Novavax’s stock jumped around 30% on Tuesday after the biotech company unveiled promising new vaccine data and a broad cost-cutting push that includes major layoffs. The announcements are a sign of hope for investors after last quarter, when the company raised doubts about its ability to stay in business and decided not to provide full-year guidance. Novavax’s stock closed Tuesday at $9.52. The company’s share price is down more than 7% so far this year, giving it a market value of nearly $821 million. Novavax is now betting on its cost controls and new vaccines to help it stay afloat, forecasting 2023 sales of $1.4 billion to $1.6 billion, according to its first-quarter earnings report. The Gaithersburg, Maryland-based company said its combination vaccine targeting Covid and the flu produced a strong immune response against the viruses and was well tolerated in a phase two trial. Novavax shared similar trial results ...
Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years. The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence. This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022. For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart. In reaching their decision, the MHRA’s experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to ...
After raking in billions with its Pfizer-partnered vaccine, BioNTech is turning to new ventures as its revenues plummet. BioNTech reported first-quarter revenues of €1.27 billion (1.4 billion), a far cry from 2022’s first-quarter haul of €6.37 billion ($7.03 billion). Despite the downturn, the quarter went “fully to our expectations,” CFO Jens Holstein said on a conference call. Sales-wise, the current quarter should be the weakest of 2023, Holstein said. The company’s COVID-19 vaccine revenue guidance for 2023 stands at €5 billion ($5.4 billion), which is “something we can live with,” the CFO added. Meanwhile, BioNTech believes the United States’ transition to a commercial COVID-19 vaccine market could provide new growth opportunities. But as its pandemic-related business struggles, BioNTech is busy advancing its pipeline as it looks for its next big growth driver. The company’s pipeline includes multiple oncology ventures, including an HER2-targeted antibody-drug conjugate (ADC) that it’s working on with ...
Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product. ...
Merck on Thursday reported first-quarter revenue and adjusted earnings that topped Wall Street’s expectations, despite a steep drop in sales of its Covid antiviral treatment molnupiravir. Sales of molnupiravir plunged to $392 million during the period, down 88% from the $3.2 billion reported for the first quarter of 2022. Merck said the decrease is primarily the result of lower sales in the U.S., U.K., Japan and Australia. The company reported total revenue of $14.5 billion for the quarter, down 9% from a year earlier. But excluding the Covid drug, Merck said its revenue grew 11%. Here’s what Merck reported compared with Wall Street’s expectations, based on a survey of analysts by Refinitiv: Earnings per share: $1.40 adjusted, vs. $1.32 expected Revenue: $14.49 billion, vs. $13.78 billion expected Merck’s stock closed more than 1% higher Thursday. The shares are up more than 3% for ...
Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027. The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added. The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom. Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially ...
By Michael Greenwood, M.Sc.Reviewed by Danielle Ellis, B.Sc. Doggybone DNA ™ (dbDNA) is a technology developed by biotech company Touchlight, which is a form of linear plasmid with applications in genetic engineering and therapeutics. Plasmids are small circular double-stranded DNA molecules naturally generated by bacterial cells, some eukaryotes, and archaea and separate from chromosomal DNA. Plasmids can self-replicate by using host enzymes, and each carries at least one gene, most of which are beneficial to the host. The gene(s) carried by the plasmid may then be incorporated into the genome for expression. For example, a plasmid may encode a gene that produces a protein with antiphage functionality, allowing viral resistance to be incorporated into the bacterial chromosome. Plasmids are transferred between bacterial cells via pili; thus, beneficial genes carried by plasmids can be disseminated and incorporated into the chromosomal DNA of neighboring cells. Owing to the natural function of plasmids, they can be ...
The FDA approval of AbbVie’s oral CGRP inhibitor Qulipta in chronic migraine could unleash a fresh phase of growth for the drug. That is the conclusion of survey data gathered by Spherix Global Insights, which found most physicians are very willing to prescribe the drug to patients with chronic migraine. Prior to the FDA approval, Spherix spoke to 74 neurologists and 101 primary care physicians about the migraine market, including their interest in prescribing Qulipta for the treatment of patients who have headaches at least 15 days per month. The survey suggests that AbbVie’s work to drum up interest in Qulipta since winning approval in episodic migraine in 2021 has primed the product for growth. Almost two-thirds of the surveyed neurologists said they would be very willing to prescribe Qulipta to chronic migraine patients, up from half earlier in the launch. Similarly, more than 50% of primary ...
Christopher Newman Editor “This is a showdown about whether the most valuable patents in the entirety of the patent system are valid,” one law expert said. The nearly decade-long patent feud between Amgen and rivals Sanofi and Regeneron has divided the biopharmaceutical industry, with drugmakers taking different sides in a U.S. Supreme Court case that could have far-reaching effects. At issue are patents for powerful cholesterol-lowering medicines known as PCSK9 inhibitors. Regeneron and Sanofi brought the first, Praluent, to market in 2015. Amgen followed one month later with a similar medicine, called Repatha. The drugs work by boosting liver cells’ ability to hoover up LDL, or “bad,” cholesterol. Amgen has long claimed Sanofi and Regeneron infringed on patents it secured for Praluent. The fight has slowly winded its way through the U.S. legal system to reach the Supreme Court. There, judges could disrupt the $160 billion-per-year market for antibodies by deciding how broadly ...
The US Centers for Disease Control and Prevention updated its recommendations on the Covid-19 vaccines on Wednesday to allow another dose of the bivalent booster for people who are 65 and older or who have weakened immune systems and who “want the option of added protection” against the coronavirus. The move aligns with Tuesday’s US Food and Drug Administration actions to allow these groups to get additional booster doses ahead of the fall vaccination campaign. On Wednesday, members of CDC’s Advisory Committee for Immunization Practices met to discuss the changes and expressed their support for them, although the committee did not vote. Monovalent mRNA vaccines, which protect only against the original strain of the coronavirus, will no longer be recommended in the United States, the CDC says. The updated bivalent shots from Moderna and Pfizer/BioNTech protect against the original strain as well as the BA.4 and BA.5 subvariants ...
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