Vertex Higher on its Cystic Fibrosis Drug

Vertex jumps after ‘wowing’ analysts with cystic fibrosis data

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Shares of Vertex (VRTX) are on the rise after the company reported positive data from Phase 1 and Phase 2 studies of three different triple combination regimens in people with cystic fibrosis who have one #F508del mutation and one minimal function mutation.

Reacting to the news, several Wall Street analysts upgraded the stock to buy-equivalent ratings and raised their price targets on the shares.

BUY VERTEX

In a research note to investors this morning, Janney Capital analyst Debjit Chattopadhyay upgraded Vertex to Buy, stating that the Phase 2 data for its three triple combination programs in CF were “significantly above the most optimistic expectations.”

The analyst argued that the quality of the data should allow Vertex to potentially accelerate commercialization under the “New FDA” and importantly sets the bar very high for competition. Citing its “potential dominance of CF,” Chattopadhyay said he thinks Vertex becomes the “most logical large-cap M&A target.”

Chattopadhyay was not the only analyst upgrading the stock this morning.

His peer at Cowen also upgraded Vertex to Outperform, saying efficacy data from its triple regimens showed “breakthrough-quality” results, and will very likely “dramatically” improve the quality of life and extend the life span of 80% of the 75K patients with CF worldwide.

Phil Nadeau pointed out that he expects a launch in 2021 and $10B in franchise sales in 2025. The analyst raised his price target on the shares to $200 as he sees a 10-year path of revenue growth for Vertex.

Meanwhile, Barclays analyst Geoff Meacham told investors that he thought the Phase 2 data in CF was an “unequivocal success and constitutes a major de-risking event.” Citing more confidence in the viability of the triple combo and the likely accelerated development path, the analyst upgraded Vertex to Overweight and raised his price target on the stock to $180.

Also this morning, Raymond James analyst Laura Chico upgraded Vertex to Outperform, with a $181 price target, citing the “compelling” efficacy data for its triple-combo CF regimens.

WOW: JPMorgan analyst Cory Kasimov began his research note with “Wow. Just wow,” following last night’s data release from Vertex.

To say that the initial results for Vertex’s triple combinations beat expectations would be an understatement, Kasimov told investors, adding that the data not only sets up well to reach a large majority of the CF patient population, but also greatly increases the competitive hurdle while also enhancing the scarcity value of the company. He raised his price target on the shares to $175 and reiterated an Overweight rating on the name.

Credit Suisse, Stifel, Citi and Piper Jaffray also raised their price targets on the stock following the data release.

OTHERS TO WATCH

Competitor Galapagos (GLPG) is sliding in morning trading following Vertex’s CF data announcement.

However, commenting on the news, H.C. Wainwright analyst Andrew Fein said the data may also be “encouraging” in a roundabout way for Galapagos and another smaller company exploring an add-on to a CF doublet combo, Proteostasis (PTI).

If increasing the dosing of the Vertex compounds does not differentiate them further in efficacy, then this consistency in benefit “may truly be a class phenomenon,” and similar results should be expected from any competitor add-on agent out there, he suggested.

PRICE ACTION

In Wednesday’s trading, shares of Vertex (VRTX) have gained about 22% to $161.26, while Galapagos and Proteostasis have dropped over 4% and 3%, respectively.

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Watch Nektar Therapeutics on its Opioid Painkiller

Nektar says NKTR-181 shows ‘significantly less abuse potential’ than oxycodone

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Nektar Therapeutics (NKTR) announced topline results from an oral Human Abuse Potential study of #NKTR-181, an opioid analgesic that is the first full mu-opioid agonist molecule designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids.

The NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose of 400 mg and at a supratherapeutic dose of 3 times to 12 times greater than its analgesic dose range of 100 mg to 400 mg compared to common therapeutic doses of a Schedule II opioid, oxycodone.

In the study, NKTR-181 400 mg had a significantly lower rating of peak liking compared to oxycodone 40 mg; NKTR-181 400 mg had a significantly lower rating of peak liking compared to oxycodone 60 mg; NKTR-181 600 mg had a significantly lower rating of peak liking compared to oxycodone 40 mg; NKTR-181 600 mg had a significantly lower rating of peak liking compared to oxycodone 60 mg; and NKTR-181 1200 mg had a significantly lower rating of peak drug liking compared to oxycodone 60 mg.

This dose was not statistically different from #oxycodone 40 mg, the company said.

Ivan #Gergel, Chief Medical Officer of Nektar, said, “It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.

Further, and critically important in the context of this public health emergency, NKTR-181’s less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation…We are committed to bringing this new pain treatment to patients and physicians as quickly as possible.”

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Stocks to Watch: Paratek Pharmaceuticals Study Meets EndPoint

Paratek study meets primary, secondary FDA, EMA efficacy endpoints

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Paratek Pharmaceuticals (PRTK) announced positive top-line results from a pivotal Phase 3 clinical study comparing its once-daily, oral investigational antibiotic, omadacycline, to twice-daily oral linezolid in the treatment of acute bacterial skin and skin structure infections.

The study met all of its primary and secondary endpoints required to support approval for this indication by the U.S. Food and Drug Administration and the European Medicines Agency.

This represents the third positive Phase 3 registration study of omadacycline.

“This successful study demonstrates the potential of an oral-only dosing regimen of omadacycline, which would enable treatment in the outpatient setting and potentially reduce the need for admission to the hospital,” said Michael Bigham, Chairman and Chief Executive Officer of Paratek.

“The utility of the oral only dosing regimen represents a significant potential benefit to patients and prescribers who are in need of new, effective oral agents to combat serious community-acquired infections.”

The pivotal Phase 3 clinical study known as #OASIS-2 evaluated the efficacy and safety of once-daily, oral-only omadacycline compared to twice-daily, oral-only linezolid in 735 adults with ABSSSI.

#Omadacycline met the FDA-specified primary endpoint of statistical non-inferiority in the modified intent-to-treat population compared to linezolid at the early clinical response 48 to 72 hours after the first dose of study drug.

The ECR rate for omadacycline was 87.5% compared to 82.5% for linezolid.

Additionally, omadacycline met statistical NI compared to linezolid for the EMA-specified co-primary endpoints at the post therapy evaluation, 7 to 14 days after completion of therapy in the mITT and the Clinically Evaluable populations.

Clinical success rates at PTE in the mITT population for the omadacycline and linezolid arms were 84.2% vs. 80.8%, respectively; and in the CE population were 97.9% vs. 95.5%, respectively.

Omadacycline demonstrated high clinical success rates for infections caused by the most common #ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus.

STOCK PRICE

PRTK last traded at $24.95. Stock has a 52-week trading range of $9.80 – $26.10.

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TherapeuticsMD Tumbles on FDA Update

TherapeuticsMD drops as TX-004HR update seen not reading ‘well at all’

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Shares of TherapeuticsMD (TXMD) plunged in pre-market trading on Monday after the company provided a regulatory update on the status of its New Drug Application for TX-004HR.

REGULATORY UPDATE

In a statement, TherapeuticsMD provided an update on the status of its NDA for TX-004HR, its investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse, saying that it participated in a Type A Post-Action Meeting on June 14 with the FDA’s Division of Bone, Reproductive, and Urologic Products.

At the meeting, the two sides discussed the complete response letter that TherapeuticsMD previously received for the NDA, which also allowed the company to present new information it believes could address concerns raised in the letter and “positively” impact the status of the NDA.

TherapeuticsMD said it has formally submitted the new information for consideration per the FDA’s request.

However, the company noted that while it continues to have “productive” dialogue with the FDA related to its review, it has not yet received a formal timeline for a conclusion of this review.

#TherapeuticsMD said it “looks forward” to working with the FDA to address its concerns and sees further clarity on the pathway forward for the NDA “in the coming weeks,” adding that it “reserves the right to pursue the FDA’s formal dispute resolution process if a reasonable timeline to address such concerns cannot be established.”

WHAT’S NOTABLE

On May 8, TherapeuticsMD said it received the CRL from the FDA regarding the TX-004HR NDA.

At the time, the company said it planned to meet with the FDA as soon as possible to address the concerns raised in the letter, which involved “the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial.”

Adam #Feuerstein, who previously wrote about biotech stocks for TheStreet and currently is a senior writer for StatNews, tweeted in May that the company lacks the cash to conduct the type of safety study of TX-004HR requested by the FDA, without cutting expenses or raising more money, adding that a delay for this product “could be fatal” for the company.

Feuerstein tweeted this morning that TherapeuticsMD’s regulatory update on resolving the CRL “does not read well at all.”

ANALYST COMMENTARY PRIOR TO UPDATE

Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform recently ahead of the FDA meeting update, and said there was a “reasonable probability” of positive news.

Olson argued that data on complete response letters provides confidence that there are likely no other TX-004HR approvability issues besides lack of long-term endometrial safety data beyond the 12 weeks studied in REJOICE and that there are likely no approvability issues that would have any implications for TX-001HR.

PRICE ACTION

In pre-market trading on Monday, TherapeuticsMD is down 12%.

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TherapeuticsMD Could Double by the End of September

Watch TherapeuticsMD into FDA meeting on September 29th

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#Oppenheimer analyst Jay #Olson upgraded TherapeuticsMD (TXMD) to Outperform recently ahead of an expected Food and Drug Administration meeting update, saying there is a “reasonable probability” of positive news.

Olson argued that the company is likely to resubmit #TX-004HR, its investigational vaginal drug product candidate for the treatment of vulvar and vaginal atrophy in postmenopausal women, by the end of the month, with a potential FDA approval by September 29.

#Vulvovaginal atrophy ( #VVA ) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation, soreness, and dyspareunia with urinary frequency, urgency, and urge incontinence. It can occur at any time in a woman’s life cycle, although more commonly in the postmenopausal phase, during which the prevalence is close to 50%.

APPROVAL BY SEPTEMBER

In a research note to investors, Oppenheimer’s Olson upgraded TherapeuticsMD to Outperform from Perform, with a $10 price target, as he expects details of the company’s meeting with the FDA around July 14 and believes there is a “reasonable probability” of positive news.

The analyst noted that the elimination of the TX-004HR 25 mcg dose is a positive as the remaining 4 and 10 mcg doses both provide essentially no systemic exposure to estrogen.

Moreover, he pointed out that he is encouraged by the recent North American Menopause Society’s position statement which he believe supports TX-004HR versus higher dose competitors.

Additionally, Olson argued that data on Complete Response Letters provides confidence that there are likely no other TX-004HR approvability issues besides lack of long-term endometrial safety data beyond the 12 weeks studied in REJOICE and that there are likely no approvability issues that would have any implications for TX-001HR, its drug product candidate for the treatment of vasomotor symptoms related to menopause.

The analyst believes TherapeuticsMD is likely to resubmit TX-004HR by July 31, with a potential FDA approval by September 29, assigning a 60% probability to this scenario.

Overall, Olson told investors that he sees TherapeuticsMD as an “underappreciated asset,” with potential to successfully penetrate and expand the market for treatment of menopausal symptoms with wholly owned products TX-004HR and TX-001HR, while an existing prenatal supplement business provides a commercial foundation.

PRICE ACTION

In Thursday afternoon trading, shares of TherapeuticsMD rose 6% to $5.32 per share. The stock is up about 23% over the last month.

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Dexcom Tumbles on Abbott, Big Foot Deal

Bigfoot stomps on Dexcom shares with Abbott partnership

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Shares of Dexcom (DXCM) are slipping after Bigfoot Biomedical selected Abbott’s (ABT) #FreeStyle Libre as the continuous glucose monitor for its diabetes management system.

Jefferies analyst Raj #Denhoy says the decision to choose Abbott over Dexcom and others was a surprise move, and is an endorsement of “simplicity over point accuracy.”

BIGFOOT SELECTS ABBOTT

In a statement today, Abbott and Bigfoot Biomedical announced that they have entered into an agreement to develop and commercialize diabetes management systems, integrating the former’s FreeStyle Libre glucose sensing technology with the latter’s insulin delivery solutions in the U.S.

Abbott will provide Bigfoot with the next generation of its FreeStyle Libre #glucose sensing technology, which will be utilized in the development of personalized systems intended to optimize #insulin delivery without the need for fingerstick calibration of a glucose sensor.

#Bigfoot said it anticipates initiating a pivotal trial incorporating FreeStyle Libre technology in 2018 at clinical research sites across the U.S. The FreeStyle Libre system is currently pending approval by the Food and Drug Administration in the U.S.

SURPRISING DECISION

Commenting on the news, #Jefferies’ Denhoy told investors that the selection of Abbott’s #Libre over Dexcom and others comes as “a surprise” and is an endorsement of “simplicity over point accuracy” in the future of glucose monitoring and diabetes management.

Bigfoot will use the second-generation Libre, which will include real-time communication, in its pivotal trial starting in 2018, with approval expected in late 2019/early 2020, the analyst pointed out.

Additionally, Denhoy noted that Bigfoot has granted Abbott a period of exclusivity as its Continuous Glucose Monitoring, or #CGM, sensor partner, though Abbott can partner with other systems.

The analyst reiterates a Buy rating and $58 price target on Abbott’s shares.

PRICE ACTION

In Thursday’s trading, shares of Dexcom dropped almost 4% to $69.11, while Abbott’s stock has gained about 1% to $47.99.

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Arena Pharmaceuticals Reports Positive Ralinepag Results, Shares Rise!

Arena reports successful primary efficacy analysis in Phase 2 trial of ralinepag

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Arena Pharmaceuticals (ARNA) announced Phase 2 results for ralinepag, an investigational, long-acting, orally administered prostacyclin receptor agonist under development for the treatment of pulmonary arterial hypertension, or #PAH.

In this 61-patient study, the primary efficacy analysis demonstrated a statistically significant absolute change from baseline in pulmonary vascular resistance compared to placebo.

#Ralinepag also demonstrated numerical improvement in 6-minute walk distance.

Ralinepag improved median PVR by 163.9 dyn.s.cm-5 from baseline compared to a 0.7 dyn.s.cm-5 worsening from baseline in the placebo arm. Patients treated with ralinepag had a 29.8% improvement in PVR compared to the placebo arm and a 20.1% improvement in PVR compared to baseline.

Additionally, adverse events observed in the study were consistent with other prostacyclin treatments for the management of PAH, with headache, nausea, diarrhea, jaw pain and flushing being the most commonly reported adverse events.

“The positive outcome of this Phase 2 trial in a contemporary PAH patient population is an important milestone in the development of ralinepag for the treatment of patients suffering from this grievous illness. It is exciting to see the positive nonclinical pharmacological profile translating into potentially the first oral prostacyclin therapy that may approach consistent therapeutic levels without the complexity of parenteral therapy. These data give us confidence to move expeditiously toward a Phase 3 clinical program,” said Preston Klassen, Chief Medical Officer of Arena.

ARNA closed at $18.39 on Monday, shares last traded at $25.50.

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Nektar Therapeutics Announces Positive Results

Nektar presents new ‘positive’ preclinical results for NKTR-358

 

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Nektar Therapeutics (NKTR) announced positive preclinical results for NKTR-358, a first-in-class resolution therapeutic for autoimmune disease.

The new preclinical data demonstrate that treatment with NKTR-358 induces profound regulatory T cell effects and suppresses inflammation in multiple preclinical models.

The data were highlighted in an oral presentation at the 13th Annual World Congress on Inflammation on July 9, 2017.

“These studies show that NKTR-358 increases the suppressive capacity and prolongs activation and proliferation of regulatory T cells with limited effects on conventional T cells in order to address the imbalance found in many autoimmune diseases,” said Jonathan Zalevsky, PhD, Senior Vice President, Biology and Preclinical Development at Nektar Therapeutics. “NKTR-358 also demonstrated suppression of antigen-driven inflammation in multiple preclinical models including systemic lupus erythematosus.

We are very excited about NKTR-358’s potential as a resolution therapy in autoimmune disease.”

Autoimmune diseases cause the immune system to mistakenly attack healthy cells in a person’s body.iv A failure of the body’s self-tolerance mechanisms enables the formation of the pathogenic auto-reactive T lymphocytes that conduct this attack. NKTR-358 works by optimally targeting the interleukin-2 (IL-2) receptor complex in order to stimulate proliferation and activation of regulatory T cells. By increasing the number of regulatory T cells, the pathogenic auto-reactive T cells can be controlled and the proper balance of effector and regulatory T cells can be achieved to restore the body’s self-tolerance mechanisms.

In preclinical studies, #NKTR-358 demonstrates attenuated and optimized affinity for human IL-2 receptors to promote biological activity favoring activation of regulatory T cells over conventional T cells. This preferential activity combined with prolonged exposure in vivo led to significant Treg mobilization in blood and spleen following a single subcutaneous administration in rodents.

Increases in regulatory T cells were sustained for 7 to 10 days, and were concomitant with increases in cytometric markers of activation and increased suppressive capacity.

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Cara Therapeutics’ Rise Could Continue

Watch Cara Therapeutics into osteoarthritis pain results

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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.

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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

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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.

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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.”

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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

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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

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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

 

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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.

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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

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#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.

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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.