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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.