FDA rejects Intercept’s drug application, shares plunge

Intercept receives FDA CRL for obeticholic acid recommending additional data

Intercept Pharmaceuticals (ICPT) announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis.

stockwinners.com ICPT
Shares plunge following FDA’s comments

The CRL indicated that, based on the data the FDA has reviewed to date, the Agency has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.

NASH is the severe form of Non-Alcoholic Fatty Liver Disease (NAFLD). It can lead to liver cancer, cirrhosis, and liver transplants.

The FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.

Intercept had previously disclosed that, based on the FDA’s decision to postpone a tentatively scheduled advisory committee meeting, it was expected that the Agency’s review of its NDA would extend beyond the PDUFA goal date and that the FDA would move forward with rescheduling the Adcom.

The NDA submission for OCA is the first for NASH and was based on data from 35 clinical trials and more than 1,700 NASH patients treated with the drug.

OCA is the only investigational NASH drug with Breakthrough Therapy designation and has uniquely demonstrated reproducible ability to reverse or otherwise stabilize liver fibrosis in patients with advanced fibrosis due to NASH.

According to the FDA draft guidance for NASH fibrosis, of the histologic features of NASH, fibrosis is considered the strongest predictor of adverse clinical outcomes, including liver-related death.

Estimated number of people suffering from fatty liver, Stockwinners

There is currently no approved therapy for this devastating disease, which has become a leading cause of liver failure and resulting poor clinical outcomes.

A number of other companies working on NASH treatments are also moving lower, with CymaBay (CBAY) down about 3% and NGM Biopharmaceuticals (NGM) fractionally lower.

Other companies exploring NASH treatments include Madrigal Pharmaceuticals (MDGL), Novo Nordisk (NVO), Genfit (GNFT), Eli Lilly (LLY), and Alnylam Pharmaceuticals (ALNY).

ICPT closed at $77.49, last traded at $48.00, down 38%.

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Arena Pharmaceuticals higher on ulcerative colitis data

Bristol Myers Squibb (BMY) reported positive ulcerative colitis treatment data. The report sent shares of Arena Pharmaceuticals (ARNA) higher.

Arena shares jump of Bristol Myers data, Stockwinners

The study tested Bristol Myers’ Zeposia in patients with moderate to severe ulcerative colitis. At weeks 10 and 52, the experimental ulcerative colitis treatment induced clinical remission and maintained remission, respectively.

Zeposia belongs to a class of oral drugs known as sphingosine-1-phosphate receptor modules, or S1P. This is the first time an S1P drug has shown strong effectiveness in ulcerative colitis treatment, suggesting these drugs could beat out another class called janus kinase inhibitors, or JAKs.

Arena is also testing out an S1P drug, etrasimod.

Etrasimod is a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena, and designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5 which may lead to an improved efficacy and safety profile.

Etrasimod provides systemic and local effects on specific immune cell types and has the potential to treat multiple immune-mediated inflammatory diseases including ulcerative colitis, Crohn’s disease, and atopic dermatitis.

Etrasimod is an investigational compound that is not approved for any use in any country.

Canter Comments

Cantor Fitzgerald analyst Alethia Young raised the firm’s price target on Arena Pharmaceuticals (ARNA) to $88 from $68 and reiterates an Overweight rating on the shares.

Bristol Meyers’ (BMY) positive topline data this morning from the pivotal study of its sphingosine-1-phosphate ozanimod in ulcerative colitis is a “positive readthrough” to Arena’s etrasimod ulcerative colitis program, Young tells investors in a research note.

The analyst increased her probability of success to 80% from 75% and is now “very confident” in the Phase 3 success of etrasimod.

#Young also thinks that #S1P1 as a class is shaping up to be a “big commercial opportunity” and increased her peak sales to $3B.

She thinks Arena shares will be up at least 10% today on Bristol’s news given that ozanimod and etrasimod are both S1P1s and this is the first positive Phase 3 readout for the class in ulcerative colitis, says the analyst.

Credit Suisse

Credit Suisse analyst Martin Auster raised the firm’s price target on Arena Pharmaceuticals (ARNA) to $87 from $77 and keeps an Outperform rating on the shares after Bristol-Myers (BMY) announced that S1P modulator ozanimod met its primary endpoint of clinical remission in the Phase 3 “True North” study of adults with moderate to severe ulcerative colitis.

Auster views ozanimod’s topline success as de-risking for the S1P class and sees positive read-through for Arena’s etrasimod, he tells investors. He has increased his view on the odds of success for etrasimod in ulcerative colitis following Bristol’s report, the analyst added.

ARNA is up 16% to $68.04

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ChemoCentryx shares soar on data

ChemoCentryx, VFMCRP say pivotal phase-III ADVOCATE trial met primary endpoints

Vifor Fresenius Medical Care Renal Pharma, or VFMCRP, and ChemoCentryx (CCXI) announced positive topline data from the pivotal phase-III ADVOCATE trial of avacopan, an orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).

ChemoCentryx shares soar on its ANCA drug, Stockwinners

ANCA vasculitis is an autoimmune disease affecting small blood vessels in the body. It is caused by autoantibodies called ANCAs, or Anti-Neutrophilic Cytoplasmic Autoantibodies.

This global study, in which a total of 331 patients with ANCA vasculitis were enrolled, met both of its primary endpoints, disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS.

Remission was defined as a BVAS score of zero and being off glucocorticoid treatment for ANCA vasculitis for at least the preceding four weeks.

BVAS remission at week 26 was achieved in 72.3% of the avacopan treated subjects vs. 70.1% of subjects in the glucocorticoid standard of care control group.

Sustained remission at 52 weeks was observed in 65.7% of the avacopan treated patients vs. 54.9% in the glucocorticoid standard of care control group, achieving both non-inferiority and superiority to glucocorticoid standard of care.

Importantly, subjects who received avacopan experienced additional benefits compared to those in the glucocorticoid standard of care control group.

These benefits, assessed as pre-specified secondary endpoints, include: Significant reduction in glucocorticoid-related toxicity; Significant improvement in kidney function in patients with renal disease at baseline; Improvements in health-related quality of life metrics.

The topline safety results revealed an acceptable safety profile in this serious and life threatening disease with fewer subjects having serious adverse events in the avacopan group than in the glucocorticoid standard of care control group.

A full analysis of the data is underway and expanded results are expected to be announced in the coming weeks. “These results exceed our expectations,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx.

“Today we mark the dawn of a new and historic period in the lives of ANCA vasculitis patients. This day we have for the first time demonstrated that a highly targeted therapy aimed at the very center of the ANCA disease process is superior to the traditional approach of broad immune suppression therapy; a therapy which the present findings may make obsolete. Until now ANCA vasculitis patients have had to endure regimens that contain chronic high doses of steroids and all their noxious effects, but with today’s data it is clear that the time of making patients sick with steroid therapy in an attempt to make their acute vasculitis better may at last be over. Working with our partner VFMCRP, we plan to make regulatory submissions for full marketing approval to both the European Medicines Agency and the FDA in 2020.”

CCXI is up $26.68 to $34.65

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Assurance IQ sold for $2.35 billion

Prudential acquires Assurance IQ for $2.35B plus additional earnout up to $1.5B

Prudential Financial (PRU) announced that it has signed a definitive agreement to acquire Assurance IQ, “a profitable, fast-growing direct-to-consumer platform that transforms the buying experience for individuals seeking personalized health and financial wellness solutions.”

Prudential Financial (PRU) announced that it has signed a definitive agreement to acquire Assurance IQ, "a profitable, fast-growing direct-to-consumer platform that transforms the buying experience for individuals seeking personalized health and financial wellness solutions."
Prudential pays $2.35 B for Assurance. Stockwinners

Terms of the acquisition include a total upfront consideration of $2.35 billion, plus an additional earnout of up to $1.15 billion in cash and equity, contingent upon Assurance achieving multi-year growth objectives.

Under the terms of the agreement, Assurance will become a wholly owned subsidiary of Prudential under the U.S. Businesses division.

Prudential buys Assurance IQ for $2.5B, Stockwinners

Assurance co-founders Michael Rowell and Michael Paulus will continue to focus on the growth of Assurance.

Rowell will remain CEO of Assurance and report to Andrew Sullivan, who will assume the role of executive vice president and head of U.S. Businesses as of December 1.

Paulus will remain president of Assurance.

The acquisition is expected to be modestly accretive to EPS and ROE starting in 2020.

In addition to enhancing the growth of Prudential’s financial wellness businesses, the acquisition is expected to generate cost savings of $50 million to $100 million, in addition to the $500 million of expected margin expansion by 2022 discussed at Prudential’s June Investor Day.

Prudential plans to use a combination of its current cash, debt financing and equity to fund the acquisition, which is expected to close early in the fourth quarter of 2019. Prudential’s Board of Directors unanimously approved the transaction.

Prudential’s Board of Directors has authorized a $500 million increase to its share repurchase authorization for calendar year 2019.

As a result, the share repurchase authorization for the full year 2019 is $2.5 billion.

As of June 30, Prudential had repurchased $1.0 billion of shares of its common stock under this authorization.

Prudential expects to fully utilize this increased share repurchase authorization by the end of 2019.

PRU +$2.21 to $81.85

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Sorrento Therapeutics reports positive Parkinson’s disease study, shares rise

Sorrento Therapeutics announces top line results from Parkinson’s disease study


Sorrento Therapeutics announces top line results from Parkinson’s disease study, Stockwinners

Sorrento Therapeutics (SRNE) announced top line results in a discovery study aimed at exploring potential benefits of resiniferatoxin in controlling neuro-inflammatory processes associated with Parkinson’s disease in a rodent model.

Many clinical and pathological studies have shown that the disease extends beyond the substantia nigra and involves non-dopaminergic neurotransmitter systems that mediate both motor and non-motor symptoms.

Several therapeutic strategies have been proposed to treat such symptoms. However, despite the significant morbidity associated with these symptoms, research into and drug development for these problems remain scarce.

Transient receptor potential vanilloid 1, or TRPV1, is involved in pain perception and is highly expressed in sensory neurons. TRPV1 is also present in the brain where it may play a role in modulating neuronal function, controlling motor behavior and regulating neuroinflammation.

TRPV1 receptors are considered an important modulator of basal ganglia functions, and pharmacological changes to cells expressing those receptors might lead to protective therapies in Parkinson-induced motor symptoms.

Intrathecal administration of RTX at 7 days after AAV-A53T resulted in improved motor function analyzed by fine motor kinematic analysis when compared to control mice administered with vehicle for RTX.

No significant adverse effects after RTX infusion were observed. However, no significant effects in dopamine and its metabolites levels in striatum were observed.

The findings demonstrated activity of intrathecal administration of RTX at the early intervention paradigm to rescue motor deficits in AAV-A53T model.

The lack of effect on dopamine levels suggest that behavioral recovery is driven by mechanisms other than direct protection of nigrostriatal dopaminergic neurons, including modulation of neuroinflammation and/or analgesic effect of RTX after IT delivery.

A provisional patent has been filed for non-dopaminergic therapeutic approach with resiniferatoxin for symptomatic relief of motor symptoms associated with Parkinson’s disease.

The full results of the study will be released in publication in a scientific journal and presented at an upcoming neurosciences conference later this year.

Enabling preclinical work will continue with the goal of filing an IND by the end of the year. If results are confirmed, human clinical trials to start soon after. announces top line results from Parkinson’s disease study

Sorrento Therapeutics announced top line results in a discovery study aimed at exploring potential benefits of resiniferatoxin in controlling neuro-inflammatory processes associated with Parkinson’s disease in a rodent model.

Many clinical and pathological studies have shown that the disease extends beyond the substantia nigra and involves non-dopaminergic neurotransmitter systems that mediate both motor and non-motor symptoms.

Several therapeutic strategies have been proposed to treat such symptoms. However, despite the significant morbidity associated with these symptoms, research into and drug development for these problems remain scarce.

Transient receptor potential vanilloid 1, or TRPV1, is involved in pain perception and is highly expressed in sensory neurons.

TRPV1 is also present in the brain where it may play a role in modulating neuronal function, controlling motor behavior and regulating neuroinflammation. TRPV1 receptors are considered an important modulator of basal ganglia functions, and pharmacological changes to cells expressing those receptors might lead to protective therapies in Parkinson-induced motor symptoms.

Intrathecal administration of RTX at 7 days after AAV-A53T resulted in improved motor function analyzed by fine motor kinematic analysis when compared to control mice administered with vehicle for RTX.

No significant adverse effects after RTX infusion were observed. However, no significant effects in dopamine and its metabolites levels in striatum were observed.

The findings demonstrated activity of intrathecal administration of RTX at the early intervention paradigm to rescue motor deficits in AAV-A53T model.

The lack of effect on dopamine levels suggest that behavioral recovery is driven by mechanisms other than direct protection of nigrostriatal dopaminergic neurons, including modulation of neuroinflammation and/or analgesic effect of RTX after IT delivery.

A provisional patent has been filed for non-dopaminergic therapeutic approach with resiniferatoxin for symptomatic relief of motor symptoms associated with Parkinson’s disease. The full results of the study will be released in publication in a scientific journal and presented at an upcoming neurosciences conference later this year.

Enabling preclinical work will continue with the goal of filing an IND by the end of the year. If results are confirmed, human clinical trials to start soon after.

SRNE closed at $4.09.

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Caladrius Biosciences tumbles on disappointing results

Caladrius says no improvement in primary endpoint in T-Rex study results

Caladrius tumbles on results, Stockwinners
Caladrius tumbles on results, Stockwinners

Caladrius (CLBS) announced top-line results from the Sanford Project: T-Rex study, a prospective, randomized, placebo-controlled, double-blind Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of the company’s CLBS03 as a treatment for recent-onset type 1 diabetes, or T1D, in adolescents.

The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study, however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at one year was observed at the group level.

As with many Phase 2a trials, the database from this study is large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03.

In addition, the data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy.

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.

Different factors, including genetics and some viruses, may contribute to type 1 diabetes. Although type 1 diabetes usually appears during childhood or adolescence, it can develop in adults.

Despite active research, type 1 diabetes has no cure. Treatment focuses on managing blood sugar levels with insulin, diet and lifestyle to prevent complications.

CLBS is down $1.26 to $4.08.

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Amarin sharply higher on data

Amarin soars after REDUCE-IT study meets primary endpoint

Amarin sharply higher on data, Stockwinners
Amarin sharply higher on data, Stockwinners

Amarin (AMRN) announced topline results from the Vascepa cardiovascular outcomes trial, REDUCE-IT, a global study of 8,179 statin-treated adults with elevated CV risk.

REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance, in major adverse CV events in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo, Amarin said in a statement.

Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL controlled by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 150-499 mg/dL and either established cardiovascular disease or diabetes mellitus and at least one other CV risk factor. Key topline results include approximately 25% relative risk reduction, demonstrated to a high degree of statistical significance, in the primary endpoint composite of the first occurrence of MACE, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

This result was supported by robust demonstrations of efficacy across multiple secondary endpoints, the company said.

It added that Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling.

The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and placebo treatment groups.

Median follow-up time in REDUCE-IT was 4.9 years. Amarin said it is “eager to share REDUCE-IT data in greater detail with both the medical community and regulatory authorities.”

REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association on November 10, 2018 in Chicago, Illinois.

“We are delighted with these topline study results,” said John Thero, president and CEO of Amarin.

“Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT.”

It notes, “As previously described, given the successful topline results of REDUCE-IT, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States.”

Shares of Amarin (AMRN) closed at $2.99, it last traded at $12.30.


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Navigators Group sold for $2.1 billion

Hartford Financial to acquire Navigators for $2.1B in cash 

Navigators Group sold for $2.1 billion, Stockwinners
Navigators Group sold for $2.1 billion, Stockwinners

The Navigators Group (NAVG) announced that it has entered into a definitive agreement to be acquired by The Hartford Financial Services Group (HIG) in an all-cash transaction that values Navigators at approximately $2.1B.

Under the terms of the agreement, Navigators stockholders will receive $70.00 per share in cash upon the closing of the transaction.

The $70.00 per share offer price represents a multiple of 1.78 times Navigators’ fully diluted tangible book value per share as of June 30, 2018 and an 18.6% premium to the 90-trading-day average stock price.

The transaction, which was unanimously approved by Navigators’ Board of Directors, is subject to regulatory and stockholder approvals and other customary closing conditions, and is expected to close in the first half of 2019.

Navigators expects to continue paying regular quarterly dividends consistent with past practice prior to closing.

Completion of the transaction is not subject to any financing conditions. Navigators’ founder, and shares controlled by other members of his family, which represent approximately 20% of total shares outstanding, have agreed to vote in support of Navigators’ transaction with The Hartford.

The agreement includes a “go-shop” provision designed to afford an opportunity for other potential acquirers to determine whether they are interested in proposing to acquire Navigators.

Accordingly, for 30 days Navigators will have an opportunity to solicit competing acquisition proposals. If the Board of Directors accepts a competing proposal during the “go-shop” period that The Hartford does not match, the successful competing bidder would pay a termination fee to The Hartford.

NAVG closed at $64.25.


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Zynerba lower following disappointing results

Zynerba says target blood levels in ZYN001 THC-Prodrug patch study not achieved

Zynerba lower following disappointing results, Stockwinners
Zynerba lower following disappointing results, Stockwinners

Zynerba Pharmaceuticals (ZYNE) announced top line results from a Phase 1 clinical program studying ZYN001, the Company’s patent-protected, pro-drug of tetrahydrocannabinol delivered via a transdermal patch, in healthy volunteers.

The program assessed the safety and pharmacokinetics in single and multiple doses of several formulations of ZYN001.

The top line results of this Phase 1 study indicate that target blood levels of 5 to 15 ng/ml THC were not achieved.

ZYN001 was very well tolerated with minimal skin erythema.

There were no serious adverse events or discontinuations for subjects receiving ZYN001.

As a result of these data, the Company will focus its development efforts and investments on the ZYN002 Fragile X syndrome, developmental and epileptic encephalopathy and adult refractory epilepsy programs.

The company expects that this change will extend its cash runway into the second half of 2019.

This Phase 1 study was a single and multiple dose, placebo-controlled first-in-man study to assess the safety and pharmacokinetics of ZYN001 administered as a transdermal patch to healthy adult subjects.

Several formulations and patch wear times ranging from 24 hours to 14 days were assessed in in 60 healthy subjects who were randomized to ZYN001 or placebo.

ZYNE closed at $9.61, it last traded at $7.60.


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Juniper Pharmaceuticals sold for $139.6 Million

Catalent agrees to acquire Juniper Pharmaceuticals for $11.50 per share 

Juniper Pharmaceuticals sold for $139.6 Million, Stockwinners
Juniper Pharmaceuticals sold for $139.6 Million, Stockwinners

Catalent (CTLT) announced that it has agreed to acquire Juniper Pharmaceuticals (JNP), including its Nottingham, U.K.-based Juniper Pharma Services division.

When combined with Catalent’s existing industry-leading drug development and manufacturing capabilities in the U.S. and Europe, the acquisition of Juniper will expand and strengthen Catalent’s offerings in formulation development, bioavailability solutions and clinical-scale oral dose manufacturing, and will complement its integrated global clinical and commercial supply network. Juniper’s nearly 150 employees have deep scientific expertise in formulation development, and supply, and will augment Catalent’s current portfolio of solid-state screening, preformulation, formulation, analytical, and bioavailability enhancement solutions, including development of spray-dried dispersions, with integrated development, analytical, and clinical manufacturing co-located in its Nottingham facility.

Catalent will continue to support Juniper’s CRINONE franchise marketed by Merck KGaA outside of the U.S.

Juniper’s Intravaginal Ring development pipeline was previously licensed to Dare Bioscience, and Catalent will not be involved in the further development of this program.

The acquisition of Juniper is subject to certain customary closing conditions, including that a majority of Juniper’s shares are tendered into the offer, and is expected to close in the first quarter of Catalent’s 2019 fiscal year, which began on July 1, 2018.

Like Catalent, Juniper has expertise in solid-state and preclinical formulation screening for lead-candidate selection, phase-appropriate dose-form development, and superior technologies for challenging molecules, which will strengthen and expand on Catalent’s OptiForm Solution Suite platform.

Juniper provides bioavailability enhancement solutions for the development of poorly soluble compounds, including nano-milling, spray drying, hot-melt extrusion, lipid-based drug delivery, and cGMP clinical manufacturing, including specialized facilities and controls for potent and controlled substances. Under its acquisition agreement with Juniper, a subsidiary of Catalent will promptly commence a tender offer to purchase all of Juniper’s shares for a price of $11.50, net to the seller in cash.

Following the conclusion of the tender offer, Catalent intends to complete the transaction by acquiring the remainder of the Juniper shares at the same price through a merger with a newly formed wholly owned subsidiary of Catalent.

JNP closed at $8.70. CTLT closed at $41.82.


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Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah, Stockwinners
Novartis receives positive CHMP opinion for Kymriah, Stockwinners

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Kymriah – a novel one-time treatment that uses a patient’s own T cells to fight cancer.

The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma that is relapsed or refractory after two or more lines of systemic therapy in adults.

If approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union for both DLBCL and B-cell ALL.

Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients.

In Europe, ALL accounts for approximately 80% of leukemia cases among children, and for those patients who relapse, the outlook is poor. This low survival rate is in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, and further highlights the need for new treatment options.

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally.

For patients who relapse or don’t respond to initial therapy, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant or because salvage chemotherapy or ASCT have failed.

The positive CHMP opinion is based on two pivotal Novartis-sponsored global, multi-center, Phase II trials, ELIANA and JULIET, which included patients from Europe, the US, Australia, Canada and Japan. The collaboration of Novartis and the University of Pennsylvania has led to historic milestones in CAR-T cell therapy since 2012, including the initiation of the first global CAR-T trials, the PRIME designation granted by the EMA for Kymriah in pediatric patients with r/r B-cell ALL, and the approval of Kymriah in two distinct indications by the US Food and Drug Administration.

ELIANA is the first pediatric global CAR-T cell therapy registration trial, treating patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain. JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL.

JULIET is also the largest global study evaluating a CAR-T cell therapy in patients with DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and the EU, including: Austria, France, Germany, Italy, Norway and the Netherlands.

The Novartis CAR-T cell manufacturing platform includes cryopreservation, the process of freezing patients’ harvested cells in order to preserve them, which provides physicians with the flexibility to decide when to initiate both the harvesting of patients’ cells and the infusion of Kymriah, based on each patient’s condition, and allows for this individualized treatment approach on a global scale.

The European Commission will now review the CHMP recommendation to deliver its final decision, applicable to all 28 EU member states, plus Iceland, Liechtenstein and Norway.

NVS closed at $73.00, it last traded at $75.50.


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Incyte says REACH1 trial met primary endpoint

Incyte says REACH1 trial met primary endpoint of ORR for Ruxolitinib

Incyte says REACH1 trial met primary endpoint, Stockwinners
Incyte says REACH1 trial met primary endpoint, Stockwinners

Incyte (INCY) announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib, or Jakafi, in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease.

The study met its primary endpoint, demonstrating an overall response rate of 55% at Day 28.

In addition, the best overall response rate , the number of patients achieving a response at any time point during the study, was 73%.

The most common treatment-emergent adverse events of any grade were anemia, thrombocytopenia and neutropenia.

Based on these data from REACH1, Incyte plans to file a Supplemental New Drug Application for the approval of ruxolitinib for the treatment of steroid-refractory acute GVHD with the U.S. FDA during the third quarter of 2018.

“The results of the REACH1 study demonstrate the potential of ruxolitinib to meaningfully improve the outcomes of allogeneic transplant patients who develop steroid-refractory acute GVHD and further underscore the promise of JAK inhibition to advance the treatment of this potentially-devastating condition,” said Steven Stein, M.D., Chief Medical Officer, Incyte.

“We look forward to sharing additional results from this study with the medical community, and to working with U.S. regulatory authorities to submit our supplementary new drug application seeking approval of ruxolitinib in this indication later this year.”

INCY closed at $73.43, it last traded at $74.65.


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Ionis Pharmaceuticals is in focus

Biogen, Ionis Pharmaceuticals expand drug development collaboration

Biogen will pay Ionis $1B in cash

Biogen (BIIB) and Ionis Pharmaceuticals (IONS) announced they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases.

This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies.

Biogen says BAN2401 did not meet primary endpoint. Stockwinners.com
Biogen will pay Ionis $1B in cash

It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy.

Under the terms of the collaboration, Biogen will pay Ionis $1B in cash, which will include $625M to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an approximately 25% cash premium, and a $375M upfront payment.

Biogen will have the option to license therapies arising out of this collaboration and will be responsible for their development and commercialization.

In addition, Biogen may pay milestone payments, license fees and royalties on net sales.

The companies plan to advance programs for a broad range of neurological diseases for which few treatment options exist today.

Disease areas include dementia, neuromuscular diseases, movement disorders, ophthalmology, diseases of the inner ear, and neuropsychiatry.

Biogen will have the first choice of neurology targets on which to exclusively collaborate with Ionis.

In this collaboration, Ionis will be responsible for the identification of antisense drug candidates based on selected targets, while Biogen will be responsible for and pay for non-clinical studies, clinical development, manufacturing, and commercialization. Biogen and Ionis expect the deal to close in the second quarter of 2018.

IONS closed at $45.85. BIIB closed at $266.02.


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ChemoCentryx is in focus

ChemoCentryx publishes findings of role of CCR2 in kidney glomerulus

ChemoCentryx publishes findings of role of CCR2 in kidney glomerulus. Stockwinners.com
ChemoCentryx publishes findings of role of CCR2 in kidney glomerulus

ChemoCentryx  (CCXI) announced the peer-reviewed publication of positive results from in vivo studies examining the efficacy of inhibiting the chemokine receptor known as CCR2 in the treatment of focal segmental glomerulosclerosis, a debilitating chronic kidney disorder with no approved treatment option.

Data presented in the publication show that blocking CCR2 provides rapid and sustained renal protection in two well-established models of FSGS, as measured by reduction in proteinuria and improvement in multiple histological parameters.

The findings were published in the journal PLOS ONE under the title “CCR2 antagonism leads to marked reduction in proteinuria and glomerular injury in murine models of focal segmental glomerulosclerosis.”

Key findings from the study include: In two murine FSGS models, CCR2 inhibition markedly reduced proteinuria and improved renal function, both as a single agent and in combination with renin-angiotensin-aldosterone system blockade; The combination of CCR2 inhibition and RAAS blockade was as effective as the combination of endothelin receptor inhibition and RAAS blockade; and Improvements in renal function observed with CCR2 inhibition were associated with encouraging histological changes, as assessed by decreased glomerular sclerosis, mesangial expansion and tubular collapse, including increased podocyte density.

CCR2 antagonism leads to marked reduction in proteinuria and glomerular injury in murine models of focal segmental glomerulosclerosis.

CCXI is down 31 cents to $14.68.


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Valeant higher amid debt offering, insider buying

Valeant moves higher amid debt offering, insider buying

Insurers are dropping Valeant's top products. See Stockwinners.com Market RadarValeant moves higher amid debt offering, insider buying

Shares of specialty pharmacy company Valeant (VRX) are higher this afternoon amid a relatively weak market backdrop.

DEBT OFFERING

On March 12, Valeant announced a private offering of $1.25B aggregate principal amount of unsecured senior notes due 2026. The proceeds of the newest offering will help fund the repurchase of $1.25B of outstanding debt, including its 6.375% Senior Notes due 2020, 5.375% Senior Notes due 2020 and up to $100M of its 6.750% Senior Notes due 2021.

Wells Fargo analyst David #Maris said earlier this week that less than two weeks after filing a shelf offering, Valeant Pharmaceuticals launched a $1.25B offering of unsecured senior notes due 2026.

Based on discussions with his firm’s high yield debt analyst, Maris estimates the debt likely has a 9%-plus coupon.

Valeant is looking to push out 2020 maturities, which may be reflective of its business outlook for the period between now and maturity, Maris told investors earlier in the week.

INSIDER BUYING

In a regulatory filing after the close of trading Tuesday night, Valeant chairman and CEO Joseph Papa disclosed the purchase of 30,000 common shares of the company at a price of $16.05 per share.

EARNINGS

Late in February, Valeant reported adjusted EBITDA was $875M for Q4, as compared to $1.047B for Q4 of 2016, a decrease of $172M. Revenue for Q4 was $2.16B, just below forecasts for $2.2B.

Unfortunately, Valeant also said it expects sales of $8.1B-$8.3B in 2018, below the $8.37B consensus. Shares of the drug maker dropped precipitously after the recent earnings report.

ANALYSTS ON EARNINGS

Soon after Valeant’s Q4 results, Wells Fargo analyst David Maris said Valeant reported “weak” Q4 results, noting that when adjusted for divestitures, two of the company’s three business units showed revenue declines and the third, B&L/International, had a slowdown from Q3 to “only” 4% growth.

Valeant didn’t give an adjusted EPS figure, but he calculates its Q4 adjusted EPS at 98c, compared to his 99c estimate and consensus of 97c. Maris, who said at the time, he does not see “the stabilization, the turnaround, or the transformation Valeant mentions in its earnings presentation.”

Maris kept an Underperform rating on the stock.

PRICE ACTION

Shares of Valeant are up 5.7% to $16.99.


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