In post-IPO par­ty, Nas­daq’s new­com­ers Ar­mo, Men­lo and Sol­id soar with­in hours of list­ing

Three new­ly-mint­ed biotech stocks are leap­ing in val­ue just days af­ter list­ing on the Nas­daq, send­ing a clear sig­nal to in­dus­try that in­vestors’ in­sa­tiable ap­petite will car­ry in­to 2018. Al­though there’s no sign of this ac­tiv­i­ty slow­ing down, the col­lec­tive gid­di­ness of the in­dus­try is start­ing to alarm the more con­ser­v­a­tive among us. Go-go days come to an end at some point, right?

One com­pa­ny reap­ing the ben­e­fits of the mar­ket is Ar­mo Bio­sciences $AR­MO, which went pub­lic just this morn­ing rais­ing $128 mil­lion. The late-stage im­munother­a­py com­pa­ny priced its of­fer­ing at $17 per share on a $526 mil­lion val­u­a­tion. Ar­mo quick­ly saw its share price soar, clos­ing the day at $29.74 — 75% high­er than where it start­ed. Mar­ket cap? $845 mil­lion by mar­ket close.

In­de­pen­dent biotech in­vestor Brad Lon­car said he knew Ar­mo would do well be­cause its lead prod­uct can­di­date plays in a pop­u­lar are­na.

“‘Cy­tokines’ is a buzz­word we will be hear­ing a lot in 2018,” Lon­car wrote in an email. “(Nek­tar) is the biggest sto­ry of the year so far, and it’s easy for bankers to call this the next Nek­tar.”

Jet­ting north, Ar­mo is joined by Men­lo Ther­a­peu­tics $MN­LO, which we saw go pub­lic yes­ter­day rais­ing $119 mil­lion. The com­pa­ny priced at $17 per share on a $403 mil­lion val­u­a­tion. By to­day at mar­ket close, its stock was up 68% clos­ing at $28.51.

And last, there’s Sol­id Bio­sciences $SLDB, which list­ed on the Nas­daq this morn­ing. It raised $125 mil­lion at $16 per share. De­spite new rev­e­la­tions that its most ad­vanced drug can­di­date has been un­der FDA scruti­ny since mid-No­vem­ber, Sol­id still man­aged to close the day up at $22.62 per share — a 41% in­crease.

Lon­car said the per­for­mance of the first batch of IPOs this year — helped along by two ma­jor M&A deals from Cel­gene and Sanofi — cer­tain­ly bodes well for the im­me­di­ate fu­ture.

“Biotech is on fire since those two deals on Mon­day and I do think it is in­dica­tive of a strong IPO sea­son ahead,” Lon­car said.

Still, things are start­ing to look a lit­tle too hot for some. “You keep your hand on the eject but­ton,” an un­named hedge fund man­ag­er told STAT’s Dami­an Garde. And Lon­car — un­prompt­ed — tacked this on the end of his email.

“To be hon­est, I think it is all too frothy,” Lon­car wrote. “But it usu­al­ly takes months of froth for a reck­on­ing to hap­pen. I wouldn’t be sur­prised if we are still in the ear­ly stages of this.”


Im­age: shut­ter­stock

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Fresh tri­al da­ta for­ti­fy po­si­tion of Roche's oral ther­a­py in spinal mus­cu­lar at­ro­phy bat­tle­ground

With an FDA decision date looming, Roche on Wednesday unveiled positive pivotal data on its blockbuster-bound oral spinal muscular atrophy (SMA) drug in patients with the most severe form of the muscle-wasting disease.

The FDA is set to make its decision on the therapy, risdiplam, by May 24. It is expected to compete with Biogen’s Spinraza and Novartis’ Zolgensma.

Partnered with PTC Therapeutics, the Roche drug was tested in 41 patients aged 1-7 months with type 1 SMA, a rare genetic muscle-wasting disease. The trial, dubbed FIREFISH, measured efficacy via the proportion of infants sitting without support after 12 months of treatment, and longer.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Hal Barron and Emma Walmsley, GSK

GSK’s ‘break­through’ BC­MA can­cer drug gets a pri­or­i­ty re­view — and a big win for the on­col­o­gy R&D team

After largely whiffing the past 2 years on the pharma R&D front, GlaxoSmithKline research chief Hal Barron has seized boasting rights to a key win that puts them back in the cancer drug development game.

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Who are the young bio­phar­ma lead­ers shap­ing the in­dus­try? Nom­i­nate them for End­points' spe­cial re­port

Update: Nominations open through end of day, Monday, January 27

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.

John Oyler, Endpoints

BeiGene lines up its first shot at crack­ing the megablock­buster PD-1 mar­ket for lung can­cer. But can they over­come un­der­dog sta­tus?

BeiGene took another big step towards challenging Merck, Bristol-Myers Squibb, AstraZeneca and some other Big Pharma heavyweights for a share of the lucrative lung cancer market for the PD-(L)1s racking up billions in annual revenue.

The China-based biotech $BGNE run by CEO John Oyler posted positive top-line progression-free survival results for their pivotal Chinese study on their PD-1 antibody tislelizumab combined with chemo for squamous non-small cell lung cancer in frontline cases. Squamous NSCLC accounts for about 30% of the overall lung cancer market.

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Brex­it fears, Wood­ford woes over­shad­owed UK biotech and cut 2019 fi­nanc­ing by al­most half

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.