On February 20, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that representatives from the Company’s executive and clinical development teams will be attending the BMT Tandem Meetings, the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) (Press release, Actinium Pharmaceuticals, FEB 20, 2018, View Source [SID1234524062]).The conference is being held February 21 through February 25, 2018, at the Salt Palace Convention Center in Salt Lake City, Utah.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Actinium’s planned Phase 2 trial for Actimab-MDS will be highlighted in the Company’s Product Theater, Actimab for CD33 Expressing Hematologic Malignancies, which will feature Dr. Sergio Giralt, Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center and Dr. Koen van Besien, Director, Stem Cell Transplant Program at Weill Cornell Medical Center. The planned Phase 2 trial for Actimab-MDS will study Actinium’s anti-CD33-actinium-225 antibody radio-conjugate (ARC) as a myeloablative agent prior to a bone marrow transplant for patients with high-risk myelodysplastic syndrome (MDS) with a p53 genetic mutation. Actinium will be conducting an investigator meeting with representatives from current and prospective clinical trial sites from the Company’s pivotal Phase 3 SIERRA trial for Iomab-B. Also, Actinium will formally meet with the Iomab-B Scientific Advisory Board (SAB) to discuss the ongoing SIERRA trial and other initiatives in improved myeloablation.

Dr. Mark Berger, Chief Medical Officer of Actinium said, "With our mission at Actinium to improve the pathway for patients undergoing bone marrow transplants, the annual BMT Tandem Meetings is a critical forum that enables us to meet with Key Opinion Leaders (KOLs) in the area of bone marrow transplant medicine to share our latest research findings and learn from others. Our attendance at this event offers a rich opportunity to gain insight into the latest developments in our field of science. We are very much looking forward to our investigator and SAB meetings that will provide us with the opportunity to further highlight Iomab-B’s highly differentiated profile and discuss certain aspects of the SIERRA trial such as our recent protocol amendment, crossover rates and case studies with representatives from leading bone marrow transplant centers."

The BMT Tandem Meetings include an exciting scientific program that addresses state-of-the-art issues in bone marrow transplant. Meeting attendees include investigators, clinicians, laboratory technicians, clinical research professionals, nurses, pharmacists, administrators and allied health professionals seeking to benefit from its hematopoietic cell transplantation focused program.

Sandesh Seth, Actinium’s Executive Chairman said, "Our Iomab-B and Actimab-MDS drug candidates are critical elements to our overall strategy at Actinium to improve transplant access and outcomes via improved myeloablation. We anticipate this year’s conference to be even more productive for us than last year as we are attending as the only company with a multi-disease, multi-product pipeline focused on improved myeloablation."

About BMT Tandem Meetings

Annually, the BMT Tandem Meetings are the largest gathering in North America of worldwide experts in blood and marrow transplant patient care, clinical investigation and laboratory research. Over 3,000 transplant physicians in over 500 transplant centers from >50 countries participate in the CIBMTR. The ASBMT has a membership of over 2,300 clinicians and researchers. By combining our meetings, we expect over 3,200 participants at next year’s meetings representing more than 50 countries, with approximately 20% coming from outside the United States.

On February 20, 2018 Medtronic plc (NYSE: MDT) reported financial results for its third quarter of fiscal year 2018, which ended January 26, 2018 (Press release, Medtronic, FEB 20, 2018, View Source;p=RssLanding&cat=news&id=2333238 [SID1234524055]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company reported third quarter worldwide revenue of $7.369 billion, an increase of 1 percent as reported, or 7 percent on a comparable, constant currency basis, which adjusts for the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred in the second quarter, and a $177 million positive impact from foreign currency.

As reported, third quarter GAAP net loss and loss per share (LPS) were $1.389 billion and $1.03, respectively. GAAP results included a $2.2 billion net charge primarily related to the U.S. transition tax charge as part of U.S. tax reform. As detailed in the financial schedules included through the link at the end of this release, third quarter non-GAAP net income and diluted EPS were $1.592 billion and $1.17, increases of 3 percent and 4 percent, respectively. Adjusting for the divestiture and a negative 1 cent impact from foreign currency, third quarter non-GAAP diluted EPS increased 12 percent.

Third quarter U.S. revenue of $3.912 billion represented 53 percent of company revenue and decreased 5 percent as reported, or increased 6 percent on a comparable basis. Non-U.S. developed market revenue of $2.355 billion represented 32 percent of company revenue and increased 7 percent as reported, or 5 percent on a comparable, constant currency basis. Emerging market revenue of $1.102 billion represented 15 percent of company revenue and increased 12 percent on both a reported and a comparable, constant currency basis.

"Our results reflect a solid quarter for Medtronic, and as we expected, a strong turnaround from the first half of our fiscal year," said Omar Ishrak, Medtronic chairman and chief executive officer. "We continue to execute on our broad, sustainable growth strategy, driving therapy innovation and global market penetration, while delivering enterprise synergies to enable margin improvement."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide third quarter revenue of $2.800 billion increased 10 percent, or 7 percent on a constant currency basis. CVG revenue performance was driven by strong, mid-teens growth in CSH and mid-single digit growth in CRHF and APV, all on a constant currency basis.

CRHF third quarter revenue of $1.457 billion increased 6 percent, or 4 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-teens constant currency growth in AF Solutions, as well as strong adoption of the Micra Transcatheter Pacing System and TYRX absorbable antibacterial envelope. Heart Failure grew in the mid-single digits on a constant currency basis, driven by strong double digit constant currency growth in Mechanical Circulatory Support from sales of the HVAD(TM) System, as well as continued solid demand for the company’s portfolio of quadripolar cardiac resynchronization therapy pacemakers (CRT-P).
CSH third quarter revenue of $886 million increased 18 percent, or 14 percent on a constant currency basis, led by low-thirties constant currency growth in transcatheter aortic valves on the strength of the CoreValve Evolut PRO and U.S. intermediate risk indication. Coronary grew in the low-double digits on a constant currency basis, driven by strong demand for the company’s Resolute Onyx(TM) drug-eluting stent in the U.S. and Japan.
APV third quarter revenue of $457 million increased 7 percent, or 5 percent on a constant currency basis. Aortic grew in the low-single digits on a constant currency basis, driven by the performance of the Valiant Captivia thoracic stent graft system. Peripheral grew in the mid-single digits on a constant currency basis, driven by double digit growth in both PTA balloons and drug-coated balloons. High-single digit growth in endoVenous was driven by a strong performance of the VenaSeal(TM) closure system.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide third quarter revenue of $2.041 billion decreased 16 percent as reported, or increased 6 percent on a comparable, constant currency basis. MITG revenue performance was driven by high-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

SI third quarter revenue of $1.384 billion increased 7 percent on a comparable, constant currency basis, driven by growth from new products in Advanced Energy and Advanced Stapling, including LigaSure(TM) vessel sealing instruments with nano-coating, endo stapling specialty reloads, and the Signia(TM) powered stapler.
RGR third quarter revenue of $657 million increased 3 percent on a comparable, constant currency basis. GI and Hepatology grew in the low-double digits on a comparable, constant currency basis, with strength across the GI therapeutics, diagnostics, and ablation product lines. Respiratory and Patient Monitoring grew in the low-single digits on a comparable, constant currency basis, with strength in Nellcor(TM) pulse oximetry sensors given the strong incidence of influenza in the U.S.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide third quarter revenue of $1.944 billion increased 7 percent, or 5 percent on a constant currency basis. Group results were driven by low-double digit growth in Brain Therapies, high-single digit growth in Pain Therapies, and mid-single digit growth in Specialty Therapies, offsetting flat results in Spine, all on a constant currency basis.

Spine third quarter revenue of $661 million increased 1 percent, or was flat on a constant currency basis. Mid-single digit constant currency growth in bone morphogenetic protein (BMP) partially offset low-single digit declines in Core Spine, which were consistent with the Core Spine market.
Brain Therapies third quarter revenue of $585 million increased 13 percent, or 10 percent on a constant currency basis. Neurovascular grew in the high-teens on a constant currency basis, with strength across its stroke product portfolio. Neurosurgery grew in the low-double digits on a constant currency basis, led by strong sales of the StealthStation S8 surgical navigation system and O-arm2 surgical imaging system.
Specialty Therapies third quarter revenue of $398 million increased 8 percent, or 6 percent on a constant currency basis. High-single digit growth in Pelvic Health and ENT was partially offset by low-single digit declines in Transformative Solutions, all on a constant currency basis.
Pain Therapies third quarter revenue of $300 million increased 10 percent, or 8 percent on a constant currency basis. The division returned to growth on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as growth in drug pumps.
Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide third quarter revenue of $584 million increased 17 percent, or 13 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems, and has made great progress on its ability to meet this demand, as evidenced by the improved sequential revenue growth.

IIM third quarter revenue grew in the high-teens on a constant currency basis, driven by the U.S. launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3 CGM. In international markets, IIM delivered low-twenties constant currency growth on the continued strength of the MiniMed 640G system.
DSS third quarter revenue grew in the mid-single digits on a constant currency basis, with growth in consumables benefitting from customer base growth and improved patient utilization.
NDT third quarter revenue declined in the mid-single digits on a constant currency basis, given the commercial focus on the MiniMed 670G launch and competitive pressures.
Guidance
Medtronic today reiterated its fiscal year 2018 revenue and non-GAAP guidance. The company’s guidance is given on a comparable, constant currency basis, which accounts for the divestiture of certain businesses from its prior period Patient Monitoring & Recovery division by removing the financial impact of these businesses from the second, third, and fourth quarters of fiscal year 2017, as well as removing the impact of foreign currency.

In fiscal year 2018, the company continues to expect comparable, constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency remains fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $480 million to $500 million for the fiscal year, including an approximate $300 to $320 million positive impact in the fourth fiscal quarter.

In fiscal year 2018, the company continues to expect diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a comparable, constant currency basis from the prior year comparable EPS of $4.37. Assuming current exchange rates remain similar for the rest of the year, the foreign exchange impact on the company’s non-GAAP EPS would be approximately negative 4 cents for the fiscal year, including an approximate 2 cent negative impact in the fourth fiscal quarter.

"Looking ahead, we are confident in our ability to deliver mid-single digit constant currency revenue growth and strong constant currency EPS leverage, this fiscal year and beyond," said Ishrak. "We remain keenly focused on executing to deliver dependable results as we continue to leverage our global diversification and scale to fulfill our Mission of alleviating pain, restoring health, and extending life for millions of people around the world."

Webcast Information
Medtronic will host a webcast today, February 20, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the third quarter financial schedules and non-GAAP reconciliations, click here. To view the third quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On February 20, 2018 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of March (Press release, Incyte, FEB 20, 2018, View Source;p=RssLanding&cat=news&id=2333288 [SID1234524053]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cowen and Company 38th Annual Health Care Conference on Tuesday, March 13, 2018 at 12:00 pm (EDT) in Boston; and
Barclays Global Healthcare Conference on Wednesday, March 14, 2018 at 9:30 am (EDT) in Miami
The presentation will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

On February 19, 2018 St. Louis-based startup Unleash Immuno Oncolytics, which has developed viral-based biologics to attack cancerous tumors, reported that it has attracted a major investment from publicly-traded Japanese company Oncolys BioPharma (Press release, Unleash Immuno Oncolytics, FEB 19, 2018, View Source [SID1234540110]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Unleash is an immunotherapy company that develops genetically-engineered adenoviruses to harness the immune system to fight cancer. While malignant tumors can trick the body’s immune system from attacking them, the Unleash viruses trigger the body’s immune system into action. By introducing a virus designed specifically to attack cancer, the virus invades the cancer cells, then unleashes the body’s ability to recognize and fight those malignant cells, thus killing the virus and killing the cancer.

Oncolys, a publicly-traded company on the Tokyo Stock Exchange that also is developing oncolytic adenoviruses, has invested $3 million into Unleash to advance its lead patented programs UIO-512 and UIO-702 toward clinical trials. The programs have already shown promising proof-of-concept results in animal models and human explants.

An additional $330,000 investment from Oncolys also gives it an equity position within Unleash sister company Precision Virologics, which has developed biologically-targeted vaccines for Zika and Chikungunya. Less than a year ago, Oncolys invested $500,000 into those programs.

"We are honored to initiate this partnership with the Oncolys team, also leading developers of oncolytic viruses, who assessed tremendous potential in Unleash’s technology," Daniel Katzman, Unleash CEO, said. "Oncolys’ solid expertise in manufacturing and clinical development of oncolytic viruses is of great value for advancing our virus-based therapies through clinical trials."

Unleash Immuno Oncolytics was founded on the basis of licensing complementary viral-based technologies developed by research groups led by David T. Curiel, MD, PhD, Director of the Biologic Therapeutics Center at Washington University in St. Louis, and Osvaldo Podhajcer, PhD, member of the CONICET, National Council for Scientific and Technological Research of Argentina, and Head of the Laboratory of Molecular and Cellular Therapy at the Fundación Instituto Leloir in Buenos Aires, Argentina.

"This collaboration will allow us to expand our efforts in developing the next generation of oncolytic viruses for the treatment of cancer," Curiel said. "Labeled as promising for many years, now oncolytic viruses are in the forefront of cancer research. Unleash is positioned to become a leading player in this new field."

"I’m proud to see our research project advancing its way towards clinical trials and helping patients in need," Podhajcer said. "We are amazed by the level of interest it created among world-class organizations."

BioGenerator is the lead investor in Unleash and also supported the company with entrepreneur training through its Fundamentals program, non-dilutive grants, intellectual property strategy, independent third-party evaluation, and moving the company from Argentina to St. Louis’ Cortex Innovation Community.

"St. Louis’ innovation economy has to be globally-connected to grow and thrive, so being home to a company from Argentina with validated investors from Japan is another big step forward for our community," Donn Rubin, President & CEO of BioSTL, said. "With this new investment from Oncolys BioPharma, we’re seeing Unleash take a lead role in developing next-generation immunotherapy and solidifying St. Louis’ reputation as a world-class research hub."

On February 19, 2018 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that Allergan has exercised the third option to develop and commercialize DARPin product candidates from its 2012 discovery alliance agreement with Molecular Partners (Press release, Molecular Partners, FEB 19, 2018, View Source [SID1234524046]). Upon the exercise of this option, Molecular Partners granted Allergan an exclusive license to the selected multi-DARPin product candidates for use in ophthalmology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Building on abicipar with phase 3 wet AMD topline data expected in H2 2018, these novel multi-DARPin product candidates further expand Molecular Partners’ and Allergan’s DARPin pipeline in ophthalmic diseases with high unmet medical need.

All amounts payable under the option exercises are included in the aggregate milestone payments and the tiered royalty payments previously disclosed in the company’s July 21, 2015 press release. For the exercise of the third option, Molecular Partners is entitled to certain success based development, regulatory and sales milestone payments aggregating up to USD 320 million, as well as tiered royalty payments (up to low double-digit percentage range) on any future product sales.

About abicipar
Abicipar is a long-acting mono-DARPin drug candidate that inhibits vascular endothelial growth factor A (VEGF-A) and is currently under investigation for the treatment of two major causes of blindness worldwide: neovascular, or wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Abicipar has the potential to require less frequent injections into the eye than the current anti-VEGF standards of care, while providing equal or better improvements in vision, both seen as major patient benefits in these indications. Molecular Partners granted an exclusive license to Allergan for Abicipar in May 2011.

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.

Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and has entered into Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.