Novavax seeks FDA authorization for COVID-19 shot

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• Novavax (NVAX +7.9%) shares are trading higher after announcing that the company submitted a request to the FDA seeking the Emergency Use Authorization (EUA) for its COVID-19 vaccine, NVX-CoV2373.
• Maryland-based biotech has requested the FDA clearance for the protein-based vaccine for use in those aged 18 years and above.
• The regulatory submission is backed by pre-clinical, clinical, and manufacturing data, including the results from two large pivotal studies where the vaccine was found to have an overall efficacy of nearly 90% with a favorable safety profile.
• Developed in partnership with the U.S. government, NVX-CoV2373 is currently undergoing a booster study as well a trial targeted at those aged 12 – 17 years.
• Novavax (NASDAQ:NVAX) has already secured the European clearance as well as the emergency use listing (EUL) of the World Health Organization (WHO) for the vaccine.

Comments

[Randol33]

PT of about $65, Was wondering what people were buying these past few days?Guess retail speculators just likes to hold bags.

[panalex]

@Randol33 whose PT?
that may still work btw for whoever got March $75 puts at ~$10 last week...

[TommyIrish]

@Randol33

Stock is moving up unless there is some cataclysmic failure.

For a few months.

Longer term - anyone's guess.

[jk051992]

I am in on NVAX...at least for a short term. Even at $300 the valuation will be nothing compared with moderna.

[zenstar666]

@jk051992 That's exactly the reason I predicted a PT of at least $500 to achieve parity with the then Moderna market cap and total number of issued shares about 2 years ago. Methinks I could be on target...provided management behaves, run an efficient ship and not issue any more diluting shares.

[Rational Investment Advice Please]

Israel, the leader in getting population vaccinated, purchased 5 million jabs the other day. That seems very positive along with this EUA submission.
Just a couple more hurdles (FDA approval and mass production), and NVAX should secure leadership in his area.
I think I'll be purchasing more tomorrow. Hope price takes a dip, so I can buy a few more.

[spinlessandfactful]

I hope the NVAX sheds its checkered recent past and emerges as a new player much more serious and comes to the arena ready to play. Yes past fumbles aside keeping its word on FDA EUA submission has scored well at this point though not to the liking of the most optimistic. But how this FDA application is managed and brought to a successful finish line is going to dictate the sp movement going forward. The US is nowhere saturated with variants emerging and need for boosters and the like and so the market is still going to be available only for those that can effectively fill the demand and with a clean slate and utmost transparency. GLTA.

[smartshihtzu]

$NVAX NOT dependent on US market for sales. However, FDA approval will come regardless and demand will be here too for pediatrics, boosters,stragglers, hesitancy, annual flu combos or stand alone annuals. But still huge primary market for BILLIONS of doses now in countries all over the world desperate for more vaccine.

[autumn leaf]

@smartshihtzu Given the company is tiny, really wondering if they are up to the challenge to successfully distribute the vaccines to the other countries.

[JZNY]

@autumn leaf they may be tiny for now but they have multiple distribution partners. Of which, some are leaders in production such as SII as well as S. Korean and Japanese partners.

[panalex]

@smartshihtzu all this is prolly coming but just keep in mind that boosters, pediatrics etc. require separate approvals. Spain approved NVAX booster though

[TommyIrish]

Jeez - does this management always leave everything to the last second - looking forward to the ER - have they managed to curtail the EPS bleed?

Guessing ACTUAL authorization moves the stock to $130.

A fair breeze $180 by June - $100 calls would pay off.

Longer term?

No doubt they will find a way to blow it...

[autumn leaf]

@TommyIrish EUA is a great leap. however, commercialization dictates the financial success of the product. I would love to watch how Novavax convinces people to get the shots. I don't trust the SII though.

[TommyIrish]

@autumn leaf

Not a stock for widows and orphans.

Going up if they can deliver - at least until June.

Collapsing if they can't - maybe later.

[JZNY]

@autumn leaf iMHO, they won’t need much convincing. I personally have been waiting for the NvAX 2373 shot to be available for the longest time and would give an arm or leg to get the jab. I am confident many think like me. Additionally, poorer, warmer climate countries will have no choice but take NVAX 2373 due to logistical reasons but their efficacy, safety profile are also best in class.

[autumn leaf]

I hope it'll get approval soon and make debut in the US market soon. I only want to get the Novavax as the third short.

[JZNY]

@autumn leaf Likewise, been waiting since summer 21.

[Waxphilosophic]

I am a longtime shareholder of $NVAX. I have lost interest in the past year, however. Has the company actually delivered any product to these other countries? Has its vaccine been used by anyone other than the test subjects?

[smartshihtzu]

@Waxphilosophic you are so behind in your reading in the past 3 months

[1to3 Investing]

@Waxphilosophic They are delivering millions of doses around the world. NVAX should have pretty good revenue numbers next Q based on what is already happening. Future sales a few years down the road would be in combined Flu shots... a nice market that will want yearly doses and updates for.

[General Buck Turgidson]

great news. this vaccine should be a game changer. hopefully the approval comes rapidly.

[User 52335558]

Here and I thought NVAX has been trying to get approval in the USA since the beginning? It has really taken them this long to say, "You know what, maybe we should ask the country we reside in for approval."? I think they missed the boat by a few months. PFE stock price was $50 after approval, it's gained a whole $2 since then. Biotech is falling out of favor and NVAX missed the boat IMO.

[jwr23]

@inick2005i Most drugs take 8-10 years...2 yrs is still exponentially quick when all things considered. How is it when billions of smart people around the world will, at the very least, have to get annual jabs for the next 100 yrs be missing the boat? Using a safer and proven method, as or more reliable, and little to none logistic issues compared to mRna's. Also, NVAX will be the first to offer combo jabs with a class leading flu vaccine because the mRNA's will have a difficult time adding/stabilizing multiple strains compared to the proven protein setup. Trust the facts and not the fear mongers.

[panalex]

@inick2005i for PFE the profit of this vax (shared with BNTX) is a drop in the bucket compared to their total revenue. but look no further than their partner BNTX for an example of what this one product can do to a relatively small startup.

[pat45]

FDA will take over a month to review, and may need more info...USA already has plenty of vaccines and MRNA just got full approval not just EUA

[kfitzat]

@pat45 yeah, full approval... still crap though

[sKibi]

Need UK, Japan, Canada, and even New Zealand to complete the “high income country” regulatory approvals that preceded this filing for profit generation.

Then need to announce multi-valent clinical trial to add delta and omicron to the mix for broad spectrum protection.

[Ishi Kenjo]

God forbid if a better choice is allowed in America. Israel & Germany just bought tens of millions of doses. Southeast Asia is using even more Novavax. It is about time Americans get a better choice too. I own Pfe as a div payer stock but they disgust me the way they own our government. J & J, Astrazenica, Moderna all showed negative bidily effects. Novavax is a multi-decade, time tested proven type unlike mrna short term Guinnea Pig danger. The natural advuvant is healthier for the body... the supply was limited whuch delayed production. But patience is a virtue for investors & consumers. 👍

[genomegk]

@Ishi Kenjo Shouldn't you hold off on whining until after the FDA/US government gives you reason to?
Speaking of which what part of "Developed in partnership with the U.S. government, NVX-CoV2373" do you not understand

[bale002]

Hopefully this will be the start of some semblance of free and fair competition among these periodic mitigative shots (there are no vaccines for coronaviruses), with no in-your-face mandates.

[Crayfishkaliari]

ADE ain't got ya yet? Test your luck with Novavax!

[Mason A]

Thought that was supposed to have happened in October.

Would be nice for Americans to have a "traditional" option. Maybe could have had better vaccine uptake.

[sts66]

@Mason A October? Wasn't it last June? Then Sept? Then EOY? Will be interesting to see how long it takes FDA to give them EUA.

[kfitzat]

@sts66 better than rushing an unfinished product like others?

[sts66]

@kfitzat What unfinished product? mRNA vaccines you get today are identical to the ones you got the first day they got EUAs.

[jeffk100]

wow, i stand corrected. Never thought this deadline would be met by this mgmt.

[Buzz Stockyear]

Just in time as Omicron cases are expected to decline in a couple of weeks.

[Crayfishkaliari]

@Buzz Stockyear won't stop them from taking credit lol...

[sKibi]

@Buzz Stockyear not so fast. B.A2 showing resurgence and reinfecting B.A1 convalescents. Don’t know what Mother Nature is cooking up in its laboratories but I bet it’s spinning the viral mutation roulette wheel 24/7 with a few trillion replications a day.

[sts66]

@sKibi B.A2 is reinfecting recovering B.A1 patients? I can't believe those two variants can be that different so that you get zero protection from already being infected recently - I think WHO would have assigned it a separate name if that were the case.

[Mark Kratzer]

The cream always floats to the top. Best in class with the safest, mote efficacious Covid. Also the seasonal flu shot Nanoflu on deck ready for approval. The combo seasonal/Covid and boosters will allow N to skyrocket with the low float. Also a prime buyout target due to robust pipeline.

[calendarspread]

About time

[TommyIrish]

@calendarspread

About BLOODY time!