Why iRhythm Technologies Stock Skyrocketed

 

• The Centers for Medicare and Medicaid Services (CMS) has issued payment rates for 2022.
• iRhythm had hoped CMS would establish national pricing, but it didn't.
• However, investors viewed the CMS Final Rule as good news for the company.

Shares of iRhythm Technologies (NASDAQ:IRTC) skyrocketed by 59% in Wednesday trading after the Centers for Medicare and Medicaid Services (CMS) released its Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) Final Rule on Tuesday.

The MPFS details the payment policies and rates for services provided to Medicare beneficiaries. iRhythm had hoped that CMS would establish national pricing as well as continued carrier pricing for several procedure codes related to external electrocardiogram (ECG) monitoring. These codes are used by healthcare providers to submit for payment for the company's Zio XT heart monitoring service.

CMS didn't fulfill iRhythm's wishes. But the healthcare stock surged regardless, because investors viewed the Final Rule as favorable to the company.

iRhythm Technologies President and CEO Quentin Blackford acknowledged the company's disappointment that the 2022 physician fee schedule didn't include national pricing. However, Blackford said that iRhythm is working with Medicare Administrative Contractors (MACs) to establish pricing for the relevant procedure codes. Blackford said that the company "believe[s] the Final Rule is potentially constructive in our conversations with the MACs. We will share updates at the appropriate time."

Investors will hear more from iRhythm about the CMS fee schedule during the company's third-quarter earnings call, which is scheduled for Thursday after the market close. Wall Street expects iRhythm to report quarterly revenue of $83.5 million and an adjusted loss of $1.10 per share in that update.

https://www.fool.com/investing/2021/11/03/why-irhythm-technologies-stock-skyrocketed-today/

Teva Sells Record $5 Billion of Sustainability-Linked Bonds

 Teva Pharmaceutical Industries Ltd., one of the largest generic-drugmakers in the world, sold a record $5 billion in bonds tied to environmental, social and governance targets.

The company, through its finance units, raised the funds in U.S. dollar and euro denominated bonds on Tuesday after the offering was upped by $1 billion, according to a person with knowledge of the matter. The longest portion of the four-part deal, a euro-denominated 8.5-year security, yields 4.375%, after initially being marketed in the high 4% area, the person said.

“The upsizing of the issuance is a testament to the demand for ESG-linked bonds,” Bloomberg Intelligence analyst Mike Holland said in a telephone interview Tuesday. “It certainly doesn’t hurt that this deal is wrapping up on the same day that Teva, along with J&J and Endo, have their first win in California.”

Superior Court Judge Peter Wilson in Santa Ana on Monday rejected claims that units of J&J, Teva, Endo International Plc and Abbvie Inc.’s Allergan Plc duped doctors and patients about the addictiveness of opioid painkillers and created a so-called “public nuisance” tied to the medications.

Proceeds from the bond sale together with cash on hand will fund a $3.5 billion tender offer announced last week for a series of notes maturing through 2024, according to a statement. Proceeds will also be used to pay back outstanding debt upon maturity or earlier redemption and for general corporate purposes.

“The company has been guiding for a large liability management exercise for some time but concerns around litigation risks had thrown a wrench in the gears for them to be able to do a regular bond financing,” said Holland.

https://finance.yahoo.com/news/teva-sell-record-5-billion-152310124.html

NRx: Favorable Safety Report in NIH Sponsored Study in Patients with Life-Threatening COVID

 After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients

- ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo

- ACTIV-3b Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19

https://finance.yahoo.com/news/nrx-pharmaceuticals-announces-favorable-safety-150400241.html

Ocugen Nov. 9 call on Q3 results, business update

 Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it will host a conference call to discuss its third quarter 2021 financial results and provide a business update at 8:30 a.m. ET on Tuesday, November 9, 2021.

Ocugen will issue a pre-market earnings announcement on the same day. Investors are invited to participate on the call using the following details:

• Dial-In Number: (844) 873-7330 (U.S.) or (602) 563-8473 (international)

• Conference ID: 8198297

• Webcast: Available in the “Investors” section of the Ocugen website and archived for approximately 45 days following the call

https://finance.yahoo.com/news/ocugen-host-conference-call-tuesday-220800538.html

S.Korean Teens Drive up COVID-19 Cases Ahead of Full School Reopening

 South Korea said on Wednesday it would ramp up COVID-19 testing at schools after a sharp rise of infections among children, weeks ahead of a plan to fully reopen schools nationwide.

The surge comes as new social distancing rules aimed at a phased return to normal came into effect on Monday as a part of the country's plan to gradually move toward living with COVID-19 on the back of high vaccination rates.

South Korea has fully vaccinated nearly 90% of its adult population but only began inoculating children aged between 12 and 17 in recent weeks, administering just 0.6% of the age group with both doses so far.

"There is a growing concern as the frequency of new cluster outbreaks has been increasing, centred on educational facilities such as private tuition centres and schools," Interior and Safety Minister Jeon Hae-cheol said.

The government would expand the use of portable polymerase chain reaction (PCR) diagnostic tests for COVID-19 in schools in Seoul and neighbouring regions, and mobilise more virus-prevention personnel in overcrowded schools, he said.

South Korea plans to fully reopen schools nationwide from Nov. 22.

The country reported 2,667 new cases for Tuesday, an increase of more than 1,000 from the day earlier. Nearly one fourth of the new cases were found in teenagers, officials said.

"The teenagers spend a lot of time in communal living such as schools and tuition centres and they are also active in social activities," Son Young-rae, a senior health ministry official, told a briefing.

"We believe that the risk of infection will inevitably rise and the confirmed cases will continue to surge stemming from these teenagers."

South Korea has not seen a noticeable increase in seriously ill cases among teens, with just one out of 378 severe COVID-19 patients being treated in hospitals. South Korea has also reported a relatively low mortality rate of 0.78%.

Vaccination for the 12-17 age group began in October, using Pfizer/BioNTech, shots.

https://www.usnews.com/news/world/articles/2021-11-03/south-korean-teens-drive-up-covid-19-cases-ahead-of-full-school-reopening

China COVID-19 cases spike ahead of Communist Party conclave

 China’s new locally transmitted COVID-19 cases spiked to a near three-month high and tighter curbs to contain the spread are expected in the capital Beijing in the run-up to a key gathering of the highest-ranking members of the Communist Party next week.

The National Health Commission confirmed on Wednesday 93 new local symptomatic cases for Nov. 2, up from 54 a day earlier and the highest daily count since Aug. 9 at the peak of China’s last major outbreak.

Beijing reported eight new local infections, the most since Jan. 19.

While the new cases accrued each day by the Chinese capital city since late October have remained very modest compared to outside of China, the country’s zero-tolerance policy has meant the imposition of strict measures to contain the spread of the virus at all costs.

Temperature screening has been set up at entrances of shopping malls, supermarkets, hotels, cinemas and subway stations, while a legion of personnel on the ground check the health codes of visiting individuals on their mobile phones.

Beijing authorities have also repeatedly told residents to refrain from traveling out of the city, postpone weddings, simplify funeral arrangements, and cut back on all non-essential gatherings.

Of the flights scheduled on Wednesday at Beijing Daxing Airport, 60.4% have been cancelled as of the morning, while 49.8% of flights at Beijing Capital Airport have been scrapped.

The rise in Beijing infections comes as the 300-plus members of the Communist Party’s Central Committee prepare to gather in a major closed-door meeting on Nov. 8-11. It will be the committee’s sixth and penultimate so-called plenum of its five-year term before the next big Party Congress in 2022.

At the plenum, President Xi Jinping is expected to push through a resolution that will cement his authority and legacy and strengthen his case for a precedent-breaking third term starting next year.

Outside of Beijing, new local infections were reported in the north, northeast and northwest in provinces and areas including Heilongjiang, Hebei, Gansu, Inner Mongolia, Ningxia and Qinghai.

New cases were also seen the southwest of China, in the municipality of Chongqing as well as the provinces of Sichuan and Yunnan.

The southern province of Jiangxi reported two new cases.

Inclusive of cases imported from overseas, China reported 109 new confirmed infections for Nov. 2 compared with 71 a day earlier.

As of Nov. 2, mainland China had 97,423 confirmed cases.

https://newsinfo.inquirer.net/1509842/china-covid-19-cases-spike-ahead-of-communist-party-conclave

AbbVie preps filings after ABBV-951 tops oral Parkinson’s drugs in trial

 AbbVie has reported that a subcutaneous infusion of Parkinson’s disease candidate ABBV-951 was more effective than standard oral therapy in a phase 3 trial, paving the way for regulatory filings.

ABBV-951 is based on foslevodopa and foscarbidopa – delivered via a subcutaneous device once a day – with the aim of providing full 24-hour control of Parkinson’s symptoms that can’t be achieved easily with oral dosing of levodopa and carbidopa.

The head-to-head trial showed that patients taking ABBV-951 had a statistically significant increase in “on” time without dyskinesia – in other worlds period where the muscle symptoms associated with Parkinson’s were controlled without involuntary, uncontrolled movements – at 12 weeks.

There was also a reduction in “off” hours, when Parkinson’s symptoms re-emerge, which tend to get longer as the disease progresses, and the tolerability of subcutaneous delivery was generally good with only mild or moderate side effects, according to AbbVie.

If approved, ABBV-951 could be an alternative to oral therapy – whose efficacy tends to fall off over time – as well as sustained delivery approaches such as AbbVie’s own Duopa, a form of carbidopa/levodopa delivered in gel form via a gastric tube and pump that requires a surgical procedure.

Duopa is generally reserved for use in people with advanced Parkinson’s disease who are still responding well to levodopa-based therapy, but despite its limitations still manages to bring in around $500 million a year. AbbVie sees ABBV-951 as an approach that could significantly expand that market.

In the study, the increase in “on” time without dyskinesia at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa, with decreases in “off” time of 2.75 hours and 0.96 hours, respectively.

“Patients need more therapeutic options to control their symptoms and troublesome dyskinesia for this debilitating disease,” said Jason Aldred, of the University of Washington, a principal investigator of the study.

“These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with advanced Parkinson’s,” he added.

AbbVie said full results from the phase 3 study – called M15-736 – will be presented at a future medical meeting or submitted for publication in a peer-reviewed journal.

https://pharmaphorum.com/news/abbvie-preps-filings-after-abbv-951-tops-oral-parkinsons-drugs-in-trial/