Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis
Well-tolerated with comparable safety profile to intravenous ertapenem
Spero intends to complete NDA submission for U.S. regulatory approval of tebipenem HBr in the second quarter of 2021
https://finance.yahoo.com/news/speros-spro-ind-accepted-fda-141002256.html
“Standard review process triggered a pause to vaccination to allow review of safety data,” says an AstraZeneca (NYSE:AZN) spokesperson after a Phase 3 study of its COVID-19 vaccine (developed with University of Oxford) has been put on hold across the U.S. after a suspected serious adverse reaction on a U.K. participant.
LabCorp (LH -0.2%) announces testing method that can simultaneously detect COVID-19, influenza A / B, and respiratory syncytial virus (“RSV”).
The single test will help doctors diagnose patients and make decisions about treatment options; available to patients through doctors, hospitals, and other authorized healthcare providers nationwide.
LabCorp has also submitted an application to the U.S. Food and Drug Administration to offer the combined test through its Pixel by LabCorp™ at-home test collection kit, which would offer added convenience and accessibility.
https://seekingalpha.com/news/3612174-labcorp-launches-combined-test-for-covidminus-19-flu-and-rsv
NY Governor Cuomo, in a briefing in NYC, announces that as part of the efforts related to school reopenings, NY will now require the publication of a daily “report card” for every school to give parents and teachers “confidence” about where their school stands in terms of potential outbreaks.
The site will be run by the NY Department of Health, absorbing data from a variety of sources, including testing centers and schools so that the information is not reliant on the school districts’ dissemination of data. The site can be found here: https://schoolcovidreportcard.health.ny.gov/
The site is designed to show the positivity rate, number of tests conducted, and whether a student or teacher who tested positive did so in a remote learning capacity, or whether it was in-person.
Stocks involved in Covid-19 testing include Laboratory Corp (NYSE:LH), Abbott Labs (NYSE:ABT), Quest Diagnostics (NYSE:DGX), Co-Diagnostics (NASDAQ:CODX), Fulgent Genetics (NASDAQ:FLGT) and Opko’s BioReference (NASDAQ:OPK), to name a few.
https://seekingalpha.com/news/3612186-new-york-starts-school-covidminus-19-report-card
A failed Phase 3 clinical trial, IMpassion131, evaluating the combination of Roche’s (OTCQX:RHHBY +1.0%) Tecentriq (atezolizumab) and chemo agent paclitaxel for the first-line treatment of patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC), an unapproved indication for the doublet therapy, may have implications for Tecentriq’s current approved use in TNBC.
The FDA says its continued accelerated approval of Tecentriq plus Bristol Myers Squibb’s (BMY -2.6%) Abraxane (paclitaxel protein-bound particles for injectable suspension [albumin-bound]; nab-paclitaxel) for first-line unresectable locally advanced PD-L1-expressing TNBC, granted in March 2019, may be contingent on proving benefit in additional studies. It is continuing its review of results from ‘131 and will announce any changes to Tecentriq’s prescribing information as appropriate.
The agency based its accelerated nod on positive progression-free survival data from another Phase 3, IMpassion130.
The Tecentriq combo was the first cancer immunotherapy regimen approved for breast cancer.
Senate Majority Leader Mitch McConnell said he’ll set up for a floor vote as soon as this week on a “targeted” virus aid proposal focused on “the very most urgent healthcare, education, and economic issues.”
The trimmed-down Republican pandemic relief package is being introduced in the Senate today, he said; the vote will take place on Thursday, Bloomberg reports, citing McConnell. (Updated at 3:37 PM ET).
The $500B bill, about half the size of a measure McConnell put forth earlier this summer, is likely to be blocked by Democrats, the Associated Press reported.
Reuters puts the size of the bill at ~$300B, citing senior aides. The bill would be supplemented by some unspent funds from the CARES Act, which was enacted at the end of March, the aides told Reuters.
McConnell says the new proposal “does not contain every idea our party likes” and expects that “Democrats will feel the same.”
“Yet Republicans believe that many serious differences between our two parties should not stand in the way of agreeing where we can agree and making laws that helps our nation,” he said in a statement.
McConnell’s bill would provide more than $100B to help schools reopen, protect businesses and others against lawsuits as they reopen, include $300/week supplemental unemployment insurance benefit (vs. $600/week in the CARES Act), and write off $10B in earlier post office debt.
Oppenheimer analyst Silvan Tuerkcan has downgraded Constellation Pharmaceuticals (CNST -4.0%) to Perform from Outperform, and lowered price target to $20 from $47 driven by new 25% Probability of Success versus prior 60% for its lead asset CPI-0610, in myelofibrosis, a rare bone marrow cancer.
The analyst notes that the company plans to initiate MANIFEST-2 pivotal study for CPI-0610 in the second half of the year, and expects to enroll ~310 patients. Based on the earlier MANIFEST study, he estimates that CPI-0610 + ruxolitinib causes significant reductions of platelet counts, which lead to ruxolitinib dose reduction.
The analyst, however, is concerned about the probability of CPI-0610 + ruxolitinib beating ruxolitinib alone on efficacy, as he believes patients in the ruxolitinib alone arm could end up with higher doses of ruxolitinib than patients in the CPI + ruxolitinib arm.
In December last year, the company announced that in the first-line treatment arm, 80% of evaluable patients receiving CPI-0610 + ruxolitinib experienced at least a 35% spleen response (SVR35) at week 12, while in evaluable patients resistant to or intolerant of ruxolitinib who received CPI-061 as add-on treatment, the SVR35 rate was 25% at week 24.
New data in June, showed positive action in the myelofibrosis study.
https://seekingalpha.com/news/3612258-constellation-pharma-downgraded-to-perform-oppenheimer
