Cara Therapeutics’ Rise Could Continue

Watch Cara Therapeutics into osteoarthritis pain results

Stockwinners.com/blog

Cara Therapeutics (CARA) has soared this month amid the wider biotech rally, but research firm Janney argues the stock could continue higher on a pending release of data from a study of its potential treatment for osteoarthritis pain.

BACKGROUND

Cara Therapeutics is a clinical-stage researcher focused on treating pain and pruritus, or itching, by targeting the body’s so-called “kappa” #opioid receptors.

The company’s pipeline includes #CR845 and #CR701, the former of which is in advanced studies for both oral and intravenous forms.

In its most recent earnings report on May 4, Cara said it expects top-line data from the Phase 2b trial of oral CR845 for osteoarthritis-related pain in Q2, and the company confirmed on its conference call that the trial is “now fully enrolled at 480 patients and on track for a data readout later in Q2.” Cara’s second quarter ends June 30.

JANNEY SEES BIG POTENTIAL MOVE

Janney’s Ken #Trbovich said Wednesday he expects “significant volatility” in Cara Therapeutics as investors await the Phase 2 osteoarthritis data.

Highlighting the stock’s all-time highs on the back of the biotech rally and Friday’s announcement of “breakthrough therapy” designation, the analyst nevertheless says positive osteoarthritis data can “easily justify” a move into the $31-$36 range, though he warns that negative results could take the stock to $10-$15.

The long-term potential of oral #CR845 in chronic pain is “tantalizing” for a company whose market cap remains below $1B — with Trbovich offering Nektar’s (NKTR) 42% surge on the back of Phase 3 opioid data as an example — but the analyst cautions that the pending results are only mid-stage and that “a portion” of the potential upside has already been priced in.

Modeling the company on a discounted cash flow basis while factoring any potential dilution necessary to fund and launch oral CR845, Trbovich ends up at $31-$34 per share assuming peak sales of just over $1B.

On the other hand, he expects a retrace to $15 if data is negative, or even as low as $10-$12 if results are particularly bad and investors apply the news to Cara’s pain program for intravenous CR845.

POSITIVE HINT FROM UNRELATED TRIAL

H.C. #Wainwright analyst Corey Davis wrote June 22 that the osteoarthritis data is “expected any day.” #Davis added that Cara’s announcement that week of continuing its Phase 3 trial of I.V.

#CR845 in postoperative pain after an interim analysis — while largely unconnected from the osteoarthritis trial — is “still a slight positive indicator” given the lack of futility or safety signals.

PRICE ACTION:

CARA last traded at $27.72.

See our recent post on CARA.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

PerkinElmer to buy EUROIMMUN for $1.3B in cash

PerkinElmer to buy Germany’s EuroImmun for $1.3B in cash

PerkinElmer reaffirms its 2017 revenue and EPS guidance

stockwinners.com/blog

PerkinElmer (PKI) announced that it has entered into a definitive agreement to acquire EUROIMMUN Medical Laboratory Diagnostics AG. The agreement provides that PerkinElmer will acquire up to a 100% stake in EUROIMMUN.

The total purchase price of the transaction based on all outstanding shares being acquired will be approximately $1.3B in cash.

EUROIMMUN is based in Lubeck, Germany, with approximately 2,400 employees. The company has extensive expertise and capabilities across immunology, cell biology, histology, biochemistry and molecular biology.

EUROIMMUN is expected to generate approximately $310M in revenue this year, and over the last five years, the company has averaged revenue growth of 19%.

In 2016, the company generated sales in more than 130 countries worldwide, with approximately 45% of revenues in China, 30% in Europe, Middle East & Africa, 5% in the Americas and 20% in Rest of World.

The transaction is subject to customary closing conditions and is currently anticipated to close in the fourth quarter of 2017 following the receipt of required standard regulatory approvals. The acquisition is expected to be accretive to PerkinElmer’s 2018 non-GAAP EPS results by approximately 28c-30c. Additionally, PerkinElmer is reaffirming its 2017 revenue and EPS guidance.

PerkinElmer is reaffirming its 2017 revenue and EPS guidance following the  announcement of the EUROIMMUN acquisition.

PerkinElmer, Inc. provides products, services, and solutions to the diagnostics, research, environmental, industrial, food, and laboratory services markets worldwide. The company operates through two segments, Discovery and Analytical Solutions and Diagnostics.

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section. No credit card required. 

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Inovio Zika Vaccine Proves Effective in Mice

Inovio Pharmaceuticals INO announced its DNA-based Zika vaccine protected against Zika virus-induced damage to testes and sperm, and prevented persistence of the virus in the reproductive tract of all vaccinated male mice challenged with a high dose of the Zika virus.

This published data suggests another avenue of potential protection against the Zika virus

ino

#Inovio Pharmaceuticals #INO announced its DNA-based #Zika vaccine protected against Zika virus-induced damage to testes and sperm, and prevented persistence of the virus in the reproductive tract of all vaccinated male mice challenged with a high dose of the Zika virus.

This preclinical study data was published in Nature Communications in an article entitled, “DNA Vaccination Protects Mice Against Zika Virus-Induced Damage to the Testes,” written by Inovio scientists and collaborators.

Dr. Gary Kobinger, lead author of the study and Director of the Centre for Research in Infectious Diseases at Laval University in Quebec City, Canada, said, “Given that we know that Zika virus infection can involve the male reproductive tract and persist in humans for several months after onset of infection, this preclinical data warrants further examination as a potential means to reduce Zika virus infection of the male reproductive tract and the risk of sexual transmission of the virus.”

Dr. J. Joseph Kim, Inovio’s President and CEO, said, “This published data suggests another avenue of potential protection against the Zika virus. While detrimental effects on sperm and fertility have not yet been reported in Zika-infected human males, persistence of Zika in semen and sperm and sexual transmission by males has been documented. This new preclinical data suggests that our Zika vaccine may represent an opportunity to limit the potential for sexual transmission of the virus.

In addition to our ongoing ZIKA-001 and 002 clinical studies, we are planning for a larger phase 2 study in our efforts to bring our Zika vaccine to patients.”

To read stories similar to this, sign up for a free trial membership to Stockwinners; be sure to check the Market Radar section.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

TG Therapeutics’ Leukemia Drug Proves Effective

Adding TG-1101 to ibrutinib increased the number of patients with bone marrow confirmed CR’s, MRD negativity

The combination was well tolerated; the addition of TG-1101 did not appear to alter the safety profile of ibrutinib monotherapy

https://stockwinners.com/blog/

American Society of Clinical Oncology’s #ASCO Annual Meeting is taking place June 2 to June 6 in Chicago. Several pharmaceutical firms and biotechnology companies are presenting their new drugs and/or present progress on the status of their drugs under development. TG Therapeutics is one of those companies.

#TG Therapeutics $TGTX announced positive results from its Phase 3 $GENUINE trial of #TG-1101 plus ibrutinib in patients with previously treated high risk Chronic #Lymphocytic #Leukemia.
The trial was powered to show a statistically significant improvement in ORR of 30%, with a minimal absolute detectable difference between the two arms of approximately 20%. The trial met its primary endpoint, demonstrating a statistically significant improvement in Overall Response Rate, as assessed by blinded independent central radiology and hematology review by iwCLL criteria, compared to ibrutinib alone in both the Intent to Treat population and Treated population.
The combination was well tolerated and, apart from infusion related reactions, the addition of TG-1101 did not appear to alter the safety profile of ibrutinib monotherapy.
#Neutropenia, occurring in 9% of patients, was the most commonly reported Grade 3/4 Adverse Event in the combination arm, followed by infusion related reactions and #anemia, each reported in 5% of patients.
Neutropenia or #neutropaenia, is an abnormally low concentration of neutrophils (a type of white blood cell) in the blood. Neutrophils make up the majority of circulating white blood cells and serve as the primary defense against infections by destroying bacteria, bacterial fragments and immunoglobulin-bound viruses in the blood.  Patients with neutropenia are more susceptible to bacterial infections and, without prompt medical attention, the condition may become life-threatening.
Notably, the majority of infusion related reactions were Grade 1 or 2 in severity, with only 5% Grade 3/4 IRR observed. Median follow-up for this study was approximately 11.4 months.
In addition to the improvements in ORR, CR and MRD-negativity, a trend in improvement of Progression Free Survival was observed in the combination arm of TG-1101 plus ibrutinib as compared to ibrutinib alone.
“In addition to increasing the overall number of patients that responded to treatment with ibrutinib, adding TG-1101 to ibrutinib increased the number of patients with bone marrow confirmed CR’s, MRD negativity in peripheral blood, deepened nodal responses, and resulted in fewer patients progressing on therapy. Collectively, we see the consistent pattern of enhanced benefit as providing a compelling case for combining TG-1101 with ibrutinib in these hard to treat patients with high-risk CLL. We look forward to sharing these data with the FDA later this year to discuss filing for accelerated approval,” the company noted.

Other stocks to watch in the group: $INCY, $TSRO, $AZN, $AMGN

Visit Stockwinners to read more.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Canada Health approves Intercept’s Ocaliva

Ocaliva represents the first new treatment option in over 20 years for PBC

PBC is a chronic liver disease that causes the small bile ducts in the liver to become inflamed

 

stockwinners.com ICPT

Intercept Pharmaceuticals $ICPT announced that Health Canada has granted a conditional approval for #Ocaliva for the treatment of primary biliary cholangitis, or PBC, when used in combination with ursodeoxycholic acid, or #UDCA, in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

In May 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Ocaliva for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA).

Intercept is actively pursuing reimbursement of Ocaliva with private insurance carriers and public drug plans across Canada. The firm is pursuing the same across Europe and U.S.

PBC is a chronic, or long lasting, disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed. This causes bile to remain in the liver, which damages the liver cells over time, and results in cirrhosis, or scarring of the liver. As #cirrhosis progresses, and the amount of scar tissue in the #liver increases, the liver loses its ability to function.

#Obeticholic acid (abbreviated to OCA, trade name Ocaliva), is a semi-synthetic bile acid analogue. It is used as a drug to treat primary biliary cholangitis, and is undergoing development for several other liver diseases and related disorders. Intercept Pharmaceuticals Inc. holds the worldwide rights to develop OCA outside Japan and China, where it is licensed to Dainippon Sumitomo Pharma.

Ocaliva, given orally, binds to the farnesoid X receptor (FXR), a receptor found in the nucleus of cells in the liver and intestine. #FXR is a key regulator of bile acid metabolic pathways. Ocaliva increases bile flow from the liver and suppresses bile acid production in the liver, thus reducing the exposure of the liver to toxic levels of bile acids.

STICKER SHOCK:  It has been a year since FDA approved Ocaliva but its use has been slow. The drug’s price tag–almost $70,000 a year- has many insurance companies reluctant to approve its use and physicians from prescribing the drug. A group of researchers believe that cost of the drug needs to be around $20,000 per year in order for its use to become popular with patients, physicians and insurance companies. It is doubtful that Intercept is willing to lower its price given the cost involved with developing a new drug. We expect ICPT will be taken over by a larger pharmaceutical company such as NVS, BIIB or AMGN.

COST JUSTIFICATION

“When establishing the price for Ocaliva, we considered several factors, including the benefit that Ocaliva offers to people living with PBC, which of course is an orphan disease for which there have been no new treatments in nearly 20 years,” said the company’s chief commercial and corporate affairs officer, Lisa Bright recently. “We consider the consequences of an inadequate treatment in a progressive liver disease, including . . . liver transplants and death and the savings associated with slowing disease progression.”

STOCK PRICE: ICPT closed at $115.26. Shares have a 52-week trading range of $96.63 – $177.93. Others to watch in the sector: ARWR, ASMB, FGEN.

Visit Stockwinners to read more.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

AstraZeneca to present Cancer Drugs at ASCO Meeting

American Society of Clinical Oncology Annual Meeting is in Chicago from June 2 to June 6

AstraZeneca to present data on its drug candidates for Ovarian Cancer, Bladder Cancer, Neck and Shoulder Cancer and Lung Cancer

azn

 

#AstraZeneca $AZN , along with its global biologics research and development arm, #MedImmune, will demonstrate its progress on the company’s cancer medicine development at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, IL, June 2 to June 6.

“With three new oncology medicines addressing the unmet needs of patients with ovarian, lung, and bladder cancers approved in under three years, AstraZeneca is now halfway to delivering on its promise to launch six new medicines for cancer by 2020,” the company says.

“This progress is reflected in the 100 company-sponsored and supported abstracts, including five Best-of-ASCO presentations, 11 oral presentations and eight poster discussions, accepted for the meeting.”

These include new data on approved and potential new medicines from the company’s pipeline across multiple scientific platforms and tumor types.

‘Late-breaker’ data from the #OlympiAD trial of olaparib versus chemotherapy in HER2-negative germline #BRCA1 or BRCA2 mutated breast cancer patients are the first positive Phase III results for a poly ADP-ribose polymerase inhibitor beyond #ovarian cancer.

Additional #olaparib data will include: SOLO-2: Oral presentation of Phase III data on the relationship between health-related quality of life and patient-centered and clinical outcomes with olaparib maintenance following chemotherapy in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer and Study 19: Randomized Phase II overall survival and updated progression-free survival data for the combination of olaparib and cediranib versus olaparib alone in recurrent platinum-sensitive ovarian cancer.

AstraZeneca’s unique DDR pipeline will also be illustrated through an oral presentation of Phase I data on the WEE1 inhibitor, AZD1775, in combination with radiation therapy and temozolomide in patients with newly diagnosed glioblastoma multiforme and evaluation of intratumoral drug distribution in patients with recurrent GBM.

Additional information will also be presented from a Phase I trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline-resectable head and neck squamous cell #carcinoma.

Latest #osimertinib investigational data from the AURA3 trial to be released during an oral presentation will provide further evidence of the response to treatment in patients with epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer and central nervous system metastases. Further insights into the ability of osimertinib to cross the blood-brain barrier will be provided through updated results from the #BLOOM trial of osimertinib in patients with EGFR mutation-positive NSCLC and leptomeningeal disease.

AstraZeneca will be presenting updated data from the NSCLC and bladder cancer cohorts of the Phase I/II Study 1108 of #durvalumab in patients with advanced solid tumors. New data in locally advanced or metastatic urothelial carcinoma reinforce the May 2017 US FDA approval of #Imfinzi for the treatment of patients with locally advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before or after surgery.

Updated durvalumab monotherapy Study 1108 results in Stage IIIB/IV NSCLC will also be presented.

These data underline AstraZeneca’s forward momentum in lung cancer following the positive top-line results of the Phase III PACIFIC trial of #durvalumab as sequential treatment in patients with locally advanced, unresectable NSCLC.

In an oral presentation, MedImmune will present data on a novel relationship in NSCLC between EGFR pathway activation and the immunosuppressive molecule CD73.

Visit Stockwinners Market Radar to read more.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Changes to S&P Indexes

Standard and Poor’s is reshuffling its Indexes

Most Changes will take effect Friday June 2, 2017

stockwinners.com blog#S&P Dow Jones Indices will make the following changes to the S&P MidCap 400, S&P SmallCap 600, and S&P 500 indices:

  • IHS Markit $INFO will replace TEGNA $TGNA in the S&P 500,
  • #TEGNA and Cars.com $CARS will move to S&P 400;
  • #J.C. Penney $JCP and #Time Inc. $TIME will move to S&P 600 due to reduced market capitalization;
  • #Tuesday Morning $TUES and #Hornbeck Offshore Services $HOS are kicked out of S&P 600 due to market caps.

TEGNA is spinning off Cars.com in a transaction expected to be completed prior to the open on Thursday, June 1, pending final conditions. Post the spin-off transaction, TEGNA’s market capitalization will be more representative of the mid-cap market space.

Independence Realty Trust $IRT will replace Ultratech $UTEK in the S&P SmallCap 600 effective prior to the open on Tuesday, May 30.

S&P SmallCap 600 constituent Veeco Instruments $VECO is acquiring Ultratech in a deal expected to be completed on or about that date pending final conditions.

S&P 500 constituent Yahoo! $YHOO is expected to convert to a publicly traded, non-diversified, closed-end management investment company, following the expected sale of its operational business to S&P 100 & 500 constituent Verizon Communications $VZ in mid-June. Yahoo! will therefore be ineligible for continued inclusion in the S&P 500 following the sale.

To take advantage of the expected increased liquidity surrounding the quarterly rebalance, S&P Dow Jones Indices will remove Yahoo! from the S&P 500 effective at the open on Monday, June 19 to coincide with the June 2017 rebalance. A replacement candidate will be announced at a later date with sufficient notice to clients.

HIV Vaccine Proves 100% Effective

Overall, 27 of 27 vaccinated participants showed a positive response

The study evaluated a four-dose regimen of PENNVAX-GP DNA

ino#Inovio Pharmaceuticals $INO announced that its #HIV vaccine, #PENNVAX-GP, produced amongst the highest overall levels of immune response rates ever demonstrated in a human study by an HIV vaccine.

The vaccine candidate, PENNVAX-GP, consists of a combination of four HIV antigens designed to cover multiple global HIV strains and generate both an antibody immune response as well as a T cell immune response to both potentially prevent and treat HIV.

These preliminary results are from a study supported by the HIV Vaccine Trials Network, or HVTN, and the National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, or NIH, in collaboration with Inovio.

The study evaluated a four-dose regimen of PENNVAX-GP DNA vaccine administered by intradermal, or ID, or intramuscular, or IM, administration in combination with a DNA encoded immune activator, IL-12, or INO-9012.

Overall, 71 of 76 evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune response to at least one of the vaccine antigens. Similarly, 62 of 66 evaluated participants demonstrated an env specific antibody response. None of the placebo recipients demonstrated either a cellular or an antibody response in the study.

Notably, amongst the participants receiving PENNVAX-GP vaccine and IL-12 with intradermal immunization, 27 of 28 participants demonstrated a cellular response and 27 of 28 demonstrated an HIV env specific antibody response.

Amongst the evaluated participants receiving PENNVAX-GP and IL-12 via IM vaccination, 27 of 27 demonstrated a cellular response and 19 of 21 demonstrated an env specific antibody response. Similar immune responses and response rates were achieved via both ID and IM administration of the vaccine although participants vaccinated via intradermal vaccine administration received 1/5th the dose of vaccine compared to those vaccinated via intramuscular administration.

INO closed at $7.13, last traded at $9.90 in pre-market.

Other shares to watch: $AMGN $BIIB $ABBV $MRK $PFE

Visit Stockwinners to read more.

The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.