The president of Emirates tells CNN that the airline was not aware of some of the potential 5G rollout issues until yesterday morning, calling the situation "one of the most delinquent, utterly irresponsible" he has seen in his aviation career.
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Wednesday, January 19, 2022
Emirates president: 5G snafu is biggest screwup I've witnessed in my career
Yumanity: Partial Clinical Hold by FDA on Multidose Trials
Yumanity Therapeutics (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative disease, today announced that, in response to its IND application submitted in December 2021, it was notified via email by the U.S. Food and Drug Administration (FDA) that the FDA has placed a partial clinical hold on multidose clinical trials of YTX-7739, currently being developed for the treatment of Parkinson’s disease. The FDA has not halted all clinical programming and is permitting the Company’s planned single dose clinical trial to proceed. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s questions have been addressed.
The Company expects to receive additional detail from the FDA within the next 30 days. Yumanity anticipates working closely with the FDA to adequately address their concerns.
About YTX-7739
The Company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease and has previously reported results from 14 day and 28 day multiple dosing studies in healthy volunteers and a 28 day multiple dose clinical study in patients with Parkinson’s disease.
YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models.
Vivos: 18X Increase in Sleep Apnea Testing By Vivos Dentists Using SleepImage Tech
Vivos Also Announces Improved Pricing Agreement With SleepImage
Dentists and Patients Report Exceptional User Experience with SleepImage Home Sleep Test
Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, today announced significant increases across several key metrics for its SleepImage Home Sleep Apnea Tests (HST).
In particular, for the three-months ended December 31, 2021, versus the three-months ended December 31, 2020, Vivos reported:
an 18 times increase in the total number of HSTs given across the network of Vivos trained dentists (known as Vivos Integrated Practices or VIPs);
a 5.7 times increase in the number of VIPs administering HSTs; and
a 3 times increase in the average number of HSTs being administered per VIP.
Zogenix Nabs $1.9 Billion Takeover As Epilepsy Drug Piques UCB Interest
Belgium-based pharmaceutical company UCB will buy Zogenix (ZGNX) for up to $1.9 billion, the companies said Wednesday, leading ZGNX stock to rocket.
The deal leans into a recent trend of growing pharmaceutical interest in the epilepsy market, Mizuho Securities analyst Vamil Divan said. It follows Jazz Pharmaceuticals' (JAZZ) acquisition of GW Pharma in 2021. Zogenix makes Fintepla, a treatment for a seizure disorder called Dravet syndrome.
"We have seen increased interest from larger biopharma companies in the rare epilepsy market, but do not expect other potential buyers to step in at this point and expect the deal to close as planned by the end of the second quarter," he said in a report to clients.
In premarket trading on the stock market today, ZGNX stock soared 67.8% near 26.20.
ZGNX Stock: Fintepla's Next Approvals
The announcement comes as Zogenix works to roll out Fintepla in the U.S. and Europe. So far, the drug is approved for Dravet syndrome. But the next potential use is in Lennox-Gastaut syndrome, which is a much bigger market.
"We would expect an acceleration of Fintepla's growth in Dravet in the U.S. under UCB's lead given UCB's greater ability to invest in the launch," Divan said.
Under the terms of the deal, UCB will pay $26 per share for ZGNX stock. The deal also includes an added cash payment of $2 per share — known as a contingent value right — if Fintepla wins European approval in Lennox-Gastaut syndrome by Dec. 31, 2023.
Before that, the Food and Drug Administration will consider approving Fintepla for Lennox-Gastaut no later than March 25.
"We assume investors will likely wait for a positive FDA decision in March before becoming overly optimistic on the likelihood of the CVR playing out," Divan said.
https://www.investors.com/news/technology/zgnx-stock-rockets-on-ucb-takeover/
UnitedHealth Earnings Top Views
UnitedHealth Group (UNH) kicked off Q4 reporting for the managed-care sector before Wednesday's open, topping estimates and standing by 2022 guidance. After the report, UNH stock rose slightly in Wednesday's stock market action.
"Our strong 2021 performance and confident growth outlook for 2022 and beyond reflect the accelerating innovation and expanding capabilities across Optum and UnitedHealthcare," CEO Andrew Witty said in a statement.
UNH Earnings
Estimates: Analysts expected UnitedHealth earnings of $4.31 per share, up 71% from a Covid-hit year-ago result. Revenue was seen growing 11.7% to $73.1 billion.
Results: UnitedHealth earnings per share grew 78% to $4.48. Revenue rose 12.6% to $73.7 billion.
Medical costs as a share of premiums came in at 83.7% in Q4.
Outlook: UnitedHealth stood by initial full-year 2022 guidance that was issued ahead of its Nov. 30 investor day for adjusted EPS of $21.10 to $21.60. Analysts expect UnitedHealth to earn $21.71 per share. The company noted that it also was sticking by guidance for Medicare Advantage membership, indicating that enrollment for 2022 was on track.
UNH Stock
UNH stock rose 0.8% to 464.80 in morning trade. UNH stock closed off 1.6% to 460.99 in Tuesday's market drubbing, slipping back below its 50-day moving average.
UNH stock finished Tuesday's session 9.5% below its 509.23 record high set on Dec. 30. The managed-care sector got the year off to a rocky start, as the whole group got caught in Humana's (HUM) downdraft after the insurer warned on Medicare Advantage enrollment on Jan. 6.
If UNH can retake its 21-day line as well as its 50-day average, that could provide an entry point. A break above the 50-day average for quality stocks can provide an early entry point, especially when the test of its 50-day comes above the prior buy point. That's the case for UNH stock, which rose clear of 431.46 buy point on Oct. 20.
https://www.investors.com/news/unitedhealth-earnings-top-views-unh-stock-near-key-level/
Adma: Prelim Revenue and Business Update
Fourth Quarter 2021 Preliminary Unaudited Total Revenues of Approximately $26 Million, the Highest Quarterly Revenue for the Company Since Inception
Full Year 2021 Preliminary Unaudited Total Revenues of Approximately $81 Million, a 92% Increase Over Full Year 2020
Company Reiterates All Previously Provided Financial Targets
Ongoing Strategic Review & Debt Refinancing Activities
https://finance.yahoo.com/news/adma-biologics-announces-record-preliminary-120000914.html
Cardiff Oncology New Data from Lead Colorectal Cancer Program
12 of 35 (34%) patients treated per protocol at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI and bevacizumab achieved a complete response or partial response (CR: 1 patient; PR: 11 patients)
- 17 of 48 (35%) patients across all dose levels achieved a CR or PR. Historically, objective response rates (ORR) of 5-13% have been reported in similar second line patient populations treated with various different drug combinations, including the standard of care chemotherapy of FOLFIRI with bevacizumab1-4
- 5 of 48 (10%) patients discontinued the trial to pursue potentially curative metastasis-directed therapy (surgical resection or microwave ablation)
- Median progression-free survival (mPFS) across all response-evaluable patients (n=48) is 9.4 months and has not yet been reached in those treated per protocol at the RP2D. Historically, mPFS of ~4.5-5.7 months has been reported in a similar patient population treated with standard of care chemotherapy of FOLFIRI with bevacizumab1-4
- The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated with no major or unexpected toxicities attributed to onvansertib
- Company management is hosting a webcast and conference call today at 5:00 PM ET
Webcast and Conference Call
The newly announced data are being discussed today at 5:00 PM ET as part of a webcast and conference call with members of the Cardiff Oncology management team. To access the webcast, click here. To participate by phone, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13725845. Following the live event, an archived webcast will be available on the "Events" section of the Cardiff Oncology website.
https://finance.yahoo.com/news/cardiff-oncology-announces-data-lead-220000901.html