Warp Speed Head Says People Can Start Getting COVID-19 Immunized Days After EUA

 On CNBC's "Squawk on the Street," Moncef Slaoui, Head of Operation Warp Speed, discussed upcoming emergency use authorizations, how soon can people start getting immunized and getting the vaccine distributed.

Operation Warp Speed was initiated by the U.S. government to facilitate and accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.

Moderna MRNA 4.72% could file for EUA within a few days of Pfizer PFE 1.51% and BioNTech's BNTX 8.42% filing, said Slaoui.

Filing for EUA is the next step for vaccine manufacturers, but getting the vaccine in the people's hands will come soon after. 

"People can start getting immunized within a few days after emergency use authorization," said Slaoui.

Jim Cramer questioned Slaoui on the dissemination of the vaccine, but he respectfully disagreed.

https://www.benzinga.com/general/health-care/20/11/18465935/operation-warp-speed-head-says-people-can-start-getting-covid-19-immunized-days-after-eua

Vertex's Pipeline Success Odds Aren't Dismal As Some Fear: Bernstein

 Vertex Pharmaceuticals Incorporated 

VRTX 1.77% shares have come under selling pressure recently, given investor concern regarding diversity in the pipeline for this cystic fibrosis-focused biopharma.

The Vertex Analyst: Bernstein analyst Analyst Vincent Chen initiated coverage of Vertex with an Outperform rating and $275 price target.

The Vertex Thesis: Vertex's pipeline is underappreciated and offers substantial upside optionality, Chen said in a note.

The cystic fibrosis franchise could reach sales of about $10 billion by 2025, with patent exclusivity into the late 2030s and strong potential for lifecycle management. This, the analyst said, largely supports the stock's current valuation.

Despite investors selling the stock after recent setbacks, the analyst is more optimistic, especially with its multiple programs in potentially high-value indications and having near term catalysts.

The failure of alpha-1 antitrypsin deficiency, or AATD, drug VX-814 that was subsequently discontinued has more to do with idiosyncratic toxicity, likely specific to the molecule, Chen said, citing experts in AATD.

VX-864 is a separate shot on goal, he added.

"We believe the odds of success are not as dismal as investors believe, we see near term catalysts that have potential to drive upside for the stock, and take a positive view on the stock," the analyst concluded.

https://www.benzinga.com/analyst-ratings/analyst-color/20/11/18466234/odds-of-vertexs-pipeline-success-arent-dismal-as-some-fear-bernstein-says

4 Online Pharmacy Stocks To Play Rising Demand For Home Prescription Delivery

 Prescription delivery is one of the business sectors that's been spotlighted by the coronavirus pandemic. 

Even ahead of the pandemic, this space was seen as one with potential. Drugs are commodities, and pharma companies are defensive plays that tend to do well even during a downturn.

Additionally, the proportion of population in the elderly age bracket has been on the rise given the advancement in drug research and the availability of health care.

All of this adds up to a huge opportunity for prescription delivery providers. 

Prescription Delivery Stocks: Amazon.com, Inc. AMZN 0.04%: Online retail behemoth Amazon, which has disrupted several sectors, has made a big push into doorstep drug delivery. 

The company announced Amazon Pharmacy on Tuesday, a new store on Amazon that allows customers to buy prescription medicines by placing orders on their desktops or mobile devices through the Amazon App.

The total addressable market opportunity for prescriptions in the U.S. includes $360 billion in prescriptions that are filled annually, and about $150 billion in prescriptions that are written but not filled due to cost and inconvenience to customers, according to BofA Securities.

The firm estimates that a mid-to-high teens percentage share of prescriptions are fulfilled through mail or delivery.

At the high end, this would represent a roughly $95 billion annual total addressable market for Amazon Pharmacy.

The adjacent health care segments that Amazon Pharmacy could address include pharmaceutical manufacturer advertising, which translates to an additional $30 billion TAM, BofA said.

The services Amazon Pharmacy envisages include allowing customers to make pharmacy purchases on Amazon and providing customers an up to 80% discount on generic drugs and 40% discount on off-brand drugs through Prime Rx, a prescription savings benefit for Prime customers.

Amazon acquired Boston-based online pharmacy start-up PillPack in 2018, thwarting Walmart Inc's WMT 0.51% attempt to buy the company.

Walmart Pharmacy: The retail giant's pharmacy unit provides home delivery services for orders placed by phone.

Prescriptions are usually sent through first-class mail and arrive within seven to 10 business days, with expedited shipping possible for an additional fee.

Recently, Walmart's Sam's Club unit announced a partnership with DoorDash Inc for same-day delivery of prescription medicines.

Walgreens Boots Alliance Inc WBA 1.62% has a presence in the online pharmacy business through AllianceRX Walgreens Prime — a collaboration between Walgreens and pharmacy benefit manager Prime Therapeutics. Its mail-delivery service allows customers to receive a 90-day supply of maintenance medications delivered at home. 

Additionally, Walgreens also does deliveries through Walgreens Express.

CVS Health Corp CVS, which launched prescription delivery service in 2018, refined its offering to allow same-day delivery the following year. The delivery is done by Shipt.

Goodrx Holdings Inc GDRX 0.97%, which went public in late September, has seen its shares stagnate after a strong debut.

After listing at $46.70, up from the IPO price of $33, the stock ended the debut session at $50.50, a gain of 53%.

The stock was holding above the $46 level for the most part before the Amazon news pulled it lower this week.

GoodRx, founded in 2011, began as a health care platform that compares prices of medications, and offers free coupons for less than the cash price of prescriptions.

The company launched GoodRx Gold, a prescription savings program, which offers prescription mail delivery through its partner Truepill.

NowRx: This California-based, technology-enabaled pharmacy start-up uses a proprietary pharmacy software called QuickFill and advanced logistics technology to provide same-day and same-hour delivery of prescription medications.

In mid-July, the company completed a $20-million Series B funding round through SeedInvest.com, a crowdfunding platform.

The company said then it intends to use the funds to launch more high-tech micro-fulfilment centers and to accelerate the technology roadmap for its proprietary pharmacy management software and logistics technology.

Although NowRx is not publicly traded, investors can buy into the company and its future by partaking in the funding rounds.

https://www.benzinga.com/news/20/11/18454437/4-online-pharmacy-stocks-to-play-the-rising-demand-for-home-prescription-delivery

Karyopharm selinexor data from late-stage soft tissue cancer study in presentation

 

• Karyopharm Therapeutics (KPTI -1.5%) has announced presentation of positive results from the Phase 3 portion of SEAL study evaluating single agent, oral XPOVIO (selinexor) versus matching placebo in patients with liposarcoma at the Connective Tissue Oncology Society 2020 Annual Meeting. Plans to submit US marketing application during Q1 of 2021.
• As previously reported, the SEAL study met its primary endpoint of a statistically significant increase in median progression-free survival (PFS) in patients with at least two prior therapies.
• Median PFS in the XPOVIO arm was 2.83 months compared to 2.07 months in the placebo arm (hazard ratio=0.70). Data indicates that XPOVIO reduced the risk of disease progression or death by ~30%, compared to placebo.
• Estimated 6-month PFS survival probability was 23.9% in selinexor arm compared to 13.9% on placebo, with 12-month PFS survival probability of 8.4% compared to 2%.
• Also, data suggested that 7.5% of patients on the selinexor arm had more than 15% reduction in their disease burden as measured by target lesion size while none in placebo.
• The most common treatment-related adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms, manageable with dose modifications and/or standard supportive care.
• XPOVIO is currently FDA approved for the treatment of relapsed or refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma.
• Karyopharm has also submitted a supplemental marketing application with FDA for label expansion to include XPOVIO as a treatment for patients with multiple myeloma after at least one prior line of therapy. Action date is March 19, 2021.
• https://seekingalpha.com/news/3638376-karyopharms-selinexor-data-from-late-stage-soft-tissue-cancer-study-in-oral-presentation

India could get access to AstraZeneca vaccine by January: local manufacturer

 The head of an Indian company contracted to make AstraZeneca Plc's COVID vaccine said it could deliver it to health care workers and elderly Indians by January as the country's caseload of infections crossed nine million on Friday.

The Serum Institute of India, the world's largest vaccine manufacturer, has already manufactured millions of doses of the vaccine that is being developed in collaboration with Oxford University while results from late-stage trials are awaited.

Britain-based AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

On Thursday, data published in the medical journal The Lancet showed that AstraZeneca's vaccine produced a strong immune response in older adults, with researchers expecting to release late-stage trial results by Christmas.

Drugmakers Pfizer Inc and Moderna Inc have also released data from late-stage trials that shows more than 90% efficacy in their vaccine candidates.

India is watching the progress of the Pfizer and Moderna vaccines, but availability and supply could be an issue with a population as large as India's, the head of a committee advising the prime minister said this week.

Adar Poonawaala, the chief executive of the SII, said that his company would seek emergency use authorisation for the AstraZeneca vaccine as soon as authorities in the United Kingdom approved it and made it available for the general public.

"It's been a Herculean task and we are very happy now that we are almost now on autopilot waiting just for the vaccine results to come," Poonawaala told a conference on Thursday. "Then we can churn out hundreds of millions more of the vaccine."

The vaccine would be priced between $5-$6 in the retail market, but the Indian government would get it for much less, because they would buy it bulk, Poonawaala said.

It would take at least two to three years for all of India's 1.3 billion population to be covered, he said.

India has the world's second-highest number of infections, after the United States, but cases have slowed down since hitting a peak in September.

It recorded 45,882 new infections and 584 deaths in the last 24 hours, the health ministry said on Friday. India has now registered more than nine million cases of the coronavirus and 132,162 deaths.

An Indian government-backed vaccine, developed by private company Bharat Biotech, could be launched as early as February, a government scientist told Reuters earlier this month.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/India-could-get-access-to-AstraZeneca-vaccine-by-January-local-manufacturer-says-31827641/

Mnuchin says Main Street U.S. companies need grants, not loans

 

U.S. Treasury Secretary Steven Mnuchin on Friday defended his decision to end several of the Federal Reserve's key pandemic lending programs on Dec. 31, saying Congress should use the money to help small U.S. companies with grants instead.

Mnuchin, speaking on CNBC, said he and White House Chief of Staff Mark Meadows would speak with congressional Republican leaders later Friday, and planned to redouble their efforts to pass further stimulus measures.

https://www.marketscreener.com/news/latest/Mnuchin-says-Main-Street-U-S-companies-need-grants-not-loans--31829716/

Maravai LifeSciences seeks to raise $1.62B in IPO

 

• Maravai LifeSciences (MRVI) has priced its upsized IPO of 60M Class A common shares at $27.00/share, for gross proceeds of $1.62B.
• The Company initially planned to offer 50M shares at a range of $24 - $27.
• Trading kicks off today. Underwriters' over-allotment is an additional 9M shares.
• Morgan Stanley, Jefferies and Goldman are acting as joint book-running managers.
• Closing date is November 24.
• MRVI's products address customers’ needs for nucleic acid production, biologics safety testing and protein detection, and its operations are aligned to these three segments.
• https://seekingalpha.com/news/3638234-maravai-lifesciences-seeks-to-raise-1_62b-in-ipo