Bio­phar­ma IPO boom yields buoy­ant biotech pub­lic de­buts

The past week has seen a smor­gas­bord of big­ger-than-ex­pect­ed bio­phar­ma IPO de­buts led by Chi­nese biotech Leg­end, as in­vestors put their chips on the in­dus­try that is ex­pect­ed to be the tick­et out of the pro­tract­ed Covid-19 cri­sis — amid a broad­er mar­ket that is com­ing back to life with US busi­ness­es grad­u­al­ly re­open­ing.

The J&J-part­nered com­pa­ny not on­ly emerged with one of the largest pub­lic rais­es in biotech his­to­ry clock­ing in meaty $424 mil­lion, but saw its shares $LEGN soar more than 60% on its first day of trad­ing.

Leg­end — which si­lenced skep­tics such as ri­val Blue­bird bio’s Nick Leschly by earn­ing the part­ner­ship with J&J in an $350-mil­lion up­front deal for its CAR-T ther­a­py — had orig­i­nal­ly filed for a healthy $350 mil­lion IPO, based on a range of $18-$20. But they man­aged to rake in $23 per share, set­ting the stage for a wind­fall that eclipsed mam­moth rais­es from peers in­clud­ing Juno and Gala­pa­gos, but short of Mod­er­na’s record-set­ting $600 mil­lion in 2018.

Leg­end’s lead ex­per­i­men­tal drug, pur­posed as the last line of de­fense for pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, is ex­pect­ed to be put un­der reg­u­la­to­ry re­view in the sec­ond half of 2020.

Oth­er biotech per­for­mances were al­so buoy­ant, ei­ther by pric­ing above the range or thanks to up­sized of­fer­ings.

No­var­tis-backed Pli­ant Ther­a­peu­tics, for in­stance, had pen­ciled in a $86 mil­lion raise back in May. But that ini­tial es­ti­mate, much like a clutch of oth­ers in re­cent weeks, was over­shad­owed with its ac­tu­al haul: $144 mil­lion. It priced at the high end of its range at $16, but sized up the to­tal shares of­fered to 9 mil­lion.

The South San Fran­cis­co biotech, which is al­lied with the Swiss drug­mak­er on an in­te­grin in­hibitor de­signed to tack­le fi­bro­sis as­so­ci­at­ed with NASH on the ba­sis of re­search con­duct­ed by sci­en­tif­ic co-founder Dean Shep­pard, raised $100 mil­lion ahead of the IPO in a round led by No­var­tis. The com­pa­ny’s tech­nol­o­gy, which al­so holds promise in fields such as on­col­o­gy and mus­cu­lar dy­s­tro­phy, is fo­cused on TGF-β ac­ti­va­tion. Flaunt­ing a $577 mil­lion mar­ket cap, Pli­ant $PLRX fin­ished its first day of trad­ing up a healthy 39%.

Neigh­bor­ing biotech Ap­plied Mol­e­c­u­lar Trans­port al­so up­sized its of­fer­ing gen­er­at­ing a $154 mil­lion yield, well above its ini­tial $100 mil­lion es­ti­mate. The com­pa­ny, which jumped on the IPO band­wag­on per­haps more out of ne­ces­si­ty than am­bi­tion af­ter de­clar­ing sub­stan­tial doubts about its abil­i­ty to con­tin­ue as a go­ing con­cern at the end of the first quar­ter, has an in­flam­ma­to­ry-dis­ease fo­cused pipeline.

Its lead drug, AMT-101, is an IL-10 ag­o­nist en­gi­neered to tamp down in­flam­ma­tion in au­toim­mune dis­or­ders such as ul­cer­a­tive col­i­tis and rheuma­toid arthri­tis. Shares of the ear­ly-stage drug de­vel­op­er, found­ed and led by life sci­ences con­sul­tant Tahir Mah­mood, rose $AMTI 28% on its first day, grant­i­ng it a re­spectable half a bil­lion dol­lar mar­ket cap.

Fi­nal­ly, the de­but for the first Swedish com­pa­ny to list on Nas­daq in 15 years al­so reaped gains ahead of the topline read­out of its Phase III drug ex­pect­ed by the end of this year. The com­pa­ny, Cal­lid­i­tas Ther­a­peu­tics, was ini­tial­ly eye­ing a $75 mil­lion raise but up­sized its deal to raise $90 mil­lion.

The com­pa­ny’s lead drug, Ne­fe­con, is an oral for­mu­la­tion of the cor­ti­cos­teroid budes­onide li­censed from Up­p­sala Uni­ver­si­ty. The biotech has been de­vel­op­ing the drug for use in an or­phan au­toim­mune re­nal dis­ease known as IgA nephropa­thy (IgAN). En­gi­neered as an im­muno­sup­pres­sant, the drug is de­signed to keep pa­tients from pro­gress­ing to end-stage re­nal dis­ease. Shares of the com­pa­ny $CALT ticked up about 1% on its first day, mark­ing a $476 mil­lion mar­ket cap.

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

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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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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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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.

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.