Unusual Options Activity Mon 9/11/23

Stocks seeing volatility buying (bullish call buying/bearish put buying):

Calls:

• FUBO Sept 3.50 calls are seeing interest with 220 contracts trading vs. open int of 1380, pushing implied vol up around 27 points to ~126.89%
  
• TLRY Sept 5 calls are seeing interest with 430 contracts trading vs. open int of 1510, pushing implied vol up around 77 points to ~234.27%. The Co is slated to reports its next earnings in October.

Puts:

• NVAX Nov 7.50 puts are active with 90 contracts trading vs. open int of 3010, pushing implied vol down around 2 points to ~144.98%. Underlying shares -6%.
  
• CVNA Sept 49 puts are active with 60 contracts trading vs. open int of 1110, pushing implied vol down around 15 points to ~102.86%. Underlying shares +7%.

Sentiment: The CBOE Put/Call ratio is currently: 0.90, VIX: (13.83, -0.01, -0.07%).

Novavax (NVAX) finally nabs Covid-19 vaccine EUA

a. 6/22:  vol 6.7M; 2, 4, 5, 10, 11, 52, 95

b.  7/1: vol 6.4M; 12, 23, 60, 67, 82, 83

 

 

 

 

Novavax confirms that its COVID-19 vaccine has received EUA from the FDA

• Co announces that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received EUA from the FDA to provide a two-dose primary series for active immunization.
• "Today's FDA emergency use authorization of our COVID-19 vaccine provides the U.S. with access to the first protein-based COVID-19 vaccine."
• The FDA EUA was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled approximately 30,000 participants.

In the U.S., the fact sheet accompanying the vaccine warns of a heightened risk of inflammation of the heart and tissues surrounding it following administration. That's in line with the same sheets for Pfizer's (PFE) and Moderna's (MRNA) Covid vaccines. On Thursday, regulators in Europe added a warning against the risk of severe allergic reaction to the Novavax shot.

Still, experts hope adding a third vaccine technology to the U.S. coffers will help bolster the number of people vaccinated against Covid. Novavax's jab uses a protein-based technology and a tree bark chemical from Chile to boost the immune response. Pfizer and Moderna use newer messenger RNA platforms. Johnson & Johnson (JNJ) employs an empty virus to deliver its single-shot vaccine.

NVAX Stock: Small Portion Of Unvaccinated People

Novavax is late to the market, however. Pfizer and Moderna won FDA authorization in December 2020 and J&J followed in February 2021. Further, the company tested its vaccine before the emergence of the delta and omicron variants.

Novavax has global authorizations, including in younger people, but in the U.S. it will only be allowed in adults who have yet to receive a Covid shot. The Centers for Disease Control and Prevention estimates that group accounts for just 10% of people in the country.

-=Novavax (NVAX) selected to participate in Operation Warp Speed

Novavax has been selected to participate in Operation Warp Speed, U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 in 2021

Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax' proprietary Matrix-Madjuvant. Under the terms of the agreement, Novavax will demonstrate it can rapidly stand up large-scale manufacturing and transition into ongoing production, including the capability to stockpile and distribute large quantities of NVX-CoV2373 when needed. The agreement will fund the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal Phase 3 clinical trial with up to 30,000 subjects beginning in the fall of 2020.

Today's agreement also allows for a follow-on agreement with the U.S. government for additional production and procurement to support OWS' vaccine production goal. This latest federal funding supports Novavax plans to file submissions for licensure with the U.S. Food and Drug Administration (FDA).

Citron Research: Novavax (NVAX) going back to $15

 

This week's biggest % winners & losers : Feb. 25 - March 1, 19 (wk 9)

The following are this week's top percentage gainers and losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: ONCE (113.28 +119.71%), TGTX (7.21 +51.15%), PBYI (38.93 +45.91%), TNDM (69.24 +43.29%), QURE (57.31 +37.76%), HZNP (28.18 +32.92%), GH (70.59 +30.41%), BOLD (34.16 +30.03%), APLS (18.31 +28.76%), SLDB (11.35 +26.67%), CRSP (39.97 +26.21%), NTLA (16.92 +24.96%), LXRX (6.81 +23.59%), XRAY (49.13  +18.02%)
• Industrials: HSII (43.27 +27.98%), SNHY (49.53 +27.85%)
• Information Technology: ZS  (60.57  +21.68%)
• Consumer Discretionary: FTCH (28.82 +42.67%), ETSY (72.77 +28.41%), JCP (1.54 +25.2%), GPS (29.51  +19.18%)

This week's top 20 % losers

• Healthcare: NVAX (0.7 -63.41%), IMGN (2.51 -56.2%), CTMX (10.98 -38.97%), CRBP (6.3 -26.57%), INGN (106.97 -25.37%), SYNH (43.41 -22.06%), MEDP (54.74 -21.78%)
• Industrials: NCI (20.06 -25.62%), DY (46.87 -25.43%)
• Information Technology: NTNX (33.7 -36.51%), BNFT (46.04 -23.27%)
• Financials: UVE (32.8 -18.99%), HIIQ (37.21 -18.56%)
• Energy: ALTM (5.57 -31.74%), CDEV (9.27 -26.14%), SMLP (10.41 -18.93%)
• Consumer Staples: ELF (7.95 -19.29%)

-=Novavax (NVAX) respiratory infection vaccine fails in late-stage trial

Novavax, Inc. also develops NanoFlu vaccine, which is in Phase I/II clinical trial for treating seasonal influenza in older adults; and Ebola virus glycoprotein vaccine that is in Phase I clinical trial. Its preclinical programs include Zika virus; combination respiratory vaccine candidate to protect against RSV and seasonal influenza, as well as other infectious disease vaccine candidates. Novavax, Inc. was

http://www.novavax.com
Sector: Healthcare
Industry: Biotechnology
Full Time Employees: 362
Founded in 1987
Headquartered in Gaithersburg, Maryland.




Feb 28 (Reuters) - Novavax Inc said on Thursday its vaccine to prevent RSV infection, a leading cause of a respiratory disease in infants, failed to meet the main goal of a late stage study.

The vaccine was not able to lower respiratory tract infection caused by RSV, or respiratory syncytial virus, the company said.

ResVax is a vaccine administered to mothers during pregnancy intended to protect infants against RSV disease.

"While this study did not meet the pre-specified success criterion for the primary clinical endpoint of this trial, the data indicate that ResVax protects infants from some of the most serious consequences of RSV," Chief Executive Officer Stanley Erck said in a statement.

The company said it planned to meet with U.S. and European health regulators to review the data.

-=Novavax (NVAX) : RSV, NanoFlu vaccine updates

Earlier this year, analysts said investors in Novavax Inc. would be watching closely for updates in December that could be key to indicating the future of the Gaithersburg biotech.

Shares of Novavax (NASDAQ: NVAX) fell 22 percent Tuesday after the company disappointed investors by saying it would announce data for the phase 1/2 trial of its NanoFlu seasonal flu vaccine candidate in February. Investors had been looking for results on the program this month.

The company also said it will continue a phase 3 clinical trial of an RSV vaccine candidate for infants via maternal immunization. RSV is a common source of dangerous infections in infants and older adults, and Novavax is targeting a worldwide RSV vaccine market that exceeds $6 billion with multiple vaccine candidates.

This disappointment on Wall Street is something we've seen before with Novavax. In July, analysts said Novavax's cautious path forward did not meet expectations. At that time, Novavax opted to run yet another phase 2 clinical trial on its RSV vaccine candidate for elderly patients instead of moving into its phase 3 clinical trial — the final test of a product's success. That vaccine candidate had a stunning phase 3 trial failure in 2016 leading the company to retool its approach.

=Long trade : NVAX +25% (11/17)

• Nov 16:  #97,  vol. 5.0M    +25%

NVAX — is it a buy?

• 12/15/16:  #7

 

A few months later:

Novavax (NVAX) plunges after its vaccine for a respiratory virus failed in a study

• The shares dropped 84 percent to $1.35 in late trading at 4:58 p.m. New York time.

 

Novavax announces topline RSV F vaccine data from two clinical trials in older adults, Resolve Phase 3 trial did not meet pre-specified efficacy objectives :

The co announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve trial, a Phase 3 trial of RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with previous clinical experience, the vaccine was well tolerated.

• Phase 3 Resolve Trial:
  • "We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality. We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results. Historically, annual seasonal RSV ARD attack rates between 3% and 7% have been observed in older adults. In our Phase 2 trial, we observed an RSV ARD attack rate of 4.9% and an RSV msLRTD attack rate of 1.8%. In contrast, we observed an RSV ARD attack rate of 2.0% and an msLRTD attack rate of 0.4% in our Phase 3 trial. These attack rates indicate a mild RSV season in older adults this year. We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults."
• Phase 2 Rollover Trial:
• "The rollover trial demonstrated immunogenicity in all active vaccine recipients. As shown in the table above, there was a 6-fold increase in anti-F IgG in the Placebo-Vaccine arm, consistent with the Phase 2 efficacy trial. There was higher anti-F IgG at baseline in the Vaccine-Vaccine arm compared to the Placebo-Vaccine arm. Further, the Vaccine-Vaccine arm showed a greater than 2-fold increase in anti-F IgG from the higher baseline. We observed similar low attack rates and absence of efficacy of a single immunization in this trial as was observed in Phase 3 Resolve trial, although we did observe that a second season immunization could provide efficacy. The event rate comparisons made to either placebo groups suggested that the second season immunization was protective, even in a year with a very low attack rate. Further understanding of these data may come forth with full evaluation of the immune responses."

*** charts the day before ***

 

Long trade : NVAX +15% (9/16)

Long trade : NVAX +15% (5/16)

• held 2 days  Tue-Thur (i.e., sold on 3rd day)

• The following day, Monday

Novavax (NVAX) : RSV 'breakthrough'

  

Novavax shares (NVAX) surged today on the news that its vaccine for respiratory syncytial virus (RSV) proved effective in a large midstage study that company officials billed as a "historic" achievement.

Long an elusive goal in development circles after inactivated vaccines proved dangerous in the '60s, Novavax is angling to launch a late-stage program for the RSV vaccine later in the year, company execs tell Bloomberg. And CEO Stanley Erck previewed the company's blockbuster commercial expectations with Reuters yesterday, telling the news service that it could be "the largest selling vaccine in the history of vaccines in terms of revenue."

"It could be a major breakthrough," Andrew Pavia, a spokesman for the Infectious Diseases Society of America, tells the AP. But he adds that these results need to be confirmed in Phase III before the celebrations can begin. "It's not time to break out the champagne."

Coming off a great day
The news about the drug’s trial was announced Monday afternoon, but that wasn’t the only good news that day. Monday also marked the release of Novavax’s latest earnings report, and the numbers looked positive. For one, the company posted an EPS that beat the Consensus Estimate by 11.11%. Also, Novavax crushed our revenue estimate of $10 million, reporting $14 in revenues for the quarter.