- The FDA has approved one month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk patients implanted with Medtronic's (NYSE:MDT) Resolute Onyx drug-eluting stent (DES), the only such device with this indication in the U.S.
- Resolute Onyx DES was CE Mark'd in May for one-month DAPT in high bleeding risk patients.
- https://seekingalpha.com/news/3618791-medtronic-nabs-expanded-u-s-label-for-resolute-onyx-stent
Thursday, October 1, 2020
Medtronic nabs expanded U.S. label for Resolute Onyx stent
LHCG in 2 new agreements in Ga., purchases Col. hospice provider
- LHC Group (NASDAQ:LHCG) finalized two new JV agreements in Georgia and purchased a hospice provider in Colorado, each effective Oct. 1.
- In Gainesville, LHCG and Northeast Georgia Health System will share ownership of SunCrest Home Health, a provider serving patients and families in the surrounding region.
- In Colorado, LHCG will purchase Santa Rita Hospice in Aurora. The provider will operate under the At Home Hospice name in a shared space with At Home Healthcare, LHCG's home health provider in Aurora.
- LHCG also finalized a JV with University Health Care System to enhance home health and hospice services in that market. LHCG expects incremental annualized revenue from this JV of ~$8.3M and will not materially affect its 2020 EPS.
First rolling review of COVID-19 vaccine data underway in Europe
- The European Medicines Agency (EMA) has begun its first rolling review of COVID-19 vaccine data on AstraZeneca (NASDAQ:AZN) and the University of Oxford's candidate AZD1222/ChAdOx1. The review committee will be evaluating the first batch of nonclinical data from lab studies so it is premature to expect a conclusion on safety and effectiveness.
- A rolling review is way of accelerating the process. The FDA uses the same approach for high priority medicines and vaccines.
- Selected tickers: Pfizer (NYSE:PFE), BioNTech SE (NASDAQ:BNTX), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NASDAQ:MRNA), Sanofi (NASDAQ:SNY), GlaxoSmithKline (NYSE:GSK), Dynavax (NASDAQ:DVAX), Novavax (NASDAQ:NVAX)
- https://seekingalpha.com/news/3618847-first-rolling-review-of-covidminus-19-vaccine-data-underway-in-europe
- CareDx (CDNA +10.6%) is up on modestly higher volume in reaction to the release of final local coverage determination by Medicare administrator Palmetto MolDx for AlloSure Heart, a donor-derived cell-free DNA (cfDNA) test that identifies underlying cell injury leading to organ rejection.
- The company says the coverage decision paves the way for patient/provider availability of HeartCare, the combination of AlloSure Heart and AlloMap Heart, an 11-gene panel that detects changes in gene expression associated with acute organ rejection.
- https://seekingalpha.com/news/3618887-caredx-up-11-on-medicare-coverage-of-organ-rejection-test
Novartis says data confirms benefit of Zolgensma gene therapy for babies
Novartis said new interim data from an ongoing phase clinical trial for its $2.1 million-per-patient gene therapy Zolgensma showed spinal muscular atrophy patients experienced significant therapeutic benefit.
Nearly two-thirds of patients aged less than six months in the STR1VE-EU study have already achieved developmental motor milestones not observed in natural history of SMA type 1, a rare genetic disease, at a mean duration of follow-up of 10.6 months, Novartis said in a statement on Thursday.
The Swiss drugmaker said last month that Zolgensma faced a possible delay after the U.S. Food and Drug Administration (FDA) requested an additional study to examine the therapy’s efficacy in older children.
Pulmonx prices 10M IPO above range at $19
- Pulmonx (LUNG) has priced its upsized IPO of 10M common shares at $19.00/share, higher than the already raised price range of $17-$18 for gross proceeds of $190M.
- Underwriters' over-allotment is an additional 1.5M shares.
- Trading commences October 1.
- Closing date is October 5.
- https://seekingalpha.com/news/3618676-pulmonx-prices-10m-ipo-above-range-19
Dr. Reddy's launches generic Sensipar in U.S.
- Dr. Reddy’s Laboratories (NYSE:RDY) announces the launch of Cinacalcet Tablets, a therapeutic equivalent generic version of Amgen's Sensipar (cinacalcet) Tablets.
- According to IQVIA Health, the Sensipar had U.S. sales of ~$312M for twelve months ended July 2020.
- Dr. Reddy’s Cinacalcet Tablets are available in 30, 60, and 90 mg tablets.
- https://seekingalpha.com/news/3618696-dr-reddys-launches-generic-sensipar-in-u-s
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