- 12 May '20 at 12:12 am #23659
Novavax, a clinical-stage biotechnology company shares soared…
[article]1927[/article]12 May '20 at 3:06 am #23663
Up 31% BEFORE the announcement – nothing to see here …..12 May '20 at 11:17 pm #23675
H.C. Wainwright analyst Vernon Bernardino reiterated a Buy rating on Novavax shares and increased the price target from $33 to $50.
H.C. Wainwright is focused on positive top-line results for Novavax’s pivotal Phase 3 clinical trial for NanoFlu, its Matrix-M adjuvanted recombinant quadrivalent seasonal influenza vaccine candidate for adults 65 and older, Bernardino said in a Tuesday note.
The analyst is of the view that NanoFlu has a clear path to licensure.
A BLA filing for NanoFlu could occur later this year, opening up the possibility of potential commercialization in time for the start of the 2020-2021 flu season, he said.
With the CEPI funding for Novavax’s SARS-CoV-2 vaccine candidate NVX-CoV2373, Bernardino said he places significant attention on the emergent value of the coronavirus vaccine program.
“We believe CEPI’s intended investment, the largest the coalition has made so far, speaks volumes as it shows CEPI has a significant level of confidence in Novavax’ prior experience in creating and advancing clinical-stage vaccines for pandemic flu, Ebola, MERS-CoV, and SARS-CoV (the first CoV), which we believe is underappreciated,” according to H.C. Wainwright.12 May '20 at 11:18 pm #23676
B Riley FBR analyst Mayank Mamtani maintained a Buy rating and hiked the price target from $29 to $43.
The CEPI funding announcement comes ahead of Novavax’s presentation of compelling preclinical immunogenicity data at the World Vaccine Congress Wednesday, B. Riley FBR analyst Mamtani said in a Tuesday note.
The CEPI funding for Novavax, along with the $483 million in BARDA funding for Moderna Inc
, supports the rationale that pursuing alternate vaccine approaches ensures a high likelihood of COVID-19 vaccine availability next year, the analyst said.
Mamtani attributed the price target hike to expectations for the vaccine to enter the market in the second half of 2021 and utilization in high-risk elderly populations in the near-term.
The vaccine will subsequently expand to a sizable subset of the adult population globally over a multiyear period, according to B. Riley FBR.
.12 May '20 at 11:19 pm #23677
Oppenheimer analyst Kevin DeGeeter maintained an Outperform rating and lifted the price target from $19 to $38.50
Following CEPI’s $384-million grant, supporting scale-up of manufacturing and conduct of clinical trials, Oppenheimer introduced a revenue model for NVX-CoV2373, DeGeeter said in a Tuesday note.
“We view CEPI and BARDA as the two primary funding mechanisms for rapid development of COVID-19 vaccines and as effectively the gatekeepers for prioritizing the most promising science,” the analyst said.
With the CEPI grant, Novavax joins Moderna, Johnson & Johnson and Sanofi SA in the first tier of COVID-19 vaccine companies, he said.
The company’s Matrix-M saponin-based adjuvant offers a competitive advantage, supporting rapid scale-up with smaller vaccine antigen doses and offering potential benefit in older subjects, according to Oppenheimer.18 May '20 at 11:52 pm #23731
[b]Novavax Inc. (NASDAQ: NVAX) reiterated as Buy and price target was raised to $53 from $42 at B. Riley FBR. S
hares closed up almost 14% at $43.63 on Friday ahead of call.[/b]19 May '20 at 8:50 pm #23737
Novavax Seeks To Raise $250 Million From Share Sale
Novavax (NVAX) filed a prospectus to sell up to $250 million of shares of common stock as it prepares to scale up production of its coronavirus vaccine candidate.
Shares in Novavax jumped 31% to close at $56.96 in U.S. trading on Monday after their value more than doubled over the past month.
The late-stage biotech company, which is in the process of developing a coronavirus antigen vaccine candidate, said that the net proceeds from the sale of common stock will depend on the number of shares actually sold and the offering price for such shares. The company based its calculation on the event that all of the offered shares would be sold at $43.63, the closing price per share on May 15.
“We intend to use the net proceeds from this offering for general corporate purposes, including but not limited to working capital, capital expenditures, research and development expenditures, clinical trial expenditures, as well as acquisitions and other strategic purposes,” Novavax said in the prospectus filing.
The offering comes after Novavax announced last week that it will receive $384 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to develop and produce its coronavirus vaccine candidate. The biotech company has set itself the aim of producing up to 100 million vaccine doses by end of 2020. For 2021, it is planning to target large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses during the year.19 May '20 at 8:51 pm #23738
Five-star analyst Mayank Mamtani at B. Riley FBR on Monday raised his price target on the biotech stock to $53 a share from $43 and kept his Buy rating,
This was following a meeting with Novavax management to review progress on on its COVID-19 vaccine development.
“We believe NVAX not only offers a clinically validated adjuvanted recombinant nanoparticle platform (recently reporting overwhelmingly positive data in the Ph. III NanoFlu) but, also, demonstrates the ability to illicit a potent immune response at extremely low doses, boding favorably for both safety and scalability, with management guiding to 100M doses by YE20 and >1B during 2021,” Mamtani wrote in a note to investors. “With a regulatory path becoming relatively clearer, likely on the basis of Ph. IIb results by leveraging Emergency Use Authorization (EUA), we increase the probability of success, from 25% to 40%, which drives our PT increase.”20 May '20 at 1:30 am #23747MoneyNeverSleepsParticipant
[color=red][size=5][b]Novavax Dragged Down By Questions on $MRNA and Secondary Raisings
53.90 USD −3.06 (-5.37%) Closed: May 19, 2020
After hours 50.53 −3.37 (-6.25%)[/b][/size][/color]05 Jun '20 at 6:09 am #23869
Novavax wins US contract for coronavirus COVID-19 vaccine from US Department of Defense
US Department of Defense Contract for COVID-19 Vaccine, $60 million funding for manufacturing of NVX-CoV2373
10 million doses to be delivered to DoD in 2020
NVAX has said it aims to produce 100 million doses by the end of the year
Novavax began clinical trials of its coronavirus vaccine candidate in Australia in May.
Initial results from those trials are expected in July.17 Jul '20 at 11:08 pm #24173ClemSnideParticipant
Novavax, Inc.like Moderna $MRNA spikes to 52 weeks high
52 wkk high $144.54
139.14 USD +18.85 (=15.67%) Jul 17, 3:05 PM EDT ·05 Aug '20 at 12:26 am #24320
Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate
Aug 04, 2020 at 4:05 PM EDT
Phase 1 portion of the Phase 1/2 clinical trial evaluated two doses of Novavax’ COVID-19 vaccine across two dose levels (5 and 25 µg) in 131 healthy adults ages 18-59 years
NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile
The vaccine induced neutralization titers in 100% of participants
Both 5 µg and 25 µg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses
Conference call to be held on Tuesday, August 4 at 5:00 p.m. ET. Detailed data slides will be posted at 4:30 p.m. ET on novavax.com.
GAITHERSBURG, Md., Aug. 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID‑19 vaccine with and without Matrix‑M™ adjuvant in healthy adults 18-59 years of age. NVX‑CoV2373, the Company’s recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. The data have been submitted for peer-review to a scientific journal and to an online preprint server at medRxiv.org.
NVX-CoV2373 was well-tolerated and had a reassuring safety profile.
Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly. As expected, following Dose 2, greater reactogenicity was reported, although the majority of symptoms were reported as ≤ Grade 1. The average duration of events was < 2 days. Unsolicited adverse events were collected through 28 days after Dose 2. There were no severe (Grade 3) unsolicited adverse events, and the vast majority of adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported and safety follow-up continues. NVX-CoV2373 induced neutralization titers in 100% of participants; 5 µg adjuvanted dose group peak GMT: 3,906 (95% CI: 2,556; 5,970). All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional. Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses. The adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the 25 µg dose. Cellular immune responses were measured in a subset of participants, and NVX‑CoV2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a). Favorable product profile. NVX-CoV2373 is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure. “The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well‑tolerated COVID-19 vaccine with a robust immunogenicity profile,” said Gregory M. Glenn, M.D., President, Research and Development at Novavax. “Using a stringent wild-type virus assay performed by investigators at the University of Maryland School of Medicine, NVX‑CoV2373 elicited neutralizing antibody titers greater than those observed in a pool of COVID‑19 patients with clinically significant disease.” The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia. Novavax also submitted to a peer-reviewed journal data showing results of NVX‑CoV2373 immunization in cynomolgus macaques. The vaccine induced sterile immunity that prevented viral replication in the upper and lower respiratory tracts, thus showing potential to reduce COVID-19 transmission. There was no evidence of enhanced disease following challenge. These data have also been submitted to an online preprint server at medRxiv.org. For further information, including media-ready images, b-roll, downloadable resources and more, click here. Conference Call Novavax will host a conference call today at 5:00 p.m. ET. The dial-in numbers for the conference call are (866) 324-3683 (Domestic) or (509) 844-0959 (International), passcode 4319447. A replay of the conference call will be available starting at 8:00 p.m. ET on August 4, 2020 until 11:59 p.m. ET on August 11, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 4319447. A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the “For Investors”/“Events” tab on the Novavax website. A replay of the webcast will be available on the Novavax website until November 4, 2020. [color=red][size=5][b]Market Summary > Novavax, Inc.
157.17 USD +1.30 (0.83%)
Closed: Aug 4, 4:26 PM EDT ·
After hours 122.20 −34.97 (22.25%)[/b][/size][/color]05 Aug '20 at 12:38 am #24321
[size=5][b]Sell off on “Eight patients had side effects that required hospitalization” per STAT story and 25ug didn’t elicit stronger neutralizing antibody response than 5ug arm.
Talk there was no mention of CD8 T-cell responses in $NVAX note[/b][/size]
[color=red][size=5][b]Now down 30%
After hours 110.00 −47.17 (-30.01%)[/b][/size][/color]05 Aug '20 at 1:12 am #24323
[size=5][b]Novax entertaining in after hours
Now That is a Bounce $NVAX From $164 to $120 Back To $152 all in 30 minutes post market after #COVID19 Test results released – unliked & then liked – volatility to another level. Be careful out there![/b][/size]24 Feb '21 at 8:26 am #25468ClemSnideParticipant
Novavax COVID19 vaccine ‘game changer’ via WSJ
Key possible advantages over competitors:
Early data suggests $NVAX shot may be one of first shown to stem asymptomatic spread of the #coronavirus
& also potentially provide longer-lasting protection
In January of last year, employees of Novavax Inc. met at a local Maryland bar to discuss how they might salvage their careers. For decades, the small biotech had tried to develop an approved vaccine, with no success. The company had enough cash to survive only another six months or so and its shares traded under $4, with a market value of $127 million.
Today, Novavax is advancing toward authorization of a Covid-19 vaccine. Scientists believe that, if cleared, it could be one of the more powerful weapons against the pandemic, offering key possible advantages over its competitors. Some early data suggest the Novavax shot may be one of the first shown to stem asymptomatic spread of the coronavirus and also potentially provide longer-lasting protection.
If the two-shot regimen is authorized, Novavax will still face the challenge of making and distributing it in large quantities. The firm sold some manufacturing assets in 2019 when it was desperate for cash.
Investors, who left the 33-year-old company for dead last year, are betting that regulators will authorize Novavax’s vaccine in the next couple of months. They have sent shares on Nasdaq up to $229, up 106% so far this year. Late last month, Novavax released preliminary data indicating its shot was effective at protecting against Covid-19, though less so against a new strain identified in South Africa that appears to be a challenge for other shots, too. Results of the vaccine’s late-stage U.S. trial could be released late next month.
Novavax now has a market value of $15.4 billion, greater than that of companies with billions of dollars of annual sales, including generic drug giant Teva Pharmaceutical Industries Ltd.
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