Watch TherapeuticsMD into the FDA meeting

Analyst says TherapeuticsMD could jump if FDA meeting goes well 

Watch TXMD into FDA meeting. See Stockwinners.com for details

Cantor Fitzgerald analyst William Tanner reiterated his Overweight rating and $32 price target on TherapeuticsMD (TXMD) ahead of an expected meeting with the U.S. Food and Drug Administration, saying he believes shares could rally above $8 depending on the outcome.

‘BIG’ MEETING TODAY

Tanner expects TherapeuticsMD will meet with the FDA today, Friday, November 3, absent an announcement to the contrary, to discuss the next steps in the FDA’s review of the new drug application, or NDA, for TX-004 for vulvar vaginal atrophy.

Tanner expects TherapeuticsMD will most likely disclose the outcome of the FDA meeting and plans next week.

Until the announcement is made, Tanner believes the stock could be volatile. Tanner believes the outcome of the meeting could yield a stock price above $8.

POTENTIAL OUTCOMES

Tanner sees three potential outcomes for the FDA meeting, with gathering long-term safety data post-approval being the highest probability outcome given that the FDA likely has “comfort” with the safety profile of vaginally delivered, low-dose estrogen, and that observing no increase above background levels for the 4mcg and 10mcg doses of TX-004 burnishes the safety profile.

Another, less likely but “messy” outcome, is that the FDA could argue that unmet medical need “does not exist” in VVA, but the analyst contended that he doubts the FDA would cite that as a reason to stall approval of TX-004 pending long-term safety data. If the FDA does require data collection prior to granting marketing approval, Tanner believes dispute resolution will be pursued.

The least likely outcome of the meeting, Tanner said, is the FDA deciding that long-term data are unnecessary, stating that “for no other reason than to reinforce safety observations, we believe the FDA would be inclined to want the data at some point.”

WHAT’S NOTABLE

In a note to clients in September, Tanner noted TherapeuticsMD’s conference call with an author of the National Institutes of Health paper on vaginal estrogen and safety observations from the Women’s Health Initiative Observational Study.

The analyst said at the time that results of the analysis should provide the FDA “with additional comfort” regarding low-dose estrogen safety and support approval of TX-004 without the need for 12-month safety testing beforehand.

PRICE ACTION

In Friday’s morning trading, shares of TherapeuticsMD are flat at $4.60 per share. The stock is down about 20% year-to-date.


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Rent-A-Center receives $13 per share offer

Rent-A-Center shareholder Vintage Capital proposes $13 all-cash acquisition

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In a regulatory filing, it was disclosed that Vintage Capital Management, which currently own approximately 6% of the common stock of Rent-A-Center (RCII), said in a letter to the company that it is “in a unique position to deliver certain and immediate value to shareholders through an all-cash acquisition at $13.00 per share.”

In the letter to the CEO of Rent-A-Center, Vintage Capital Managing Member Brian Kahn added, “However, the value that we are willing to pay, and our interest in pursuing this transaction, is significantly impacted by whether or not our future competitors have access to proprietary information concerning RAC’s assets, including but not limited to store-level financial information and contract terms with Acceptance Now retail partners.

Due to the significant amount of work that we and our lenders have completed, as well our familiarity with the Rent-to-Own industry, we are confident that we can complete due diligence, obtain financing commitments, and execute a definitive transaction agreement within 30 days of gaining access to due diligence information.

We have engaged legal counsel and we are prepared to immediately engage additional due diligence resources to assist us with an expedited process to complete this acquisition.

In recognition of the significant costs that we will incur, and the prospect of certain and compelling value that would be immediately realized by all RAC shareholders, we ask for a 30-day exclusivity period.”

Following the filing, Rent-A-Center shares have jumped 11% to $11 per share in Friday’s pre-market trading.


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Juniper and Network-1 reach settlement

Network-1 Technologies announces settlement with Juniper

Juniper and Network-1 Technologies settle their dispute. See Stockwinners.com for details

Network-1 Technologies (NTIP) announced that it agreed to settle its patent litigation against Juniper Networks (JNPR) pending in the United States District Court for the Eastern District of Texas, Tyler Division, for infringement of Network-1’s Remote Power Patent.

Juniper was one of sixteen original defendants named in the litigation. Under the terms of the settlement, Juniper will pay $13,250,000 and receive a fully-paid license to the Remote Power Patent for its full term which expires in March 2020, which will apply to its sales of Power over Ethernet products, including those PoE products which comply with the Institute of Electrical and Electronic Engineers 802.3af and 802.3at Standards.

In September 2011, Network-1 initiated patent litigation against sixteen data networking equipment manufacturers in the United States District Court for the Eastern District of Texas, Tyler Division, for infringement of its Remote Power Patent.

Network-1 has now reached settlement and license agreements with fifteen of the sixteen original defendants.

The sole remaining defendant in the lawsuit is Hewlett-Packard Company. Network-1 seeks monetary damages based upon reasonable royalties. The trial against Hewlett-Packard is scheduled to commence on November 6, 2017.

The Remote Power Patent relates to, among other things, delivering power over Ethernet cables to remotely power network connected devices including, among others, wireless switches, wireless access points, VoIP telephones and network cameras.

In June 2003, the IEEE approved the 802.3af PoE Standard, which led to the rapid adoption of PoE.

The IEEE also approved the 802.3at Power over Ethernet Plus Standard, which increased the maximum power delivered to network devices to 40-60 watts from the current 15 watts under the 802.3af Standard.

JNPR closed at $24.40. NTIP closed at $4.15.


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