|Analysts review the pros and pitfalls involved in a Pfizer/Allergan megamerger; Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene|
|By Marilyn Mullen|
|Thursday, 29 October 2015 18:38|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 29, 2015.
The Wall Street Journal broke the news last night that Pfizer (NYSE: PFE) and Allergan (NYSE: AGN) have had some early discussions about merging into a $330 billion behemoth. Neither company is saying much, though Allergan did confirm the talks this morning. But the irresistible conclusion remains that a deal just might make sense. At the very least, Pfizer isn't being subjected to the same kind of furious backlash it faced when the company made an ill-fated--and ill-considered--attempt to acquire AstraZeneca ($AZN) last year.
Why the change of tune? Here's a sampling of what analysts are thinking. --- First and foremost: Pfizer CEO Ian Read never lost interest in a megadeal that would get his Big Pharma tax base shifted to a much more pleasant tax climate. Allergan, technically based in Ireland, would fit the bill on both scores.
Tim Anderson, a careful and longtime Pfizer observer, notes this morning that Allergan, Shire ($SHPG), AstraZeneca, and GlaxoSmithKline ($GSK) could all provide the tax inversion that Pfizer is hunting, but only Allergan seems open to a merger like this. And if it's priced around $375 to $400, those numbers would work.
"This is a comparatively low risk transaction," notes Anderson. "Allergan is (mostly) a US company operating mainly in the primary care markets which Pfizer understands well. The two organizations are geographically close, and the post-merger integration would therefore be easier than a transatlantic deal."
It would also help Pfizer make some big, overnight changes to its numbers. --- "Pfizer desperately needs a large acquisition and the resulting synergies to reinvigorate its tepid earnings growth rate," Maxim Jacobs, an analyst at Edison Investment Research, told Reuters.
Another point that would bode well for a deal: Allergan CEO Brent Saunders has never been enthusiastic about spending the big bucks on early-stage research. Pfizer's history in megadeals is well known. It mashes together huge organizations, lays off thousands and throws off anything that it doesn't want or need. An Allergan deal wouldn't be resisted based on a commitment to their R&D game plan, something that AstraZeneca and the other likely targets could never stomach. Anderson projects R&D and SG&A cuts of 40% at Allergan, given Pfizer's track record. (Allergan spent $885 million on R&D in the first six months of this year.)
So what would stop a deal? --- Evercore ISI's Umer Raffat put together some slides this morning highlighting Saunders' thoughts on a possible buyout from earlier in the year. Saunders was vaulted ever upward in the swift series of deals that made Allergan what it is today. And finding the right positions for himself and other top execs after a merger could be a big sticking point.
Any company looking to acquire Allergan would have to be open to a "culture change and change and balance to leadership and talent and management," Saunders noted.
Anderson's thoughts: "It is natural to wonder if Saunders could lead one the Pfizer divisions if the company eventually goes down the path of splitting up. However, will he stick around that long?"
Saunders' initial strategy will focus primarily on price. --- "We do not … see Allergan accepting a price below $400 per share," notes Nomura. "While Allergan's valuation has come down significantly (and unfairly in our view) due to the recent sell-off across the sector, we continue to believe this is one of the best companies in the sector with a fundamental fair value of $350. Given the benefits to Pfizer from a merger with Allergan, and accounting for typical premiums paid in our sector (around 25%), we believe that Pfizer would need to pay in excess of $400 per share to satisfy both shareholders and management."
The wild card here may be held by the Obama administration. The wave of tax inversions that hit last year spurred Treasury to come up with some new tax rules that made it harder to pull off a deal like this. Faced with the loss of Pfizer, the administration may be willing to go one more big step forward on that front. And don't forget the current controversy over drug pricing and the election year ahead. Candidates are likely to step in here as well, and Pfizer isn't likely to get much sympathy from either party for a tax dodge like this.
Still, it is interesting to note that most of the discussion today focuses on the mechanics of a deal, rather than a simple rejection of any new attempt at a megamerger. A slew of big tie-ups in 2009 led to one simple consensus: Megamergers destroy innovation and value. But that argument has gone by the wayside, for now. And Pfizer will want to leave it there.
Repros Therapeutics Inc. (RPRX) today announced that the Division of Bone, Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA) has cancelled the scheduled November 3, 2015 advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal(R), due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.
The FDA has expressed its willingness to work with Repros to address these questions. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015.
Conference Call Details:
Time: Thursday, October 29, 2015 -- 3:30 PM Eastern
Participant Dial-In Number (Domestic): 888-225-7740; International: 303-223-2694
Any investor inquiries directed to the Company should be placed through our investor relations contact --- Investor Relations: Thomas Hoffmann; The Trout Group; (646) 378-2931; [email protected]
With the Allscripts (NASDAQ:MDRX) Open platform, physician practices can deploy innovative technologies that help their organizations and their patients right away. Clients can integrate third-party applications into their Allscripts electronic health records (EHRs) and Practice Management (PM) systems in a matter of minutes or hours—instead of days or weeks. It's one of many transformational aspects of the Allscripts platform that recently motivated Microsoft to recognize Allscripts Chief Innovation Officer Stanley Crane with the 2015 CXO Next Innovation Award.
Allscripts Rapid Install™ is just one potential benefit of the flexibility of Allscripts Open platform. The Open platform reduces or eliminates the cost, time and planning involved in traditional HL7 interface implementations. As a result, physician practices can quickly deploy many Allscripts Developer Program (ADP) partner applications with little or no implementation cost. Once the practice has the Allscripts Unity™ interface engine, it acts like a power strip. The practice can then buy and use as many certified developer applications as it wants, quickly and seamlessly. Several recent installations prove that Allscripts clients can quickly activate the innovative tools they need.
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced data demonstrating that AR-12 is a promising novel antifungal agent for the treatment of onychomycosis, a common fungal infection of the fingernails and toenails, with activity against two primary fungal organisms responsible for causing the condition. Results will be presented in a poster presentation, titled "Trans-ungual Delivery of AR-12, a Novel Antifungal Drug" (Poster R6046), on Thursday, October 29 during the 2015 American Association of Pharmaceutical Scientists Annual Meeting and Exposition, being held in Orlando, FL.
Stefan Proniuk, Ph.D., Chief Development Officer of Arno Therapeutics, commented, "Onychomycosis is an infection that leads to thickened, discolored and split nails and that has increasing prevalence in the U.S. – currently affecting approximately 10% of the general population1 and resulting in a growing need for more effective drugs for improving the success rate and decreasing the required duration of topical therapy. The effectiveness of current topical therapies on the market may in part be limited due to the poor permeability of the nail plate to topically-applied therapeutic agents. AR-12 has been found to penetrate the nail bed and to be highly potent against Trichophyton rubrum fungus which is predominantly responsible for causing onychomycosis. While early, these findings indicate that AR-12 may have substantial clinical potential as a new drug candidate for treating onychomycosis as a result of its ability to penetrate across the nail plate. The results of this study provide a strong rationale for further development. Furthermore, we are pleased that AR-12 has demonstrated its potential versatility in yet another infectious disease."
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today announced its participation in three upcoming investor conferences:
The 2015 Citi Global Healthcare Conference at the New York Palace in New York City on Thursday, November 5, 2015. Isaac Ciechanover, President and CEO of Atara Bio and John McGrath, CFO of Atara Bio, will host meetings with investors during this conference.
The Goldman Sachs U.S. Emerging / SMID Cap Growth Conference 2015 at the Crowne Plaza Times Square on Thursday, November 19. Gad Soffer, COO of Atara Bio, will present at 1:10 PM ET and Gad Soffer and Chris Haqq, M.D., CMO of Atara Bio will also host meetings with investors.
The Jefferies Autumn 2015 Global Healthcare Conference at the May Fair Hotel in London on Thursday, November 19. Isaac Ciechanover, President and CEO of Atara Bio, is scheduled to present at 5:20 PM GMT, and will also host meetings with investors.
Live webcasts of the presentations at the Goldman Sachs and Jefferies conferences will be available by visiting the Investors section of the Atara Bio website at www.atarabio.com. Archived replays of these webcasts will be available on the Company's website for 14 days following the conferences.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that its Chief Medical Officer, Joseph Stauffer, D.O., M.B.A., will present a late-breaking poster at Kidney Week 2015, the American Society of Nephrology's Annual Meeting. The event will be held November 5-8, 2015 at the San Diego Convention Center.
Details for the late-breaking poster are as follows: Title: "CR845, a Novel Kappa Opioid Receptor Agonist, Reduces Moderate-to-Severe Pruritus and Improves Quality of Life in Chronic Kidney Disease Patients Undergoing Hemodialysis"
Poster Number: SA-PO1117
Session: Late-Breaking Posters
Location: Exhibit Hall A, San Diego Convention Center
Date: Saturday, November 7, 2015
Time: 10:00 a.m. – 12:00 p.m. PT
For more information on Kidney Week 2015, visit https://www.asn-online.org/education/kidneyweek/.
CAS Medical Systems, Inc. (NASDAQ:CASM), a leader in medical devices for non-invasive patient monitoring, announces the sale of assets related to its 740 SELECT® vital signs monitoring product line to Zoe Medical, Inc. The sale of the 740 SELECT product line coupled with the phase-out of earlier generation monitors completes the Company's exit from the vital signs monitoring market.
"Divesting these non-strategic assets allows for added focus on our core business of FORE-SIGHT® cerebral oximeters and sensors," said Thomas M. Patton, President and Chief Executive Officer of CASMED. "We have made substantial progress in our transition to a single-use disposables business model as FORE-SIGHT sensors sales have represented an increasingly large percentage of total sales. We have recorded 21 consecutive quarters of double-digit sensor sales growth in the U.S. and recently launched our FORE-SIGHT ELITE® products for use with pediatric and neonatal patients. Our FORE-SIGHT business continues to track well against our expectations that the second half of 2015 will be stronger than the first half."
Zoe Medical will take assignment of CASMED's vital signs monitor distribution organization after a transition period. Therefore, all customer relationships will be maintained without interruption. CASMED will continue to provide service for its legacy 740 brand monitors.
"The addition of the 740 SELECT product line to our organization represents a great opportunity to bring the technology to new markets," commented Dr. Bengt Hermanrud, Zoe Medical's CEO. "As both a developer and supplier of the SELECT, our familiarity with the product will allow us to quickly create exciting new clinical solutions for our customers."
With the divestiture of the 740 SELECT product line, CASMED has reclassified its entire vital signs monitoring results to discontinued operations. Sales of vital signs monitors were $3.7 million in 2014 and $1.3 million for the six months ended June 30, 2015. Reclassifying the vital signs monitoring to discontinued operations for both periods had no material effect on the Company's results from continuing operations.
CAS Medical Systems, Inc. (NASDAQ:CASM), a leader in medical devices for non-invasive patient monitoring, announces that it will report financial results for the third quarter of 2015 on Thursday, November 5, 2015, prior to the market's opening. Management will host a conference call to discuss these results and answer questions at 10:00 a.m. Eastern time that day.
Conference call dial-in information is as follows:
U.S. callers: (866) 239-5859
International callers: (702) 495-1913
Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company's website: www.casmed.com.
A telephone replay will be available from 1:00 p.m. Eastern time on November 5, 2015, through 11:59 p.m. Eastern time on November 19, 2015. Replay dial-in information is as follows:
U.S. callers: (855) 859-2056
International callers: (404) 537-3406
Conference ID number (U.S. and international): 59589283
The replay will also be available at www.casmed.com.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it will report financial results for the third quarter ended September 30, 2015, on Thursday, November 5, 2015, before the market opens. Chimerix's management team will host a live conference call and audio webcast at 8:30 a.m. ET on Thursday, November 5, 2015 to discuss the Company's results and provide a business overview.
To access the live conference call, please dial (877) 354-4056 (domestic) or (678) 809-1043 (international) at least five minutes prior to the start time, and refer to conference ID 65612276. A live audio webcast of the call will also be available on the Investors section of the Company's website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.
ChemoCentryx, Inc. (Nasdaq:CCXI),a clinical-stage biopharmaceutical developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, today announced that the Company's third quarter 2015 financial results will be released after market close on Monday, November 9, 2015. ChemoCentryx executive management will host a conference call beginning at 5:00 p.m. Eastern Time on November 9, 2015 to discuss these results and to answer questions.
To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 60905026. A live and archived audio webcast can be accessed through the Investors section of the Company's website at www.ChemoCentryx.com. The archived webcast will remain available on the Company's website for fourteen (14) days following the call.
Fibrocell Science, Inc. (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, will report third quarter 2015 results on Thursday, November 5, 2015, before the open of the U.S. financial markets. Fibrocell will also host a conference call and webcast at 8:30 a.m. ET on the same day to discuss its financial results and operational highlights. A question-and-answer session will follow Fibrocell’s remarks.
To participate on the live call, please dial 855-877-0343 (domestic) or +1-678-509-8772 (international), and provide the conference code 59105396 five to ten minutes before the start of the call. The conference call will also be webcast live under the investor relations section of Fibrocell's website at www.fibrocellscience.com/investors/events-and-presentations/, and will be archived there for 30 days following the call. Please visit Fibrocell's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
Geron Corporation (Nasdaq:GERN) will announce its financial results for the third quarter ended September 30, 2015, on Thursday, November 5, 2015, after the market close. Geron’s management will also host a conference call for analysts and investors on Thursday, November 5, 2015, at 4:30 p.m. Eastern Time to discuss the company’s third quarter results and recent events.
Participants can access the conference call live via telephone by dialing 888-288-0246 (U.S.); 440-996-5682 (international). The conference ID is 69664109. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only webcast is also available at http://edge.media-server.com/m/p/8h3xqwwa/lan/en. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through December 5, 2015.
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced it will release its financial and operational results for the third quarter ended September 30, 2015 on November 12, 2015 before the market opens.
Histogenics’ management will host a conference call on Thursday, November 12, 2015 at 8:30 a.m. EST. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial (855) 890-8663 (domestic) or (720) 634-2936 (international) and provide the conference ID “60793192” five to ten minutes before the start of the call.
A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com. A replay of the webcast will be archived on Histogenics’ website for approximately 60 days following the presentation.
iCAD, Inc. (Nasdaq:ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today reported financial results for the three months and nine months ended September 30, 2015.
Third Quarter Highlights:
"During the third quarter we continued to execute on our strategic initiatives to capitalize on the significant long-term opportunities in our Cancer Detection and Therapy businesses," said Ken Ferry, Chief Executive Officer. "Cancer Detection product revenue was up 17.6%, led by strong demand for upgrades to PowerLook, our 2D and 3D mammography platform, and iReveal, our breast density product, both of which we expect to double over 2014 results. We believe a main contributor to the momentum for PowerLook upgrades is our customer base preparing for the adoption of 3-D tomosynthesis and the workflow tools that we expect will significantly improve reader efficiency. In addition, we received positive feedback from customers on the launch of our iReveal breast density solution and plan to introduce a 3D capability by the end of the year, further enhancing the breast density market opportunity.
Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today highlighted the application of its GLAASTM discovery platform in MedImmune's Phase 2 clinical trial of MEDI7510. MEDI7510 is an investigational agent for the prevention of respiratory syncytial virus (RSV) under development by MedImmune, the global biologics research and development arm of AstraZeneca. MEDI7510 is composed of MedImmune's RSV sF antigen plus GLA, a synthetic molecule licensed from Immune Design's GLAAS discovery platform.
This stems from an existing agreement in which Immune Design granted MedImmune an exclusive license to use the GLAAS platform to develop and commercialize vaccines in two different infectious disease indications, one of which is RSV.
The Phase 2, double-blind, randomized, placebo-controlled study (NCT02508194) is designed to assess the efficacy of MEDI7510 for the prevention of acute RSV-associated respiratory illness in older adults. The study will also evaluate the safety and immunogenicity of MEDI7510 or placebo and immune response to MEDI7510 in Season 1 and Season 2. The trial is expected to enroll approximately 1,900 adult subjects, 60 years or older, globally.
"It's rewarding to see MEDI7510 continue to advance through clinical development," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer at Immune Design. "The field of RSV vaccines has been challenging. A small molecule that activates TLR4 and drives a Th1-type of immune response should be ideally suited to overcome the Th2-prone activity of RSV antigens, which can result in severe lung pathology. We are hopeful of the potential benefit MEDI7510 may bring to older adults."
Immunomedics, Inc. (Nasdaq:IMMU) today announced that it will host a conference call and live audio webcast on Thursday, November 5, 2015 at 10:00 a.m. Eastern Time to discuss financial results for the first quarter of fiscal year 2016, and review key clinical developments and future planned activities.
To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 54517808. The conference call will be webcast via the Investors page on the Company's website at www.immunomedics.com. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company's website for 30 days through December 4, 2015.
The Company will report financial results for the first quarter ended September 30, 2015 after the close of U.S. financial markets on Wednesday, November 4, 2015.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that it will host a conference call and live webcast discussion at 8:00 a.m. Eastern Time on Thursday, November 5, 2015, to discuss financial results for the third quarter ended September 30, 2015, and provide a business update.
To access the live conference call via phone, dial 1-844-835-6563. International callers may access the live call by dialing 1-970-315-3916. The conference ID number for the live call is 67764396.
The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. The webcast replay will be available on the website until November 10, 2015.
LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN) today announced that the Company will report sales results for the period ended September 30, 2015, prior to the opening of trading on NASDAQ on November 12, 2015, and will host a business update conference call and webcast that same day at 8:00 AM Central Time (9:00 AM Eastern Time, 2:00 PM GMT).
Sales for LivaNova's three business units will be reported in U.S. dollars for the following periods:
LivaNova intends to provide formal financial guidance for fiscal 2016 in February 2016, concurrent with the reporting of financial results for the twelve-month period ended December 31, 2015.
LifeVantage Corporation (Nasdaq:LFVN), has launched TrueScience Micro Lift Serum for immediate distribution in the United States. The TrueScience Micro Lift Serum is a natural way to instantly diminish the look of crow’s feet, baggy skin, and dark circles around the eyes. In as little as 3 minutes, it visibly tightens, smooths, and firms the skin around the eyes, quickly restoring a youthful looking radiance without sacrificing long-term skin health. The TrueScience Micro Lift Serum pairs with the revolutionary TrueScience™ Skin Care system and is only available from LifeVantage.
“Customers today expect instant results from the products they use,” said LifeVantage President and Chief Executive Officer Darren Jansen. “ Our TrueScience Micro Lift Serum is in alignment with our strategy of offering demonstrable and effective products. It’s the ideal companion to our TrueScience skin care system that uses proven ingredients to take years off of your appearance and now provides instant and long term anti-aging benefits.”
MELA Sciences, Inc. (NASDAQ:MELA), a medical technology company dedicated to developing and commercializing innovative products for the diagnosis and treatment of serious dermatological disorders, will release third quarter financial results on Thursday, November 12, after the market close. MELA Sciences President and Chief Executive Officer, Michael Stewart, and Robert Cook, Chief Financial Officer, will host a conference call at 4:30pm Eastern Time to review the Company's progress and answer questions.
Conference Call Details:
Date: Thursday, November 12
Time: 4:30pm Eastern Time
Toll Free: 888-430-8691
Replays, available through November 26, 2015
Toll Free: 877-870-5176
Replay PIN: 714691
QLT Inc. (NASDAQ:QLTI) (TSX:QLT) is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. The Company reported financial results today for the third quarter ended September 30, 2015. Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP.
Quotient Limited (NASDAQ:QTNT), a commercial-stage diagnostics company, today announced that a total of 4,981,052, or 99.6%, of its outstanding warrants were exercised prior to their expiration at 5:30 p.m. New York City time on October 26, 2015. The warrants had previously traded on the NASDAQ Global Market under the symbol "QTNTW" and were delisted in connection with their expiration.
As a result of the exercises of the warrants, Quotient received gross proceeds of approximately $35.1 million and issued a total of 3,984,823 ordinary shares. A total of 5,000,000 warrants had been issued in conjunction with Quotient's initial public offering. The 18,948 remaining warrants that were not exercised prior to the expiration time have expired. As of October 28, 2015, there were 20,961,292 ordinary shares issued and outstanding.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it will report financial results for the third quarter of 2015 on Monday, November 9, 2015.
The Company will also host a conference call on Monday, November 9, 2015, at 9:00 am EST to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers five to ten minutes prior to the start of the call: United States: +1-877-280-1254; International: +1-212-444-0412; and Israel: +972-3-721-9510. The access code for the call is 7362435.
The conference call will be broadcasted live and available for replay on the Company's website, http://ir.redhillbio.com/events.cfm, for 30 days. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.
Revance Therapeutics, Inc. (NASDAQ:RVNC), announced positive 24-week results today from its multi-center BELMONT Phase 2 active comparator study of injectable RT002. The ongoing study for the treatment of glabellar lines in 268 subjects compared the safety, efficacy and duration of effect of three doses of RT002 against placebo, and current market leader, BOTOX Cosmetic/ VISTABEL®. The topline interim data showed that RT002-- a botulinum toxin type A investigational drug product candidate for injection-- achieved its primary efficacy measurement for all three doses at 4 weeks. The study demonstrated 6-month RT002 median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale.
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that it will host a conference call on Thursday, November 5, 2015 at 11:00 a.m. Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2015.
The call can be accessed by dialing (877) 771-6242 (U.S. and Canada) or (440) 996-5676 (international), and entering passcode 66013619.
To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website for two weeks.
T2 Biosystems, Inc. (NASDAQ: TTOO), a company developing innovative diagnostic products to improve patient health, today announced that Rhode Island Hospital, the principal teaching hospital of The Warren Alpert Medical School of Brown University, the University of Alabama at Birmingham Hospital and The Statens Serum Institut in Denmark are among the first adopters of its T2Candida® sepsis diagnostic. Run on the T2Dx Instrument, the T2Candida Panel detects Candida, the most lethal cause of sepsis. T2 Biosystems provides the first and only sepsis diagnostic that provides species specific results and does not require blood culture, delivering accurate results in three-to-five hours compared to two-to-six days for a blood culture.
"We are pleased to be working with such leading institutions that are implementing our platform with the goal of improving and saving the lives of patients while reducing the cost of treating sepsis," said John McDonough, chief executive officer of T2 Biosystems. "These partnerships are an important first step towards us realizing our vision of making a difference in the management of sepsis for patients, hospitals and healthcare overall."
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for third-quarter 2015 and provided an update on the Company's development programs.
"The FDA approval of TESARO's first product, VARUBI™, offers a new treatment option for patients with cancer who are affected by nausea and vomiting caused by chemotherapy and represents a significant milestone for TESARO," said Lonnie Moulder, CEO of TESARO. "Our field organization is fully in place, and we look forward to providing VARUBI™ to patients in mid-November. In addition to VARUBI™, we are building a franchise around niraparib in ovarian cancer, and we are enthusiastic about the potential to expand our development program for this molecule to include several new tumor types. The Phase 3 NOVA trial of niraparib was initiated more than two years ago, and patient enrollment completed seven months ago. Based upon a recently completed HRD assessment of tumor samples and a greater than anticipated duration of treatment, we now look forward to top-line data from NOVA in the second quarter of 2016. We are very optimistic about the potential of niraparib for patients with ovarian, breast and other cancers."
Transcat, Inc. (NASDAQ:TRNS), a leading provider of accredited calibration and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, announced that Lee D. Rudow, President and Chief Executive Officer, and John J. Zimmer, Senior Vice President of Finance and Chief Financial Officer, will present at the Drexel Hamilton Micro-Cap Conference in New York City on November 12, 2015.
The Transcat presentation is scheduled to begin at 9:30 a.m. ET. A link to the live webcast of the presentation, along with presentation materials, will be available at www.transcat.com/investor-relations. An archive of the presentation will be available in the Investor Relations section of the website, along with a transcript once available.
Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced financial results for the third quarter and nine months ended September 30, 2015.
Jay Shepard, Chief Executive Officer, commented, "With the initiation of VITAL, our Phase 2 trial for once-monthly treatment in adult GHD patients, we added another significant market opportunity for somavaratan during the quarter. We believe there is significant need for a long-acting treatment in this adult population. With three late-stage trials and our ongoing Extension Study, Versartis is continuing to make important advancements in the clinical development of somavaratan and is positioning the company for long-term growth within very attractive markets."
Mr. Shepard continued, "As we entered the fourth quarter, we continued to make good progress enrolling children into our ongoing pediatric studies and remain on track to complete enrollment of VELOCITY by the middle of 2016. Looking ahead into 2016, we have a clear focus on the development of somavaratan for both pediatric and adult patients across several geographies. To date, we have generated promising efficacy and safety results that we believe position somavaratan as the leader among current long-acting growth hormone therapies in development."
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of antibody therapeutics, announced the Company will host a conference call on Thursday, November 5, 2015, at 4:30 p.m. Eastern time to discuss third quarter 2015 financial results and provide an update on its endocrine franchise.
The webcast can be accessed via the Investors & Media section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on February 5, 2016. Telephone numbers for the live audiocast are 877-369-6589 (U.S./Canada) and 408-337-0122 (international).