KS Bancorp Receives $35 a share Offer

First Citizens proposes to acquire KS Bancorp for $35 per share in cash

First Citizens BancShares (FCNCA) said it has made a proposal to acquire KS Bancorp (KSBI) for $35.00 per share in cash, in a transaction valued at approximately $45.8M, representing a 49.6% premium over KS Bancorp’s (KSBI) closing trading price on July 12, 2017, and a 84% premium over KS Bancorp’s book value per share as of March 31, 2017.

The proposal was conveyed today in a letter to KS Bancorp’s Board of Directors. First Citizens has decided to make its proposal public in order to inform KS Bancorp’s shareholders of the compelling proposal that would provide immediate liquidity to them at a substantial premium to book value and the market’s assessment of KS Bancorp’s value.

“Our objective is to engage in substantive discussions with KS Bancorp and conduct customary due diligence so that we and KS Bancorp can together quickly bring this compelling transaction to KS Bancorp’s shareholders,” said Frank B. Holding, Jr., chairman and CEO of First Citizens.

“We are disappointed by KS Bancorp’s rejection of our offer without any discussion, and were surprised that the reason given for this was a contemplated S corporation reorganization that we understand would involve a buyout of a significant number of KS Bancorp shareholders. We believe that KS Bancorp shareholders will favor the immediate liquidity at a substantial premium that our acquisition proposal would provide.”

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TherapeuticsMD Could Double by the End of September

Watch TherapeuticsMD into FDA meeting on September 29th

Watch TherapeuticMD ahead of FDA Meeting. See Stockwinners.com Market Radar

#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

Dexcom tumbles on Bigfoot news. See Stockwinners.com Market Radar

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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Yandex Jumps on Uber Tie Up

Yandex and Uber to combine businesses in Russia and neighboring countries

Yandex and Uber Join Forces. See Stockwinners Market Radar to read more.

Yandex (YNDX) and Uber are combining their ridesharing businesses in Russia, Kazakhstan, Azerbaijan, Armenia, Belarus and Georgia into a new company.

Uber will also contribute its UberEATS business in the region to NewCo.

In addition, Uber has agreed to invest $225M and Yandex has agreed to invest $100M into NewCo, valuing it at $3.725B on a post-money basis.

After these investments, and subject to certain adjustments at closing, NewCo will be owned approximately 59.3% by Yandex, 36.6% by Uber, and 4.1% by employees of the company, on a fully diluted basis.

Tigran Khudaverdyan, currently the CEO of Yandex.Taxi, will become the CEO of the combined business.

After the closing of the transaction, consumers will be able to use both Yandex and Uber apps while the driver-side apps will be integrated. The transaction is expected to close in Q4.

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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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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.