Inovio Gets Reddit Call To Action As Investment Firm Boosts Stake

 Inovio Pharmaceuticals (INO) surged Monday on a Reddit call to action and after investment firm BlackRock upped its stake in the biotech company. INO stock soared to a five-month high.

The Reddit post details "a battle against corruption in the FDA, Big Pharma and shorts." Inovio Pharma is one of several biotech companies working on a Covid-19 vaccine. It's also testing a treatment for a precancerous condition of the cervix.

Shares of INO stock catapulted 31.5% near 16.80 in afternoon trading on the stock market today.

In addition to the Reddit call, INO stock jumped on BlackRock's investment. A Securities and Exchange Commission filing shows BlackRock now owns more than 14.2 million shares of INO stock, or 8.4% of the company.

https://www.investors.com/news/technology/ino-stock-catapults-higher-reddit-call-blackrock-investment/

Hedge fund that bought Covid vaccine maker Vaxart low, sold high, exits board

Armistice Capital bought pre-Covid shares of Vaxart for little more than a quarter and became the largest institutional shareholder. Now with the fund's stake at less than a 1% stake, its two representatives are leaving the board.

https://www.bizjournals.com/sanfrancisco/news/2021/01/29/covid-vaccine-coronavirus-vaxart-armistice-capital.html

B of A Cuts Moderna to Underperform on Valuation

 Moderna  (MRNA) was sliding Monday after a Bank of America analyst downgraded the biotech, a prominent vaccine producer, to underperform from neutral with a $150 price target, saying the company's valuation was stretched.

Shares of the Cambridge, Mass., company at last check were down nearly 10% to $156.34.

Analyst Geoff Meacham said in a note to investors that Moderna's shares quintupled  (up 425%) in 2020 and are up 66% year-to-date, adding that they are "attaining levels that are increasingly difficult to justify on a fundamental basis."

"Indeed," he said, "the momentum has continued despite new covid-19 vaccine data from Novavax  (NVAX) - Get Report and Johnson & Johnson's  (JNJ) - Get Report phase 3 study approval."

Meacham said that Moderna and Pfizer have best-in-class vaccine efficacy thus far, "but volumes and lower price points from Novavax, JNJ, Astra-Zeneca  (AZN) - Get Report and others should affect cumulative sales expectations from Moderna.

"Although we acknowledge that vaccines are clearly the most promising solution for the covid-19 epidemic, and a potential incremental revenue driver exists in addressing new variants," Meacham said, "the number of vaccine options with compelling characteristics (single injection, lower cost, clean safety) could begin to weigh on Moderna's margins and market share longer-term."

Modern's covid-19 vaccine received emergency-use authorization from the U.S. Food and Drug Administration on Dec. 18, and the company started supplying the federal government shortly thereafter.

Last week, Moderna reported that it was on track to deliver on its commitment of about 100 million doses to the U.S. government by the end of the first quarter.

CNBC reported last week that Moderna asked the FDA to allow it to include 15 doses in each vial of its covid-19 vaccine, up from 10 doses.

https://www.thestreet.com/investing/stocks/moderna-slides-on-bank-of-america-downgrade-to-underperform

Oppenheimer Downgrades Invitae to Perform Rating

  Investment bank Oppenheimer on Monday downgraded Invitae to a Perform rating, seeking more clarity on the integration of its hereditary cancer and women's health business after the acquisition of ArcherDx last year and other segments of its business. 

Last month, Invitae conservatively projected around $450 million in revenues in 2021 after factoring in continued COVID-19 impact. However, the consensus Wall Street estimate for this year's revenues was much more optimistic at $513.7 million. 

"While we view 2021 guidance for revenues of $450M-plus as potentially conservative, in our view, opportunities for further multiple expansion may be limited contributing to increased risk of underperformance for Invitae shares," Oppenheimer analyst Kevin DeGeeter wrote in a note to investors. He wrote that while ArcherDx allows Invitae to expand into somatic cancer testing and liquid biopsy, the investment firm is unconvinced that the company has made a strong case for expanding its business with this acquisition beyond pharma collaborations. As such, Oppenheimer's 2021 revenue estimate for Invitae is $450.7 million.

Furthermore, DeGeeter noted that other diagnostics competitors in the space, such as Exact Sciences, invested in providing COVID-19 testing, which has helped grow revenues. Invitae "has generated no material COVID-19 testing revenue," DeGeeter wrote, adding that although Oppenheimer raised its price target from $48 to $51 in early January, "we do not view current valuation as an attractive entry point for new money."

Although earlier Oppenheimer supported the company's overarching strategy of providing lower cost testing to broaden access to genetic testing, DeGeeter said the investment firm wants "more transparency on segment performance and revenue impact from aggressive M&A activity."

https://www.genomeweb.com/business-news/oppenheimer-downgrades-invitae-perform-rating#.YBhU-uhKjIU

Reddit Army Declares ‘BioWar’ as Shorted Biotechs Soar

 BioCryst Pharmaceuticals Inc. blew past a five-year high as Reddit investors rallied around a call to start a “#BioWar” on the heavily-shorted biotech that develops rare disease drugs.

The stock, which recently ended development on a Covid-19 drug, rallied as much as 36% on Monday after a poster on Reddit’s WallStreetBets forum called it “the most undervalued stock in the market” while another said a brewing #BioWar was “about sticking it to the shorts in a massive way.”​

Indeed, BioCryst is a short target with about 17% of float, or $259 million, sold short, according to financial analytics firm S3 Partners. But it’s also a hedge fund pick held by the likes of Citadel and the well-known biotech outfit, Baker Bros. Advisors LP.

Before Monday’s rally, shares of BioCryst had already shrugged off the scuttling of a Covid-19 trial supported by the National Institutes of Health. The company is expected to generate less than $31 million in revenue for all of 2020.

Novavax Inc., another heavily-shorted biotech, has also garnered interest across chat forums, which could benefit funds like RA Capital Management and Perceptive Advisors, which hold stakes in the company. The stock has more than doubled in the past few trading days, albeit on key positive results for its Covid-19 vaccine candidate. The short position on Novavax stands at $1.5 billion, according to S3.

https://www.bloomberg.com/news/articles/2021-02-01/reddit-army-declares-biowar-as-shorted-biotechs-soar?srnd=markets-vp

Lilly drives more access to COVID-19 antibodies with new infusion centers

 Eli Lilly's COVID-19 monoclonal antibody isn't getting as much use as it could, thanks to logistical hurdles. So the drugmaker is taking matters into its own hands.

The pharma, in partnership with local health systems, is setting up dedicated local infusion centers across its home state of Indiana, with centers already up and running in the central, northern and southern parts of the state. So far, the infusion centers have delivered antibody therapy to more than 1,700 high-risk Hoosiers with COVID-19, Lilly reported.

Lilly’s antibody treatment bamlanivimab, along with Regeneron’s combination imdevimab and casirivimab, both have FDA emergency use authorization to treat high-risk patients with mild to moderate cases of COVID-19 who aren’t hospitalized.

But that’s also part of the problem. Infusions must be prescribed and administered in a hospital or clinic setting, but patients already admitted to the hospital with more severe cases of COVID-19 aren’t eligible.

While Lilly is providing operational support to the three infusion sites in Indiana, it doesn't currently have plans to establish more pilot sites, a Lilly spokesperson said in an email. The pharma is sharing insights and lessons learned from the three sites with governments, health systems and other stakeholders.

"Our goal is to help gain learnings on how to effectively and quickly launch infusion sites and to share those learning with any hospital or health system willing to consider setting up their own sites. Lilly is proud to offer resources, available to any health system interested in setting up their own infusion site," the spokesperson said.

Regeneron applauded Lilly’s local infusion center effort. “We continuing to work with federal/state governments, healthcare systems and individual providers to raise mAb awareness and ease the administration process, but don’t have a formal program like this to announce at the moment," a spokesperson said.

The logistics surrounding the new antibody treatments have proven daunting not only for patients and healthcare providers but also for the drugmakers. Without full FDA approval, both companies are also restricted in how they can promote the drugs.

Regeneron executives, speaking at the J.P. Morgan Healthcare Conference, said last month that the slow uptake of antibody therapies is "a problem."

Society has “to do a much better job” at getting antibody treatments to patients, R&D chief George Yancopoulos said, noting that Regeneron should work more closely with the U.S. government to figure out effective ways to get its cocktail to those who need it.

One direct way both companies are offering help is with a geolocation map. Lilly and Regeneron are co-sponsors of the National Infusion Center Association’s locator, which lists COVID-19 antibody availability, along with that of other infused drug treatments.

Specific to COVID-19 antibody treatments, the Department of Health and Human Services (HHS) last month launched its own national online locator. Healthcare providers and patients can search for nearby healthcare facilities in the U.S. and its territories that HHS reports have received shipments of Regeneron or Lilly’s therapies.

HHS has struck deals to buy 300,000 Regeneron and 3 million Lilly treatment courses. Its latest data shows that more than 785,000 treatments of monoclonal antibodies have been shipped.

While this particular circumstance has presented its own outreach challenges, it’s not uncommon among pharma companies to facilitate access to treatment or testing through healthcare provider and patient resources.

Both Gilead and AbbVie, for instance, helmed hepatitis C testing efforts after both debuted therapies to treat the disease. AbbVie, for instance, drove a testing and education tour bus along with the American Legion across the U.S. in 2018 with free one-day test results.

Bayer, for its part, launched a “Test Your Cancer” awareness program in early 2019 to make people aware of genomic testing options for solid tumor cancer patients. Bayer and partner Lilly co-market Vitrakvi, approved to treat solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, no matter the type.

https://www.fiercepharma.com/marketing/lilly-partners-home-state-indiana-to-drive-more-access-to-covid-19-antibody-infusions

Pfizer, Moderna hold lead; new data from J&J, Novavax show 'room for everyone' in vax market

 With Novavax and Johnson & Johnson data now in hand, the world has efficacy numbers on at least five COVID-19 vaccine programs. That's plenty for analysts to parse—and they're busy doing not only that, but also sizing up the market as the field of top players grows.

The upshot? Blockbuster sales to go around, but Pfizer and Moderna will continue to lead the pack, partly thanks to their ability to quickly deploy mRNA against new variants. And for Moderna, at least, that means almost $14 billion in projected sales just this year from one team of analysts.

The efficacy data feed into those calculations, but there are caveats, SVB Leerink analyst Mani Foroohar, M.D., wrote in a Monday note to clients. Johnson & Johnson’s headline efficacy number of 66% was lower than its mRNA competitors—and Novavax’s 89% figure—but “a direct comparison can be misleading” because of differences in trial populations and the tough new variants circulating around the world.

J&J, for instance, ran part of its phase 3 trial in South Africa, and Novavax has phase 2b from the country, where a tough new variant is circulating widely. Both companies said their vaccines' results varied country to country. The variant eluded the full effects of the Pfizer and Moderna vaccines in lab studies, and, now, those companies are developing boosters.

In earlier studies, the Pfizer and Moderna programs were more than 90% effective against COVID-19 infections. AstraZeneca’s program was 70% effective in a phase 3 trial, but a dosing error raised questions that prompted a follow-up phase 3 set to read out this month. In AZ’s first phase 3 trial, the vaccine was 90% effective in participants who received a half-dose followed by a full dose.

On an “apples to apples basis,” Foroohar wrote that J&J offers “a compelling one-dose profile with much more straightforward distribution and logistics than market leaders” Moderna and Pfizer, both of which are already distributing their respective mRNA shots. Those two-dose vaccines require storage at freezing temperatures, while J&J's shot can be refrigerated for up to three months.

Aside from J&J's top-line efficacy number, the vaccine was 85% effective against severe disease and offered "complete protection" against COVID-19 hospitalization and death in the massive phase 3 trial.

Meanwhile, analysts with ODDO BHF said after the latest data there’s “room for everyone” in the market, but that mRNA vaccines show “superior efficacy.” They’re projecting $13.7 billion in COVID-19 vaccine revenues for Moderna this year. Foroohar's team projects $9.5 billion in revenues for Moderna's program this year.

In the big picture, the recent results from J&J and Novavax are “heartening for humanity’s progress against the virus,” Foroohar wrote. Challenges from new variants remain, though, and there the mRNA programs hold a speed-of-development edge. The analyst predicts J&J and Novavax will start to capture global market share in the second half of this year and beyond, but, because of the strong data profile and head start for the Pfizer and Moderna programs, those companies will hold “dominant share."

As new variants circulate, the analyst’s team increased their projected "revaccination rate” for the coming years. They predict Pfizer-BioNTech and Moderna will capture the “dominant revaccination share.”

Aside from the data releases late last week, AstraZeneca’s vaccine scored an authorization in Europe. The company has been entangled in a supply controversy there, and, Sunday, officials said the company would boost supply by 9 million doses to 40 million doses overall in the first quarter. That’s half of the company’s original target.

In a note Monday, SVB Leerink analyst Andrew Berens and his team projected $1.9 billion in revenues for the AstraZeneca vaccine this year, followed by $3 billion next year. The revenues will be offset by expenses, though, as the company pledged to sell its vaccine on a not-for-profit basis during the pandemic.

In addition to the research work underway in Western countries, China's Sinopharm has touted efficacy results of 79% for its vaccine program.

https://www.fiercepharma.com/pharma/while-pfizer-and-moderna-hold-lead-new-data-from-j-j-novavax-show-there-s-room-for-everyone