IPO mar­ket warms with Spero, Al­lena head­ing to Wall Street

Two Boston biotechs are div­ing in to a frothy IPO mar­ket this morn­ing as they head­ed to the Nas­daq to raise a com­bined $152 mil­lion.

An­tibi­otics com­pa­ny Spero Ther­a­peu­tics brought in $77 mil­lion by sell­ing 5.5 mil­lion shares at $14 each. The com­pa­ny orig­i­nal­ly hoped to raise $92 mil­lion in the of­fer­ing, ac­cord­ing to a state­ment filed with the SEC in late Oc­to­ber. Spero’s IPO was helped along with sup­port from in­sid­ers, with Spero back­ers com­mit­ting to buy 39% of its IPO ($30 mil­lion) be­fore it went live.

Spero is one of the many com­pa­nies tack­ling drug-re­sis­tant an­tibi­otics. Its ex­per­i­men­tal drug SPR741 is meant to punch up the ef­fec­tive­ness of an­tibi­otics by pen­e­trat­ing the out­er cell mem­branes of Gram-neg­a­tive bac­te­ria. The com­pa­ny al­so has a broad-spec­trum prod­uct, SPR994, in Phase I clin­i­cal tri­als. The clear ma­jor­i­ty of the cap­i­tal raised in its IPO is in­tend­ed to car­ry SPR994 through clin­i­cal tri­als, ac­cord­ing to the SEC state­ment.

The oth­er new­com­er to the mar­ket, Al­lena Ther­a­peu­tics, raised $75 mil­lion in its IPO, sell­ing 5.3 mil­lion shares at $14 apiece. That’s al­so be­low ear­li­er pre­dic­tions. Last month in an SEC fil­ing, Al­lena said it ex­pect­ed to raise $98 mil­lion at $16 per share. Al­lena share­hold­ers bagged $25 mil­lion, or about 31%, of the com­pa­ny’s to­tal of­fer­ing.

Al­lena ar­rives on Wall Street with a bit of bag­gage: two Phase II flops. Al­lena’s lead drug is ALLN-177 for hy­per­ox­aluria, which oc­curs when too much ox­alate is present in urine. The con­di­tion can dam­age the kid­neys. ALLN-177’s re­cent Phase IIb tri­al failed to demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in uri­nary ox­alate ex­cre­tion. But the biotech claimed a suc­cess for some post-hoc analy­sis and a sec­ondary end­point: time-weight­ed av­er­age 24-hour uri­nary ox­alate ex­cre­tion. That’s what they want the FDA to sign off on as their pri­ma­ry end­point for a piv­otal study, which will fo­cus on more se­vere cas­es of en­teric hy­per­ox­aluria. They’re head­ed for the Phase III tri­al next year, with da­ta ex­pect­ed in 2019. Pro­ceeds from this IPO will be used to fund the piv­otal tri­al.

Al­though both com­pa­nies raised cap­i­tal on the low end of their ranges, the ac­tiv­i­ty is still in­dica­tive of a warm­ing IPO mar­ket for biotechs. IPO re­search firm Re­nais­sance Cap­i­tal re­port­ed in Sep­tem­ber that biotechs helped dri­ve up the av­er­age re­turns of the 29 of­fer­ings in Q3.

We start­ed out the year with sev­er­al an­a­lysts pre­dict­ing an okay­ish year for biotech IPOs — not 2014 hot, but equal to or slight­ly bet­ter than the 28 IPOs we saw last year. So far, we’re look­ing at a slight­ly hot­ter year than last. With Spero and Al­lena added to the mix, we’re at 33 IPOs in 2017.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.

(Image: Associated Press)

No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,700+ biopharma pros reading Endpoints daily — and it's free.