Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase 2b/3 trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC). Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.
Gilead Sciences (GILD) and Galapagos NV (GLPG) have announced positive topline results from a Phase 2b/3 trial evaluating the efficacy and safety of the selective JAK1 inhibitor filgotinib in 1,348 patients with moderately to severely active ulcerative colitis (UC).UC is a chronic, idiopathic inflammatory disease affecting the colon and often involves periods of remission interspersed with periods of active disease.Filgotinib 200 mg achieved all primary endpoints in the placebo-controlled trial, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo.However Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10.Rates of adverse events were low and comparable across treatment groups.“Patients with moderate to severe ulcerative colitis can struggle to effectively manage their disease. These topline data suggest that filgotinib could play a role in helping more patients achieve a meaningful and sustained improvement in treatment response with an oral therapy.” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.In this trial, clinical remission was defined as an endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1.Among biologic-naïve patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (26.1%) compared with placebo (15.3%). Among biologic-experienced patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg (11.5%) compared with placebo (4.2%).Patients who achieved clinical response or remission after 10 weeks of treatment with filgotinib 100 mg or 200 mg were subsequently re-treated. At Week 58, 37.2% of biologic-naïve and biologic-experienced patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% treated with placebo.Of patients receiving filgotinib 100 mg, 23.8% achieved clinical remission at Week 58, compared with 13.5% treated with placebo.As for safety, the serious adverse events rate in biologic-naïve patients came out as 4.7% (100mg), 1.2% (200mg) and 2.9% (control arm). For biologic-experienced patients the rates for the 100mg, 200mg, and control arm were 5.3%, 7.3% and 6.3%, respectively.Two deaths were observed in the filgotinib 200 mg treatment group in the maintenance trial but neither was assessed as related to the study drug by the investigator.Overall TipRanks data shows that out of the 28 analysts covering Gilead in the past three months, 15 have a Hold rating on the stock, 8 say Buy and 5 say Sell, adding up to a Hold consensus. The $79.39 average price target suggests 7% upside potential lies ahead. (See Gilead stock analysis on TipRanks) Shares are currently trading up 14% year-to-date.Related News: Bluebird Prices New Shares At $55, Seeks To Raise $500 Million Moderna Spikes 21% Amid “Positive” Early-Stage Covid-19 Vaccine Data AstraZeneca-Merck Lynparza Prostate Cancer Treatment Gets FDA Approval More recent articles from Smarter Analyst: * Microsoft Seeks $2B Stake In India’s Jio Platforms- Report * Boeing Cuts 6,770 Jobs In U.S.; CFRA Upgrades Stock To Buy * Google Faces Arizona Lawsuit Over ‘Unfair’ Location Data Storing * Novavax Seeks To Make 1 Billion Covid-19 Vaccine Doses; Top Analyst Ramps Up PT To $61
Vertex (VRTX) is at a 52-week high, but can investors hope for more gains in the future? We take a look at the company's fundamentals for clues.
Coronavirus is probably the 1 concern in investors' minds right now. It should be. On February 27th we published an article with the title Recession is Imminent: We Need A Travel Ban NOW. We predicted that a US recession is imminent and US stocks will go down by at least 20% in the next 3-6 […]
At this time, I'd like to turn the conference over to Elizabeth Goodwin. Thank you all for joining us today for the audio webcast of Galapagos' first quarter 2020 results. This recorded webcast is accessible via the Galapagos website homepage and will be available for replay later on today.
[Editor's note: "5 Biotech Stocks to Buy for a Strong Growth Prognosis" was previously published in December 2019. It has since been updated to include the most relevant information available.]Biotech stocks have to be the ultimate risk and reward equities. No other sector comes close to the return potential of the sector. Just take a look at the gains for the SPDR S&P Biotech ETF (NYSE:XBI). The ETF and sector benchmark has managed to post average annual returns of nearly 19% over the last decade. That's pretty insane and underscores the kind of potential that biotech stocks can have.But they also come with a ton of risk to get that return. They don't call them lotto tickets for anything. Many biotech stocks are just one bad trial away from crashing, burning and causing plenty of heartache for their shareholders.InvestorPlace - Stock Market News, Stock Advice & Trading TipsHowever, there are ways to hedge your bets.Aside from going into a broad ETF like the XBI, the key is making sure that investors focus on developmental pipelines, partnership and plenty of cash on their balance sheets. Having a drug actually in the marketing stages doesn't hurt either. It's here that investors can find success in the sector. * 8 Stocks to Buy in March for a Coronavirus Rebound With that in mind, here are five biotech stocks that have plenty of potential. Galapagos NV (GLPG)Source: Shutterstock A good way to spot top clinical-stage and early-entry biotech stocks is finding those firms with top-notch partners. And Galapagos NV (NASDAQ:GLPG) couldn't have picked a better partner than biotech royalty Gilead Sciences (NASDAQ:GILD). Last year, GILD upped its partnership stake in GLPG via a nearly $4 billion payment as well as a $1.1 billion equity stake. All in all, Gilead will now own 22% of Galapagos.There's a good reason why GILD would want to pony up that kind of cash for the biotech firm. It needs to fill potential revenue holes in its aging pipeline and GLPG has the goods.Galapagos has one of the richest and largest development pipelines around. The drug company has multiple late-stage programs as well as 25 different drugs in discovery/early trial stages. This includes its potential blockbuster in Filgotinib.This was the first partnership with Gilead and after impressive phase-3 data for the rheumatoid arthritis drug, the duo submitted a marketing application with the FDA earlier this month. Meanwhile, successful initial idiopathic pulmonary fibrosis data, as well as beginning trials for new cystic fibrosis medicines, could all bare significant fruit for GLPG.That's an impressive amount of "shots on goal" for a clinical-stage biotech stock. The best part is, based on the rich deal, the speculation is that Galapagos wanted to stay independent rather than receive a full buyout from GILD. This means it can make the full use of that pipeline with future royalty and milestone payments. It also means investors in GLPG stock can as well. Blueprint Medicines (BPMC)Source: Shutterstock There are a few mega-trends in the world of biotech stocks. Gene therapy is a major one. Another is the concept of small-molecule drugs. Small-molecule drugs are generally more stable than their biologic counterparts and can more commonly be taken as pills as opposed to injections.Though some injected biologics can be taken outside of a healthcare setting (notably Abbvie's (NYSE:ABBV) Humira), many need to be administered by a doctor, nurse or other medical professional. This makes small-molecule drugs better for accessibility and ongoing treatments.This focus on small-molecule drugs makes Blueprint Medicines (NASDAQ:BPMC) a potential real winner among the biotech stocks. * 10 Stocks That Every 20-Year-Old Should Buy BPMC current roster of developmental drugs focuses on various cancers. And the beauty is that pill-delivery system. It really works. Avapritinib -- which treats systemic macrocytosis (SM) and gastrointestinal stromal tumors (GIST) -- managed to shrink these tumors in 86% of the patients treated.That's a high percentage for any study. The late trial success allowed Blueprint to submit a marketing application to the FDA for it. The firm has also seen great success targeting other cancers in several other early trials -- with the small -molecule delivery system leading the way.These successes allowed BPMC to plot its course of action for next year. That should include two marketed drugs, four in application stages and more than a dozen in trials and preclinical investigation. Given the wins already, there's no reason to think blueprint won't get there. Ligand Pharmaceuticals (LGND)Source: Shutterstock If one partner is good, then having more than 100 is better. And this is the case for Ligand Pharmaceuticals (NASDAQ:LGND). LGND counts big shots like Amgen (NASDAQ:AMGN), Pfizer (NYSE:PFE) and generic drug specialist Teva (NASDAQ:TEVA) as some of its partners/licensees. The key is Ligand's business model.Ligand doesn't actually develop drugs itself. What it does is provide development platforms that help other biotech stocks and pharmaceutical companies create drugs more effectively. That huge difference has allowed Ligand to quietly become one of the sector's secret stars.Ligand gets upfront payments, development milestones and backend payments on sales after the drugs hit the marketing stages. So far, at least nine drugs using Ligand's tech have been approved. But many more are in the late stages of trials.Perhaps the best part is much of the development risk is pushed on the firms using LGND's tech. Ligand gets paid something either way.As a result, LGND is one of the few biotech stocks out there that is actually profitable. Moreover, the steady stream of royalties has allowed the firm to build up a massive war chest of just under $1.4 billion in cash on its balance sheet. While it's too early to talk about dividend potential, LGND could be on its way to initiating a payout in the future as more drugs hit pharmacy shelves using its technology.And yet, shares of LGND could be a massive bargain. After some hype has left the stock, investors can score shares about 30% below their year-ago levels. Vertex Pharmaceuticals (VRTX)Source: Shutterstock Dominating a disease can mean some big-time revenues for biotech stocks. When it comes to cystic fibrosis, Vertex Pharmaceuticals (NASDAQ:VRTX) is pretty much the only game in town. Three of its FDA-approved drugs -- Kalydeco, Orkambi, and Symdeko -- have a monopoly on the disease.]Its massive foothold on cystic fibrosis treatments have made VRTX a cash cow for investors. Last year, Vertex managed to sell more than $3 billion worth of medicines to treat the disease. However, this year it's looking to eclipse that rate.In 2019, VRTX expects to report product revenue of $3.5 billion to $3.7 billion. That puts it on track to reap more than $5 billion in annual sales by 2024. Those robust sales have also helped balloon its cash balance to nearly $4 billion at the end of the quarter.And the future is robust for Vertex as well. * 7 Ideal Stocks to Buy for Cautious Investors The firm is working on a proven combination therapy of its three drugs to help boost its results further, while Symdeko earlier this year received approval from the FDA to be used in children.The best news for VRTX could be a recent foray into gene editing that could treat cystic fibrosis completely. Partnering with CRISPR Therapeutics (NASDAQ:CRSP), Vertex recently started the first human trial using a CRISPR-based product. That drug -- CTX001 -- also received FDA fast track status and could be a huge revenue booster if approved.With its strong dominance, hefty cash flows and continued sales increases, VRTX has quickly become one of biotech's brightest stars. BioMarin Pharmaceuticals (BRMN)Source: Shutterstock Thanks to continued advances in science and technology, we're able to tackle more rare and orphan diseases. And thanks to their generally small patient population sizes and difficulty of treatment, drugs targeting this niche of the market often come with sky-high prices. For biotech stocks like BioMarin Pharmaceuticals (NASDAQ:BMRN) this is a revenue win.BRMN has made a name for itself by only targeting rare diseases and has the most success in this area. The firm currently has seven drugs on the market targeting illnesses such as phenylketonuria and Batten disease.BioMarin has continued to see rising sales and prescriptions for these medications. For example, during the last reported quarter, Vimizim and the PKU franchise managed to generate year-over-year revenue growth of 33% and 23%, respectively. All in all, total revenues for BRMN topped $460 million.And those revenues could keep soaring into the future.For one thing, rare disease medications often come with longer exclusivity rights. This gives BMRN a very long runway to ward off generic competition. Secondly, rare disease medications generally have no trouble getting covered by health insurers. This allows patients to actually get their hands on the high-priced meds in the first place.Adding in BioMarin's beefy pipeline and you have a recipe for success. Analysts expect the firm to finally start turning a profit by 2020 -- especially if its new hemophilia drug turns out to be a blockbuster.Disclosure: At the time of writing, Aaron Levitt was Long CRSP and the iShares NASDAQ Biotechnology ETF (IBB) -- which owns all the stocks on this list. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 5 Large-Cap Dividend Stocks to Buy * 3 of the Worst ETFs in 2019 * 7 Biotech Stocks to Buy and Hold in 2020 The post 5 Biotech Stocks to Buy for a Strong Growth Prognosis appeared first on InvestorPlace.
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on Jan. 15) 10X Genomics Inc (NASDAQ: TXG ) Aimmune Therapeutics ...
H.C. Wainwright analyst Debjit Chattopadhyay reiterated a Buy rating on Galapagos (NASDAQ:GLPG) NV on Monday, setting a price target of $302, which is approximately 39.09% above the present share price of $217.12.
These are the biotechnology stocks with the best value, fastest growth, and most momentum for Q2 2020.
Galapagos (GLPG) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
The Buffalo Discovery Fund’s Dave Carlsen on seven stock picks, from video-game makers to water-purification companies.
Gilead (GILD) and Galapagos announce positive data on filgotinib for the treatment of ulcerative colitis.
Gilead Sciences (GILD) collaborates with Eisai for the distribution and co-promotion of its rheumatoid arthritis candidate, filgotinib. The companies will jointly commercialize the drug, if approved.
Gilead's (GILD) earnings fall short of estimates but sales beat the same in the fourth quarter of 2019.
Gilead (GILD) files an NDA for filgotinib with the FDA for the treatment of adults with moderate-to-severe rheumatoid arthritis.
The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 14.) Adaptimmune Therapeutics PLC – ADR (NASDAQ: ...
In a phase 2b/3 study in ulcerative colitis, the drug candidate met its goals, but with results that didn't appear better than those of a potential competitor.
Galapagos NV (Euronext: GLPG) (NASDAQ: GLPG) and Ryvu Therapeutics S.A. (WSE: RVU) today announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation.
The Business Times devoted our first print edition of the year to previewing the companies, people and trends to watch across the Bay Area's main industries in 2020. Here's a look at what to expect in biotech and health. People to Watch Jennifer Doudna, UC Berkeley: Will 2020 be the year when gene-editing CRISPR technology co-inventor Jennifer Doudna wins the Nobel Prize?
It's pretty hard to ignore the impact of Covid-19 on the global and domestic economy. But the shutdown in the U.S. economy, while swift, was also swiftly managed by the administration and Congress, as well as the Federal Reserve. This has helped buoy the markets after a precipitous initial drop. And it has allowed enough time for investors to process everything that has happened and reset their expectations -- looking away from certain risks and into cleaning-supply companies and biotech stocks.Previous to Covid-19, there was the feeling the economy was nearing recession sometime this year. Now we're in one.However, this remains an uneven market. Big stocks like Amazon (NASDAQ:AMZN) and Netflix (NASDAQ:NFLX) are doing even better under these difficult conditions. But other consumer stocks aren't.InvestorPlace - Stock Market News, Stock Advice & Trading TipsThat's why I wanted to talk about an opportunity that doesn't have to do with consumer-driven stocks -- the seven beautiful biotech stocks to buy here. These companies are set up to endure long drug approval processes that happen over good times and bad. * CRISPR Therapeutics (NASDAQ:CRSP) * Acceleron Pharma (NASDAQ:XLRN) * Neurocrine Biosciences (NASDAQ:NBIX) * Galapagos NV (NASDAQ:GLPG) * Incyte Corp (NASDAQ:INCY) * Regeneron Pharmaceuticals (NASDAQ:REGN) * Gilead Sciences (NASDAQ:GILD)They're built to be immune from general market forces, especially the big one these days -- consumer spending -- and to benefit from powerful technology that's popping up in all kinds of industries. Biotech Stocks to Buy: CRISPR Therapeutics (CRSP)Source: Catalin Rusnac/ShutterStock.com CRISPR is a Swiss biotech that is one of the leaders in CRISPR technology. This is a new and fast-growing field. CRISPR (it stands for clustered regularly interspaced short palindromic repeats) is a DNA segment containing short repetitions of base sequences.By using these, scientists are learning to identify where there is a break in the pattern that may signal a disease and then repair (or edit) that sequence. This is a revolutionary concept in treating disease, since it is the first step toward personalized medicine.Currently the research is hoping to build treatments to help battle many different cancers and other diseases. But eventually the technology can be applied to a much broader field of needs.The company is well funded and will continue to make a difference, even sequencing Covid-19.The stock is up 37% in the past year and over 30% in the past month. Acceleron Pharma (XLRN)Source: Pavel Kapysh / Shutterstock.com Acceleron is a biopharmaceutical company that has been around since 2003. Last year was a wild ride for the firm, and the volatility continued into 2020.In September, one of its drugs in trials was rejected by the FDA and the stock tanked. Then, shortly after that, its drug luspatercept, which treats a rare blood disorder, was approved.And then, in late January, data from a Phase 2 trial of another drug it has in the approval process for pulmonary arterial hypertension (PAH), showed significant positive results in treating the disorder. This is the kind of situation that can attract big buying pressure on Wall Street of the kind I want to see in Growth Investor.Needless to say, the stock is now up 134% in the past year, and 38% in the past month.One of its largest shareholders is Bristol Myers Squibb (NYSE:BMY). Acceleron had been doing a lot of work with Celgene when BMY bought Celgene. This is a great partnership to have when looking to market, manufacture and distribute these new drugs. Neurocrine Biosciences (NBIX)Source: Shutterstock Neurocrine Biosciences has been in business for over 25 years and specializes in developing treatments for people suffering with neurological, endocrine and psychological disorders.It currently has treatments for tardive dyskinesia and endometriosis. It has candidates for Parkinson's, uterine fibroids and congenital adrenal hyperplasia. Last year, there was talk that Biogen (NASDAQ:BIIB) may have been looking at NBIX as an acquisition to build on its own work in some of these sectors.It's a solid company that has a good balance of revenue-generating drugs and a solid, focused drug pipeline. Neurocrine has a unique niche and will remain an attractive takeover target for larger pharmaceutical companies and biotechs.The stock is up 17% for the past year, and 20% in the past month. Galapagos NV (GLPG)Source: Jarretera / Shutterstock.com Galapagos is a Belgian company that specializes in small molecule and antibody therapies.It was a solid performer and has been around for over 20 years. But its big break happened last year when Gilead approached the company and offered it a $5 billion partnership deal. This brought the stock to the attention of many U.S. investors who hadn't paid much attention to it.And by December, that partnership paid off. GILD filed with FDA for speedy review of filgotinib, a potential blockbuster drug that GLPG developed and had in Europe in Japan but not the U.S. The U.S. is the market where the money is made, since pricing is far more dynamic than in other countries.The approval came in December. And this could mean big things for both companies. But since then, Covid-19 has taken the spotlight and Gilead's remdesivir has been all the buzz.GLPG stock is up over 80% in the past 12 months, and almost 45% in the past month. Its management has also been wise enough to partner with a genomics company that provides what's sometimes nicknamed "the mother of all technologies" to help discover new treatments and drug combinations. Incyte Corp (INCY)Source: Eyesonmilan / Shutterstock.com Incyte has been around since the early 1990s and is good-sized biopharmaceutical company with a $21 billion market capitalization.Currently it has two drugs in the marketplace, one of those is in the US. Its big drug is Jakafi (ruxolitinib), which treats a rare form of blood cancer and is also approved to manage acute graft-versus-host disease in adults.It also has a drug that it acquired from ARIAD Pharmaceuticals for European distribution. Its Iclusig (ponatinib) is used to treat leukemia, and INCY stock hopes to make the drug available in the U.S. after approval from the FDA.Incyte also has a good number of drugs in the pipeline and has the financial wherewithal to keep moving them forward, even now.The stock is up 36% in the past 12 months, and over 60% in the past month. Regeneron Pharmaceuticals (REGN)Source: madamF / Shutterstock.com Regeneron is one of those biotech stocks that has been a direct Covid-19 beneficiary.It has a number of drugs in the market and around 30 drugs in its pipeline. It has been around since 1988 and has a $62 billion market cap, so this is no one-trick pony rolling the dice on a potential blockbuster. It has built its reputation over time, delivering solid drugs in important sectors.But the added juice at this point is its arthritis drug Kevzara that it co-markets with Sanofi (NASDAQ:SNY). It has been given to patients in China and New York (the co-founder of Regeneron is from Queens) but the testing isn't broad enough to deliver any conclusive information.Obviously, the bet on Kevzara being a treatment is just that, a bet. But it has brought more attention to REGN, which is a quality pharma. And Regeneron also has its eye on the big picture of next-generation technology to supercharge its genomics research at the Regeneron Genetics Center.The stock is up almost 62% in the past year and up 22% in the past month. Gilead Sciences (GILD)Source: Michael Moloney / Shutterstock.com Gilead has been a big name among biotech stocks for a long time. It was a key player in finding a treatment for HIV/AIDS. And was also a pioneer in finding a highly effective once-a-day regimen for hepatitis C.While it still makes a good amount of money from these blockbusters, it hadn't had a big hit in a while and the stock flat-lined as investors wondered if its best days were behind it.But it has made some interesting acquisitions and partnerships in the past couple years, one of those being with Galapagos.And now, remdesivir is in two Phase 3 clinical trials as a treatment for Covid-19. This, along with the promising partnership with GLPG stock that's already delivering results, promises that GILD could beback in the running with two potential blockbusters. Even one would be great news.The stock is on the move, up 30% in the past 12 months, and 13% in the past month. And it is still off its 2015 highs, so there's plenty of headroom if either - or both - these drug live up to their promise.Gilead is one of the "big kahunas" in this space, and now a household name, thanks to the fight against Covid-19. It, too, is partnering with smaller labs to harness the power of the game-changing technology of our time: artificial intelligence (AI). The AI Master KeyIf artificial intelligence sounds futuristic, even far-fetched -- well, keep in mind, you're already using it every day. If you've ever used Alphabet's (NASDAQ:GOOG, NASDAQ:GOOGL) Google Assistant or Apple's (NASDAQ:AAPL) Siri … if you've had Netflix (NASDAQ:NFLX) recommend a movie or Zillow (NASDAQ:Z) recommend a house … even an email spam filter … then you've used artificial intelligence.In this new world of AI everywhere, data becomes a hot commodity.As scientists find even more applications for artificial intelligence -- from hospitals to retail to self-driving cars -- it's incredible to imagine how much data will be involved.To create AI programs in the first place, tech companies must collect vast amounts of data on human decisions. Data is what powers every AI system. As one AI researcher from the University of South Florida puts it, "data is the new oil."To cash in, you'll want the company that makes the "brain" that all AI software needs to function, spot patterns and interpret data.It's known as the "Volta Chip" -- and it's what makes the AI revolution possible.You don't need to be an AI expert to take part. I'll tell you everything you need to know, as well as my buy recommendation, in my special report for Growth Investor, The A.I. Master Key. The stock is still under my buy limit price -- so you'll want to sign up now. That way, you can get in while you can still do so cheaply.Click here for a free briefing on this groundbreaking innovation.Louis Navellier had an unconventional start, as a grad student who accidentally built a market-beating stock system -- with returns rivaling even Warren Buffett. In his latest feat, Louis discovered the "Master Key" to profiting from the biggest tech revolution of this (or any) generation. Louis Navellier may hold some of the aforementioned securities in one or more of his newsletters. More From InvestorPlace * America's 1 Stock Picker Reveals Next 1,000% Winner * 25 Stocks You Should Sell Immediately * 1 Under-the-Radar 5G Stock to Buy Now * The 1 Stock All Retirees Must Own The post 7 Beautiful Biotech Stocks to Buy Here appeared first on InvestorPlace.