Category: Health

Merck & Co. ~ ArQule $2.7 Billion

ArQule shares surge after the cancer drug specialists agreed to a $2.7 billion takeover bid from Merck & Co.

Merck & Co. said Monday that it will acquire oncology specialist ArQule in a $2.7 billion deal that marks the latest in a string of takeovers in the cancer drug sector. Merck said it will pay $20 a share for Woburn, Massachusetts-based ArQule, a premium of more than $10 to the stock’s closing price of $9.66 Friday on the Nasdaq. The group, which focuses on research and development of targeted therapeutics to treat cancers and rare diseases, will be merged into the broader Merck & Co., the companies said.

“We are proud that Merck has recognized the contributions that ArQule, together with its scientific collaborators, has made to the field of precision medicine in oncology with ARQ 531 for the treatment of B-cell malignancies and with the rest of our clinical-stage pipeline,” said ArQuel CEO Paolo Pucci. “With this agreement, ArQule’s pipeline will benefit from Merck’s vast capabilities and determined engagement to benefit the patients who we have always strived to serve.”  

ArQule shares were indicated some 103% higher in early trading following news of the Merck takeover to change hands at $19.64 each. Merck shares, meanwhile, were marked 0.57% lower at $88.34 each.

Merck’s move to buy ArQule follows a $2.5 billion takeover of San Diego, California-based Synthorx by France’s Sanofi SA earlier Monday. Sanofi said it will pay $68 a share for Synthorx, which focuses on cancer and autoimmune disorder treatments, in a deal that will bolster its immuno-oncology pipeline. 

FDA accepts Pfizer’s application for Braftovi doublet for colorectal cancer

Under Priority Review status, the FDA accepts Pfizer’s (PFE -0.5%) supplemental application seeking approval for Braftovi (encorafenib), combined with Eli Lilly’s (LLY +3.2%) Erbitux (cetuximab), for the treatment of BRAFV600E mutation-positive metastatic colorectal cancer in patients who have previously received one or two prior lines of therapy. The agency’s action date is in April 2020. The FDA approved the kinase inhibitor in June 2018 for BRAFV600E- or BRAFV600K-positive melanoma.

As published in The New England Journal of Medicine (NEJM), results from the BEACON CRC trial showed improvements in overall survival (OS) and objective response rates (ORR) for both the BRAFTOVI Doublet and BRAFTOVI Triplet (BRAFTOVI, MEKTOVI and ERBITUX) combination, compared to ERBITUX plus irinotecan-containing regimens (Control).1 In descriptive analyses comparing the Doublet and Triplet arms, the results showed comparable efficacy between the Doublet and Triplet in the overall population. The BRAFTOVI Triplet and Doublet showed no unexpected toxicities.

AstraZeneca PLC ADR

FDA advisory committee backs AstraZeneca’s Lynparza for pancreatic cancer

AstraZeneca PLC (AstraZeneca) is a biopharmaceutical company. The Company focuses on discovery and development of products, which are then manufactured, marketed and sold. The Company focuses on three main therapy areas: Oncology, Cardiovascular & Metabolic Disease (CVMD) and Respiratory, while selectively pursuing therapies in Autoimmunity, Infection and Neuroscience.

In CVMD, it is expanding its portfolio into the cardiovascular-renal area with late-stage assets, such as ZS-9 and roxadustat, as well as investing to explore the benefits of its SGLT2 and GLP-1 franchises in chronic kidney disease (CKD) and heart failure (HF). The Company has approximately 40 projects in Phase I, including 29 new molecular entities (NMEs), and 11 oncology combination projects. It has approximately 40 projects in Phase II, including 25 NMEs; four significant additional indications for projects that have reached phase II, and seven oncology combination projects.

“English-Swedish multinationalpharmaceutical and biopharmaceutical company. In 2013, it moved its headquarters to Cambridge, UK, and concentrated its R&D in three sites: Cambridge; Gaithersburg, Maryland, USA (location of MedImmune) for work on biopharmaceuticals; and Mölndal (near Gothenburg) in Sweden, for research on traditional chemical drugs.[5] AstraZeneca has a portfolio of products for major disease areas including cancercardiovasculargastrointestinal, infection, neurosciencerespiratory and inflammation.” ~ Wikipedia

Quidel up 8% as Beckman appeal starts

Quidel Corporation develops, manufactures, and markets diagnostic testing solutions for applications primarily in infectious diseases, women’s health, and gastrointestinal diseases. The company was founded in 1979 and is based in San Diego, California.

Thinly traded diagnostic test maker Quidel (QDEL +8.3%) is up on more than double normal volume, albeit on turnover of only 407K shares, in apparent response to opening arguments in its appeal of a lower court ruling allowing Beckman (DHR +1.5%) to sell certain Quidel-licensed tests directly to customers instead of sourcing them from the company per their agreement.

In December 2018, a California state court granted a stay on Beckman’s motion for summary judgement.

According to MDC Financial’s Michael Cohen, the opening statements appear to favor Quidel. A decision from the appeals court should be issued in ~90 days. Quidel remains confident that it will prevail.

CEL-SCI Corporation | NYSEMKT

The Dangers Of CEL-SCI Corporation

CEL-SCI’s move from $3 to $8 on fairly minor news appears exaggerated.

Multikine has a several yearlong history of struggling to complete its Phase 3 study.

CEL-SCI faces major financial constraints whether Multikine is approved or not.

CEL-SCI Corporation (CVM) is a small-cap company engaged in the research and development of immunotherapy, known mostly for their investigational cancer immunotherapy drug Multikine which is currently in Phase 3 studies. 

Zynerba Pharmaceuticals, Inc. | NASDAQ

Zynerba New Patent “Treatment of Autism Spectrum Disorder with Cannabidiol”

Jun. 11, 2019 8:28 AM ET|About: Zynerba Pharmaceuticals, Inc. (ZYNE)|By: Mamta Mayani, SA News Editor

The USPTO has issued Zynerba Pharmaceuticals (NASDAQ:ZYNE), Patent No. 10,314,792, titled “Treatment of Autism Spectrum Disorder with Cannabidiol” which includes claims directed to methods of treating autism spectrum disorder by administering a therapeutically effective amount of synthetic cannabidiol.

The new patent will expire in 2038.

The issuance of this patent comes as enrollment progresses in Phase 2 BRIGHT study evaluating the safety, tolerability and efficacy of Zygel for the treatment of children and adolescents with Autism Spectrum Disorder.

Zynerba Pharmaceuticals

Enhancing connections in the central nervous system. 

Why Cannabinoids ?

Cannabinoids interact with specific receptors and pathways implicated in a range of diseases throughout the body to produce pharmacologic effects. These include potential inhibition and modulation of several pathways resulting in a cumulative anti-convulsive effect, and the modulation of the endocannabinoid system, which regulates emotional responses, behavioral reactivity to context, and social interaction. 

There are three types of cannabinoids: phytocannabinoids, or plant-derived and found in the Cannabis plant; endocannabinoids, or cannabinoids the body produces to control certain biochemical pathways; and synthetic cannabinoids, or those pharmaceutically manufactured to be structurally and functionally identical to phyto- and endocannabinoids. The two most researched cannabinoids are Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD).  Despite their similar chemical structures, CBD is a compound that doesn’t produce the euphoric effects or “high” associated with THC and Cannabis.

At Zynerba, we focus our current development efforts on CBD as it has demonstrated positive effects in the CNS and is non-euphoric and non-addictive.

ZygelTM (ZYN002 CBD Gel)

Zygel is the first and only pharmaceutically-produced CBD, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. Zygel is being developed for patients suffering from FXS, ASD in pediatric patients, 22q, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE).

Fitbit: Trust The Process (FIT)

Has it Hit the Bottom ?? Really Want to Believe

Samsung, Fitbit join NY transit payment system

Fitbit continued a string of beating quarterly analyst estimates.

The company returned to important growth in devices sold in order to grow the community for premium subscription services.

The Fitbit Healthcare Services business will drive the stock far above $5.

As Fitbit (FIT) continues making progress towards being a healthcare services provider in addition to basic fitness and wellness tracking, investors need to relax and trust the process with the stock at $5….

Exelixis, Inc. (EXEL) | NASDAQ

EXEL $19.33 -0.46 (-2.32%)

Exelixis is on a Mission to Help Cancer Patients Recover Stronger and Live Longer

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need.

Our discovery efforts have resulted in four approved products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.

ZIOPHARM Oncology, Inc. (ZIOP)

ZIOPHARM Oncology, Inc., a biotechnology company, focuses on acquiring, developing, and commercializing a portfolio of immuno-oncology therapies for treating heterogenous solid tumors and unknown antigens. The company develops two immuno-oncology platform technologies, including Sleeping Beauty (SB), which is based on the genetic engineering of immune cells using a non-viral transposon/transposase system to reprogram T-cells outside of the body for infusion; and Controlled IL-12, which delivers interleukin 12 or IL-12, a master regular of the immune system, in a controlled and safe manner to focus the patient’s immune system to attack cancer cells.

Its lead gene therapy product candidate is Ad-RTS-hIL-12 plus veledimex, which is in Phase I clinical trial, to treat patients with recurrent glioblastoma and breast cancer. The company is also developing chimeric antigen receptor (CAR) T-cell and T-cell receptor T-cell therapies. ZIOPHARM Oncology, Inc. has license agreement with Precigen, Inc. and MD Anderson Cancer Center; research and development agreement with the National Cancer Institute, and Ares Trading S.A. The company is headquartered in Boston, Massachusetts.

CEL-SCI Corporation


Multikine Immunotherapy in Head and Neck Cancer

CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It is focused on the development of Multikine (Leukocyte Interleukin, Injection), an investigational immunotherapy under development for the treatment of certain head and neck cancers, and anal warts or cervical dysplasia.

Cel-Sci Corporation (CVM) is a small-cap market ($78M) clinical stage cancer biopharmaceutical company.