The Medicines Co. sold for $9.7B

Novartis to pay $85 per share in cash for each MDCO share

The Medicines Company (MDCO) announced that it has entered into definitive agreement in which Novartis (NVS) will acquire the company for $85 per share in an all-cash transaction, implying a fully diluted equity value of $9.7B.

Novartis to pay $85 per share in cash for each MDCO share, Stockwinners

The stock closed Friday down $1.21 to $68.55. See our previous blog post.

The purchase price represents a premium of approximately 45% to The Medicines Company’s closing share price of $58.65 on November 18, the last trading day prior to news reports of a potential transaction between The Medicines Company and Novartis.

Novartis receives positive CHMP opinion for Kymriah, Stockwinners
Novartis to pay $85 per share in cash for each MDCO share, Stockwinners , Stockwinners

The transaction was unanimously approved by the boards of both companies. Under the terms of the merger agreement, Novartis will commence a tender offer to purchase all outstanding shares of The Medicines Company for $85 per share in cash.

Following the completion of the tender offer, a wholly owned subsidiary of Novartis will merge with The Medicines Company and shares of The Medicines Company that have not been tendered and purchased in the tender offer will be converted into the right to receive the same price per share.

Completion of the transaction is expected in Q1 of 2020, pending the successful completion of the tender offer and other customary closing conditions.

Until that time, The Medicines Company will continue to operate as a separate and independent company. The company expects to file regulatory submissions for inclisiran in the U.S. in Q4 of 2019 and in Europe in the first quarter of 2020.

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Cara Therapeutics shares jump on KALM-1 data

Cara Therapeutics announces topline data from KALM-1 Phase 3 trial

Cara reports positive top-line data from CR845, Stockwinners
Cara reports positive results from the KALM-1 pivotal Phase 3 trial of Korsuva Injection in hemodialysis patients , Stockwinners

Cara Therapeutics (CARA) announced topline data from the KALM-1 pivotal Phase 3 trial of Korsuva Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus, or CKD-aP.

Chronic kidney disease-associated pruritus ( #CKD-aP ) is a distressing, often overlooked condition in patients with CKD and end-stage renal disease. It affects ~40% of patients with end-stage renal disease and has been associated with poor quality of life, poor sleep, depression, and mortality.  Despite being an annoyance, CKD-associated pruritus (CKD-aP) can adversely affect the quality of life (QOL) and medical outcomes. 

The proportion of patients on 0.5 mcg/kg of Korsuva Injection achieving a three-point or greater improvement from baseline in the weekly mean of the daily 24 hour Worst Itching Intensity Numeric Rating Scale, or WI-NRS, score at week 12 was 51% vs. 28% for patients on placebo.

The proportion of patients on 0.5 mcg/kg of Korsuva Injection achieving a four-point or greater improvement from baseline in the weekly mean of the daily 24 hour WI-NRS score at week 12 was 39% vs. 18% for patients on placebo.

Patients on #Korsuva Injection experienced a 43% improvement in the average total Skindex-10 score at week 12 vs. patients on placebo.

Patients on Korsuva Injection experienced a 35% improvement in the average total 5-D Itch score at week 12 vs. patients on placebo.

Korsuva was generally well-tolerated with a safety profile consistent with that seen in earlier Korsuva clinical trials.

Overall, the incidence of adverse events, or AEs, and serious AEs were similar across both Korsuva and placebo groups.

The most common treatment emergent AEs reported in greater than 5% of patients were diarrhea, dizziness, nasopharyngitis and vomiting.

CARA is up 12.5% to $20.21 per share.

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Axovant higher on data

Axovant jumps following update on Tay-Sachs Disease gene therapy program

Axovant higher on gene data, Stockwinners

Shares of Axovant (AXGT) have surged higher today following the company’s report of three-month data from an investigator-initiated study administering investigational AXO-AAV-GM2 gene therapy in a patient with advanced infantile Tay-Sachs disease, a rare and fatal pediatric eurodegenerative genetic disorder.

Tay-Sachs disease (TSD) is a fatal genetic disorder, most commonly occurring in children, that results in progressive destruction of the nervous system. Tay-Sachs is caused by the absence of a vital enzyme called hexosaminidase-A (Hex-A). Without Hex-A, a fatty substance, or lipid, called GM2 ganglioside accumulates abnormally in cells, especially in the nerve cells of the brain. This ongoing accumulation causes progressive damage to the cells.

In children, the destructive process begins in the fetus early in pregnancy. However, a baby with Tay-Sachs disease appears normal until about six months of age when its development slows. By about two years of age, most children experience recurrent seizures and diminishing mental function. The infant gradually regresses, and is eventually unable to crawl, turn over, sit or reach out. Eventually, the child becomes blind, cognitively impaired, paralyzed and non-responsive. By the time a child with Tay-Sachs is three or four years old, the nervous system is so badly affected that death usually results by age five.

The study is evaluating a total dose of 1.0x 1014 vg of AXO-AAV-GM2 in a 30-month-old child with advanced infantile Tay-Sachs disease.

AXO-AAV-GM2 was administered into the cisterna magna and lumbar spinal canal only.

Due to the patient’s advanced disease, a co-delivered intrathalamic injection of AXO-AAV-GM2 was not administered.

Future patients in the program, who are expected to be treated earlier in their disease course, will receive AXO-AAV-GM2 co-delivered into the thalamus bilaterally as well as into the cisterna magna and spinal canal.

“AXO-AAV-GM2 was generally well-tolerated and no serious adverse events have been reported as of the 3-month visit. At 3 months, no clinically relevant laboratory abnormalities were observed following AXO-AAV-GM2 administration.

The patient’s clinical condition was stable from baseline to month 3 without clinical deterioration observed on neurological exam.

Furthermore, there was no significant deterioration in the condition from the pre-treatment magnetic resonance imaging of the brain at baseline to the post-treatment MRI at month 3,” the company announced in press release earlier this morning.

Additionally, Chardan has upgraded Axovant to Buy from Neutral following the data report.

In morning trading, Axovant shares are up 46c, or 31%, to $1.94.

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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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Tesaro sold for $75 per share

Tesaro to be acquired by GSK for approx. $5.1B

 

Tesaro could be sold soon, Stockwinners
Tesaro sold for $75 per share, Stockwinners

GlaxoSmithKline (GSK) and TESARO (TSRO) announced that the companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO, an oncology-focused company based in Waltham, Massachusetts, for an aggregate cash consideration of approximately $5.1B.

The proposed transaction significantly strengthens GSK’s pharmaceutical business, accelerating the build of GSK’s pipeline and commercial capability in oncology. The acquisition price of $75 per share in cash represents a 110% premium to TESARO’s 30 day Volume Weighted Average Price of $35.67 and an aggregate consideration of approximately $5.1B including the assumption of TESARO’s net debt.

Zejula’s revenues in its current approved indication as second-line maintenance treatment for ovarian cancer were $166 million for the 9 months ended 30 September 2018.

GSK expects the acquisition of TESARO and associated R&D and commercial investments will impact Adjusted EPS for the first two years by mid to high single digit percentages, reducing thereafter with the acquisition expected to start to be accretive to Adjusted EPS by 2022. GSK’s guidance for full-year 2018 Adjusted EPS growth remains unchanged at 8 to 10% at CER.

GSK continues to expect to deliver on its previously published Group Outlooks to 2020, but following the acquisition of TESARO now expects Adjusted EPS growth at CER for the period 2016-2020 to be at the bottom end of the mid to high single digit percentage CAGR range.

GSK confirms no change to its current dividend policy and continues to expect to pay 80p in dividends for 2018. GSK expects to fund the acquisition from cash resources and drawing under a new acquisition facility.

Please click here and read our blog when we predicted this transaction.


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Incyte reports positive data

Incyte announces Phase 2b trial of ruxolitinib cream met primary endpoint

Incyte says REACH1 trial met primary endpoint, Stockwinners
Incyte reports positive data, Stockwinners

Incyte Corporation (INCY) announced positive results from its randomized, dose-ranging, vehicle- and active-controlled Phase 2b study evaluating ruxolitinib cream in patients with atopic dermatitis who are candidates for topical therapy.

The study, part of the True-AD clinical trial program, met its primary endpoint, demonstrating that ruxolitinib cream 1.5% administered twice daily significantly improved Eczema Area and Severity Index scores – a measurement of the extent and severity of AD – from baseline versus vehicle control at Week 4.

Additionally, treatment with ruxolitinib cream 1.5% BID resulted in a rapid and sustained reduction in itch versus vehicle, a key secondary endpoint.

These results were shared in an oral presentation today at the 27th European Academy of Dermatology and Venerology Congress in Paris, France.

Key study results included: Significantly improved EASI score in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4, the primary endpoint, and improvement in EASI score versus the active control, triamcinolone 0.1% cream, at Week 4, a secondary endpoint.

Significantly improved EASI scores in the ruxolitinib cream 1.5% BID arm versus vehicle at Weeks 2 and 8. Significantly greater changes in EASI score in the once daily ruxolitinib cream 1.5% and 0.5% arms versus vehicle at Week 4.

Significantly more Investigator’s Global Assessment responders – a measure of disease severity – in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4, and greater IGA response rates across other ruxolitinib arms versus vehicle.

Rapid and sustained reductions in itch numerical rating scale score observed as early as within two days from the initiation of therapy, and a more pronounced reduction in itch with ruxolitinib cream 1.5% BID and QD than with triamcinolone cream 0.1% BID.

Ruxolitinib cream was well-tolerated at all dosage strengths and was not associated with clinically-significant application site reactions.

All treatment-related adverse events were Grade 1 or Grade 2 in severity. Ruxolitinib cream is the first JAK1/JAK2 inhibitor to exhibit positive results as a topical monotherapy in the AD patient population.

Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis of AD.

These data support the planned initiation of a global, pivotal Phase 3 program, for which preparations are already underway.

INCY closed at $66.51.


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Valeritas reports positive insulin study, shares rise

Valeritas announces ‘positive’ results from V-Go WeArable Insulin Delivery study

Valeritas reports positive insulin study, Stockwinners
Valeritas reports positive insulin study, Stockwinners

Valeritas Holdings (VLRX) announced positive results from the EffectiveNess of V-Go WeArable Insulin Delivery for Basal-BoLus ThErapy Study.

Three poster presentations at the American Diabetes Association Meeting in Orlando, Florida, reported that patients who switched from insulin pens and syringes to V-Go significantly improved blood glucose while lowering insulin dose.

The first ENABLE Study poster evaluated the clinical benefits in patients with type 2 diabetes who switched from using insulin pens and syringes to deliver their insulin regimen with V-Go for insulin delivery.

The 283 patient, retrospective study demonstrated clinically and statistically significant reductions in A1C by over 1% and insulin total daily dose at three and seven months.

The percent of patients at high risk was reduced by nearly 50% after switching to V-Go.

In addition, over 50% of all patients in the study achieved an A1C less than 8%.

The second analysis from the ENABLE study confirmed V-Go provided a clinical benefit in a patient population poorly controlled on conventional basal-bolus therapy delivered by multiple daily injections using insulin pens and syringes.

The analysis in 186 patients with type 2 diabetes demonstrated lowering of A1C by -1.0 at three months which was sustained at seven months and statistically significant with a Pless than0.0001.

Insulin TDD was reduced by 30% with V-Go use. To determine if TDD was a factor in the change in A1C, patients were separated into three approximately equal groups based on baseline TDD, 60 to 90 U/day, or greater than 90 U/day.

Results demonstrated statistically significant A1C reductions across all TDD groups of -1.0, -0.8, -1.2, respectively, each with a Pless than0.001.

The third ENABLE study poster evaluated the impact of duration of diabetes on change in A1C and insulin TDD when switching patients with type 2 diabetes from insulin delivery via insulin pen or syringe to V-Go.

Patients with known duration of diabetes were stratified into five groups based on duration of diabetes. Clinically and statistically significant reductions in A1C from baseline at both three and seven-month intervals were observed in all five duration of diabetes strata.

All strata also benefited from reductions in TDD with the exception of the duration stratum with the lowest baseline TDD, which maintained similar dosing on V-Go compared to baseline.

VLRX closed at $1.42, It last traded at $2.25.


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