Biotech week ahead, Sept. 13

Biotech stocks retreated in the holiday-shortened week ending Sept. 10, reversing course from the previous week.

Humanigen, Inc. 

HGEN +13.68%

was among the biggest decliners of the week after the company said the Food and Drug Administration refused to authorize its COVID-19 treatment for emergency use. Mersana Therapeutics, Inc. (MRSN) and Apellis Pharmaceuticals, Inc. (APLS) pulled back notably in reaction to clinical trial disappointments.

On the other hand, Surrozen, Inc. (NASDAQ: SRZN), which went public via a SPAC deal, advanced notably. Stifel initiated coverage of the stock with a Buy rating and $19 price target

In a big-ticket M&A announcement, Kadmon Holdings, Inc. 

KDMN +7.88%

 struck a deal to be acquired by French pharma giant Sanofi 

SNY +1.51%

 for $1.9 billion in cash.

Here are the key catalytic events scheduled for the unfolding week:

Conferences

International Association for the Study of Lung Cancer, or IASLC, 2021 World Conference On Lung Cancer: Sept 8-14 (virtual event)
Morgan Stanley 19th Annual Global Healthcare Conference: Sept. 9-15 (virtual event)
BofA Global Healthcare Conference 2021: Sept. 15-16 (virtual event)
European Society for Medical Oncology 2021 Congress: Sept. 16-21 (virtual event)
International Workshop On CLL, or iwCLL: Sept. 17-20 (virtual event)

PDUFA Dates

The FDA is scheduled to rule on Calliditas Therapeutics AB 

CALT +6.09%

's new drug application for Nefecon in IgA nephropathy by the PDUFA action date of Wednesday, Sept. 15.

Biogen Inc. 

BIIB +0.11%

 and Samsung Bioepis await FDA's verdict on their Biologic license application for SB11, a biosimilar to Roche Holding AG 

RHHBY +1.06%

's Lucentis, which is indicated for a slew of retinal vascular disorders. The decision is likely to be announced by Friday, Sept. 17, estimated based on the 10-month standard review period from the date of filing.

Adcom Calendar

FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet on Friday, Sept. 17, between 8:30 am and 3:45 pm, to discuss Pfizer, Inc. 

PFE +1%

/BioNTech SE 

BNTX +0.62%

's COVID-19 vaccine, Comirnaty, for administration of a third dose, or "booster" dose in individuals 16 years of age and older.

Clinical Readouts/Presentations

Standalone Releases

Hepion Pharmaceuticals, Inc. 

HEPA +2.35%

 is scheduled to release additional data from its Phase 2a ‘AMBITION' NASH clinical trial of CRV431 before the market opens Monday, Sept. 13,

IASLC World Lung Conference Presentations

Coherus BioSciences, Inc. 

CHRS +2.41%

 will make a mini-oral presentation of CHOICE-01 Phase 3 study of toripalimab versus placebo in combination with first-line chemotherapy for advanced non-small cell lung cancer. The presentation is scheduled for Monday, Sept. 13 at 8:10 pm.

ESMO Presentations

Among the companies due to present at ESMO 2021 include:

Merck & Company, Inc. 

MRK +0.46%

: new Phase 3 results for Keytruda in melanoma and in recurrent, persistent or metastatic cervical cancer

AstraZeneca PLC 

AZN +0.05%

: interim results from the ORCHARD Phase 2 trial studying the combination of Tagrisso and savolitinib in patients with advanced EGFR-mutated non-small cell lung cancer, with MET alterations whose disease progressed on 1st-line Tagrisso; results from the DESTINY-Breast03 Phase 3 trial of Enhertu for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane

MacroGenics, Inc. 

MGNX +0.05%

: interim safety and efficacy data from Phase 2/3 MAHOGANY study of margetuximab in combination with retifanlimab in advanced gastric and gastroesophageal junction cancer.

Gritstone bio, Inc. 

GRTS +0.05%

: GRANITE Phase 1/2 data in advanced solid tumors and data from the SLATE v1 shared neoantigen immunotherapy program in KRAS mutant advanced solid tumors

Aileron Therapeutics, Inc. 

ALRN +0.05%

: preliminary data from its Phase 1 study of ALRN-6924 in healthy volunteers and final data from its completed Phase 1b study of ALRN-6924 in patients with small cell lung cancer receiving second-line topotecan treatment.

Coherus BioSciences: interim results of the JUPITER-06 Phase 3 Study of Toripalimab versus placebo in combination with first-Line Chemotherapy for treatment-naive advanced or metastatic esophageal squamous cell carcinoma

Corcept Therapeutics Incorporated 

CORT +0.38%

: results from the Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer

iwCLL Presentations

TG Therapeutics, Inc. 

TGTX +2.23%

 will present data from the Phase 1/2 study of umbralisib + ublituximab + Merck's Keytruda in patients with relapsed/refractory chronic lymphocytic leukemia and Richter's transformation.

Earnings

MaxCyte, Inc. 

MXCT +6.4%

 (Monday, after the close)

IPOs

Redwood, California-based Procept Biorobotics Corporation NASDAQPRCT has filed with the SEC a preliminary prospectus for offering 5.5 million shares in an initial public offering to be priced between $22 and $24. Procept Biorobotics, a commercial-stage surgical robotics company, expects to list its shares on the Nasdaq under the ticker symbol PRCT.

Tyra Biosciences Inc. NASDAQTYRA, a Carlsbad, California-based precision-oncology company, is proposing to offer 6.7 million shares in an IPO. The company expects to price the offering between $14 and $16, and intends to list its shares on the Nasdaq under the ticker symbol TYRA.

Dice Therapeutics, Inc. NASDAQDICE is planning to offer 10 million shares in an IPO, with the pricing estimated to be in the range of $15-$17. The South San Francisco, California-based company is a biopharma, leveraging its proprietary technology platform to build a pipeline of oral therapeutic candidates to treat chronic diseases in immunology and other therapeutic areas.

https://www.benzinga.com/news/21/09/22900556/the-week-ahead-in-biotech-sept-12-18-calliditas-fda-decision-adcom-review-for-pfizerbiontech-covid-1

Legal action begins over UK covid quarantine hotel rules

 A law firm representing travellers is taking the government to court over the UK's quarantine hotel policy.

Passengers must spend 11 nights in a quarantine hotel on returning from red list countries, even if fully vaccinated and testing negative for Covid.

London-based firm PGMBM said it had called for a judicial review into the policy, but the government had refused.

The cost of staying in a quarantine hotel is now £2,285.

More than 60 locations including Turkey, Mexico, Kenya and many countries in Africa and Latin America are currently on the red list.

The other European countries with mandatory quarantine involving hotel detentions - Ireland and Norway - have amended their schemes so fully vaccinated travellers are exempt from needing to quarantine.

If PGMBM's claim was successful, not only would double-vaccinated travellers no longer have to quarantine at the hotels, but the government could also be forced to refund the fees of all those who were vaccinated and still had to stay there.

It is estimated more than 100,000 people have been forced to quarantine in hotels since the policy came into force in February this year.

PGMBM said it was launching a legal case, representing "multiple" clients. It described the policy as an "unlawful deprivation of liberty" that violated fundamental human rights.

It is now asking anyone who was forced to stay in hotel quarantine to register their details and help form a class action aimed at forcing the government to reverse its policy.

One of the firm's clients, Ozgur Akyuz, a bus driver from Hackney, said his pregnant wife and three-year-old daughter caught Covid while staying in hotel quarantine two weeks ago.

"They were put in a hotel near Heathrow and it was filthy. She was crying all day long," he said.

"She saw a rat in her room and kept being served bacon and sausages, even though she told them she didn't eat pork.

"I ended up cooking food at home to take to her, and I also bought a rat trap from B&Q to give her peace of mind because the hotel did nothing."

Mr Akyuz said both his wife and daughter tested positive for Covid on the third day of quarantine, despite having tested negative when they left Turkey.

"They were allowed home after 10 days but I then caught Covid from them. So we have all had it. If she had come home to quarantine, chances are none of us would have got it."

The government has said it has taken "decisive action" to protect the country, including the quarantine system. Other countries around the world had taken equivalent action, it said.

This is the second case PGMBM has brought about quarantine hotels. The first was on the grounds of financial hardship and resulted in the government offering the option to pay in 12 monthly instalments for those facing financial hardship.

https://www.bbc.com/news/business-58538885

'We're Not Done Yet': Biden To Announce More Pandemic Measures

 US Surgeon General Dr. Vivek 'masks don't work... wait just kidding' Murthy on Sunday defended the Biden administration's new Covid vaccine mandates - calling them an "appropriate legal measure" to keep people safe.

Murthy, a known flip-floper, also "challenged the notion that Biden’s new policies reflect a flip-flop from the idea that vaccination should not be mandated," saying that they were simply responding to a situation 'that's changed due to the Delta variant,' according to Politico.

"From the beginning, the president and all of us said 'we've got to use every lever we have to fight this pandemic," said Murthy.

Of course, given that Biden and Fauci are on record opposing vaccine mandates - Murthy's word salad is simply a lie.

Murthy also said there's more to come

"We're not done yet," said Murthy, adding that while vaccines are the 'backbone' of the government's multi-pronged effort, "we know that there are other mitigation measures," including masking, testing and social distancing.

"How quickly we get to a level where cases are low and stay low really depends on what we do collectively - not just the government - but each of us, as private citizens and what universities and schools and businesses do. If we work quickly to get people vaccinated, then we will get there faster," he continued, adding "one of the things we cannot afford to do is allow the Covid-19 experience to turn us against each other. Our enemy is the virus, it is not each other," (a line he repeated on ABC).

We somehow missed Murthy's condemnation of liberals wishing death on unvaccinated Americans.

Speaking on CNN, Murthy then said that President Biden will announce new steps to slow the spread of Covid-19 before the UN General Assembly meets - though he didn't elaborate on what those may be.

"The president will be making announcements ahead of the UN General Assembly about additional measures that we’re taking to help vaccinate the world," said Murthy.

"There will be more actions that we continue to work on, especially in the global front," he added.

"We also know this virus transcends borders ... That’s why, even as we execute this plan at home, we need to continue fighting the virus overseas, continue to be the arsenal of vaccines."

https://www.zerohedge.com/covid-19/were-not-done-yet-biden-announce-more-pandemic-measures

Cal. Med Ethics Prof With Natural Immunity Sues University Over Vaxx Mandate

 by Jonathan Turley,

We recently discussed the lawsuit filed by a George Mason University professor who refused to get the Covid vaccine upon the recommendation of his doctors and due to his natural antibodies after recovering from the virus. GMU later relented and gave him an exception. However, now a University of California professor has sued on the same ground. Aaron Kheriaty, professor of psychiatry and human behavior at the University of California at Irvine, is the latest effort to force review of the issue of natural antibodies as a protection from Covid.

Kheriaty is suing the Board of Regents and the University president due to his antibodies from a case of Covid-19 in July 2020. He told SBG “[i]f my immunity is as good, indeed, very likely better, than that conferred by the vaccine, there doesn’t seem to be any rational basis for discriminating against my form of immunity and requiring me to get a different form of immunity.”

What is most interesting about the case is that Kheriaty serves as director of UCI’s Medical Ethics Program and is a member of the UC Office of the President Critical Care Bioethics Working Group. Kheriaty has complained that it is now verboten to even raise natural antibodies despite studies showing that they may be even more effective than vaccines.  A study (often cited by the CDC) suggests the opposite.

Kheriaty cited studies showing that recovery yields considerable protection, including a study from researchers at the La Jolla Institute for Immunology found that that the immune systems of those who recovered from COVID-19 had durable memories of the virus up to eight months after infection.  He goes into detail on such studies. Thus, this is not some screed against vaccines but a science based challenge.

There has been an obvious aversion of the CDC and the Biden Administration in addressing the natural antibody issue. Most media have held that same line and there has been little discussion of such objections.

The challenge for Kheriaty is whether a court will find that taking the vaccine as someone with natural antibodies has not been found to be dangerous or harmful. As a result, it may conclude that it is simply too difficult for employers to establish natural antibodies and their specific level of protection. However, the same difficulty is present by vaccinated individuals who will likely have differing levels of protection over time.

Past challenges to mandates have included the natural antibody issues.  Recently, in a challenge to Indiana University’s mandate, the U.S. Court of Appeals for the Seventh Circuit rejected a motion for a preliminary injunction. The Court noted that there is not “a fundamental right ingrained in the American legal tradition” to refuse a vaccine. Challenges have also bee rejected to policies at Houston Methodist Hospital and Los Angeles Unified School District.

This case however presents the natural antibody case in its strongest and most direct terms. The odds are in favor of the university but it could be a case with potential for the Supreme Court.

Here is the complaint: Kheriaty Complaint

https://www.zerohedge.com/covid-19/california-medical-ethics-prof-natural-immunity-sues-university-over-vaxx-mandate

1 in 5 Americans Say Employer Requires Vaccination

 The share of Americans who are required by their employer to get vaccinated against COVID-19 took a jump up in August to 19 percent, according to a Gallup poll.

As Statista's Katharina Buchholz notes, the number had been as low as 9 percent in July and 6 percent in June.

You will find more infographics at Statista

Over the past couple of months, many major companies and government branches have released vaccination requirements and the type of employer issuing requirements goes beyond obvious ones like healthcare providers and the military. The full approval of the Pfizer vaccine on August 23 helped make the legal footing of employer-mandated vaccinations sounder.

According to Fortune, companies that require vaccinations for employees in order to work from their premises include Bank of America, Facebook, Google, Microsoft, Netflix and Uber. Three federal departments – those for defense, veteran affairs and health and human services – also require them without alternatives for frontline workers. Six states – Colorado, Maine, New York, Oregon, Rhode Island, and Washington - have released mandates for healthcare workers to get vaccinated or be terminated, while the more common mandates for state and local government employees normally leave the option of regular testing and sometimes masking for the unvaccinated.

The Equal Employment Opportunity Commission, an independent federal government agency, has said that it is legal for employers to require all employees who physically enter a workplace to be vaccinated against COVID-19, as long as the employers also comply with the Americans with Disabilities Act in order to accommodate those who cannot be vaccinated for medical reasons.

https://www.zerohedge.com/covid-19/one-five-americans-say-employer-requires-vaccination

3M, Qiagen to comply with Biden's COVID-19 vaccination, test mandate

 3M Co, the biggest U.S. producer of N95 masks, and German genetic testing specialist Qiagen said separately on Friday that they will comply with the Biden administration's new COVID-19 vaccination and testing mandate for workplaces.

"We strongly support all initiatives aiming to increase vaccination rates especially at the workplace," Qiagen told Reuters in an email.

Qiagen said it had already updated its policies to make vaccination compulsory for certain employee groups at its U.S. locations.

3M, the diversified manufacturer which makes everything from Post-It notes and adhesives to industrial sandpaper, said it will comply with the mandate while also adding that it was strongly encouraging its employees to get vaccinated.

U.S. President Joe Biden on Thursday announced policies requiring most federal employees to get COVID-19 vaccinations and pushing large and small private employers to have their workers inoculated or tested weekly.

The White House said it will spend nearly $2 billion on 280 million rapid COVID-19 tests to support the drive.

Abbott Laboratories, one of the largest U.S. manufacturers of rapid COVID-19 tests, said it was quickly working to scale up manufacturing of its two tests - BinaxNOW and ID NOW test kits - including hiring additional employees.

Increased capacity will ensure availability of tens of millions more tests in the coming weeks and months, the medical device maker said.

The new vaccination mandate could apply to as many as 100 million Americans - close to two-thirds of the country's workforce - and amount to Biden's strongest push yet for inoculation.

Southwest Airlines Co, which has more than 54,000 employees, said it was prepared to move toward compliance with the mandate.

"We continue to strongly encourage our Employees to seek and obtain vaccination, and to share their vaccination status with us," the company said.

https://www.marketscreener.com/quote/stock/QIAGEN-N-V-40135659/news/QIAGEN-N-3M-Qiagen-to-comply-with-Biden-s-COVID-19-vaccination-test-mandate-36398899/