured” the company. It has lost approximately $300 to $400 million in total revenues from its federal loan refinancing business, according to the filing.
“As a result, SoFi has lost approximately $150 to $200 million in profits during that period. Those numbers also significantly understate the moratorium’s harmful effects, because they do not take into account the growth that SoFi’s federal student-debt refinancing business would otherwise have experienced,” the filing reads.
The administration extended the student loan pause — which was put in place because of the pandemic and was set to end Dec. 31, 2022 — to the end of June 2023, as it awaits the Supreme Court’s decision, expected in June.
The White House said that the pause will end no later than June 30, 2023 and payments will resume 60 days after the pause ends.
“The payment pause is legal, as is our plan to provide one-time debt relief to tens of millions of borrowers most at risk of delinquency and default when they return to repayment,” an Education Department spokesperson said in an emailed statement. “This lawsuit is an attempt by a multi-billion dollar company to make money while they force 45 million borrowers back into repayment — putting many at serious risk of financial harm. The Department will continue to fight to deliver relief to borrowers, provide a smooth path to repayment, and protect borrowers from industry and special interests.”
J&J Janssen, Protagonist ace top line in Phase 2b psoriasis study
Protagonist Therapeutics Inc (NASDAQ: PTGX) announced topline results from its collaboration with Janssen Biotech Inc, a part of Johnson & Johnson (NYSE: JNJ), in the FRONTIER 1 Phase 2b trial of oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis.
Data from the 255-patient study showed that JNJ-2113 achieved the study's primary efficacy endpoint, with a statistically significant greater proportion of patients achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at Week 16 in all five treatment groups.
A clear dose-response was observed across an eight-fold dose range. Treatment was well tolerated, with no meaningful difference in the frequency of adverse events across treatment groups versus placebo.
Data will be presented from various pre-clinical and clinical studies on JNJ-2113 at medical conferences beginning in the second quarter of 2023.
JNJ-2113 (formerly PN-235) was discovered and is being developed under the license and collaboration agreement between Protagonist and Janssen Biotech.
Protagonist completed a Phase 1 study of JNJ-2113 in healthy volunteers in October 2021.
Janssen retains exclusive, worldwide rights to develop in Phase 2 and beyond and commercialize compounds derived from the research conducted under the agreement against a broad range of indications.
Virax Biolabs Starts Distribution Of Avian Flu Test Kits In Europe
Virax Biolabs Group Limited (NASDAQ: VRAX) has announced the distribution of an Avian Influenza A Virus real-time PCR test kit to the European markets.
What Happened: The test kit detects and differentiates ribonucleic acid from AIV and the H5, H7, and H9 subtypes, including the H5N1 strain currently spreading in Europe.
It also serves as an initial screening test for individuals exposed to AIV-infected livestock or a high-risk environment.
The specialized diagnostic kit can be found by contacting the company's sales representatives.
In January, Virax Biolabs introduced a human papillomavirus test kit in the European Union, with shipments anticipated to start in Q1 of 2023.
Why It's Important: Human infections with AIV have occurred in many countries, predominately after exposure to infected poultry or virus-contaminated environments.
Six main hemagglutinin subtypes of bird flu viruses have infected people, resulting in mild-to-severe illness with a wide range of symptoms and complications.
These six subtypes include H3, H5, H6, H7, H9, and H10 viruses. Among these, H5N1 and H7N9 viruses have caused the majority of infections which occur in humans.
https://finance.yahoo.com/news/exclusive-virax-biolabs-starts-distribution-141518026.html
Powell says interest rates likely need to rise more than expected
The Federal Reserve will likely need to raise interest rates more than expected in response to recent strong data and is prepared to move in larger steps if the “totality” of incoming information suggests tougher measures are needed to control inflation, Fed Chair Jerome Powell told lawmakers on Tuesday.
“The latest economic data have come in stronger than expected, which suggests that the ultimate level of interest rates is likely to be higher than previously anticipated,” Powell said in opening remarks at a hearing before the Senate Banking Committee.
The remarks were his first since inflation unexpectedly jumped in January and the government reported an unusually large increase in payroll jobs for that month.
Stocks fell after Powell’s comments, with the Dow sliding more than 300 points, or 1%.
While some of that unexpected economic strength may have been due to warm weather and other seasonal effects, Powell said the Fed was cognizant it may also be a sign the central bank needs to do more to temper inflation, perhaps even returning to larger rate increases than the quarter-percentage-point steps officials had been planning to stick with.
“If the totality of the data were to indicate that faster tightening is warranted, we would be prepared to increase the pace of rate hikes,” Powell said.
The Fed will hold its next policy meeting on March 21-22, with the release this Friday of the government’s monthly jobs report and an inflation report next week now critical in policymakers’ judgment about whether they are again slipping behind the inflation curve, or can stick with the more tempered policy planned at their last meeting.
But in either case, Powell’s comments mark a stark acknowledgment that a “disinflationary process” he spoke of repeatedly in a Feb. 1 news conference may not be so smooth.
Although inflation “has been moderating” since its peak last year, Powell said, “the process of getting inflation back down to 2% has a long way to go and is likely to be bumpy.”
Even before Powell presented his testimony, the hearing began with a sharp prelude. Sen. Sherrod Brown (D-Ohio), the chair of the committee, said the Fed’s rate hikes ignored what he viewed as a chief cause of inflation — high corporate profits.
“Raising interest rates certainly won’t stop business from exploiting all these crises to jack up prices,” Brown said.
Sen. Tim Scott (R-SC), the highest-ranking Republican on the panel and a possible 2024 presidential candidate, retorted that the Biden administration’s spending policies were more to blame.
Possible labor market softening
Powell’s testimony marked his first public remarks on an issue now at the center of Fed discussion as officials weigh whether recent data will prove to be a “blip,” as one of his colleagues suggested, or be seen as evidence that the central bank needs to lean on the economy even harder than expected.
In his testimony, Powell noted that much of the impact of the central bank’s monetary policy may still be in the pipeline, with the labor market still sustaining a 3.4% unemployment rate not seen since 1969, and strong wage gains.
In a comment that may well be seized on by some Senate Democrats, Powell suggested that the labor market might have to weaken for inflation to fall across the broad services sector, a labor-intensive part of the economy where prices continue to rise.
“To restore price stability, we will need to see lower inflation in this sector, and there will very likely be some softening in labor market conditions,” Powell said.
Powell’s last monetary policy report to Congress was in June, which was early in what became the most aggressive cycle of Fed rate increases since the 1980s. That monetary tightening has driven up borrowing costs for home mortgages, a topic of particular sensitivity for elected officials, contributed to volatility in traditional equity markets as well as alternative assets like cryptocurrencies, and sparked some broader debates about the Fed’s efficacy.
Inflation has fallen since Powell’s last appearances in Congress. After topping out at an annual rate of 9.1% in June, the Consumer Price Index dropped to 6.4% in January; the separate Personal Consumption Expenditures price index, which the Fed uses as the basis for its 2% target, peaked at 7% in June and had fallen to 5.4% as of January.
https://nypost.com/2023/03/07/feds-jerome-powell-says-rates-likely-need-to-higher-faster/
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