Ar­a­digm los­es CEO, CMO and CFO fol­low­ing reg­u­la­to­ry dis­as­ter; Omeros shares go up on pos­i­tive re­sults for blood clot treat­ment

→ As Ar­a­digm $ARDM con­tends with the af­ter­math of a dis­as­trous reg­u­la­to­ry jour­ney, it has let go of three of its top ex­ec­u­tives in an ap­par­ent mea­sure to cut costs. CEO Ig­or Gon­da, CMO Juer­gen Froehlich and CFO Nan­cy Peco­ta have re­signed from all of their po­si­tions at the trou­bled biotech. John Siebert, cur­rent chair­man of the board, will step in as ex­ec­u­tive chair­man and in­ter­im prin­ci­pal ex­ec­u­tive of­fi­cer. If Ar­a­digm wants an­oth­er chance at the FDA for its in­haled an­tibi­ot­ic Lin­haliq, which it in­di­cat­ed it would like to do, it would need fresh cash to fu­el a whole new PhI­II pro­gram.

→ By com­par­ing the per­for­mance of its drug against his­tor­i­cal da­ta in a Phase II study, Omeros has de­clared that OMS721 leads to a sig­nif­i­cant in­crease in me­di­an over­all sur­vival for pa­tients with a type of blood clot as­so­ci­at­ed with stem cell trans­plant. Among a to­tal of 19 hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy (HCT-TMA) pa­tients, the me­di­an OS was 347 days, a big im­prove­ment com­pared to the 21 days record­ed in lit­er­a­ture. The bio­mark­ers al­so looked pos­i­tive to re­searchers. Four deaths oc­curred, dur­ing the study, but the com­pa­ny said on­ly one was pos­si­bly drug-re­lat­ed. Omeros’ shares $OMER edged up 12% in pre-mar­ket trad­ing, slow­ly re­cov­er­ing from a Wednes­day slump that some say were spurred by re­ports that their oth­er drug will lose re­im­burse­ment un­der the new fed­er­al bud­get.

→  Ver­tex Phar­ma $VRTX says its Phase II study of the nono­pi­oid pain drug VX-150 hand­i­ly beat out a place­bo in treat­ing post-sur­gi­cal pain. The suc­cess in Phase II helps clar­i­fy re­searchers’ plans for the next round of stud­ies as it looks to ad­vance a new ap­proach to pain in the mid­dle of an opi­oid ad­dic­tion epi­dem­ic. Their drug clear­ly fell short of a com­para­tor arm of pa­tients giv­en the com­mon­ly pre­scribed opi­oid med­i­cine hy­drocodone+ac­eta­minophen, but may prove good enough as a sub­sti­tute in many cas­es.

→  Switzer­land’s San­thera Phar­ma­ceu­ti­cals (SIX: $SANN) struck a deal with Polyphor to in-li­cense POL6014, a clin­i­cal-stage ther­a­py for cys­tic fi­bro­sis and oth­er neu­trophilic pul­monary dis­eases such as non-cys­tic fi­bro­sis bronchiec­ta­sis, al­pha-1 an­tit­rypsin de­fi­cien­cy and pri­ma­ry cil­iary dysk­i­ne­sia.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.