A scientist works in a laboratory at the Novavax facility in Gaithersburg, Maryland (Jon Cherry/Bloomberg via Getty Images)

No­vavax tem­pers its rev­enue ex­pec­ta­tions as it un­veils PhI­II da­ta for bi­va­lent boost­er

As No­vavax re­ports third quar­ter re­sults, the vac­cine mak­er is tem­per­ing its ex­pec­ta­tions once again on Covid-19 sales.

The com­pa­ny re­port­ed that it net­ted $725 mil­lion in Q3 and ad­min­is­tered around 94 mil­lion dos­es so far, but it has low­ered its fi­nan­cial guid­ance for the year fur­ther to an even $2 bil­lion from an ex­pect­ed $2.3 bil­lion just last quar­ter. The com­pa­ny al­so low­ered its guid­ance from an es­ti­mat­ed $5 bil­lion dur­ing its Q2 re­sults.

This is cer­tain­ly not what in­vestors want to hear, as the com­pa­ny’s stock price $NVAX finds it­self trad­ing be­low $20 a share and down 86% since the start of the year.

No­vavax’s vac­cine roll­out ear­li­er this year had been com­pound­ed by months of de­lays due to fil­ings and man­u­fac­tur­ing con­cerns, but even as the com­pa­ny got the cov­et­ed EUA from US reg­u­la­tors and the shot serves as an al­ter­na­tive to the more com­mon mR­NA vac­cines, it still came with some lim­i­ta­tions. The EUA not­ed that in­creased risks of my­ocardi­tis and peri­cardi­tis, along with faint­ing and oth­er ad­verse ef­fects, may oc­cur with the shot.

De­spite falling de­mand for boost­er shots, No­vavax is forg­ing ahead against chop­py winds with its boost­er can­di­date to counter the Omi­cron vari­ant.

The topline re­sults from its Phase III tri­al showed that No­vavax’s BA.1 vac­cine can­di­date had met the pri­ma­ry “strain-change end­point,” dis­play­ing a “neu­tral­iz­ing” re­sponse. How­ev­er, the da­ta al­so showed no ben­e­fit for the No­vavax bi­va­lent vac­cine can­di­date com­pared to the BA.1 vac­cine can­di­date or “pro­to­type vac­cine” in the over­all pop­u­la­tion.

The re­port­ed an­ti­body re­spons­es coun­ter­ing BA.1 showed “sim­i­lar re­spons­es across the three vac­cine groups.” For the BA.5 strain, re­spons­es al­so showed there was “no ben­e­fit” for the BA.1 or bi­va­lent can­di­dates when com­pared to the pro­to­type vac­cine.

Gre­go­ry Glenn

On the re­sults, Gre­go­ry Glenn, the pres­i­dent of Re­search and De­vel­op­ment at No­vavax said:

To­day’s re­sults show that use of our pro­to­type vac­cine as a boost­er in­duces cross-re­ac­tive re­spons­es to a broad range of vari­ants with the po­ten­tial to pro­tect against fu­ture strains. This is a hall­mark of our vac­cine tech­nol­o­gy and shows the suit­abil­i­ty of our cur­rent pro­to­type vac­cine as a boost­er even as the COVID-19 land­scape con­tin­ues to evolve. Our vac­cine, which pro­vides a broad im­mune re­sponse even in the face of evolv­ing vari­ants, presents a po­ten­tial strat­e­gy to pro­tect against COVID-19 now and in­to the fu­ture.

The most com­mon symp­tom of the can­di­date was pain or ten­der­ness, with fa­tigue al­so be­ing re­port­ed.

The ini­tial vac­cine showed that it was 80% ef­fec­tive at pre­vent­ing symp­to­matic dis­ease in pa­tients 12 to 17 years old, but the vac­cine had been faced with man­u­fac­tur­ing de­lays as well as play­ing catch up with the Omi­cron vari­ant.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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