ESET Chief Security Evangelist Tony Anscombe shares advice on how to keep your virtual meet-ups private and safe while you're holed up at home during the pandemic

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With Zoom – and Zoom-bombing – being all the rage, here’s why the app’s default password settings may be leaving the backdoor wide open

The post Ever needed a Zoom password? Probably not. But why not? appeared first on WeLiveSecurity

In worst-case scenarios, some vulnerabilities could even allow attackers to take control over the central units and all peripheral devices connected to them

The post Serious flaws found in multiple smart home hubs: Is your device among them? appeared first on WeLiveSecurity

If you’re trying to be responsible towards the planet, also be responsible to yourself and take these steps so that the device doesn’t end up costing you more than you’ve saved

The post Buying a secondhand device? Here’s what to keep in mind appeared first on WeLiveSecurity

Source: Streetwise Reports   04/22/2020

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from ROTH Capital Partners, Moderna Inc., Company Note, April 19, 2020

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Moderna, Inc.

ROTH makes a market in shares of Moderna, Inc. and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has managed or co-managed a public offering for Moderna, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: AVDL:NASDAQ, )

Source: Streetwise Reports   04/28/2020

SmileDirectClub Inc. (SDC:NASDAQ) today announced "it has been issued a patent for its SmileShop intellectual property from the U.S. Patent & Trademark Office which further strengthens the telehealth dentistry pioneer's efforts to bring affordable, accessible oral care to more people through its unique and innovative teledentistry platform and direct-to-consumer business model." The firm claimed that the patent will prevent other clear aligner competitors from duplicating its business model for the next 18 years.

The company's CEO David Katzman commented, "This patent designation is a significant validation of our unique customer-oriented care model, and expands our category ownership, including the manufacturing and retail experience...As the industry pioneer and inventor of the SmileShop concept, this patent is recognition that SmileDirectClub offers an innovative way for consumers to access oral care that is safe, doctor-directed and convenient. We look forward to welcoming customers back to our SmileShops at the earliest and safest possible time."

"We are focused on the entire teeth straightening and care process, and we now own the manufacturing process of our clear aligner products, the customer experience via our teledentistry platform, as well as the retail experience for clear aligner therapy. This patent is another step in our process as we continue to grow and protect our business," Katzman added.

The firm advised that "the patent encompasses the unique SmileShop concept and process" which includes appointment scheduling, conducting an intraoral scan, generating an approved treatment plan by a licensed dentist or orthodontist and then creating and shipping the aligners to the customer. The company noted that so far more than one million customers have used its clear aligner therapy platform.

The company stated that it is planning to slowly reopen its SmileShops in the U.S. and other markets starting in May as local governments begin to lift business restrictions. The firm indicated that it will be supplying all of its SmileShop team members with face shields and other PPE and will institute staggered appointment times, temperature scans and other social distancing and sanitary measures to provide a safe experience for all staff and customers.

SmileDirectClub is an oral care company headquartered in Nashville, Tenn. The firm stated that it is the creator of the first direct-to-consumer medtech platform for teeth straightening. The company has since expanded its business and now offers its products directly through dentist and orthodontists' offices. Some of the products offered by the company include aligners, impression kits, retainers and whitening gel. In addition to the U.S., the company also operates in Australia, Canada, Germany, Hong Kong, Ireland, New Zealand and the U.K.

SmileDirectClub began the day with a market capitalization of around $2.1 billion with approximately 385 million shares outstanding and a short interest of about 10.4%. SDC shares opened more than 26% higher today at $6.76 (+$1.37, +26.42%) over yesterday's $5.39 closing price. The stock has traded today between $6.13 to $6.80 per share and is currently trading at $6.64 (+$1.25, +23.14%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: SDC:NASDAQ, )

Source: Streetwise Reports   05/01/2020

Seattle Genetics Inc. (SGEN:NASDAQ) yesterday announced financial results for the first quarter ended March 31, 2020.

The company also provided an update on commercial results achieved in the quarter for its lead medicines including ADCETRIS® (brentuximab vedotin) and PADCEV^™ (enfortumab vedotin-ejfv) and the U.S. Food and Drug Administration's (FDA) approval and launch of TUKYSA^™ (tucatinib).

The company's President and CEO Clay Siegall, Ph.D., commented, "We have had a remarkable start to 2020, delivering record product sales in the first quarter that are now coming from both ADCETRIS and PADCEV. Notably, strong PADCEV sales in the first full quarter of launch reflect the unmet need among patients with metastatic bladder cancer...With the recent approval of TUKYSA for patients with metastatic HER2-positive breast cancer, we have now launched our third product just four months after our second...We are also preparing for European commercial operations and have hired general managers in major European markets ahead of potential ex-U.S. approvals of TUKYSA. With two new products, growing revenues, and an advancing pipeline of novel cancer programs, we have exciting prospects for future growth."

The company highlighted that ADCETRIS net sales in the U.S. and Canada increased by 22% to $164.1 million in Q1/20, compared to $135 million in Q1/19. The firm indicated that PADCEV net sales in the U.S. reached $34.5 million in Q1/20, which was its first full quarter of commercialization. The company added that royalty revenues in Q1/20 were $20.4 million and collaboration and license agreement revenues in Q1/20 totaled $15.6 million.

The firm reported a net loss for Q1/20 of $168.4 million, or $0.98 per diluted share, compared to net loss of $13.3 million, or $0.08 per diluted share for Q1/19. The company explained that "the net loss in Q1/20 included a net investment loss of $59.1 million primarily associated with its common stock holdings in Immunomedics, which are marked-to-market, compared to a net investment gain of $38.1 million in Q1/19."

The company advised that its TUKYSA was approved by the FDA for patients with HER2-positive metastatic breast cancer who have received one or more prior anti-HER2 regimens in the metastatic setting. The firm mentioned that it also expects to be able to report topline data in late Q2/20 or Q3/20 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.

The company noted that it is regularly monitoring the effects of the COVID-19 situation and is maintaining its business outlook estimates for FY/20 that it provided previously on February 6, 2020. For FY/20 it expects ADCETRIS net product sales of $675–700 million, royalty revenues of $105–115 million and collaboration and license agreement revenues of $30–50 million. The firm advised that for FY/20 it expects that R&D expenses will range from $860–950 million with SG&A expenses of $475–525 million.

Seattle Genetics is headquartered in Bothell, Wash., and is a global biotechnology company focused on discovering and commercializing cancer medicines.

Seattle Genetics has a market capitalization of around $23.7 billion with approximately 172.5 million shares outstanding. SGEN shares opened 2.75% higher today at $141.00 (+$3.77, +2.75%) over yesterday's $137.23 closing price and reached a new 52-week high price this morning of $157.00. The stock has traded today between $140.05 and $157.00 per share and is currently trading at $148.51 (+$11.28, +8.22%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: SGEN:NASDAQ, )

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American Express has

IDEX Biometrics...

Payment service provider and direct card acquirer ECOMMPAY have...

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