Why Biodesix Fell

 

• Biodesix Inc's BDSX 26.32% second-quarter revenues grew 183% Y/Y to $11.9 million, but short of the $21.14 million consensus.
• COVID-19 testing revenues grew to $6.1 million from $1.4 million in Q2 2020, while lung diagnostic revenues rose to $4.8 million from $2.3 million, and biopharma revenues increased to $1.0 million from $596,000 a year ago.
• In Q1 FY21, Biodesix recorded $23.2 million in COVID-19 testing revenue, and it noted that the sequential decline was consistent with its prior expectations as COVID-19 vaccinations accelerated in Q2.
• Meanwhile, the firm said that lung testing revenues continued to recover due to the uptake in COVID-19 vaccinations. It added that growth in this segment was led by its blood-based Nodify XL2 and Nodify CDT tests.
• Further, the launch of its 72-hour blood-based, liquid biopsy next-generation sequencing test is expected in Q1 2022, supplementing Biodesix's VeriStrat and GeneStrat proteomic tests, which can return results in 36 hours.
• Biodesix had an EPS loss of $(0.41) compared to $(30.06) a year ago. The consensus Wall Street estimate was for a loss of $(0.29).
• The firm's R&D spending rose 57% to $3.3 million, while its sales, marketing, general, and administrative costs grew 68% to $11.4 million.
• Biodesix exited the quarter with $56.3 million in cash and cash equivalents.

https://www.benzinga.com/news/earnings/21/08/22448760/why-did-biodesix-stock-fall-26-today

Switzerland asks Chinese media to remove Covid-19 quotes from ‘fake’ citizen

 Several Chinese websites featured a quote by a Swiss biologist who did not appear to exist.

• The supposed scientist, Wilson Edwards, was quoted saying he had faced US pressure for backing a Covid-19 origins report by China and the WHO.

• Several Chinese newspaper websites have removed comments about the coronavirs pandemic that were "wrongly presented" as coming from a Swiss biologist who does not appear to exist, Switzerland's foreign minister said Wednesday.

• The press and social media comments attributed to a biologist identified as Wilson Edwards took aim at alleged US pressure on researchers amid the pandemic.

  Chinese authorities and state media outlets have led an aggressive pushback against criticism abroad of China's handling of the outbreak.

  A message inserted with the post, written in English and Chinese, said no Swiss citizen named Wilson Edwards appeared on registries or academic articles from the biology field. It said the Facebook account where comments attributed to Wilson were published was opened on July 24.

  Pierre-Alain Eltschinger, a spokesman for the Swiss Department of Foreign Affairs, said the comments were “wrongly presented as coming from a Swiss biologist”.

  “Several Chinese newspapers have since pulled down those comments,” he said in an email, without specifying.

  In the CGTN article, Wilson was quoted as saying he and fellow researchers had faced pressure and intimidation from the US and some media outlets for supporting conclusions in a joint study by China and the Geneva-based World Health Organization on the origins of Covid-19.

  The study, released publicly in March, presented several hypotheses about how the pandemic started but no firm conclusions.

  “For the government, protecting hospital structures now has priority, no longer protecting the non-vaccinated population,” it said while keeping in place scaled-back curbs on public life it adopted in June as new cases were on the decline.

  New cases have since rebounded to more than 2,000 a day. More than 730,000 people in Switzerland and tiny neighbour Liechtenstein have had confirmed infections and around 10,400 have died of the disease since the pandemic broke out last year.

• The Swiss embassy in Beijing highlighted its suspicions about the quoted scientist on Tuesday with a Twitter post: “Looking for Wilson Edwards, alleged [Swiss] biologist, cited in press and social media in China over the last several days.”
• “If you exist, we would like to meet you!” the embassy tweeted.
• The embassy said that while it appreciated Switzerland receiving attention, it “must unfortunately inform the Chinese public that this news is false”.
• “While we assume that the spreading of this story was done in good faith by the media and netizens, we kindly ask that anyone having published this story take it down and publish a corrigendum,” the embassy post said.
• An authenticated Facebook account of China’s People’s Daily newspaper still had an English language reference to an article from CGTN, the international arm of the Chinese state broadcaster, quoting Wilson.
• Meanwhile, the Swiss government plans to halt most free Covid-19 testing for people who are not vaccinated now that nearly half the population has got the jabs, it said on Wednesday.

• https://www.scmp.com/news/world/europe/article/3144734/switzerland-asks-chinese-media-remove-covid-19-quotes-fake

AbbVie's Soliton Acquisition Hits a Snag at FTC

 In May, AbbVie's Allergan Aesthetics announced it was buying Soliton in a deal worth about $550 million. Now, the Federal Trade Commission (FTC) has requested additional information about the deal, according to a filing by Soliton with the U.S. Securities and Exchange Commission (SEC) on August 6.

The request has added another 30 days to the schedule after the two companies comply with the second request unless it is extended by either company or terminated earlier by the FTC.

Under the deal's original terms, Allergan Aesthetics, best known for BOTOX and CoolSculpting, will pay $22.60 per share for each Soliton outstanding share. The key value in the sale is Soliton’s RESONIC, a novel technology platform that leverages non-invasive, high-frequency sound waves to disrupt targeted cellular structures and connective tissue. The U.S. Food and Drug Administration (FDA) granted it 510(k) clearance for temporary improvement and appearance of cellulite and for use with laser tattoo removal.

At the time, Carrie Strom, AbbVie senior vice president and president, Global Allergan Aesthetics, stated, “There is a huge unmet need to address cellulite and effective treatments have been elusive and frustrating for consumers. Soliton’s technology offers a new, completely non-invasive approach with clinically proven results to reduce the appearance of cellulite with no patient downtime.”

AbbVie acquired Allergan, completing the acquisition in May 2020 for $63 billion. The FTC has indicated that it is increasing its reviews of certain mergers, with pharma being one particular area of interest. Acting FTC Chairwoman Rebecca Kelly Slaughter has indicated that AbbVie’s acquisition of Allergan was one of the recent deals that caused the agency to increase its scrutiny.

Just last week, AbbVie returned rights to a product it picked up in the Allergan acquisition. It terminated the license and collaboration deal with Molecular Partners for abicipar pegol. The original agreement was between Allergan and Molecular Partners. When AbbVie acquired Allergan, the rights to the drug were transferred to AbbVie.

The FDA rejected the drug for neovascular age-related macular degeneration (nAMD) on June 26, 2020. The rejection was over safety concerns. The drug had been studied in two identical Phase III trials, CEDAR and SEQUOIA, comparing abicipar pegol to Genentech's Lucentis (ranibizumab). 

The drug hit the primary endpoint, which was the proportion of patients with the best corrected visual acuity (BCVA) change from baseline less than or equal to 15 letters in the study eye at Week 52. It was non-inferior with similar efficacy to Lucentis after six or eight injections compared to 13 Lucentis injections at 52 weeks.

With the return of the drug, Molecular Partners said it expects to create a special committee to evaluate the program and decide what the next steps are. Molecular Partners will collaborate with AbbVie to study other Designed Ankyrin Repeat Proteins (DARPin) candidates for ophthalmic diseases.

In the filing with the SEC, Soliton stated that it and AbbVie would “continue to work cooperatively with the FTC staff in its review of the proposed transaction.” In addition, both companies expect to keep their original timeline for the deal, which they believe will close in the second half of 2021.

https://www.biospace.com/article/abbvie-s-acquisition-of-soliton-hits-a-snag-with-the-ftc/

Israel to expand use of COVID drug that gets 88% of patients out of hospital

 The Health Ministry has approved the expanded use of an innovative COVID-19 treatment that helped 15 out of 17 severe patients who took it to be released from the hospital one day after receiving their final dose.

The drug, MesenCure, has been tested by Rambam Medical Center as part of a Phase I/II trial. The ministry has approved allowing any interested Israeli hospital to take part in the Phase II trial and to use the drug for additional approved patients.

The goal of the expanded trial, which will include a minimum of 50 patients, is to confirm the safety and efficacy of the drug, which was developed by Bonus BioGroup.

MesenCure, which consists of activated Mesenchymal Stromal Cells (MSCs) that are isolated from the adipose tissue of healthy donors, was found to reduce inflammation and alleviate respiratory and other symptoms in patients suffering from life-threatening respiratory distress brought on by COVID-19.

Back in May, the company reported on 10 COVID patients between the ages of 45 to 75, all with severe symptoms. Ninety percent of them also had comorbidities.

The data showed a 40% decrease in lung inflammation from treatment – from 55% to 15%, as seen in chest X-rays, in the first five days after treatment. One month later, lung inflammation reached 1%.

Additionally, patients showed significantly improved respiratory function, with blood oxygen saturation increasing to 95% and lung functioning returning to almost entirely normal levels after only one month.

The company’s CEO Shai Meretzki had shared a laboratory image of a healthy lung, a sick lung and lung treated with MesenCure with The Jerusalem Post in May.

“The treated lung looks almost identical to the normal, healthy lung – complete healing, complete prevention of damage to the lung,” Meretzki said.

Most strikingly, patients were discharged from the hospital after a median duration of only one day following the treatment.

Since then, six additional patients received MesenCure, bringing the numbers to 15 out of 17 who were released – 88%.

Bonus was founded in 2008. It has been working with MSCs for a decade from its Haifa headquarters, where it developed its core product, a tissue-engineered bone graft that is also based on MSCs.

When the coronavirus outbreak started in early 2020, Bonus started investigating the potential of MSCs to possibly reduce the cytokine storm in COVID-19 patients.

The company said that the drug could also be used to treat other, similar indications, including, lower respiratory tract infections, asthma and chronic obstructive pulmonary disease, which together, represent a global market expected to exceed $43 billion per year by 2026.

https://www.jpost.com/health-science/israel-to-expand-use-of-covid-drug-that-gets-88-percent-of-patients-out-of-hospital-676397

US study: Moderna vaccine far better than Pfizer at preventing Delta infection

Moderna’s coronavirus vaccine is considerably more effective at repelling the Delta variant of the virus than Pfizer-BioNTech’s inoculation, according to research conducted in several US states by the Mayo Clinic.

The study uploaded to medRxiv ahead of peer review this week found that while both vaccines were highly effective in preventing infection in January, before the introduction of Delta — hovering at around 90 percent — by July the effectiveness of both shots had dropped.

However, one was still far more effective than the other — while Moderna was down to 76 percent, Pfizer was down to 42%. The study was conducted among over 50,000 patients.

It is not currently known whether the drop in effectiveness is a result of Delta’s ability to bypass the vaccine, an erosion in protection offered over time, or a combination of both factors.

Israel, which has vaccinated its population almost exclusively with the Pfizer shot, is currently administering third doses to adults over 60 in the hope of raising protection. According to one top expert Tuesday, this effort may be bearing fruit.

The Mayo Clinic study found that across multiple states, those inoculated with Pfizer were twice as likely to experience a breakthrough infection despite being vaccinated, as compared to Moderna.

“In Florida, which is currently experiencing its largest COVID-19 surge to date, the risk of infection in July after full vaccination with mRNA-1273 (the Moderna shot) was about 60% lower than after full vaccination with BNT162b2 (Pfizer),” the researchers said.

Still, both vaccines appeared to remain highly effective (over 90%) at preventing severe illness.

The researchers concluded that “our observational study highlights that while both mRNA COVID-19 vaccines strongly protect against infection and severe disease, further evaluation of mechanisms underlying differences in their effectiveness such as dosing regimens and vaccine composition are warranted.”

Israel has predominantly relied on Pfizer’s vaccine to inoculate its population, but has also purchased millions of doses of Moderna’s version.

Both companies are currently developing booster shots that will target newer variants such as Delta, but these will take many more months to reach the market.

The COVID-19 vaccine is Moderna’s only commercially approved product. It is also developing several vaccines that aim to guard against the flu, Zika and HIV among other viruses. Those are all in early stages of clinical testing, according to its website.

The company, which was formed to commercialize mRNA vaccine technology, said it had nearly doubled in size over the past year, from 930 employees to around 1,800. It reported $4.35 billion in total revenue, thanks to the vaccine and some grants.

https://www.timesofisrael.com/us-study-moderna-vaccine-far-better-than-pfizer-at-preventing-delta-infection/

New vaccinations have nearly doubled from last month: CDC

 The average pace of first doses being administered across the United States has nearly doubled from a month ago, according to a federal government tally. The uptick is the latest sign of growing interest in the shots amid surging COVID-19 cases around the country and a push to vaccinate children ahead of the new school year.

Nationwide, the country was averaging around 441,198 new vaccinations per day as of August 5, according to figures released Tuesday by the Centers for Disease Control and Prevention. That represents a 95% increase from the mere 226,209 average of first doses recorded a month prior, on July 5.

The sharp turnaround comes after the average pace of new vaccinations had been plummeting for months, bottoming out around 218,696 on July 7.

Since then, the pace of first doses has steadily climbed in nearly every state. Some of the largest increases have come in areas that had long lagged the nationwide vaccination average, and are now besieged by spikes in COVID-19 cases, hospitalizations, and deaths.

In Alabama, which has one of the lowest vaccination rates in the U.S., the average pace of new vaccinations has climbed more than 100% according to the CDC's figures from July 22. The next largest increase was in Louisiana, where first shots have accelerated 84%, followed by Nebraska and Minnesota. Alabama and Louisiana are among the states that have seen some of most severe COVID-19 surges so far this summer.

The largest share of first doses in the past two weeks has gone to adults between 25 and 39 years old. That group made up more than 25% of all Americans who started their COVID-19 vaccination regimens over the past two weeks.

Some of those new first doses may have been driven by a growing list of employers moving to push their workers to get the shots, including hospital employees and government workers. The share of unvaccinated Americans who said they would get a COVID-19 vaccine "only if required" fell from 6% to 3% last month, according to a poll from the Kaiser Family Foundation.

However, the largest uptick in first doses over the past month has been in children. More than 4 in 10 adolescents, ages 12 to 15 years old, now have at least one dose of a COVID-19 vaccine — up 8.5% from a month prior. The share of older teens who have had at least one shot climbed 6.5 percentage points over the past month to more than 50% nationwide.

The Biden administration last week touted its own efforts to aid school districts in getting students vaccinated. For older teens headed to college, some 675 campuses have moved to require vaccinations for at least some of their students or staff, according to a tally by The Chronicle of Higher Education.

And with many children still yet to be fully vaccinated, many public health experts have renewed calls for states not to loosen mitigation measures ahead of the next school year.

"Despite high adult vaccination, the risks of both in-school SARS-CoV-2 transmission and resulting infections among students, educators/staff, and their household members remain high when the delta variant predominates and students are unvaccinated," concluded the authors of a recent study funded in part by the CDC, which has yet to be peer-reviewed.

While children tend to face less severe symptoms of the disease, many are now flooding into hospitals at record numbers with COVID-19. Federal health officials have said they are investigating surging cases of the COVID-19 Delta variant among children.

https://www.cbsnews.com/news/covid-vaccine-rate-doubles-cdc-data/

Pentagon: Service Members Can Request Exemptions From COVID-19 Vaccine Mandate

 By Li Hai of the Epoch Times,

US military service members will be allowed to seek an exemption from the soon-to-be-mandated COVID-19 vaccines, which would be determined by individual military service regulations, a Pentagon spokesperson said.

“There is a religious exemption possibility for any mandatory vaccine, and there’s a process that we go through to counsel the individual both from a medical and from a command perspective about using a religious exemption,” Pentagon press secretary John Kirby said during a press briefing on Aug. 10.

The department would make sure that every individual with reservations gets proper counseling on the COVID-19 vaccine’s safety and efficacy, Kirby said. Both a medical professional and a commander would counsel the individual about the risks of not being vaccinated and how that might affect deployability, assignments, travel, teammates, and the mission.

“We take freedom of religion and worship seriously in the military. It’s one of the things that we sign up to defend,” Kirby said. “And so it’s something that’s done very carefully.”

Service members also will be able to apply for medical exemptions, Kirby said. “The primary care physician will be able to help make that determination,” he added.

A service member can’t request an exemption just because he or she doesn’t want to take the vaccine, Kirby said.

“You’ve got to go through a process to get that approved. Troops who have pre-existing medical conditions, or on the advice of their physician might not have to take the vaccine,” Kirby told Fox News on Aug. 10. “But if you’re just objecting because you’re objecting, once it’s become mandatory, that’s a lawful order, and our expectation is that you’re going to obey that order.”

“Nobody is looking for strong, punitive disciplinary measures here. Frankly, we believe that most troops will respond positively to the order, just like they do in every other mission-critical order that they’re issued. But there are tools available to commanders, short of disciplinary action, to try to get soldiers to do the right thing.”

Defense Secretary Lloyd Austin announced on Aug. 9 that the Department of Defense would require all active-duty military members to get a COVID-19 vaccine.

“I want you to know that I will seek the President’s approval to make the vaccines mandatory no later than mid-September, or immediately upon the U.S. Food and Drug Administration (FDA) licensure, whichever comes first,” Austin said in a memo sent to all Pentagon employees.

Currently, the three COVID-19 vaccines in the United States—Pfizer, Moderna, and Johnson & Johnson—are all being distributed under emergency use authorization.

Austin didn’t mention the possible exemptions, and a Pentagon spokesperson declined to answer at the time.

President Joe Biden expressed his support for the mandate almost immediately.

“I strongly support Secretary Austin’s message to the force today on the Department of Defense’s plan to add the COVID-19 vaccine to the list of required vaccinations for our service members not later than mid-September,” Biden said in a statement.

“These vaccines will save lives. Period. They are safe. They are effective. Over 350 million shots have been given in the United States alone.”

According to Pentagon, more than 73 percent of active-duty military members have received at least one shot of the vaccine to date.

https://www.zerohedge.com/covid-19/pentagon-service-members-can-request-exemptions-covid-19-vaccine-mandate