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.

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.”

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.

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.”