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Tuesday, December 1, 2020

Anixa Biosciences, Cleveland Clinic in ovarian cancer vaccine pact

 

  • Anixa Biosciences (ANIX +4.5%) has entered into a license agreement with Cleveland Clinic for exclusive, world-wide rights to an ovarian cancer vaccine technology. The development-stage vaccine targets the extracellular domain of anti-mullerian hormone receptor 2 (AMHR2-ED), that appears in many types of ovarian cancer.
  • Anixa and Cleveland Clinic are already collaborating on a preventative breast cancer vaccine, and human trials are expected to commence in early next year.
  • https://seekingalpha.com/news/3640425-anixa-biosciences-cleveland-clinic-in-ovarian-cancer-vaccine-pact

Auris Medical AM-301 in encouraging preclinical action against SARS-CoV-2

 

  • Auris Medical (EARS +63.1%) has announced efficacy data from testing AM-301 in vitro, a drug-free nasal spray for protection against airborne pathogens and allergens.
  • AM-301 was tested for its capability to prevent or mitigate SARS-CoV-2 infection of nasal epithelial cells. In saline-treated control cultures, Sars-CoV-2 replicated efficiently, resulting in a rapid increase in viral titer. In contrast, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection.
  • 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls. 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively.
  • The company says its looks forward to taking AM-301 through additional tests and advancing the program towards the submission of regulatory applications in 2021.
  • https://seekingalpha.com/news/3640409-auris-medical-soars-afterminus-301-shows-encouraging-preclinical-action-against-sars-covminus

India says may not need to vaccinate entire population to control COVID

 India may not need to vaccinate all of its 1.3 billion people if it manages to inoculate a critical mass and break the transmission of the coronavirus, senior government officials said on Tuesday.

Indian Prime Minister Narendra Modi, who toured the facilities of three vaccine makers over the weekend, has emphasized the importance of a vaccine to rein in COVID-19.

In October, he said that the government was preparing to reach every single citizen as soon as a vaccine was ready.

World Health Organization experts have pointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity.

“The government has never spoken about vaccinating the entire country,” Rajesh Bhushan, the top bureaucrat in India’s federal health ministry, told a news conference on Tuesday without reference to Modi.

India currently has the world’s second-highest number of coronavirus infections, behind only the United States, with 9.46 million cases and 137,621 deaths.

India recorded 31,118 new coronavirus cases on Tuesday, the lowest daily tally since Nov. 17, data from the health ministry showed.

“...If we are able to vaccinate a critical mass of people, and break that virus transmission, then we may not have to vaccinate the entire population,” Balram Bhargava, Director General of the state-run Indian Council Of Medical Research, said at the press briefing.

India’s plan to roll out a COVID-19 shot in the first few months of 2021 wouldn’t be impacted by an alleged adverse reaction during AstraZeneca’s COVID-19 vaccine trial, Bhushan said.

A 40-year-old Indian man said in a complaint over the weekend that he had suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the British drugmaker’s partner, Serum Institute of India.

The incident is currently under investigation.

https://www.reuters.com/article/us-health-coronavirus-india-cases/india-says-may-not-need-to-vaccinate-entire-population-to-control-covid-idUSKBN28B3OT

VBI Vaccines files US application for hep B vaccine

 

  • VBI Vaccines (VBIV -0.4%) has submitted marketing application with the FDA seeking approval for Sci-B-Vac, its 3-antigen prophylactic hepatitis B vaccine candidate, for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
  • Recently, the company filed marketing application to the European Medicines Agency, and expects to submit regulatory approval applications in the U.K. and Canada in Q1 of 2021.
  • In October, the company announced presentation of abstracts at the ID Week conference from two Phase 3 trials evaluating the vaccine candidate.
  • https://seekingalpha.com/news/3640400-vbi-vaccines-files-us-application-for-hbv-vaccine

Hospital Stocks Are Heading Higher. So Are Covid-19 Cases

 Coronavirus hospitalizations have soared to all-time-highs, threatening to strain health-care facilities across the U.S. again. But this time, investors are less concerned.

Shares of several publicly traded hospital systems finished November with their best performances in months, with national hospital operators including Tenet Healthcare Corp. and HCA Healthcare Inc. both jumping at least 21%. That is far better than the S&P 500's 11% monthly gain and the 7.8% rise for the index's health-care sector.

November sent the U.S. stock market on yet another wild ride, driven by a string of positive Covid-19 vaccine results and a quicker-than-expected resolution of the presidential election. Both events helped push major U.S. stock indexes to new records as traders scrambled to scoop up investments that have been beaten-down this year. In addition to hospital stocks, shares of retailers, restaurants, energy stocks and cruise liners also jumped. Elsewhere across financial markets, crude oil, junk bonds and metals such as copper and platinum rallied.

On its face, the recent outperformance of hospital stocks could be perceived as one of the beneficiaries of the latest round of bargain-hunting by investors -- after all, hospital chains such as Tenet and Universal Health Services Inc. are both still trading 11% or more below their respective 2020 highs after plunging during the market rout.

Yet some investors and analysts say they also believe that the recent rally has legs that could extend beyond November, even as rising Covid-19 cases threaten to overrun hospitals again.

"We're bullish," said A.J. Rice, a health-care services analyst at Credit Suisse, which has an "outperform" rating on Tenet, Universal Health and HCA. "Absent a national lockdown again, we think these companies can deliver on expectations and even exceed them. And that should be sufficient to at least relatively outperform the market overall."

Driving the optimism around hospital and health-care facilities, analysts and investors say, is increased clarity about the months ahead. Although two key Senate seats in Georgia won't be decided until the January runoff election, many traders are anticipating that the government will remain divided -- an outcome that reduces the chances of a major health-care overhaul.

And statements from some of the Supreme Court's conservative justices suggest the Affordable Care Act may survive its latest test, a case argued last month by Republican-leaning states seeking to challenge it.

The survival of the Affordable Care Act -- combined with a gridlocked government -- would make it unlikely that health-care policy will substantially change. That in turn, analysts said, will be advantageous for hospitals, which have benefited from greater volumes of insured patients.

"The [election] outcome probably is as good as we could have hoped," said Whit Mayo, managing director of equity research at UBS. "The [chance] of seeing more coverage is probably greater than less coverage. And that's almost always a good thing for everyone in health-care services."

One of the biggest challenges for hospital systems in the months ahead will be the sharp climb in Covid-19 cases, which public-health officials expect will worsen in the coming weeks as more Americans test positive after traveling for Thanksgiving. The U.S. reported more than 135,000 new coronavirus infections Sunday, according to the Covid Tracking Project, and hospitalizations surged to more than 93,000 -- a new record.

The jump in cases threatens to overtax hospital systems again. But this time, investors and analysts expect hospital systems to better weather the Covid-19 influx, thanks to a deeper understanding of how to treat the virus and how to manage hospital capacity. And unlike this spring, when states across the country imposed restrictions on elective procedures, analysts anticipate that local governments will instead leave those decisions to hospital systems.

Already, many hospitals seem more willing to push ahead with the profitable procedures that hospitals routinely conduct, especially after many systems have enjoyed a faster-than-expected rebound in hospital visits for non-coronavirus patients. That -- along with cutting expenses, including via furloughs and reducing salaries at some companies -- has helped turn around hospitals' financial landscape.

Federal assistance earlier this year, including $175 billion in direct aid approved by Congress for health-care providers across the U.S., has also delivered relief.

"I do think investors are becoming comfortable with the fact that hospitals can operate in a Covid environment and that everything doesn't have to go into a complete shutdown," said Frank Morgan, a research analyst at RBC Capital Markets.

Still, even with vaccine optimism, some analysts note that the Covid-19 landscape could shift sharply if outbreaks significantly worsen in the coming weeks. Some nonprofit hospitals have begun putting elective surgeries on pause, and health-care workers are anxious about what could be a sustained influx of patients after already enduring an unrelenting year.

Even so, investor sentiment on hospital companies and the overall health-care sector remains positive. In its latest survey released in November, Bank of America said that health care remains the most overweight sector among fund managers.

Recent options activity, meanwhile, has indicated that investors became increasingly bullish on HCA and Universal Health in November, compared with the month before, said Michael Khouw, chief investment officer of Optimize Advisors. Activity in the options market implies that, on average, traders expect a nearly 7% increase in share price for HCA by mid-March and an almost 12% increase for Universal Health by mid-April, according to his data analysis.

https://www.marketscreener.com/quote/stock/UNIVERSAL-HEALTH-SERVICES-40311163/news/Hospital-Stocks-Are-Heading-Higher-So-Are-Covid-19-Cases-31908086/

Boston Scientific Sells BTG Specialty Pharmaceuticals Unit for $800 M

 Boston Scientific Corp. on Tuesday said it agreed to sell its BTG specialty pharmaceuticals business for $800 million in cash to affiliates of SERB, a European specialty pharmaceutical group backed by private-equity firm Charterhouse Capital Partners.

The Marlborough, Mass., maker of medical devices said the sale, which it expects to complete in the first half of 2021, will result in a pretax loss of about $200 million, which it will book in the fourth quarter.

Boston Scientific said the BTG business makes antidotes used in hospitals and emergency-care settings, including the CroFab, DigiFab and Voraxaze products, which are expected to generate roughly $210 million in revenue this year. The unit has five facilities and about 280 employees around the world.

Boston Scientific, which acquired BTG PLC last year for about $3.7 billion net of cash on hand, said it will have shed two non-medical-device portions of the U.K. interventional medicine company for more than $1 billion in net proceeds.

https://www.marketscreener.com/quote/stock/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-Sells-BTG-Specialty-Pharmaceuticals-Unit-for-800-Million-31908944/

UnitedHealth guidance for 2021 includes $1.80-per-share hit from COVID-19

 UnitedHealth Group Inc. UNH, -0.47% said Tuesday it now expects full-year revenue of about $257 billion, yielding per-share earnings of about $15.90 and adjusted EPS of $16.75. The FactSet consensus is for EPS of $16.73 and revenue of $256.7 billion. The company offered the updated guidance in a statement ahead of an analyst day. It also set guidance for 2021 for revenue to range from $277 billion to $280 billion and adjusted EPS to range from $17.75 to $18.25. Those numbers include a $1.80 per share hit from continuing COVID-19 effects, such treatment and testing costs, the impact of people deferring care into 2021 and other factors. The FactSet consensus is for EPS of $18.39 and revenue of $278.5 billion. Shares were up 0.5% premarket and have gained 14.4% in the year to date, while the S&P 500 SPX, -0.46% has gained 12% and the Dow Jones Industrial Average DJIA, -0.90% has gained 3.9%.

https://www.marketwatch.com/story/unitedhealth-sets-guidance-for-2021-that-includes-a-180-per-share-hit-from-covid-19-effects-2020-12-01