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Tuesday, December 1, 2020

FDA OKs new use of Roche's Xolair

 

Goldman tips Codiack, Arcutis, Oak Street Health as Buys

 Goldman Sachs analysts are pounding the table on three stocks in particular, noting that each could surge over 40% in the year ahead. After running the trio through TipRanks’ database, we found out that the rest of the Street is also standing squarely in the bull camp.

Codiack BioSciences (CDAK)

As we have all learned from coronavirus pandemic, some new thing in medical science can make huge impact on our world. Codiack aims to turn that principle to good. This research-oriented pharmaceutical aims to turn exosome therapeutics into a whole new class of medicines. Exosomes are the degradation mechanism RNA, and can transfer genetic material around a body.

And therein lies the potential. Codiack has developed a design platform for the engineering of exosome proteins capable of carrying and protecting drug molecules through cell walls. In effect, the proteins will mimic the pathways used by viruses – but are non-viral, and are designed to carry a ‘payload’ of therapeutic agents. If successful, exosome therapy offers doctors the ability to design a drug that will deliver specific agents to specific cells to fight specific disease.

Codiack is involved in all aspects of exosome therapeutics, from design to manufacturing, and currently has an active pipeline of agents – seven, in all – in various stages of discovery, preclinical testing, and the beginnings of Phase 1 trials.

In the biosciences, success or failure is all about that pipeline, and in its diverse, active pipeline of agents in a new sector of biotechnological pharmaceuticals, Codiack has a fine resource to attract investors. To get those investors, the company went public this past October, selling 5.5 million shares at an opening price of $14.10 per share.

Among the healthcare name's fans is Goldman Sachs analyst Graig Suvannavejh. The analyst wrote, “Biopharma industry interest in exosomes has long been high, but engineering them for a specific function and manufacturing at scale have both proven challenging. Among a field of multiple competitors, CDAK has made the most significant progress on both fronts, and as such we view their technology platform as best-in-class.”

"Given share underperformance (-37%) since the IPO, we find risk/reward highly compelling at current levels, and with key 2021 data sets to provide potential de-risking and positive share inflection," the analyst concluded.

Suvannavejh rates CDAK a Buy, and his $29 price target shows the extent of his confidence – it implies a 222% upside for the coming year. (To watch Suvannavejh’s track record, click here)

Overall, Codiack has a Strong Buy from the analyst consensus – 3 reviewers have put up Buy ratings in recent weeks. The stock is selling for $8.90, and its $24 average price target implies a 166% one-year upside potential. (See CDAK stock analysis on TipRanks)

Arcutis Biotherapeutics (ARQT)

Acrutis is a pioneering researcher in the treatment of dermatological disease. Arcutis is involved in discovering the next generation of dermatological treatments – an important niche, especially when one realizes that one common ailment, psoriasis, has not seen an FDA approval for a novel treatment in over two decades.

The company is leveraging recent advances in immunology and inflammation to find new approaches to skin treatment. The goal is to make it easier for patients and doctors together to manage conditions like psoriasis, alopecia, atopic dermatitis, seborrheic dermatitis, and vitiligo, to name just a few.

The company's lead candidate, ARQ-151 (roflumilast cream), is about to enter a phase 3 trial for atopic dermatitis, and is in an advanced phase 3 stage in Plaque Psoriasis.

Arcutis has recently issued an update on positive data from the Phase 2 trials of ARQ-151 in atopic dermatitis. The drug is a once-daily treatment, and has demonstrated significant patient relief from symptoms, especially itching and itching-related sleep problems.

This is another stock in Suvannavejh’s coverage universe. The Goldman analyst is impressed by developments in the company’s pipeline work, noting: “ARQT provided an update on the outcome of its end-of-Phase 2 meetings with the FDA, following their Phase 2a trial of ARQ-151 in atopic dermatitis (AtD). Feedback from regulators was broadly encouraging, in particular, acknowledging the robust long-term safety data being generated by ARQT for ARQ-151 in plaque psoriasis…”

Accordingly, Suvannavejh rates ARQT a Buy, and sets a $36 price target that indicates room for 40% upside growth in 2021. (To watch Suvannavejh’s track record, click here)

Arcutis has 2 recent Buy reviews, making the consensus rating a Moderate Buy. The stock’s average price target is $37, suggesting a 44% upside from current levels. (See ARQT stock analysis on TipRanks)

Oak Street Health (OSH)

With the last stock, we move from medical research to medical care. Specifically, Oak Street Health is a primary care clinic operator, and part of the Medicare Network. The company has operations and clinics in Illinois, Indiana, Michigan, Pennsylvania, and Ohio, along with New York, North Carolina, Rhode Island, Tennessee, and Texas. It has been in operation for eight years, and went public this past summer, holding the IPO in August.

In the third quarter, the company’s first as a publicly traded entity, OSH brought in $217.9 million in revenue. The revenue number was up 56% from the year-ago quarter. Earnings per share matched expectations, at 15 cents.

The company’s expansion proceeds apace, and in October, Oak Street entered New York by opening, in Brooklyn, its 70th location. A planned expansion in Texas, involving a partnership with Walmart, is also proceeding as planned, and Oak Street has opened its first Walmart Community Clinic the Dallas-Fort Worth area city of Carrollton.

Robert Jones, covering this stock for Goldman, set a $74 price target to back his Buy rating. At currently levels, this target implies an upside of ~58% in the next 12 months. (To watch Jones’ track record, click here)

“Results suggest operations are still on track, with few incremental updates since the 2Q call, where management noted a resumption of center openings, (pivoted) marketing efforts, and in-person visits despite COVID. In 3Q, OSH opened 13 new centers and is on track for 73-75 by end of year… The company maintained that it is continuing to operate at a high level in places with elevated COVID case counts like Chicago and Detroit,” Jones noted.

All in all, the Strong Buy analyst consensus rating OSH is based on 8 reviews, breaking down to 7 Buys and just a single Hold. The stock is selling for $46.94, and its $61.29 average price target suggests it has a ~31% upside for the coming year. (See OSH stock analysis on TipRanks)


UnitedHealth Group: 2021 Revenues To Eclipse $277 B

 UnitedHealth Group said its 2021 revenues will reach $277 billion next year as the company unveiled its business strategy Tuesday.

Already the nation’s largest health insurance company, UnitedHealth is poised to grow its top line by about 8%. UnitedHealth operates commercial, Medicaid and Medicare Advantage plans via its UnitedHealthcare health insurance unit and is also expanding its medical care provider business across the country under its fast-growing Optum unit.

As the company began its annual investor day virtually Tuesday morning, UnitedHealth said its 2021 outlook will include revenues of “$277 billion to $280 billion, net earnings of $16.90 to $17.40 per share, and adjusted net earnings of $17.75 to $18.25 per share.”

This growth will follow an updated 2020 performance that included an updated projection Tuesday of 2020 revenues expected to be about $257 billion, “with net earnings to approach $15.90 per share and adjusted net earnings to approach $16.75 per share.”

UnitedHealth chief executive David Wichmann said the company’s strategy will continue to push a move to value-based medical care models while escalating the use of technology to make sure patients get care that they need when they need it. As one example in his opening statements, he said patients will get more digital coaching along with advancements in telehealth.

“United is how we will deliver the future of health,” Wichmann told analysts and investors.

The meeting also marked the return of Sir Andrew Witty, who left UnitedHealth Group as head of Optum earlier this year on a leave of absence to a position at the World Health Organization to aid the development of vaccines against Covid-19. “I look forward to the kind of innovation this company can uniquely deliver,” Witty, who is president of UnitedHealth and CEO of Optum, said speaking from the United Kingdom after he was introduced by Wichmann.

https://www.forbes.com/sites/brucejapsen/2020/12/01/unitedhealth-group-2021-revenues-to-eclipse-277-billion/

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