Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Dr. Missling said yesterday that they will have enough funds for at least a full year without needing to raise funds, He also said they are starting undisclosed INDs which can cost 100s of millions! Reading between the lines, they have huge money coming..So imo this is just the tip of a HUGE isberg with BIIB.
Buying! Data was only for 4 months, you cannot reverse liver destruction in such a short time frame. Drug is safe and longer and larger trial fully enrolled. Imo buying here will make me 100%+. Also $1.5 million just raised and that guy is pretty smart in his investments.
Remission! Should reach new highs of $95+ Hearing more news around October 18th
With over 1,600 drug doses administered there is now substantial clinical trial experience with GR-MD-02. There is no evidence of serious adverse effects related to the drug, highlighting the good safety profile of the therapy in this patient population with advanced stage disease. In the NASH-CX trial 64 patients have already completed 6 months of dosing with a low drop-out rate of only 3 patients prematurely exiting the trial.
In support for continued funding of the NASH-CX trial, a private placement financing for $1.5 million from a single source was signed on September 22, 2016. “It is encouraging that we have the confidence of a highly-respected businessman such as Mr. Richard Uihlein, who has now invested $1.5 million in Galectin through a limited partnership investment fund, which adds to his current significant stake in the company,” added Peter Traber, M.D., Galectin's president, chief executive officer and chief medical officer. “Mr. Uihlein is further committed to helping the company progress through the completion of the NASH-CX trial.
41 week data should be available by October 5th ( 10 weeks after 31 week data on July 27th). Slide 50 days at science conference. Anyone want to guess which conference it is?
ZYNE in same space as GWPH with low float ! Take a strong look.
Summit's (SMMT) drug received fast-track status, which will dramatically speed the review process. They are currently trading just above $100 million market capitalization but could easily run to $1B (a 10x gain) before they file for NDA. Recall that SRPT reached about $1.5B before approval and eteplirsen only addresses 13% of the DMD population, whereas Summit's drug is intended for the entire DMD population !!
SMMT Receives Fast Track Designation From US FDA for Ezutromid in the Treatment of Duchenne Muscular Dystrophy
Source: GlobeNewswire Inc.
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with the fatal muscle wasting disease DMD.
“Fast Track designation underscores the importance that the FDA places on developing new treatments for life-threatening disorders, such as DMD, and aligns well with our recently outlined strategy to accelerate the development of ezutromid to market,” said Glyn Edwards, Chief Executive Officer of Summit. “As a utrophin modulator, ezutromid has the potential to significantly advance the state of care for all patients with DMD, regardless of their underlying genetic fault. We look forward to ezutromid’s continued progress in our ongoing Phase 2 clinical trial, PhaseOut DMD.”
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions that address an unmet medical need. Advantages of Fast Track designation include opportunities for more frequent interactions with the FDA during all aspects of development, submission of a New Drug Application (‘NDA’) on a rolling basis, and eligibility for accelerated approval and priority review. This designation is in addition to ezutromid being granted Orphan Drug designation by the FDA and the European Medicines Agency.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000 boys and young men in the developed world. The disease is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company’s lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration and the European Medicines Agency have granted Orphan Drug designation to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation by the FDA.
See Less
BLRX and NASH news:
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year."
Major NASH news from BLRX
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year."
BLRX NASH news:
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year."
Huge revenue generated on every page hit worldwide. You cannot even imagine what is coming.
Drone sales could add $30 to stock price.
NASH news for BLRX
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year."
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
Philip Serlin, Chief Financial and Operating Officer of BioLineRx, said, "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system. Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year."
IPO in Alzheimers explodes(ACIU) but has its problems in efficacy. This should help AVXL valuations.
http://seekingalpha.com/article/4006234-ac-immune-ipo-potential-proceed-caution
URRE buys even more Lithium claims today, see News.
Announced today URRE acquires more lithium claims !
What time is the conference next week??
Conference on Tiesaday the 27th !!
Adding more Lithium !
Uranium Resources, Inc. (URI) (URRE) (ASX:URI), announced today that it has entered into an agreement to acquire certain placer mining claims comprising the Sal Rica lithium brine project from Mesa Exploration Corporation (Mesa Exploration) (MSA.V) (MSAJF). The project is comprised of approximately 9,800 acres (3,960 hectares) of placer mining claims covering a highly prospective target for lithium-enriched brines in the Pilot Valley region of northwestern Utah. The target area is situated within a region of known brine-hosted lithium mineralization and is approximately 25 miles (40 kilometers) north of the town of Wendover, Utah in Box Elder County.
News: URRE adds to Lithium Claims !
Uranium Resources, Inc. (URI) (URRE) (ASX:URI), announced today that it has entered into an agreement to acquire certain placer mining claims comprising the Sal Rica lithium brine project from Mesa Exploration Corporation (Mesa Exploration) (MSA.V) (MSAJF). The project is comprised of approximately 9,800 acres (3,960 hectares) of placer mining claims covering a highly prospective target for lithium-enriched brines in the Pilot Valley region of northwestern Utah. The target area is situated within a region of known brine-hosted lithium mineralization and is approximately 25 miles (40 kilometers) north of the town of Wendover, Utah in Box Elder County.
GalT's science remains best of breed in the NASH sector and the whole gastroenterology area. Market cap worth $50 after recent acquisition in this space.
Imo APPL or similar buys AIRG above $50. Major growth !
Parkinsons data worth $50+ imo
USPS Statement on Next Generation Delivery Vehicles Prototype Selection and Request for Proposal for Commercial Off-the-Shelf Delivery Vehicles
The six selected suppliers include AM General, Karsan, Mahindra, Oshkosh, Utilimaster, and VT Hackney and the contract awards are valued at $37.4 million. The suppliers also have the discretion to team or subcontract with additional suppliers, and it is anticipated some will do so to develop the finished prototypes.
(From USPS website) They are looking to replace 180,000 vehicles. Multi billion dollar contract !
WKHS could win major part of a multi billion contract from USPS. Looking to replace 160,000+ mail delivery vehicles!
http://about.usps.com/news/statements/091616.htm
A $1.7B TBRA-like deal for Galt would = $57/share !
Look at TBRA today Shorts ! $4 yesterday
Woodford knows what can happen.
AMZN or BABA could acquire 10x higher.
Very bullish Seeking Alpha article just published on ZYNE with high price target. Google it.
OSK could win multi billion contract from USPS. Looking to replace 180,000 mail delivery vehicles!
http://about.usps.com/news/statements/091616.htm
AIRG major IOT player, The company also believes that the Internet of Things (IoT) will offer a promising growth opportunity moving forward. Airgain is right to bet on IoT, as the industry and its devices is expected, over the next five years, to double to almost 12 billion.
In some way or another, IoT devices all rely on either Bluetooth, near field communication (NFC), or Wi-Fi, and these are the kind of technologies that need complex antenna system
s, just what Airgain specializes in.
The company also believes that the Internet of Things (IoT) will offer a promising growth opportunity moving forward. Airgain is right to bet on IoT, as the industry and its devices is expected, over the next five years, to double to almost 12 billion.
In some way or another, IoT devices all rely on either Bluetooth, near field communication (NFC), or Wi-Fi, and these are the kind of technologies that need complex antenna systems, just what Airgain specializes in.
Will this be our buyer?
Takeda, a Japanese drug company, is prepared to spend as much as $15 billion for possible acquisitions in an effort to increase its business in the U.S., the Financial Times reports, citing sources.
The drug maker has told investors it would like to purchase U.S. companies developing drugs for cancer, gastrointestinal conditions and central nervous system diseases, such as Alzheimer's, according to the sources.
Airgain’s potential market is huge, as it’s catering to the continually increasing demand for new technological innovations requiring maximum throughput: video streaming, media adapters, and access points, among others.
The company also believes that the Internet of Things (IoT) will offer a promising growth opportunity moving forward. Airgain is right to bet on IoT, as the industry and its devices is expected, over the next five years, to double to almost 12 billion.
In some way or another, IoT devices all rely on either Bluetooth, near field communication (NFC), or Wi-Fi, and these are the kind of technologies that need complex antenna systems, just what Airgain specializes in.