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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CBO Delays Health Care Bill Analysis, Stocks to Watch

CBO delays health care bill analysis 

Stocks to Avoid, Stocks to Buy on margin

The Congressional Budget Office had been scheduled to release an analysis Monday on the latest GOP bill, including estimated cost and scope of insurance coverage, but the Senate Budget Committee said the release had been postponed, according to Associated Press.

The committee did not indicate an explanation or when the analysis was expected, the report noted.

The CBO’s announcement comes after Senate Majority Leader Mitch McConnell said he was delaying a highly anticipated Senate vote this coming week on the bill, after Sen. John McCain’s disclosed that he had undergone surgery.  Doctors had advised McCain to recover in Arizona this week.

Publicly traded hospital operators include HCA Holdings (HCA), LifePoint (LPNT), Tenet Healthcare (THC), Community Health (CYH) and Quorum Health (QHC), and health insurance providers include Aetna (AET), Anthem (ANTM), Centene (CNC), Cigna (CI), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH) and WellCare (WCG).

 

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Barron’s is Bullish on Adidas, Cisco, Whirlpool and Gilead

Barron’s, the weekly publication owned by the Wall Street Journal, in its latest issue is bullish on several names. They include:

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Adidas could double as profit margins expand, Barron’s says – Despite the nearly 40% run up in the past 12 months, adidas (ADDYY) shares still have significant upside, particularly if the company can make good on its goal of achieving the lofty profit margins of rival Nike (NKE), Victor Reklaitis writes in this week’s edition of Barron’s, citing portfolio managers for European equities at Hermes Investment Management.

Vertex, Gilead seen as innovators, Barron’s says – Jason #Kritzer and Samantha Pandolfi, co-managers of Eaton Vance Worldwide Health Sciences fund, believe it is “a great time” to invest in the health care sector, with a lot of innovation under way by drugmakers, medical-device companies and companies developing technologies used to deliver health care, Johanna Bennett writes in this week’s edition of Barron’s. Eaton Vance finds innovation in Vertex (VRTX), Zoetis (ZTS), and Gilead (GILD), publication notes.

Visteon rally far from over, Barron’s says – In a follow-up story, Barron’s tells readers that while shares of Visteon (VC) are up sharply this year, due to the popularity of the company’s auto electronics, the stock could have more room to run. Rapid earnings growth could power Visteon’s shares to $116 from $105, and a deal could lift them even higher, the publication notes, adding that potential buyers include nontraditional auto plays, such as Apple (AAPL) and Alphabet (GOOGL; GOOG), which are developing driverless cars.

Cisco seems undervalued as future looks brighter, Barron’s says – Seen as “Old Tech,” Cisco (CSCO) seems overlooked, while Verint Systems appears overvalued, Vito Racanelli writes in this week’s edition of Barron’s. With its 3.7% dividend yield, the former could be just “the ticket for a healthy-double-digit annual return” with somewhat low downside over the next 24 months, the publication notes.

Trade policy may favor some Americans over others, Barron’s say – Steel tariffs and import restrictions may secure profits for steel mills and employment for steel workers, but will inevitably drive up the cost of any product, Thomas Donlan writes in this week’s edition of Barron’s, noting that other American companies are the customers of the U.S. steel industry and protectionism will not put them first. While protecting steel is supposed to solidify national defense, protectionism actually “hardens the economic arteries of commerce,” Donlan added. Companies that may be impacted by Trump’s potential steel tariffs include U.S. Steel (X), AK Steel (AKS), Nucor (NUE), Steel Dynamics (STLD), ArcelorMittal (MT), Alcoa (AA), and Century Aluminum (CENX).

Whirlpool could rise 35% next year, Barron’s says – Whirlpool (WHR) is a “cash machine” for shareholders, and despite coping with the aftermath of the U.S. housing crisis, price competition from South Korean rivals, and troubled markets like Brazil, the maker of washers, dryers, dishwashers, ovens, and refrigerators has more than doubled earnings since 2012, Robin Goldwyn Blumenthal writes in this week’s edition of Barron’s. The shares remain cheap, the publication noted, but the stock may be worth about $260 a share, or 35% higher, if Whirlpool can continue to execute well in the year ahead.

Orion Engineered aiming for continued gains, Barron’s says – The carbon-black market is growing twice as fast as the commodity business and is more profitable, Nicholas #Jasinski writes in this week’s edition of Barron’s. Orion Engineered (OEC) is the smallest of the three key global players, after Cabot (CBT) and Aditya Birla, but is the largest in the specialty carbon-black market, and “a little gem hiding in all of this black dust,” the publication noted. Orion’s long-term relationships with customers give the company the bargaining power to negotiate contracts indexed to the cost of carbon black’s main input, namely oil, the report added.

Bearish Names

Premium video on demand may pressure movie-theater operators, Barron’s says – This year, stocks of AMC Entertainment (AMC), Regal Entertainment (RGC) and Cinemark (CNK) have declined due to a “mediocre” summer box office on franchise fatigue, more beguiling choices on Netflix (NFLX) or Amazon (AMZN), and as technology is changing people shop, Kopin Tan writes in this week’s edition of Barron’s. Studios and distributors like Comcast’s (CMCSA; CMCSK) Universal Pictures or Walt Disney (DIS) are now debating how to roll out “premium video-on-demand,” which lets viewers watch a movie within a day to 50 days after it hits the big screen, the publication adds, pointing out that while this can benefit the studios, theaters will have much to lose.

Verint looks overvalued given performance, Barron’s says – Riding the “tech momentum” but looking overvalued, Verint Systems weakening track record over the past four years suggests that investor enthusiasm is misplaced, Vito Racanelli writes in this week’s edition of Barron’s. Verint Systems (VRNT) does not look like a tech company with sustainable growth, with its revenue growth dropping steadily, the report notes.

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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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Gilead Receives EMA Approval

The European Medicines Agency validated Gilead’s #bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults

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Gilead Sciences’ Marketing Authorization Application for an investigational, once-daily single tablet regimen containing bictegravir, a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 infection in adults has been fully validated and is now under evaluation by the European Medicines Agency.

BIC/FTC/TAF has demonstrated high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase 3 clinical trials among treatment-naive adult patients and among virologically suppressed adult patients who switched regimens.

The MAA for BIC/FTC/TAF is supported by data from four Phase 3 studies in which the regimen met its primary objective of non-inferiority at 48 weeks.

Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin.

The BIC/FTC/TAF filing will be reviewed by the #EMA under the centralized licensing procedure for all 28 member states of the European Union.

Gilead (GILD) submitted a New Drug Application for BIC/FTC/TAF in the U.S. on June 12.

#Bictegravir in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.

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Cara Therapeutics Reports Positive Results for Chronic Kidney Disease

Cara Therapeutics announces summary data from Oral CR845 Phase 1 trial

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Cara Therapeutics (CARA) announced summary results from its Phase 1 safety and pharmacokinetic trial of Oral CR845 in chronic kidney disease, or #CKD , patients undergoing hemodialysis.

The Phase 1 results showed that all four tablet strengths of Oral #CR845 were generally well-tolerated when administered either daily or after dialysis three times per week.

Top-line pharmacokinetic analysis indicated that plasma levels of CR845 attained after oral administration of doses up to 2.5 mg were comparable to or exceeded those attained with clinically efficacious intravenous doses of CR845 for the treatment of moderate-to-severe CKD-associated pruritus, or CKD-aP, in hemodialysis patients.

The plasma levels of CR845 attained after oral administration of the 1.0 mg tablet strength approximated those attained with the 1.0 mcg/kg I.V. CR845 dose, which demonstrated significant clinical benefit in the recently reported Phase 2/3 trial in hemodialysis patients with CKD-aP.

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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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MetLife to Buy Fortress Investment’s Logan for $250 Million

MetLife to acquire Logan Circle Partners for roughly $250M in cash

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MetLife (MET) and Fortress Investment Group (FIG) announced a definitive agreement for MetLife to acquire Logan Circle Partners, L.P., Fortress’ traditional fixed income asset management business, for approximately $250M in cash.

Following the anticipated separation of Brighthouse Financial next month and assuming the closing of the Logan Circle Partners acquisition, MetLife’s Investment Management business would have more than $560B in total assets under management, of which more than $140B would be managed on behalf of third parties.

Under the terms of the agreement, MetLife will acquire 100% of Fortress’ ownership stake in Logan Circle Partners.

This transaction will not impact MetLife’s existing $3B repurchase authorization, which is expected to be completed by year-end 2017. The transaction is subject to customary closing conditions and regulatory approvals, and is expected to close in the third quarter of 2017.

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Advisory Board Could Be Sold for $1.5 Billion

UnitedHealth, Vista nearing deal to buy, split Advisory Board

Stocks to Buy, Take over targets

UnitedHealth (UNH) and Vista Equity Partners are close to a deal to buy and split up Advisory Board (ABCO), a health and education consultant, Bloomberg reports, citing people familiar with the matter.

According to the report, UnitedHealth would acquire Advisory Board’s health-care unit and Vista would acquire its education business, which may sell for as much as $1.5B.

Vista has focused on high-growth software companies in recent years. First-quarter education revenue at Advisory Board, while comprising only 33 percent of the company’s overall sales, grew 15 percent from a year earlier. Health-care sales declined 6.6 percent, excluding exited programs.

UnitedHealth’s consulting unit focuses on aiding leaders of hospitals and insurers, implementing new technologies and advising health plans on how to design products and set rates.

Advisory Board’s consulting and research projects include collecting bills after care, improving patient care and helping hospitals and doctors with strategy and planning.

An announcement could be up to a month away given the complicated structure of the deal, the people noted.

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