• Business
    Benzinga

    How Close Are Biotechs To Bringing A COVID-19 Treatment To Market?

    The COVID-19 virus has sent the market and the global economy into a tailspin. The Organisation for Economic Co-operation and Development slashed its global growth forecast for 2020 Monday by 0.5 points to 2.5% versus already-weak 2.9% growth in 2019.Global banks have begun talking up the economy with the promise of stimulus injection.As the world and China in particular battle the deadly pandemic, a small batch of biotechs and a handful of big pharma companies are racing against time to bring to the market potential treatment and/or vaccines to combat the virus.Rocky R&D Pathway For Coronavirus Products Investors scurrying for cover amid the bloodbath in the stock market are investing in biotechs that are targeting the new coronavirus.COVID-19 levered biotechs are offering investors an opportunity due to the kind of returns the stocks can generate in the eventuality that R&D efforts come to fruition.Given that most of the investigational therapies are vaccines are only in the animal testing stage, is it too early to take a headlong plunge into these stocks?"Given the community spread in the U.S., particularly in the states of Washington and California, we believe the current administration's support for rapid development of vaccines and therapies in the U.S. could pave the way for an accelerated regulatory pathway to be made available by government agencies for the rapid market entry of such products that show conclusive efficacy against COVID-19," H.C. Wainwright analyst Raghuram Selvaraju said in a note.The analyst estimates it would take around 18-24 months to complete the clinical development of a COVID-19 vaccine.Benzinga reviewed the COVID-19-related updates from biotechs to gain an understanding of how close each is in bringing a treatment or vaccine to market. See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA DatesGilead: The Frontrunner? Large-cap biopharma Gilead Sciences, Inc.'s (NASDAQ: GILD) investigational drug remdesivir has the World Health Organization's seal of approval."There is only one drug right now that we think may have real efficacy and that's remdesivir," WHO assistant director-general Bruce Aylward said at a late February press briefing in China.Remdesivir is an investigational nucleotide analog with broad spectrum antiviral activity that has shown in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS.Gilead has initiated two Phase 3 studies in adults diagnosed with COVID-19 following the FDA's rapid review and acceptance of the IND filed by the company.The company said it expects to enroll 1,000 patients at medical centers, mainly in Asia, beginning in March.Chinese health authorities have initiated two trials with remdesivir in infected patients in the Hubei province, and those clinical trial results are anticipated in April.The U.S. National Institute of Allergy and Infectious Diseases, or NIAID, has initiated a Phase 2 study to test remdesivir in hospitalized adult patients diagnosed with COVID-19.Inovio Sets Timeline Inovio Pharmaceuticals Inc (NASDAQ: INO) is working with Chinese contract development manufacturer Beijing Advaccine Biotechnology to develop INO-4800, a DNA vaccine for COVID-19, unveiled an accelerated development timeline.The company expects to commence a Phase 1 trial in April and mass produce the vaccine by the end of 2020 to be used in case of emergency or for further trials.One advantage of DNA vaccines is that they do not require refrigeration or cold chain logistics, according to H.C. Wainwright. Moderna's Vaccine Candidate To Enter Clinics Moderna Inc (NASDAQ: MRNA) said in late February it has shipped MRNA-1273, its mRNA vaccine targeting COVID-19, to the NIAID to be used in a Phase 1 study.H.C. Wainwright said Moderna could begin Phase 1 trials around the same time as Inovio.Novavax In Animal Testing Novavax, Inc. (NASDAQ: NVAX) said in late February that it is assessing multiple nanoparticle vaccine candidates in animal models to zero in on an optimal candidate for human testing.The company said it expects clinical trials to begin by the end of spring 2020. Vir Biotech Identifies Antivirals Vir Biotechnology Inc (NASDAQ: VIR) is working with WuXi Biologics on a COVID-19 treatment. The company said it has identified a number of monoclonal antibodies that bind to COVID-19 and is conducting research to determine if these can be effective as treatment and/or prophylaxis against the virus.Cocrystal Pharma Licenses Treatment Candidates Cocrystal Pharma Inc (NASDAQ: COCP) said Feb. 24 it has licensed from the Kansas State University Research Foundation antiviral compounds to treat norovirus and coronavirus infections. The company said it plans to pursue preclinical and clinical development of these compounds.NanoViricides Screens Compounds NanoViricides Inc (NYSE: NNVC) said in its fourth-quarter earnings release Feb. 24 it intends to perform initial testing of drug candidates for safety and effectiveness in cell culture studies in its own BSL-2 virology laboratory at its Shelton campus, using low-threat coronavirus strains.Vaxart's Vaccine Program Kicks Off Vaxart Inc (NASDAQ: VXRT) said in late January it has begun work on a program to develop an oral COVID-19 vaccine.The company said it plans to generate vaccine candidates based on the published genome of the coronavirus. Glaxo Lends Tech To Enhance Vaccine Efficiency GlaxoSmithKline plc (NYSE: GSK), though not developing a vaccine, has forged two tie-ups to aid COVID-19 vaccine research.The company announced a collaboration with the Coalition of Epidemic Preparedness Innovations, or CEPI, to provide its pandemic vaccine adjuvant vaccine technology to enhance the development of an effective vaccine against COVID-19.An adjuvant is added to vaccines to enhance its immune response. CEPI will work with Glaxo and entities funded by it that want to test their vaccine platform with Glaxo's adjuvant technology.Glaxo also announced Feb. 24 a research collaboration with Chinese biotech Clover for the latter's protein-based COVID-19 vaccine candidate S-Trimer, which is to be tested with the former's pandemic adjuvant system in preclinical studies.J&J, Sanofi Work With BARDA Johnson & Johnson (NYSE: JNJ) said in mid-February that its Janssen unit will work along with the Biomedical Advanced Research and Development Authority, or BARDA, on potential treatments for COVID-19.Janssen will work with the Belgium-based Rega Institute for Medical Research for screening potential compounds.The company said it is working with BARDA on a COVID-19 vaccine that will leverage its AdVac and PER.C6 technologies, which the company said will help rapidly upscale production of an optimal vaccine candidate.Sanofi SA (NASDAQ: SNY) also has a working relationship with BARDA to develop a COVID-19 vaccine using its recombinant DNA platform that it said will help produce an exact genetic match to proteins or antigenfound on the surface of the virus.This could be formulated to stimulate an immune response to protect against the virus, Sanofi said. Pfizer Joins The Race Pfizer Inc. (NYSE: PFE) reportedly said Monday it has identified some antiviral compounds from its development pipeline that could potentially treat COVID-19 infection.The pharma company said it plans to work with a third party to screen the compounds, with the results from the screening expected by the end of March. If they are found effective, Pfizer said it plans to begin clinical trials by the end of the year.The Race For COVID-19 Drugs Gilead as well as Moderna and Inovio could have an edge over the others, as Gilead's remdesivir is already in the clinics, while the latter two are set to start Phase 1 trials soon.Most others are still screening compounds or pursuing animal testing.The sell-side is guarded in its view regarding the value a potential therapy/vaccine could bring to its developer."Previous potential therapeutics for pandemics have failed to generate value in the medium-to-long term," Baird analyst Madhu Kumar said in a recent note.Photo courtesy of the CDC. Latest Ratings for GILD DateFirmActionFromTo Mar 2020RBC CapitalDowngradesTop PickOutperform Feb 2020DZ BankDowngradesBuyHold Feb 2020BarclaysInitiates Coverage OnUnderweight View More Analyst Ratings for GILD View the Latest Analyst Ratings See more from Benzinga * The Daily Biotech Pulse: Mesoblast To Test Candidate On Coronavirus Symptoms, Proxy Battle Ahead For Rockwell Medical, Glaukos to Join S&P SmallCap 600 Index * The Week Ahead In Biotech (March 8-14): Bristol-Myers Awaits FDA Nod For Liver Cancer Combo Therapy, Earnings Flow Continues * 4 Biotech Stocks Moving On COVID-19 Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Celebrity
    Scary Mommy

    Corey Feldman Accuses Charlie Sheen Of Raping Corey Haim In New Documentary

    Corey Feldman alleges that Charlie Sheen raped the late Corey Haim in 1986 Actor Corey Feldman has been vocal for years about the sexual abuse he and his late friend Corey Haim — who died from pneumonia in 2010 — suffered in Hollywood as young child actors, and now in a new documentary (My) Truth: []

  • Politics
    The Fiscal Times

    Trump’s Coronavirus Tax Cut Falls Flat on Capitol Hill

    President Trump promised Monday evening that his administration would quickly announce “very major,” very “substantial” and “dramatic” steps to boost the economy in the face of the coronavirus threat.That might not be so easy. When Trump made his announcement, the administration and Congress had not settled on any such steps, and reactions from Congress suggest that there’s no quick consensus on a plan, though lawmakers prefer measures to help hourly workers and affected industries.Trump wants a payroll tax cut: The measures under consideration by the administration reportedly center on a temporary payroll tax cut as well as paid leave for hourly workers, targeted tax breaks for industries hit by the outbreak and loans for affected small businesses.Trump on Tuesday met with Republican senators at their weekly lunch and reportedly told them he wants a payroll tax holiday to run beyond the November election because he does not want the taxes to rise back to normal just before voters decide whether to give him another term. "I was just with the Republican senators and they were just about all there, mostly all there and there's a great feeling about doing a lot of the things," he told reporters afterward.The payroll tax funds Social Security and Medicare. Employees and employers each pay 6.2% on the first $137,700 of wage and salary income for Social Security and 1.45% of their income for Medicare, plus an additional 0.9% surtax for married filers earning over $250,000.The proposed tax cut could reportedly amount to $40 billion a month, though that could change depending on the size and duration of the cut.But Tuesday’s Senate GOP meeting ended without any specific plan for an economic stimulus package or agreement on how to proceed. Democrats, meanwhile, are working on their own plan and reportedly could start rolling out elements of their package as soon as Wednesday.Adding to the uncertainty, lawmakers are scheduled to leave town Friday until March 23, making it unlikely that any plan gets enacted over the next two weeks.That timeline would require any legislative action be done with extraordinary speed, and House Speaker Nancy Pelosi indicated Monday that it might not be possible, prompting an angry response from Trump on Twitter. But Pelosi met Tuesday with Treasury Secretary Steven Mnuchin to discuss a relief package. Hesitation on Capitol Hill: While Trump wants to “go big” on a fiscal stimulus package, lawmakers were questioning the wisdom of a payroll tax cut even before Tuesday’s GOP Senate meeting with the president and his economic team.Reactions to the proposal on Capitol Hill suggest it could be difficult to reach a quick consensus about the next steps to take. Democrats have essentially dismissed the idea of a payroll tax cut and have outlined a different set of priorities for a stimulus package, including paid sick leave and extended unemployment insurance for people put out of work. “The administration seems to believe that the answer to any problem is another tax cut,” Senate Minority Leader Chuck Schumer said.Members of the president’s own party — and some of his own aides — are reportedly cool to the idea as well, though they generally agree that a stimulus is needed.At a meeting with Trump on Monday night, Treasury Secretary Steven Mnuchin, National Economic Council Director Larry Kudlow and Acting Director of the Office of Management and Budget Russ Vought argued that it is too early to enact such a cut, according to Politico.Some Republicans on Capitol Hill have also expressed hesitation about a payroll tax cut. * “Well, I usually love tax cuts, but I think it’s a little premature,” Sen. John Cornyn of Texas told Politico. * Sen. Lindsey Graham of South Carolina questioned whether the cost of the cut would be more effective if applied to specific sectors of the economy. * And Senate Majority Leader Mitch McConnell has reportedly made clear in private that he opposes the idea. “McConnell has made clear he ‘detests’ pursuing this particular policy, which would probably add to federal debt and deficits, and he has said many conservative GOP senators share his view,” The Washington Post reported.Questioning the effectiveness of a payroll tax cut: Lawmakers and economists alike have expressed doubts about whether a payroll tax cut would do much to mitigate the economic fears and fallout stemming from the coronavirus outbreak.“A payroll tax cut might be the correct response to an economic downturn, but it is far too broad to have a significant impact on the source of this potential crisis. It might help the stock market in the short run but it will be expensive,” Paul Winfree, the former deputy director of the Domestic Policy Council in the Trump White House told Politico. “Furthermore, it won’t help people who either can’t work because they’re home sick or are caring for someone who is sick. Nor will further incentives for people to work through supply-side policies to help contain the coronavirus epidemic.”Some also worried that a payroll tax cut might incentivize virus-spreading behavior compared to other forms of stimulus. “We don’t want people having to choose between a paycheck and preventing the spread of the disease,” said Rep. Don Beyer (D-VA), vice chairman of the Joint Economic Committee, according to the Post.Other possibilities for a coronavirus relief plan: Trump also said Tuesday that his administration would provide help to airlines and cruise lines, though he provided no details. And GOP senators variously suggested infrastructure spending and federal bailouts for the shale drilling industry hit by the sudden oil price war between Saudi Arabia and Russia. The administration is reportedly also looking at ways to enact a guarantee of paid sick leave without going through Congress.Like what you're reading? Sign up for our free newsletter.

  • Business
    Bloomberg

    Virus Makes Lobsters So Cheap That Sellers Face a Fatal Blow

    (Bloomberg) -- The coronavirus outbreak is turning one luxury treat reserved for special occasions into a meal bargain hunters can afford.U.S. lobster prices have plummeted to the lowest in at least four years after the spread of the virus halted charter flights to Asia at a time when sales usually boom for Chinese New Year celebrations.The fallout has left thousands of pounds of unsold lobster flooding North American markets and squeezing U.S. businesses that were already hurting from lost sales due to China’s tariffs from its trade war with Washington.“This is like a fatal blow,” said Stephanie Nadeau, owner of Arundel, Maine-based The Lobster Co., which saw orders to Hong Kong shrivel from about 1,000 boxes a week to a total of 120 boxes -- each carrying 33 pounds -- since late January. “I’m about to lay off most of my employees.”The U.S. used to be the main supplier of live lobster to China as exporters tapped into surging demand from the Asian nation’s growing middle class. Buyers turned to relatively cheaper supply from Canada after Beijing placed retaliatory tariffs on American crustaceans in 2018.Lobster FlightsCanada typically sent about nine charter flights a week, with a total of 1.5 million pounds of the shellfish, from Nova Scotia to South Korea and mainland China for everything from restaurants and markets to business meetings and weddings.But as the coronavirus outbreak disrupted travel and transport in Asian nations including China, Canadian product began flooding the U.S. market, according to research company Urner Barry, which has been tracking food prices since 1858. That pushed prices lower, said Liz Cuozzo, seafood market reporter at Urner Barry.Prices for New England halves -- a whole lobster weighing 1.5 pounds -- have tumbled 17% since Jan. 20 and are currently at $8.10, the lowest for the period since at least 2016, she said. They typically rise this time of year as supplies are tighter before the main fishing season begins. Last year, they cost $10.70, with the 10-year-average at $9.85.Demand for live Canadian lobster has dwindled to 5% of normal volumes in mainland China since the Lunar New Year when restaurants started canceling reservations and people stayed home, said Stewart Lamont, managing director of Tangier Lobster Company in Nova Scotia.Inventory SwellsLobsters have been sold aggressively over the last month to try and get ahead of the decline in export valuations and companies are moving out some of their inventory, he said in an email. While fishers have been relatively insulated from the price decline, dealers and exporters in Canada and the U.S. have taken a substantial inventory loss and are charging importers and distributors in the Pacific Rim as much as 35% less than a month ago, he said.Lobsters that sold a month ago for C$11.75 to C$12.50 a pound plus freight charges are now selling for C$8.95 to C$9.65 plus freight, Lamont said. That kind of price drop at this time of year happening so quickly is almost “unprecedented,” he said.“It does not mean the lobsters are so cheap now in the market,” Lamont said by email. “It means that all of December and January they were very expensive.”It’s not just the U.S. and Canada that are affected. Australia counts China as the main destination for its rock lobster exports and its seafood industry will likely see a significant short-term impact, the nation’s agriculture ministry said in a report. New Zealand said it’ll allow a limited release of rock lobster back into the wild after Chinese buyers canceled orders.There’s a risk that other markets may shut down as the virus spreads, and uncertainty swirls over how many smaller merchants or mom-and-pop restaurants in China may be out of business and not return to buy following the outbreak, said Mark Barlow, owner of Island Seafood in Eliot, Maine.The Lobster Co.’s Nadeau saw her inventory lose 40% of its value as shore prices dipped from C$10 ($7.45) to C$6, and was forced to sell 50,000 pounds at a loss. She is laying off eight people from her staff of 14. “My customers got creamed and I got creamed,” she said.(Updates starting in 7th paragraph)\--With assistance from Anna Kitanaka.To contact the reporter on this story: Jen Skerritt in Winnipeg at contact the editors responsible for this story: James Attwood at , Pratish NarayananFor more articles like this, please visit us at bloomberg.comSubscribe now to stay ahead with the most trusted business news source.©2020 Bloomberg L.P.

  • U.S.
    AFP

    Coronavirus: top US universities move classes online

    Major American universities -- including Harvard, Princeton and Columbia -- have been forced to cancel classes because of the coronavirus and move lessons online, affecting tens of thousands of students. Ahead of the start of spring break at the end of this week, Harvard on Tuesday announced it would transition to having all classes online by Monday 23 March. The university, located in Cambridge, Massachusets, asked its 36,000 graduate and undergraduate students not to return to campus after the spring recess and to continue studying remotely "until further notice."

  • U.S.
    In The Know

    Catastrophe strikes 10 minutes after teen passes his driving exam

    The man, identified as only Mr. Zhang, had passed his driving test just 10 minutes prior and was on a narrow bridge when the incident occurred.