The pan­dem­ic IPOs keep rolling, as Gen­er­a­tion, Avid­i­ty, Vax­cyte each claim 200M+

If it wasn’t al­ready, biotech’s pan­dem­ic IPO boom is in full swing.

Af­ter a week that saw the largest Chi­nese biotech IPO in his­to­ry and an­oth­er $154 mil­lion for a com­pa­ny that emerged on­ly last Sep­tem­ber, four dif­fer­ent biotechs raised over $200 mil­lion. Each of them up­sized their of­fer­ings or priced at the top end — or more — of their orig­i­nal range.

Col­lec­tive­ly, they raised $926 mil­lion, or an av­er­age of $231 mil­lion per com­pa­ny.

The new rais­es are part of a broad­er trend, as in­vestors have flocked to biotech stocks as is­lands of sta­bil­i­ty in an in­creas­ing­ly rocky and pan­dem­ic-strick­en stock mar­ket. Large­ly, that’s meant bal­loon­ing val­u­a­tions for pub­lic com­pa­nies, such as Mod­er­na and Vir, who are mak­ing treat­ments or vac­cines for Covid-19.

But the com­pa­nies go­ing pub­lic this week don’t have large Covid-19 pro­grams. They con­sist of a Chi­nese can­cer de­tec­tion com­pa­ny and three com­pa­nies that are still pre­clin­i­cal, a stage when it used to be rare for com­pa­nies to go pub­lic, let alone raise vast cap­i­tal. The new rounds are a con­tin­u­a­tion of that trend, glimpses of which were seen be­fore the out­break hit the US, as the mar­ket showed an ap­petite for such ear­ly-stage ven­tures.

Six pre­clin­i­cal biotechs have now raised over $150 mil­lion in 2020, com­pared with just two over the pre­vi­ous three years, ac­cord­ing to num­bers from Re­nais­sance Cap­i­tal. That in­cludes David Liu’s Beam Ther­a­peu­tics, which raised $180 mil­lion on a base pair edit­ing plat­form in Feb­ru­ary, Jim Wil­son’s Pas­sage Bio, and Ver­sant’s Black Di­a­mond Ther­a­peu­tics.

Ge­off Mc­Do­nough Gen­er­a­tion

Gen­er­a­tion Bio was the first com­pa­ny to go pub­lic this week, grab­bing $200 mil­lion in a twice-up­sized of­fer­ing. Run by Gen­zyme vet Ge­off Mc­Do­nough, it’s de­vel­op­ing gene ther­a­pies that can be de­liv­ered by lipid nanopar­ti­cles in­stead of vi­ral vec­tors. The idea is that the nanopar­ti­cles can last as long as the now-com­mon ade­no-as­so­ci­at­ed virus­es, while be­ing eas­i­er to scale and sell for less than the cur­rent mul­ti-mil­lion dol­lar price tags for gene ther­a­pies.

In Jan­u­ary, the com­pa­ny raised $110 mil­lion, bring­ing their to­tal to $235 mil­lion. At the time, Mc­Do­nough told End­points News they might look for an IPO in 12 to 18 months to fund their clin­i­cal work.

Avid­i­ty Bio­sciences, an Eli Lil­ly-backed an­ti­sense biotech, priced at $14 to $16, up­sized the range to $17 to $18, and then priced at the high end of that, earn­ing $259 mil­lion in the end. The com­pa­ny works on mus­cle dis­or­ders, par­tic­u­lar­ly my­oton­ic mus­cu­lar dy­s­tro­phy. They com­bine an­ti­sense oligonu­cleotides — an old way of drug­ging RNA — with hom­ing an­ti­bod­ies to cre­ate what they call an­ti­body oligonu­cleotides con­ju­gates. The idea is that the an­ti­body will guide the an­ti­sense to se­quences that were pre­vi­ous­ly dif­fi­cult to tar­get. Their last round was in No­vem­ber, for $100 mil­lion.

Vax­cyte filed for its IPO ex­act­ly two months af­ter it raised $110 mil­lion in a Se­ries D, and end­ed up rais­ing $249 mil­lion. At the time of the last raise, it was known as SutroVax — a holdover from its days as a spin­out of Sutro Bio­phar­ma — but they changed their name and lo­go in ad­vance of fil­ing for what was orig­i­nal­ly sten­ciled as a $100 mil­lion IPO.

There may be no bet­ter time to go pub­lic as a vac­cine com­pa­ny, and the re­turn of vac­cines to the cen­ter of pub­lic at­ten­tion may have boost­ed their over­all raise, but Vax­cyte is work­ing on a far dif­fer­ent mar­ket and type of in­oc­u­la­tion than coro­n­avirus. The com­pa­ny is try­ing to cre­ate a fol­low-up to Pre­vnar13, the Pfiz­er pneu­mo­nia vac­cine that’s earned over $30 bil­lion in one of the few block­buster vac­cine mar­kets. Vax­cyte’s lead prod­uct is meant to guard against 24 strains of bac­te­ria, in­stead of Pre­vnar’s 13, and is com­pet­ing against ex­per­i­men­tal in­oc­u­la­tions at Pfiz­er and else­where.

In the fi­nal large raise, Il­lu­mi­na-part­nered Burn­ing Rock Biotech, a DNA-se­quenc­ing based can­cer de­tec­tion com­pa­ny, earned $223 mil­lion, pric­ing a dol­lar above their orig­i­nal $13.50 to $15.50 range. They got to ring the open­ing bell to­day at the Nas­daq.

And on a small­er note, AI-fo­cused Chi­nese biotech, Lantern Phar­ma had an ever-so-slight­ly up­sized IPO. They filed for $25 mil­lion and raised $26 mil­lion.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,700+ biopharma pros reading Endpoints daily — and it's free.