Biotechnology without drugs in evidence is raising millions in OPI
Biotechnology without drugs in evidence is raising millions in OPI
The IPOs of Biotech are on track in an almost record year, with a lot of younger, more valued offers, and some say they are more risky, than any other in recent memory.
Driven by rapid advances in medical science and an accommodating Food and Drug Administration that is increasingly willing to accelerate the approval of innovative medicines, biotechnology companies they are taking advantage of public markets in very early stages of development, some even before they have a drug in a clinical trial.
founded last year, has no income from products and is years away from getting approval for a drug. However, it raised $ 373 million earlier this month in one of the largest initial public offerings in biotechnology history.
Therapeutic Rubius
Inc.,
RUBY 11.69%
in Cambridge, Massachusetts, raised about $ 277 million in its July IPO, the second largest amount of biotechnology this year according to Dealogic, despite not having tested a drug in humans.
Homology drugs
Inc.,
FIXX 8.13%
whose leading gene therapy product will not begin clinical trials until 2019, it raised $ 166 million in its March IPO, three years after its founding, and now has a market value of more than $ 700 million.
Biotech Bucks
Biotechnology companies have raised $ 5.56 billion in initial public offerings so far this year, placing 2018 on the path to be one of the best in the industry for IPOs.
In general, until mid-October, the IPOs included in the US list for some 52 drug developers have raised $ 5.75 billion in gross profits this year, third behind the $ 8.19 billion raised throughout 2014 and $ 7.06 billion raised in 2000, according to Dealogic data adjusted for inflation.
Another database to which some analysts point shows that so far this year, 55 biotechnologies have raised $ 5.56 billion, a loss of $ 8.340 billion adjusted for inflation in the entire 2000, $ 5.97 billion in 2014 and $ 5.74 billion in 2015. The database is maintained by Biogen. President of Inc. Stelios Papadopoulos.
In one of the stronger IPO markets In the last decade, some 209 companies have become public in the United States stock exchanges so far this year, which represents a total of $ 56.6 billion, the second largest amount since 2008 compared to the previous year to $ 88.92 billion, adjusted for inflation, increased by 249 Companies in 2014, according to Dealogic.
At least six other biotech companies are on the deck to go public before the end of the year, including NGM Biopharmaceuticals Inc., whose main drug, to treat a type of fatty liver disease, is in intermediate studies. On Wednesday, the actions of
PLC and
Twist Bioscience
Corp.
They made their public debut after the companies raised $ 200 million and $ 70 million, respectively, in OPI.
Early-stage biotechnology products, whose products have not yet been tested in human clinical trials or were only tested in early phase 1 studies, accounted for 37% of biotechnology IPOs until the third quarter of 2018 and had a value of Average market of $ 535 million, according to Ravi Mehrotra, partner of investment bank MTS Health Partners. That's more than 35% of biotech IPOs with an average market value of $ 471 million in 2015.
Phase 1 studies generally only consider safety, while phase 2 trials in the intermediate stage analyze efficacy. Phase 3 trials, much larger and longer, are generally necessary for FDA approval, but the agency has been speeding up some approvals. The FDA issued 20 new drug approvals last year, including first-time approvals and approvals for new indications of disease, under its accelerated approval program, an average increase of approximately seven per year during the 10-year period. previous years, according to an analysis of FDA data by the Journal. . The accelerated approval program allows drugs to be marketed before it has been definitively demonstrated that they provide a clinical benefit to patients and often before the advanced stage studies are completed.
Traditional drugs in late development may actually take longer to get FDA approval than some drugs in the early stages, said Alexis Borisy, a partner at Third Rock Ventures, a venture capital firm based in Boston. "The notion that a company that is preclinical is inferior is not correct," he says.
However, investors have typically looked for more evidence that a drug could work. And the additional security of more clinical research is still valued.
Tricide
Inc.
Southern San Francisco had completed a late stage study at the time of its IPO, which raised $ 256 million in June. Executive Director Gerrit Klaerner discovered the company's only medication, a treatment for a metabolic condition related to kidney disease. Tricida aims to request its approval next year.
The FDA issued 20 new drug approvals last year under its accelerated approval program, an increase of an average of about seven per year in the previous 10 years, according to an analysis of FDA data by the Journal.
Photo:
Images Getty / iStockphoto
At the meetings of investors before the IPO, "the reception we got was: 'Oh, my God, there are not many companies with Phase 3 data,'" said Dr. Klaerner. Tricida shares have risen 42.1% from their IPO to $ 19 per share.
Some industry observers warn that the quality of the participants very early It can be difficult to judge. "It's better to keep your eyes open, since this industry is as risky as ever," said Geoff Porges, an analyst at Leerink Partners LLC.
In fact, many of this year's new public biotechnology companies have struggled to maintain momentum beyond their IPOs. Around 60% of the new issues of the year are negotiated below the offer prices, according to Dealogic and FactSet. Of the top 20 biotech products for the IPO's gross earnings this year, seven were in red until Monday and were down 31% from the median of their offer price; Shares in the other 13 companies rose 43% in the median.
Shares of Rubius Therapeutics, which next year plans to begin clinical trials for its genetically engineered red blood cell treatments, dropped 28.6% on Wednesday from its IPO to $ 23 in July.
The CEO of Rubius, Pablo Cagnoni, said that scientific and technological advances allow companies to deal with multiple diseases in a short period of time, attracting investors regardless of the stage of development of the companies. "It's a bit more risk [in preclinical companies]? Maybe, "said Mr. Cagnoni. "But some of those companies will be great success stories."
Allogene has risen 27.8% from the offer price of $ 18 per share. Co-founders Arie Belldegrun and David Chang directed Kite Pharma Inc., whose genetically engineered cell therapies had been tested only in small clinical trials when the company went public in 2014. Kite was acquired by
Gilead Sciences
Inc.
for $ 11.9 billion in October 2017.
Six months later, the former Kite executives. raised $ 300 million to start Allogene and develop a different type of cell therapy that, if successful, could be easier to manufacture and administer to patients than the treatments they developed in Kite.
The lead candidate for the Allogene product has been tested only in early-stage clinical trials so far, but Allogene could begin the necessary studies for FDA approval as early as the second half of next year, the company said.
Offers like Allogene are "a bet for the administration, the reputation and the board of directors [of directors]"Mr. Porges, the analyst, said:" It is not a validation of the product or the technology, that will take many quarters, if not years. "
Write to Joseph walker in joseph.walker@wsj.com
.
!function(f,b,e,v,n,t,s)
{if(f.fbq)return;n=f.fbq=function(){n.callMethod?
n.callMethod.apply(n,arguments):n.queue.push(arguments)};
if(!f._fbq)f._fbq=n;n.push=n;n.loaded=!0;n.version='2.0';
n.queue=[];t=b.createElement(e);t.async=!0;
t.src=v;s=b.getElementsByTagName(e)[0];
s.parentNode.insertBefore(t,s)}(window, document,'script',
'https://connect.facebook.net/en_US/fbevents.js');
fbq('init', '369524843414444');
fbq('track', 'PageView');
.
SOURCE LINK ERESVIRAL.COM https://www.beviral.online
Comentarios
Publicar un comentario