Insurers/hospitals gain on perceived diminished chances of Obamacare repeal

• Health insurers and hospital operators are staging a modest rally in apparent reaction to comments from Supreme Court justice Brett Kavanaugh and Chief Justice John Roberts implying that the constitutionality of the individual mandate is "severable" from the constitutionality of the Affordable Care Act (ACA) also known as Obamacare.
• The Trump administration is arguing that the individual mandate, ruled as unconstitutional by an appeals court almost a year ago, is not severable therefore the ACA is unconstitutional and should be repealed. Democrats are opposed to a complete repeal but agree that changes are needed.
• Justice Kavanaugh believes the case is straightforward based on precedents, including an opinion he authored last term that there is a strong presumption of severability. Chief Roberts finds it hard for the administration attorney to argue that Congress intended for the entire ACA to fall if the individual mandate were struck down.
• Selected tickers: Molina Healthcare (MOH +6.1%), UnitedHealth Group (UNH -0.0%), Anthem (ANTM -0.0%), Centene (CNC +2.9%), Cigna (CI +2.1%), Humana (HUM -0.0%), Tenet Healthcare (THC +3.4%), Universal Health Services (UHS +4.3%), Community Health Systems (CYH +4.2%), HCA Healthcare (HCA +2.3%)
• https://seekingalpha.com/news/3634457-health-insurers-hospitals-in-green-on-perceived-diminished-chances-of-obamacare-repeal
  

PDS in mid-stage PDS0101/Keytruda combo trial in head & neck cancer

• PDS Biotechnology (NASDAQ:PDSB) has initiated VERSATILE-002 Phase 2 trial evaluating the combination of its lead candidate, PDS0101 and Merck's Keytruda (pembrolizumab) for the first-line treatment of head and neck cancer that has returned or spread.
• The 100-subject study will evaluate the efficacy and safety of PDS0101/pembrolizumab combo, with main efficacy endpoint as shrinkage of the tumor referred to as the objective response rate at nine months following the initiation of treatment.
• In separate partnership with the National Cancer Institute, and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer respectively.
• PDS0101 is an immunotherapy designed to treat HPV-related cancers.
• https://seekingalpha.com/news/3634223-pds-biotech-launches-mid-stage-pds0101-combo-trial-in-head-neck-cancer
  

Mallinckrodt in retrospective study on use of nitric oxide in COVID-19

• Mallinckrodt (NYSE:MNK) initiates a retrospective chart review study to collect real-world data on the use of INOmax (nitric oxide) gas for inhalation therapy in COVID-19 patients with respiratory complications.
• The company will work with Pharmerit to collect data from ~200 hospitalized adult patients who received INOmax therapy for at least 24 hours between January 1, 2020 and July 31, 2020. Results will be reviewed from admission to 30 days after discharge.
• https://seekingalpha.com/news/3634234-mallinckrodt-launches-retrospective-study-on-use-of-nitric-oxide-in-covidminus-19
  
  

Merck/Eisai's Keytruda + Lenvima meets endpoints in late-stage kidney disease study

• Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) announce new investigational data demonstrating positive top-line results from the Phase 3 KEYNOTE-581/CLEAR trial (Study 307).
• In the trial, the combinations of Merck's Keytruda plus Eisai's Lenvima and Lenvima plus everolimus were evaluated versus Sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The study enrolled approx. 1,050 patients.
• Keytruda plus Lenvima met the trial’s primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement versus Sunitinib in the intention-to-treat (ITT) study population.
• Lenvima + everolimus also showed statistically significant improvement in PFS and ORR endpoints versus Sunitinib.
• The safety profiles of both the combinations were consistent with previously reported studies.
• Merck and Eisai will discuss these data with regulatory authorities worldwide, and submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.
• https://seekingalpha.com/news/3634251-merck-eisais-keytruda-lenvima-meets-endpoints-in-late-stage-kidney-disease-study
  

BioNTech Q3 top-line up +135%

• BioNTech (NASDAQ:BNTX) Q3 results (€):
• Revenues: 67.5M (+135.2%).
• Net loss: (210M) (-597.7%); loss/share: (0.88) (-528.6%).
• Cash used in Operations: (262.7M) (-94.7%).
• Yesterday, BNTX and PFE's COVID-19 vaccine candidate, BNT162b2 demonstrated evidence of efficacy above 90%, at 7 days after the second dose against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.
• In addition to the primary endpoints, the final analysis will now include, with FDA approval, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose.
• On October 21, BioNTech and Pfizer initiated a Phase 1/2 clinical trial in Japan to evaluate safety, tolerability and immunogenicity of two doses separated by 21 days and a single dose of BNT162b2.
• BNTX and PFE have announced commercial supply agreements for more than 570M doses for 2020 and 2021, including options to purchase an additional 600M doses with multiple governments.
• Also, the company closed equity and debt financings and secured grant commitments of ~$1.2B (€1B) in combined gross proceeds, resulting in net cash receipts of $0.8B (€0.6B) in Q3.
• https://seekingalpha.com/news/3634321-biontech-q3-top-line-upplus-135-shares-continue-to-surge-on-covidminus-19-vaccine-news
  

CureVac reports further data on COVID-19 vaccine candidate

• CureVac (NASDAQ:CVAC) perks 8% premarket in reaction to publication of detailed interim Phase 1 data, following the positive topline data reported on November 2.
• The previous interim data showed that CVnCoV was generally well tolerated across all tested doses (2-12µg) and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation.
• The interim analysis shows that two doses of CVnCoV, administered 28 days apart were safe.
• No vaccine-related serious adverse events were reported.
• There were dose-dependent increases in frequency and severity of solicited systemic adverse events.
• Median titers measured in these assays two weeks after the second 12 μg dose were comparable to the median titers observed in convalescent sera from COVID-19 patients.
• Seroconversion of virus neutralizing antibodies occurred in all participants who received 12 μg doses.
• CVnCoV is safe and well tolerated and is able to boost the pre-existing immune response even at low dose levels.
• Based on these results, the 12 μg dose is selected for further clinical investigation, including a phase 2b/3 study which is expected to initiate by the end of 2020.
• The manuscript is available on medRxiv and will also be submitted for publication in a peer-reviewed journal.
• CureVac will host a conference call and webcast today at 5 p.m. CET (11 a.m. EST) to provide more insight on the interim data.
• https://seekingalpha.com/news/3634353-curevac-reports-data-on-covidminus-19-vaccine-candidate-cvncov
  

Abbott launches new device for chronic pain

• Abbott (NYSE:ABT) commences the commercial launch of IonicRF Generator, its first radiofrequency ablation device, that uses heat to target specific nerves and block pain signals from reaching the brain. It says studies have shown that a single treatment can relieve pain for six to 12 months.
• RF ablation has been used to treat pain in the lower back and sacroiliac joint.
• https://seekingalpha.com/news/3634370-abbott-launches-new-device-for-chronic-pain