In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednes­day af­ter­noon, Gene edit­ing com­pa­ny In­tel­lia and eye dis­ease com­pa­ny Iver­ic Bio an­nounced that they had each raised $300 mil­lion by sell­ing off some of their stocks. The two biotechs are the lat­est to raise mon­ey via pub­lic stock of­fer­ings, an in­creas­ing­ly pop­u­lar tac­tic used by pub­lic com­pa­nies as the in­dus­try falls back from its pan­dem­ic boom.

John Leonard

In­tel­lia’s raise comes a few weeks af­ter it post­ed an up­date on its hered­i­tary an­gioede­ma pro­gram that us­es CRISPR/Cas9 to di­rect­ly ed­it the gene that makes the pro­tein re­spon­si­ble for the at­tacks that oc­cur with the dis­ease. In that in­ter­im cut, In­tel­lia showed that pa­tients dosed with its one-time ther­a­py be­came at­tack free (at least thus far) af­ter an ob­ser­va­tion pe­ri­od of 16 weeks, with the longest pa­tient re­main­ing at­tack free for 10 months.

Fol­low­ing the da­ta re­lease, In­tel­lia CEO John Leonard bold­ly claimed that the ther­a­py “may be a func­tion­al cure.”

In rais­ing $300 mil­lion, In­tel­lia sold just over 6.5 mil­lion shares of its com­mon stock at $45.80 a share. Gold­man Sachs, the un­der­writer of the of­fer­ing, al­so has an op­tion to buy around an­oth­er 980,000 shares. In­tel­lia told End­points News in an email that the funds would be used to ad­vance its clin­i­cal and pre-clin­i­cal CRISPR-based ther­a­pies.

Thurs­day morn­ing, how­ev­er, In­tel­lia’s stock $NT­LA was trad­ing down 10%.

Iver­ic, on the oth­er hand, is work­ing to­wards an FDA sub­mis­sion for its drug for an ad­vanced form of AMD known as ge­o­graph­ic at­ro­phy. The biotech dropped sub­group da­ta on its drug in Sep­tem­ber at an oph­thal­mol­o­gy con­fer­ence in Chica­go.

In ear­ly No­vem­ber, it sub­mit­ted the first part of its NDA for avac­in­cap­tad pe­gol, a com­ple­ment C5 pro­tein in­hibitor. In this are­na, Iver­ic is trail­ing a bit be­hind Apel­lis, which is al­so de­vel­op­ing a ge­o­graph­ic at­ro­phy treat­ment, though the FDA re­cent­ly pushed its de­ci­sion dead­line on Apel­lis’ drug back to Feb­ru­ary. The de­ci­sion was ini­tial­ly slat­ed for Nov. 26.

From its stock of­fer­ing, Iver­ic said it raised $300.4 mil­lion from sell­ing 13.3 mil­lion shares of its com­mon stock at $22.50 a share. Iver­ic is giv­ing un­der­writ­ers an op­tion to buy 2 mil­lion more shares at that price. Iver­ic said in an SEC fil­ing that the mon­ey would be put to­wards “prepa­ra­tion for and, sub­ject to reg­u­la­to­ry ap­proval, po­ten­tial com­mer­cial launch of avac­in­cap­tad pe­gol in GA in the Unit­ed States, in­clud­ing the hir­ing and as­so­ci­at­ed ex­pens­es of a sales force, and for work­ing cap­i­tal and oth­er gen­er­al cor­po­rate pur­pos­es.”

Ear­li­er this month, Bio­haven al­so raised around $300 mil­lion on a pub­lic of­fer­ing. And Cerev­el, which in Au­gust in­fa­mous­ly raised $250 mil­lion based on ri­val da­ta, re­cent­ly set it­self up to sell up to $900 mil­lion worth of its stock via pub­lic of­fer­ings over the com­ing years.

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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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.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.