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EDEN PRAIRIE, Minn., April 12, 2018 (GLOBE NEWSWIRE) -- CHF Solutions, Inc.(NASDAQ:CHFS) announced today its commercial expansion into the Hong Kong market through its Asia distributor, Transmedic. Further, Transmedic has confirmed its first commercial orders for both Singapore and Hong Kong.
EDEN PRAIRIE, Minn., April 12, 2018 (GLOBE NEWSWIRE) -- CHF Solutions, Inc.(NASDAQ:CHFS) announced today its commercial expansion into the Hong Kong market through its Asia distributor, Transmedic. Further, Transmedic has confirmed its first commercial orders for both Singapore and Hong Kong.
EDEN PRAIRIE, Minn., April 12, 2018 (GLOBE NEWSWIRE) -- CHF Solutions, Inc.(NASDAQ:CHFS) announced today its commercial expansion into the Hong Kong market through its Asia distributor, Transmedic. Further, Transmedic has confirmed its first commercial orders for both Singapore and Hong Kong.
AVEO insider buy. https://ih.advfn.com/p.php?pid=nmona&article=77148381&symbol=AVEO
vTv Therapeutics, Inc. (Nasdaq:VTVT) shares closed down 78% to $0.71 following its announcement after hours Monday that data from Part A of its Phase 3 trial of azeliragon in people with mild Alzheimer’s disease did not meet its co-primary efficacy endpoints.
ARQL. Upgrade to out perform by Leernik. 15 target. Presents at AACR next week.
Don't know but a form 4 from Frost just posted.
ZIOP finally moving up. FYI they had a meeting with Jefferies yesterday.
Agree. Moving up.
CRMD watch. 024.2
10k out. Up after hours.
NueroMetrix, Inc.: An Interesting Micro-Cap Flyer? https://seekingalpha.com/article/4160264?source=ansh $NURO, $GSK
NURO. NueroMetrix, Inc.: An Interesting Micro-Cap Flyer? https://seekingalpha.com/article/4160264?source=ansh $NURO, $GSK
FYI this is on ST but I cannot find a press release on it. ArQule receives EU Orphan designation for Miransertib for treatment of Proteus syndrome (through sponsor QRC Consultan…
ARQL. FYI this is on ST but I cannot find a press release on it. ArQule receives EU Orphan designation for Miransertib for treatment of Proteus syndrome (through sponsor QRC Consultan…
CT order.
ArQule, Inc. (ARQL) Shares Bought by BVF Inc. IL
Posted by Nicole Wilson on Mar 11th, 2018
BVF Inc. IL lifted its position in ArQule, Inc. (NASDAQ:ARQL) by 122.1% during the 4th quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission (SEC). The institutional investor owned 16,436,912 shares of the biotechnology company’s stock after acquiring an additional 9,036,784 shares during the period. ArQule comprises approximately 3.3% of BVF Inc. IL’s holdings, making the stock its 10th largest position. BVF Inc. IL owned approximately 0.19% of ArQule worth $27,121,000 at the end of the most recent reporting period.
DCAR. 6m private placement.
News out. 6m private placement.
EYES.
Second Sight Medical Products, Inc. to Present at the B. Riley & Co. China Healthcare Investment Partnering Symposium
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SECOND SIGHT MEDICAL PRODUCTS IN (NASDAQ:EYES)
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Today : Thursday 8 March 2018
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Second Sight Medical Products, Inc. (NASDAQ: EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today announced that Will McGuire, President and Chief Executive Officer, will present at the B. Riley & Co. China Healthcare Investment Partnering Symposium as follows:
Date: Friday, March 16, 2018
Presentation Time: 11:30 a.m. China Standard Time
Location: InterContinental Hangzhou - Hangzhou, China
Webcast: http://wsw.com/webcast/brileyco20/eyes/
ADVM.
Adverum Biotechnologies Reports Fourth Quarter 2017 Financial Results and Provides Corporate Update
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Adverum Biotechnologies, Inc. (NASDAQ:ADVM)
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Today : Tuesday 6 March 2018
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Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today reported financial results for the fourth quarter ended December 31, 2017 and provided a corporate update.
“We enter 2018 with significant momentum following a year of critical execution to transform Adverum into a clinical-stage company,” said Amber Salzman, Ph.D., president and chief executive officer of Adverum Biotechnologies. “In ADVANCE, our Phase 1/2 clinical trial of ADVM-043 in alpha-1 antitrypsin deficiency, we have completed enrollment in the first dose cohort and have initiated patient enrollment in the second intermediate-dose cohort. We are on track to report preliminary data from this study in the second half of 2018. In addition, we plan to submit two Investigational New Drug Applications with the FDA in the second half of 2018, for ADVM-022 in wet AMD and ADVM-053 in hereditary angioedema. We begin this exciting year of clinical development and regulatory progress in a strong position, funded to execute our three lead programs through the end of 2019 with preliminary clinical data for at least two of these programs.”
Recent Progress
In February 2018, Adverum completed the dosing and evaluation of patients (n=2) in the first cohort of the ADVANCE Phase 1/2 trial for ADVM-043 in alpha-1 antitrypsin (A1AT) deficiency. Based on a review of the preliminary safety information, the independent data monitoring committee (DMC) recommended proceeding to the second cohort of patients, which is open for enrollment. Adverum has initiated patient enrollment in the second intermediate-dose cohort, which will receive an intermediate dose of ~5E12 vg/kg (equivalent to ~4E14 total vg based on an 80-kg patient). The primary endpoint is safety and tolerability, and secondary endpoints include changes in plasma concentrations of both total and M-specific A1AT levels. Additional information about this clinical trial can be found at ClinicalTrials.gov under trial identifier number NCT02168686.
In February 2018, Adverum raised $69.0 million in gross proceeds from an underwritten public offering of its common stock.
In January 2018, Adverum and Editas Medicine, Inc. announced the extension of the companies’ collaboration agreement to explore the delivery of genome editing medicines to treat up to five inherited retinal diseases.
2018 Outlook - Planned Pipeline Milestones
ADVM-043 for A1AT Deficiency
Report preliminary data from the ADVANCE Phase 1/2 clinical trial in the second half of 2018.
ADVM-022 for wAMD
Report 12-month efficacy data in non-human primates in the first half of 2018.
Complete Investigational New Drug (IND)-enabling preclinical studies.
Submit an IND Application to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
ADVM-053 for Hereditary Angioedema (HAE)
Complete IND-enabling preclinical studies.
Submit an IND Application to the FDA in the second half of 2018.
Upcoming Events
Adverum plans to attend the following upcoming conferences:
° Cowen 38th Annual Health Care Conference in Boston on March 12, 2018 at 1:30 pm ET
° Cowen 17th Annual Life Sciences Winter Meeting in Colorado, March 20-23, 2018
° ARM Cell & Gene Therapy Investor Day in New York, April 17, 2018
° ARVO 2018 Annual Meeting in Honolulu, April 29-May 3, 2018
• Poster titled “Therapeutic potential and safety of sequential intravitreal dosing to the contralateral eye of novel AAV vectors in non-human primates” on May 3, 2018, 8:15 – 10:00 am HST
• Poster titled “Long-term functional delivery of the human L-opsin cDNA via intravitreal administration of an AAV vector in Mongolian gerbils” on May 3, 2018, 8:15 - 10:00 am HST
° 2nd Annual Gene Therapy for Rare Disorders 2018 Meeting in Boston, April 30-May 2, 2018
° ASGCT 21st Annual Meeting in Chicago, May 16-19, 2018
Financial Results for the Three Months Ended December 31, 2017
Cash, cash equivalents and marketable securities were $190.5 million as of December 31, 2017, compared to $186.6 million as of September 30, 2017 and $222.2 million as of December 31, 2016. The year-end cash position, added with approximately 64 million in net proceeds raised in February 2018, is expected to fund the three lead gene therapy programs through the end of 2019, including preliminary clinical data for at least two of these programs, and through the initial stage of scaling up manufacturing capabilities.
Revenues, consisting of revenue from collaborative research, were $0.5 million for the three months ended December 31, 2017, compared to $0.5 million for the same period in 2016.
Research and development expenses were $12.0 million for the three months ended December 31, 2017, compared to $7.9 million for the same period in 2016. This increase was due to an overall increase in research and development activities for the Company’s gene therapy programs, primarily for material production costs for the ADVANCE clinical trial for ADVM-043.
General and administrative expenses were $4.0 million for the three months ended December 31, 2017, compared to $4.8 million for the same period in 2016. This decrease was primarily due to lower legal fees.
Net loss attributable to common stockholders was $14.8 million, or $0.32 per basic and diluted share, for the three months ended December 31, 2017, compared to $22.4 million, or $0.54 per basic and diluted share, for the same period in 2016.
Shares of common stock outstanding were 62.2 million as of February 28, 2018.
EYES.
Second Sight Announces Latest Expansion of Medicare Coverage for Argus II Retinal Prosthesis System
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-- Argus II Covered in Majority of Medicare Administrative Contractor Jurisdictions Across 31 States --
Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics intended to create an artificial form of useful vision for blind individuals, today announced that Palmetto GBA (Jurisdiction JJ) is the latest Medicare Administrative Contractor (MAC) to provide coverage for the Argus® II Retinal Prosthesis System (Argus II) and the related surgical procedure. As a result of this decision, coverage for the Argus II will now include Alabama, Georgia and Tennessee. This brings the total coverage of the Argus II to 31 states, two territories and the District of Columbia.
“We are pleased that blind individuals with Retinitis Pigmentosa covered by Medicare now have greater access to the Argus II with five of seven MACs nationwide covering Argus II. We continue to work with the few remaining MACs and payers towards the goal of achieving full coverage in the U.S. The significant momentum in this effort reflects recognition of our technology as the standard of care for these blind individuals,” said Will McGuire, President and CEO of Second Sight.
Effective February 26, 2018, Palmetto GBA (Jurisdiction JJ), published a local coverage article on the Argus II placement procedure (0100T). This decision authorizes coverage of Argus II under the Local Coverage Article A53044, when medically necessary, to Medicare beneficiaries in Alabama, Georgia and Tennessee.
BCRX. BioLineRx Ltd. (BLRX)
Highlights and achievements in 2017 and to date:
Continued progress and execution according to plan on multiple clinical trials for the Company's lead oncology program, BL-8040:
•Initiation of pivotal Phase 3 GENESIS study with BL-8040 as novel stem cell mobilization treatment for autologous bone-marrow transplantation, following successful meeting with the FDA earlier in the year;
•Partial monotherapy results from Phase 2a COMBAT study, investigating the combination of BL-8040 and Merck's PD-1 inhibitor, Keytruda® (pembrolizumab), in pancreatic cancer, showed significantly increased infiltration of T cells into the tumor, as well as robust mobilization of immune cells;
•Initiation of three Phase 1b/2 studies under collaboration with Genentech, exploring the combination of BL-8040 with Tecentriq® (atezolizumab), Genentech's anti-PD-L1 cancer immunotherapy agent;
•Overall long-term survival results in Phase 2a trial in relapsed/refractory AML demonstrated that the combination of BL-8040 with high-dose Ara-C (HiDAC) significantly improved overall survival, compared with historical data of HiDAC monotherapy;
•Partial results of Phase 2 study for BL-8040 as novel stem cell mobilization treatment for allogeneic bone-marrow transplantation support BL-8040 as a one-day dosing regimen for rapid mobilization of stem cells.
The Company also announced progress in expanding and accelerating its growth potential and strengthening its balance sheet:
•Acquired Agalimmune Ltd., a UK-based biopharmaceutical company developing cancer immunotherapy treatments, thereby broadening BioLineRx's position in the immuno-oncology field with a second novel lead compound, AGI-134. Pre-clinical data presented at ASCO-SITC showed complete tumor regression in the majority of mice treated with AGI-134;
•Completed underwritten public offering of American Depository Shares for gross proceeds of $28.9 million led by BVF Partners, L.P; the Company also received an additional $9.6 million direct investment from BVF Partners.
Expected significant upcoming milestones for 2018:
•Top-line results in immuno-oncology Phase 2a COMBAT study in pancreatic cancer for BL-8040 in combination with Merck's KEYTRUDA, expected in H2 2018;
•Results from the lead-in stage of the Phase 3 GENESIS study in stem-cell mobilization, expected in H2 2018;
•Initiation of Phase 1b/2 immuno-oncology study for BL-8040 in combination with Genentech's atezolizumab for non-small cell lung cancer. Partial results in Phase 1b/2 trials under collaboration with Genentech expected in H2 2018;
•Initiation of Phase 1/2a immuno-oncology study for AGI-134 in several solid tumor indications expected in mid-2018;
•Top-line results of Phase 2 study for BL-8040 in stem-cell mobilization for allogeneic transplantation expected by mid-2018.
https://ih.advfn.com/p.php?pid=nmona&article=76873656
Form 20-F
https://www.sec.gov/Archives/edgar/data/1498403/000117891318000765/zk1821295.htm
http://www.biolinerx.com/
EYES. webcast at the LD Micro Virtual Investor Conference, as follows:
Date: Wednesday, March 7, 2018
Presentation Time: 3:30 p.m. Pacific Standard Time
Webcast: http://www.investorcalendar.com/console/conference/?id=26039
ZIOP. Earnings tomorrow. Hopeing for something good on call. They are way over due for something big. Hopefully IL 12 data or a partner deal.
ZIOP new presentation. http://www.ziopharm.com/pipeline/presentations-publications
EYES. Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today provided an update on several key performance metrics, demonstrating the Company’s continued progress in executing its near- and long-term goals.
Business Highlights as of January 31, 2018:
Implanted 30 Argus® II Retinal Prosthesis Systems worldwide during the fourth quarter of 2017 for a total of 75 implants in 2017. This compares to seven implants in the fourth quarter of 2016 and a total of 42 implants in 2016, representing implant volume growth of 329% and 79%, respectively;
The first human patient was implanted with the Orion™ Cortical Visual Prosthesis System (Orion) by Nader Pouratian, MD, PhD, Vice Chairman of the Department of Neurosurgery at the Ronald Reagan UCLA Medical Center (UCLA) in late January as part of Second Sight’s feasibility clinical study;
Enrollment of the first patient(s) is expected during Q1 2018 in a clinical study of better-sighted patients with Retinitis Pigmentosa (RP) in Germany. Two sites are actively screening subjects with a third site to begin screening shortly;
Added a new Center of Excellence in Houston, TX in early January, further validating the success of the Company’s business model that emphasizes close partnering with implanting sites; and,
Reimbursement for the Argus II in Germany was renewed for the 2018 calendar year, marking the eighth year that Argus II implants have been reimbursed through the NUB program.
“We are excited about our milestones and achievements in 2017, which speak to the strength of our business and the momentum we expect for continued success in 2018,” said Will McGuire, President and CEO of Second Sight.
“The first-in-human implant of the Orion is a significant milestone for Second Sight, and a critical step forward in meeting our Company’s mission to develop devices that could potentially treat nearly all forms of blindness. We expect that an additional four patients will be included in this feasibility study at UCLA and the Baylor College of Medicine in Houston,” stated Dr. Robert Greenberg, Chairman of the Board.
“We continue to advance our Argus II R&D efforts and have initiated screening for a clinical trial in better-sighted RP patients. Second Sight is committed to executing on our strategy to expand the availability of the Argus II to a larger patient population and explore the potential of our technology to treat those suffering from other forms of blindness. We look forward to updating investors on our continued progress,” concluded McGuire.
About the Argus II Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States. Further information on the long-term benefits and risks can be found in the peer reviewed paper at: http://www.sciencedirect.com/science/article/pii/S0161642016305796
About the Orion Visual Cortical Prosthesis System
Like the Argus II, the Orion converts images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses. The Orion is designed to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma – which has the potential to treat many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
About Second Sight
Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets, the Argus® II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. New hardware and software to improve the quality of the vision produced is underway. A clinical trial to study the Argus II in better-sighted subjects earlier in the disease was recently approved in Germany. Second Sight is also developing the Orion™ Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. Second Sight’s U.S. Headquarters are in Sylmar, California, and European Headquarters are in Lausanne, Switzerland. For more information, please visit www.secondsight.com
EYES. Second Sight Medical Products, Inc. (NASDAQ:EYES) ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind patients, today provided an update on several key performance metrics, demonstrating the Company’s continued progress in executing its near- and long-term goals.
Business Highlights as of January 31, 2018:
Implanted 30 Argus® II Retinal Prosthesis Systems worldwide during the fourth quarter of 2017 for a total of 75 implants in 2017. This compares to seven implants in the fourth quarter of 2016 and a total of 42 implants in 2016, representing implant volume growth of 329% and 79%, respectively;
The first human patient was implanted with the Orion™ Cortical Visual Prosthesis System (Orion) by Nader Pouratian, MD, PhD, Vice Chairman of the Department of Neurosurgery at the Ronald Reagan UCLA Medical Center (UCLA) in late January as part of Second Sight’s feasibility clinical study;
Enrollment of the first patient(s) is expected during Q1 2018 in a clinical study of better-sighted patients with Retinitis Pigmentosa (RP) in Germany. Two sites are actively screening subjects with a third site to begin screening shortly;
Added a new Center of Excellence in Houston, TX in early January, further validating the success of the Company’s business model that emphasizes close partnering with implanting sites; and,
Reimbursement for the Argus II in Germany was renewed for the 2018 calendar year, marking the eighth year that Argus II implants have been reimbursed through the NUB program.
“We are excited about our milestones and achievements in 2017, which speak to the strength of our business and the momentum we expect for continued success in 2018,” said Will McGuire, President and CEO of Second Sight.
“The first-in-human implant of the Orion is a significant milestone for Second Sight, and a critical step forward in meeting our Company’s mission to develop devices that could potentially treat nearly all forms of blindness. We expect that an additional four patients will be included in this feasibility study at UCLA and the Baylor College of Medicine in Houston,” stated Dr. Robert Greenberg, Chairman of the Board.
“We continue to advance our Argus II R&D efforts and have initiated screening for a clinical trial in better-sighted RP patients. Second Sight is committed to executing on our strategy to expand the availability of the Argus II to a larger patient population and explore the potential of our technology to treat those suffering from other forms of blindness. We look forward to updating investors on our continued progress,” concluded McGuire.
About the Argus II Retinal Prosthesis System
Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses stimulate the retina's remaining cells, intending to result in the perception of patterns of light in the brain. The patient must learn to interpret these visual patterns, having the potential to regain some visual function. The Argus II was the first artificial retina to receive widespread commercial approval, and is offered at approved centers in Canada, France, Germany, Italy, Russia, Saudi Arabia, South Korea, Spain, Taiwan, Turkey, the United Kingdom, and the United States. Further information on the long-term benefits and risks can be found in the peer reviewed paper at: http://www.sciencedirect.com/science/article/pii/S0161642016305796
About the Orion Visual Cortical Prosthesis System
Like the Argus II, the Orion converts images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses. The Orion is designed to transmit these electrical pulses wirelessly to an array of electrodes implanted on the surface of the visual cortex, intended to result in the perception of patterns of light. By bypassing the retina and optic nerve and directly stimulating the visual cortex, a cortical prosthesis system has the potential to restore useful vision to patients completely blinded due to many reasons, including glaucoma, diabetic retinopathy, or forms of cancer and trauma – which has the potential to treat many fold more patients than for the current Argus II indications. No clinical data is yet available for the Orion.
About Second Sight
Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed, and now manufactures and markets, the Argus® II Retinal Prosthesis System. Enrollment has been completed in a feasibility trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. New hardware and software to improve the quality of the vision produced is underway. A clinical trial to study the Argus II in better-sighted subjects earlier in the disease was recently approved in Germany. Second Sight is also developing the Orion™ Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. Second Sight’s U.S. Headquarters are in Sylmar, California, and European Headquarters are in Lausanne, Switzerland. For more information, please visit www.secondsight.com
Not Canada but check out SIGO. I am long on it.
20 years FA.
Shot over.