8.22 0.00 (0.00%)
After hours: 4:00PM EDT
|Bid||8.16 x 1800|
|Ask||8.90 x 1000|
|Day's Range||8.07 - 8.71|
|52 Week Range||2.13 - 11.74|
|Beta (3Y Monthly)||0.41|
|PE Ratio (TTM)||N/A|
|Earnings Date||Oct 29, 2019 - Nov 4, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||13.00|
Jenny Harrington, CEO and portfolio manager at Gilman Hill Asset Management, and Rob Sechan, UBS Private Wealth Management, join 'Fast Money Halftime Report' to discuss what needs to happen to get the market to continue upwards.
XBiotech (XBIT) announces that Seth Forman, M.D., will Chair the Company’s upcoming randomized, double-blind, placebo controlled Phase 2 study in Atopic Dermatitis (AD). This second Phase 2 study of bermekimab to treat moderate to severe AD in adults will build on results of a recently completed randomized study that showed rapid improvement in inflammatory lesions and pruritus.
XBiotech Inc. (XBIT) announced today that Peter Libby, M.D., has been appointed to the Company’s Corporate Board of Directors. Dr. Libby has played a pioneering role in discovering how inflammation leads to cardiovascular disease. Dr. Libby is a practicing cardiovascular specialist at Brigham and Women’s Hospital in Massachusetts and he is Mallinckrodt Professor of Medicine at Harvard Medical School.
XBiotech (XBIT) announced today that the Medical Research Council (MRC), part of UK Research and Innovation, has awarded funding to study bermekimab therapy in a Phase 2 multi-center study in advanced cancers.
XBiotech Inc. (XBIT) announced today that it is the recipient of the first place 2019 Commercial Real Estate Award for Industrial Development, chosen by the Austin Business Journal. XBiotech USA Inc. received the award for its integrated R&D, administrative, and manufacturing facility located just 15 minutes from downtown Austin. XBiotech began construction of its state-of-the-art facility in 2015 as part of a master plan to build its worldwide operations headquarters.
XBiotech (XBIT) announces that Alice Gottlieb M.D., Ph.D., will Chair the Company’s upcoming Phase II study in Hidradenitis Suppurativa (HS). Dr. Gottlieb is Medical Director of dermatology at the Mount Sinai Beth Israel Campus, and Clinical Professor at the Icahn School of Medicine at Mount Sinai.
XBiotech Inc. (XBIT) announced today that the Company has been added to the preliminary list of the broad market Russell 3000® Index, which will take effect after US market close on June 28, as part of the 2019 Russell indexes reconstitution. Membership in the Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. Annual reconstitution of the Russell indexes captures the 4,000 largest US stocks as of May 10th, ranking them by total market capitalization.
XBiotech Inc. (XBIT) today announced the closing of its previously announced underwritten public offering of 4,848,485 of its common shares at a public offering price of $8.25 per share. In addition, XBiotech has granted the underwriter a 30-day option to purchase up to an additional 351,515 common shares at the public offering price, less underwriting discounts and commissions. Piper Jaffray acted as the sole underwriter in the offering.
XBiotech Inc. (XBIT) today announced the pricing of an underwritten public offering of 4,848,485 of its common shares at a public offering price of $8.25 per share. The offering is expected to close on or about June 4, 2019, subject to the satisfaction of customary closing conditions. In addition, XBiotech has granted the underwriter a 30-day option to purchase up to an additional 351,515 common shares at the public offering price, less underwriting discounts and commissions. Piper Jaffray is acting as the sole underwriter in the offering.
XBiotech Inc. (XBIT) today announced that it has commenced an underwritten public offering of common shares, subject to market and other conditions. XBiotech intends to grant the underwriter in the offering a 30-day option to purchase additional common shares. Piper Jaffray is acting as the sole underwriter in the offering. The common shares are being offered pursuant to an effective shelf registration statement on Form S-3 previously filed with and declared effective by the Securities and Exchange Commission. The prospectus supplement and accompanying prospectus relating to the offering contain important information relating to the XBiotech common shares.
XBiotech (XBIT) announced plans to advance its dermatology program for its true human antibody bermekimab with the launch of a randomized, double-blind, placebo controlled, Phase 2b clinical study in patients with moderate to severe Hidradenitis Suppurativa (HS). This Phase 2b study will evaluate safety and efficacy of bermekimab at different subcutaneous doses compared with placebo. The Company expects the first patient to be enrolled during the third quarter of 2019.
One would think that the biotechnology sector is immune from trade tensions, but that is not the case. Biotech stocks are very much prone to selloffs during heightened global insecurity. In general, U.S-China trade tensions have derailed investor confidence. Growth sectors filled with unproven businesses, such as biotechs, have been hurt the most as uncertainty is anathema to investors during downturns.In particular, tariffs and trade barriers will raise prices for consumers and crimp economic output. Add the government scrutiny over drug prices and the desire for Medicare for all, and suddenly the prospects worsen for biotech companies.If the U.S. government does not make progress toward changing the drug development and approval process, drug prices will not fall as much as investors fear. Investors could pick the most established drug companies or those with strong prospects but do not yet have a product on the market.InvestorPlace - Stock Market News, Stock Advice & Trading Tips * 7 Dividend Stocks to Buy as the Trade War Reignites There are five biotech stocks investors could buy despite the scrutiny weighing on the sector. Biotech Stocks to Buy: Allergan (AGN)Source: Everjean via FlickrMarkets are scrutinizing the leadership of CEO Brent Saunders. A group of activist shareholders tried but failed to change the executive team. In many ways, Allergan (NYSE:AGN) management is disappointing investors in executing its turnaround and growth plan. The company reported first-quarter net revenue of $3.6 billion, down 2% from last year. Without exchange rate adjustments, core growth would have been up 4.4% Y/Y.Net income grew just 1.3% from last year to $3.79 a share. The company is committed to deploying capital to improve shareholder value. It bought back $800 million of its shares and has another $2 billion left in the plan. It cut net debt/EBITDA to 2.8 times and it increased its dividends by 3% to 74 cents a share.Headwinds: The breast implant regulatory changes hurt its Natrelle line. Though a drop in textured implant sales is a headwind, 90% of Allergan's business is with smooth implants. Five approvals over the next 18 months could offset that business plus weak Alloderm and Coolsculpting revenue. The company expects approval for Cariprazine, Abicipar, Bimatoprost SR, Ubrogepant and CoolTone next.Competition for Botox is still a worry but the company reported revenue of $868 million, up by a healthy 9%, from last year's levels. Even if competition heats up, Allergan benefits from brand recognition and an established customer base. As it improves the product, the company may potentially maintain its market share in 2019. Regeneron Pharmaceuticals (REGN)Source: Shutterstock Regeneron (NASDAQ:REGN) fell sharply lower from $400 to around $325 in recent weeks. Selling pressure on its shares accelerated after the company reported first-quarter results. Earnings fell 3.5% while revenue rose 13.3%. Before the report, REGN stock traded at a P/E in the high teens on expectations that the company would sustain the 26% annual growth reported over the last five years.Skepticism over Praluent and Eylea sales growth caused investors to re-evaluate the company's growth potential. Conversely, its atopic dermatitis drug generated $374 million in quarterly sales, helped by the sequential prescription growth of 18%. An expanded indication of the drug for adolescents and children will accelerate revenue. Markets are ignoring the potential of Dupixent becoming the biggest revenue contributor to the business in the next 2-3 years. The company also received approval for treating asthma, which will further drive sales.Recent Developments: Regeneron is spending plenty of developing drugs to treat cancer. And it has four to six new molecules that it expects will advance to the clinical stage this year. This is on top of the five molecules that advanced in 2018. * 10 Stocks That Could Squeeze Short Sellers, Including CGC Staff hiring and higher SG&A costs hurt profits in the quarter but should benefit the company's bottom line in the near future. Regeneron needs to spend more to support Dupixent for asthma and for the Libtayo launches. Looking ahead, lower promotional costs and higher staff efficiency should lead to higher profits. With REGN stock now at 16 times earnings, investors should take another look at this beaten down stock. XBiotech Inc. (XBIT)Source: Shutterstock Still trading in an uptrend that began last Sept. 2018, XBiotech (NASDAQ:XBIT) is worth another look. On Mar. 1, the company, which is effectively a potential competitor to Regeneron, reported breakthrough results. In its Phase 2 trial of Bermekimab for treating atopic dermatitis, XBiotech demonstrated high efficacy for subjects. The company posted that:After only seven weeks of treatment, 71% of patients that received a 400mg bermekimab weekly regimen had at least 75% reduction in their disease.Further, the company wrote:"Within 7 weeks, using [the] patient reported Numerical Rating Scale (NRS) for itch and pain, patients receiving the 400mg bermekimab treatment regimen had 71% reduction in itch and an 84% reduction in pain."XBiotech is clearly a contender in the eczema space. If it is an eventual competitor to Regeneron, why should investors consider this stock too? XBiotech is valued with a market capitalization of just $342 million. At that level, it could attract a suiter. More clinical results that reaffirm the drug's positive results could also drive the share price higher.In its third-quarter report, XBiotech had $20.85 million in cash and reported a GAAP EPS of a loss of 14 cents. The cash on hand should cover the clinical study costs in the near-term. As the company gets closer to applying for approval, the market may grow more bullish on its stock. Dermira Inc. (DERM)Source: DermiraDermira (NASDAQ:DERM) is also developing a drug in the atopic dermatitis space. Its market cap of $571 million is still above that of XBiotech. It would have been higher if the stock did not peak at $15 in early April, only to trade at $10.70 recently.The company launched Qbrexza, a product for treating excessive sweating, seven months ago. Investor interest grew when the company posted Phase 2b data for Lebri in March. Although Regeneron's Dupixent targets IL-4 and IL-13, Lebri targets IL-13 only. The company believes that IL-13 is the central pathogenic mediator associated with the AD pathophysiology. So if its drug treats the skin barrier dysfunction, the patient itch is reduced and skin infection complications averted.Dermira is finalizing its plans for the Phase 3 study and will meet with the FDA by mid-year. The study will potentially start by the end of 2019. * 7 Winning High-Yield Dividend Stocks With Payouts Over 5% First-Quarter Results: DERM stock fell after the company reported a GAAP EPS loss of $1.49. It generated revenue of $2.45 million. These figures have little meaning at this time because the stock's valuation depends on the clinical trial results for Lebri. For now, revenue growth will depend on Qbrexza prescriptions. Expect strong sales momentum: on the company's website, page views topped 50,000 unique weekly visitors. As the company accelerates brand awareness through advertising, the market share for Qbrexza will continue growing. CRISPR Therapeutics AG (CRSP)Source: Shutterstock Continuing on the theme of biotechnology stocks in the development phase, investors should consider buying CRISPR Therapeutics AG (NASDAQ:CRSP) as shares continue to rebound. The stock fell to as low as $22 last Dec. 2018 but climbed steadily throughout this year. CRSP stock traded recently at $39.10.The company's mandate is to create transformative gene-based medicines for serious diseases. The company has roots in developing a treatment for sickle cell but is expanding its market. In April, the FDA designated its therapy candidate CTX001 for fast track review. Together with its partner, Vertex Pharmaceuticals (NASDAQ: VRTX), the drug, used for the treatment of transfusion-dependent beta thalassemia (TDT), could get to market sooner with the fast track.In February, the company announced that the first patient had been treated with CTX001 in a Phase 1/2 clinical study of patients with TDT. Enrollment for the study is ongoing.CRSPR's next-generation of I/O cell therapy will have two characteristics. First Allogeneic CAR-T will be off-the-shelf and will have more potent starting material. Second, it will have solid tumor efficacy. The benefits include targeting tumors with greater selectivity, avoiding exhaustion, and modulating suppressive TMEs (tumor microenvironments).First-Quarter Results: CRISPR reported a Q1 GAAP EPS loss of 93 cents. As a company still in the product development stage, investors need not be concerned. What is important is its cash balance of $437.5 million in cash as of March 31, 2019. With plenty of funds available to cover R&D costs, the company is unlikely to issue shares in the near-term.As of this writing, the author did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Dividend Stocks to Buy as the Trade War Reignites * 10 Stocks That Could Squeeze Short Sellers, Including CGC * 5 Tech Stocks Getting Crushed Compare Brokers The post 5 Growthy Biotech Stocks to Buy Despite the Scrutiny appeared first on InvestorPlace.
The study is being conducted and led by principal investigator Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai Medical Center2. A total of 18 patients are enrolled in the study.
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XBiotech (XBIT) announced today that breakthrough results from its Phase 2 clinical trial of its antibody therapy, bermekimab, are being presented tomorrow at a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held in Washington, DC. The presentation titled, “Bermekimab is a Rapid and Effective Treatment for Atopic Dermatitis (AD)” will take place on Saturday, March 2 at 1:10pmET in Ballroom A and will be presented by international dermatology expert, and lead researcher in the development of approved therapies for atopic dermatitis, Eric Simpson, M.D, M.C.R. Professor of Dermatology at Oregon Health & Science University, School of Medicine.
Two weeks ago, XBiotech (NASDAQ:XBIT) announced positive results from a small Phase 2 trial. It tested its antibody bermekimab for an uncommon inflammatory skin disorder called hidradenitis suppurativa "HS." Since the positive results, XBIT stock has been flying.Source: Shutterstock In fact, XBiotech stock is up from around $5 at the start of the year to $10. Traders have grown really enthusiastic, bidding shares up another 15% on Wednesday. This is a stunning turnaround from last September, when the stock plummeted to as low as $2.13 per share. At this time, it makes sense to be cautious about XBIT stock following this huge rally. Reasons For SkepticismWhen evaluating biotech companies, there's one thing that should always make you nervous. When you see a company trying to use the same product for many different conditions, it is often a bad sign. XBiotech falls firmly into that category.InvestorPlace - Stock Market News, Stock Advice & Trading TipsOver the years, XBiotech has tried their proprietary antibody for a dazzling array of clinical conditions. These include, but are not limited to: colon cancer, lung cancer, vascular restenosis, leukemia, diabetes and even ebola. After the big colon cancer effort failed to deliver what shareholders had been hoping for, the company also brought in Dr. Peter Libby to head up the company's efforts to try their antibody for heart disease and stroke. * 10 Monster Growth Stocks to Buy for 2019 and Beyond Given the way science works, if you run enough small trials, you are likely to hit statistical significance at least occasionally purely by luck. Keep trying your therapy in different applications and it will probably show a result, eventually, somewhere. For seasoned biotech investors, however, a company seemingly using their therapy as a cure-all is usually a clear sign to avoid the stock. Past XBiotech Data IssuesXBiotech has run into numerous situations which raise doubt during its short life as a public company. For one, it seems to use promotional language on many occasions. For example, in its initial IPO prospectus, the company suggested that in a trial for the pyoderma gangrenosum clinical condition: "findings in several patients suggest improved wound healing."The SEC, however, had questions about this statement, forcing XBiotech to offer up a rather less exciting version of the story. XBiotech replied to the SEC that only two patients received the full treatment. They ceded the point that because "the Company does not have sufficient patients numbers at this point, any data results could possibly be misleading to investors."That wasn't XBiotech's only brush with potentially misleading investors. In their much-anticipated colorectal cancer trials, XBiotech again presented what seemed like promising data. However, this was based on what several observers deemed flawed trial design and an odd choice of clinical endpoints. In the end, XBiotech's cancer data reportedly fell apart under scrutiny. Will Things Turn Out Better Now?XBiotech has pivoted from cancer to skin conditions with its same clinical therapy. Again, it's something to note when a company thinks one product can cure so many diseases. However, the company did report what seems like promising results in several trials for dermatological conditions. Some doctors and observers have lauded the data as "promising" and "stellar."Of course, one must use critical thinking. The latest trial, the one that seems to have started the huge run in XBIT stock, only involved 42 patients. It also is just a Phase 2 trial, which is not designed to garner FDA approval. The majority of drug candidates that pass Phase 2 trials fall apart in Phase 3 when more rigorous trial designs come into play.Many microcap biotech companies can show promising results in Phase 2, but struggle to deliver the goods in much larger and more conclusive Phase 3 trials. Given XBiotech's past history with this same compound in other conditions, it's best to be cautious. XBIT Stock VerdictI'm not an investor in many clinical-stage biotech companies, and that certainly applies to XBIT stock. As it is, most biotech companies without a commercialized product fail, and many of those have more promising stories than XBiotech.It's possible that this compound works in skin conditions despite not working previously in cancers, diabetes and a host of other conditions. But looking at the history of biotech development, the odds are pretty long.As for the stock's recent run, almost all commentary on social media relates to momentum and technical analysis. It seems like most people driving the stock up now are short-term traders. And that's fine. But don't take the recent price action as a sign of any special or inside knowledge about upcoming fundamental developments from XBiotech.And, unfortunately for shareholders, once momentum stops, it tends to reverse pretty quickly. When the people who own a stock are there for technical and momentum reasons, they tend to bail as soon as the price starts declining. If traders don't understand or care about a company's fundamental story, they won't stick around for long. All that is to say that XBIT stock will be vulnerable to a large decline in coming weeks.What would stop the current enthusiasm for Xbiotech? A market correction generally would probably cause shares to decline. There is also the possibility that it will want to raise money while the share price is high.That said, and I will give XBiotech credit here, they still had $21 million in cash as of last quarter and are only burning about $4 million per quarter in operating costs. That suggests they can make it through 2019 without raising more money.Still, that's hardly enough reason to hold onto XBIT stock after such a huge run-up.At the time of this writing, Ian Bezek held no positions in any of the aforementioned securities. You can reach him on Twitter at @irbezek. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * Are These 7 Dividend Aristocrats ETFs Fit for a King? * 7 of the Best Emerging Markets Stocks to Buy * 5 Gold Stocks That Should Glitter in 2019 Compare Brokers The post You Should Be Selling XBiotech Stock After the Huge Gains appeared first on InvestorPlace.
Premier Health Group (PHGRF) (PHGI), Neon Therapeutics Inc (NTGN), Bionano Genomics Inc (BNGO), and XBiotech Inc (XBIT) represent four biotech companies working to champion new treatments for consumers in the space. The Company has magnetized investors looking for opportunities in the biotech sector by strategically investing in products and services that demonstrate Premier's dedication to the industry, as well to patients simply looking for a means of feeling better. Premier Health Group (PHGRF) (PHGI) announced towards the end of last month that, further to itsnew release dated January 10, 2019, the Company has acquired all outstanding securities of Cloud Practice Inc. As a result of the acquisition, Cloud Practice's Founders, including CEO Jordan Visco, and entire support team, consisting of several software developers and sales staff, will join and work alongside the Premier Health team to offer tools and resources providing for better efficiency on a day-to-day basis for both physicians and customers.
XBiotech (XBIT) announced today that findings from its open label, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis (AD) will be presented at the “Late-Breaking Research: Clinical Trials” forum at the American Academy of Dermatology (AAD) Annual Meeting being held March 1-5, 2019 in Washington, D.C. The oral presentation titled, “Bermekimab is a Rapid and Effective Treatment for Atopic Dermatitis (AD)”, will be delivered by international expert and advisor for XBiotech, Eric Simpson, M.D., M.C.R., Professor of Dermatology at Oregon Health & Science University School of Medicine, during the afternoon session on March 2nd, 2019.
AUSTIN, Texas, Jan. 28, 2019 -- XBiotech (NASDAQ: XBIT) announced today that Dr. Alice Gottlieb, M.D., Ph.D., will be giving the presentation “Bermekimab Shows Efficacy for.
XBiotech (XBIT) announced today the successful outcome of its multicenter, open label, confirmatory study using bermekimab to treat patients with moderate to severe Hidradenitis Suppurativa (HS). Primary and key secondary endpoints were met in this study with significant, differentiating findings. The Company previously published data from its double-blind placebo controlled study in HS using bi-weekly, intravenous infusions of bermekimab in which safety and primary efficacy endpoints were met.
The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these symptoms stabilized or improved with treatment.
XBiotech (XBIT) announced today that its open label, proof of concept, multicenter study using bermekimab to treat patients with moderate to severe atopic dermatitis (AD) has completed and the study met all primary and secondary endpoints.
XBiotech Inc. (XBIT) today announced a successful GMP (Good Manufacturing Practices) audit by Eurofins Amatsigroup. The audit was conducted in connection with XBiotech’s distribution in Europe of its US-manufactured biological drug product. XBiotech manufactures bermekimab at its campus facility in Austin, Texas and regularly ships the drug to clinics in various countries in the European Union and the United Kingdom.