This week has been a tough one for stocks, but it's been especially tough for specialty biotechClovis Oncology(CLVS -30.62%). Following the release of its first-quarter results and operational update, the company's shares traded down sharply, and they have yet to recover. According to data provided byS&P Global Market Intelligence, as of Thursday night they had fallen almost 27% week to date.
Clovis published those results Wednesday morning and while they couldn't be called disastrous, they weren't what shareholders were yearning for. The inaugural quarter of the year saw the company take in just over $34.2 million on the top line.
That was comprised entirely of net product revenue for its Rubraca, which holds Food and Drug Administration approval for maintenance treatment of ovarian, fallopian tube, and primary peritoneal cancer. That number was down from first-quarter 2021's tally of just over $38 million.
At least the situation improved somewhat on the bottom line. For the period, the biotech posted a net loss just short of $60.2 million ($0.44 per share), which bettered the year-ago deficit of over $66 million.
Both numbers didn't quite meet analyst expectations. Those prognosticators were collectively modeling nearly $37 million on the top line, and $0.43 in per-share net loss.
As for the operational update, Clovis said that Rubraca achieved its primary endpoint of "significantly improved investigator-assessed progression-free survival (PFS) compared with placebo," in a clinical trial as a monotherapy in first-line ovarian cancer treatment.
The company added that it's expecting two additional top-line phase 3 trial readouts within the next year "with potential to address ovarian and prostate cancer patient populations."
Finally, Clovis said that next month at an industry conference, it will present initial phase 1 clinical data for its FAP-2286. This is an investigational drug that targets fibroblast activation protein (FAP).
While the company's recent news wasn't necessarily discouraging, it did not provide sufficient reason for optimism. The company remains dependent on sales of Rubraca, which isn't the only drug of its type currently on the market.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called “cytokine storm” with its lead drug candidate, lenzilumab (LENZ®), today provided a corporate update and reported financial results for the first quarter ended March 31, 2022.
“A key highlight of the first quarter was the completion of enrollment in the ACTIV-5/BET-B study. We also held a productive Type B pre-EUA meeting with FDA where we gained alignment on the data and statistical analysis plan to be included as part of the amendment to our EUA for LENZ in COVID-19 patients. In concert with the NIH, we anticipate top-line data in the primary analysis population to be reported in the second quarter, with an amendment to our EUA submission planned to follow,” stated Cameron Durrant, Chairman and Chief Executive Officer, Humanigen. “We anticipate hospitalizations from COVID-19 will continue for years to come. Published data on LENZ, confirmed by key opinion leaders and national guideline committees, including NIH, supports treatment guidance based on CRP levels and first-line utilization in hypoxic patients.”
“Hospitalizations from COVID-19 in the US continue to remain steady with a 7-day average of 2,072 new daily hospitalizations. While there have been more than 900,000 people already hospitalized in the U.S. this year to date,1 synergizing results from multiple forecasting models prepared by leading experts in epidemiology in four different scenarios forecast additional COVID-19 hospitalizations in the United States, to range from approximately 500,000 to 1,200,000 for the remainder of 2022.2 Variant agnostic treatments for hospitalized patients are still desperately needed,” commented Edward Jordan, Chief Commercial Officer, Humanigen.
“As well as its clinical benefit in reducing invasive mechanical ventilation and death, LENZ could deliver significant economic savings to health care systems. LENZ can be used in combination with remdesivir, which is currently used in 50% of hospitalized COVID-19 patients in the U.S.3 Sales of the top two hospital treatments for COVID-19 exceeded $7 billion in global revenue in 2021.4,5 We believe LENZ is well positioned to participate in this sizable and sustainable market,” he added.
First, they ban abortion. Next will be a contraception ban. Then a ban on same-sex and even interracial marriage. Soon we will all be living in “The Handmaid’s Tale.”
That’s the parade of horribles that Democrats and the media are trying to sell Americans after the leak of a draft Supreme Court opinion that would repeal a constitutional right to abortion.
IfRoe v. Wadefalls, it “would mean that every other decision related to the notion of privacy is thrown into question,” President Biden warned Tuesday. “Does this mean that in Florida they can decide they’re going to pass a law saying that same-sex marriage is not permissible?” If we can borrow a word he likes, the President is peddling disinformation.
The press is full of similar pearl-clutching about which precedent the Supreme Court might strike down next. Is it Obergefell (2015), which enshrined gay marriage? Griswold (1965), which overturned a state law prohibiting married couples from buying contraceptives? What about even Loving v. Virginia (1967), which guaranteed interracial marriage?
The correct answer is none of the above, as Justice Samuel Alito’s draft takes pains to emphasize. The leaked opinionis explicitabout distinguishingRoe and its 1992 legal revision,Planned Parenthood v. Casey, from cases on unrelated social topics.
“None of the other decisions cited by Roe and Casey involved the critical moral question posed by abortion,” the draft says. “They do not support the right to obtain an abortion, and by the same token, our conclusion that the Constitution does not confer such a right does not undermine them in any way.”
It’s true that those past decisions have been criticized by conservatives. Griswold is where the Court said the Bill of Rights has “emanations” that create “penumbras,” a phrase long lampooned by the right. Justice Anthony Kennedy’s opinion in Obergefell asserted that the Constitution guarantees rights for free Americans to “define and express their identity.” Justice Antonin Scalia’s dissent compared that line to “the mystical aphorisms of the fortune cookie.”
Yet unlike Roe, both of those decisions have established themselves as durable precedents with broad public acceptance. A Gallup poll in 2019 found that 92% of Americans believed using birth control to be “morally acceptable.” That was up three points since 2012, and it included 90% of the respondents who identified as conservative or very conservative.
On gay marriage, 70% of people told Gallup last year that the law should treat such unions no differently than traditional ones. That’s up from 58% the year Obergefell came down. As for Loving, Gallup says 94% support black-white marriages.
That stands in contrast to abortion, which remains a contested moral and political issue. As Justice Alito’s draft opinion points out, even Roe acknowledged that the state has a legitimate interest in protecting “potential life.” There’s a reason that thousands of Americans have spent nearly 50 years enduring the January cold in Washington at the annual March for Life.
In 1975 Gallup found that 21% of Americans said abortion should be always legal, 22% never legal, and 54% legal only in certain circumstances. Last year the figures were 32% always legal, 19% never, and 48% sometimes. Whatever the High Court thought it was doing in Roe and again in Casey, it didn’t come close to settling the debate. And judges are ill equipped to draw the distinctions in abortion policy that a plurality of Americans say they want.
In the marriage cases, there are also what the Court calls “reliance interests” at stake. Hundreds of thousands of Americans are married to people of the same sex. The Supreme Court isn’t going to invalidate those unions and disrupt so many lives. The same goes for interracial marriage. By the way, Justice Clarence Thomas is married to a white woman.
Roe also stands apart on what Justice Alito’s opinion calls “workability” grounds. Roe has continued to inspire a mass of litigation as modified by Casey’s “undue burden” test. No one really knows what that burden is, so states bring case after case to contest it. By contrast, Obergefell, Griswold and similar rulings have not been challenged by what Justice Scalia called “give-it-a-try” litigation.
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Democrats don’t want Americans to know all this because their political goal is to frighten them into believing that Justice Alito is some black-robed Pharisee bent on invading their bedrooms. It’s simply not true. Repealing Roe would merely return abortion policy to the states and democratic debate. That’s all.
More than a century ago, Mark Twain identified two fundamental problems that would prove relevant to the COVID pandemic. “How easy it is to make people believe a lie,” he wrote, “and how hard it is to undo that work again!”
No convincing evidence existed at the pandemic’s start that lockdowns, school closures and mask mandates would protect people against the virus, but it was remarkably easy to make the public believe these policies were “the science.”
Undoing this deception is essential to avoid further hardship and future fiascos, but it will be exceptionally hard to do. The problem is that so many people want to keep believing the falsehood.
Adults meekly surrendered their most basic liberties, cheered on leaders who devastated the economy and imposed two years of cruel and unnecessary deprivations on their children. They don’t want to admit these sacrifices were in vain.
They’re engaging in what social psychologists call “effort justification,” which has been observed in studies of painful initiation rituals for fraternities and other groups. Once people endure the pain, they convince themselves that it must have been worthwhile even when their reward is actually worthless.
If one brief bad experience can transform people’s thinking, imagine the impact of the pandemic’s ceaseless misery. It’s been a two-year-long version of Hell Week, especially in America’s blue states, with Anthony Fauci and Democratic governors playing the role of fraternity presidents humiliating the pledges.
Dr. Anthony Fauci warned Americans that the pandemic isn’t over, as things head back to normalcy.AP/ Susan Walsh
Americans obediently donned masks day after day, stood six feet apart, disinfected counters and obsessively washed their hands while singing “Happy Birthday.” They forsook visits to friends and relatives and followed orders to skip work and church. They forced young children to wear masks on the playground and in the classroom — a form of hazing too extreme even for Europe’s progressive educators.
To undo the hazing’s effects, we need to not only present the facts but also reassure people that they’re not to blame for the useless suffering. They submitted to it because they assumed the Centers for Disease Control and Prevention knew how to control disease and scientists and public-health officials would provide sound scientific guidance about public health.
Those were reasonable assumptions. They just turned out to be wrong.
Many parents are still struggling on whether or not their children should wear masks in school.AP/Marcio Jose Sanchez
CDC leaders terrified the public with worst-case scenarios based on computer models — and then used those blatantly unrealistic projections to claim unprecedented powers and experiment with untested strategies. They ordered lockdowns without even pretending to weigh the hypothetical benefits against the tangible economic, medical and social costs — not to mention the intangible costs in emotional hardship and lost liberty.
Randomized clinical trials conducted before the pandemic had repeatedly shown that masks did little or no good at preventing viral spread, but the CDC proclaimed them effective against COVID and promoted mask mandates nationwide. Federal officials stubbornly ignored the hundreds of studies around the world showing that, except in a few isolated places, lockdowns did not reduce COVID mortality and mask mandates were generally ineffective and senselessly harmful in classrooms. Instead of heeding all this evidence of their mistakes, officials did their best to suppress it and silence dissenters.
The public needs to learn what went wrong during the pandemic, but they’re not going to hear it from the Biden administration. For now, the best opportunity for a public airing of the facts may be the 2022 election campaign. Some candidates are already attacking the lockdowns and mask mandates, and pandemic strategies could become a major issue in the 2024 presidential race, especially if Ron DeSantis runs on his success as Florida’s governor.
Florida employed some of the least restrictive COVID policies, avoiding lockdowns and mask mandates, and it still fared as well or better than the national average in measures of age-adjusted COVID mortality and overall excess mortality (how many more deaths than normal from all causes occurred during the pandemic).
Florida Gov. Ron DeSantis is strongly against wearing masks.TNS/ Joe Burbank
Florida flourished economically by comparison with other states, especially California, which imposed singularly strict COVID mandates and suffered one of the nation’s worst surges in unemployment. Yet California’s overall death toll has been slightly worse than Florida’s.
If California’s cumulative rate of excess mortality equaled Florida’s, about 5,000 fewer Californians would have died during the pandemic. And if California’s unemployment rate equaled Florida’s last year, 500,000 fewer Californians would have been out of work.
Those are the hard truths that Americans need to hear after two years of COVID hazing. It won’t be easy convincing them that they fell for a deception, but it can be done, as DeSantis demonstrated at a recent appearance when he urged a group of high-school students on the podium to take off their masks. “We’ve got to stop with this COVID theater,” he said. “If you want to wear it, fine, but this is ridiculous.”
Some students on the podium kept their masks on, looking like meek pledges during Hell Week, but a few were emboldened to uncover their faces and breathe fresh air. At least for the moment, they were free to wonder whether this ridiculous fraternity was worth staying in anymore.
Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. The FDA requires extended time to review additional information the Agency requested from the companies regarding bone mineral density. The extended Prescription Drug User Fee Act (PDUFA) goal date is August 6, 2022.
