Analyst stock recommendations for AKRX

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AKRX more analyst ratings-

http://www.benzinga.com/stock/akrx/ratings

 

Sources- Benzinga and NASDAQ.com

 

MER Telemanagement Solutions (NASDAQ: MTSL) reported Q4 EPS of ($0.02), versus ($0.11) reported last year. Revenue for the quarter came in at $4.2 million, versus $1.7 million reported last year.

For earnings history and earnings-related data on MER Telemanagement Solutions (MTSL)

 

News March 1st, 2016

 

MTS – Mer Telemanagement Solutions Ltd. (NASDAQ Capital Market: MTSL), a global provider of telecommunications expense management (TEM) and enterprise mobility management (EMM) solutions, and video advertising solutions for online and mobile platforms, announced today that TMC, a global, integrated media company, has named MTS TEM Suite as a recipient of a 2016 INTERNET TELEPHONY Product of the Year Award.
MTS TEM Suite is a fully integrated Communications Lifecycle Management solution that includes a TEM, EMM and Unified Communications Management (UCM) cloud suite and a flexible managed services offering. With MTS TEM Suite, companies of all sizes and industries can benefit from increased operational efficiency and effectiveness, corporate mobile security governance and policy compliance, significant communications cost reduction, and 360-degree visibility into their communications environment. The platform’s modular design and flexible managed services offering allows companies to outsource their entire Communication Lifecycle, or only outsource selective processes depending on each company’s unique business needs.
“We are honored to have our TEM Suite solution recognized by Internet Telephony with a Product of the Year Award,” said John Venditti, VP of Marketing at MTS. “Today’s IT organizations are tasked with managing diverse communication technologies and resources. TEM Suite provides those IT organizations with a single solution to strategically manage those diverse technologies and resources and ensure they have the operational controls needed to reduce costs, mitigate corporate risk, and increase employee productivity.”
TEM Suite’s specific communication lifecycle management capabilities include: procurement, provisioning, wireless help desk, IT asset management, invoice auditing, bill management, mobile device management (MDM), BYOD (bring your own device) management, wireline and wireless usage capture, wireless optimization, bill payment, contract negotiation and management, dispute resolution and management, allocation and chargeback, call accounting, private calls management, tenant resale and billing, and full lifecycle reporting and dashboards.

 

Source- The street and streetinsider

WASHINGTON, Sept. 15, 2015 /PRNewswire/ — Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Vanda’s filing of a supplemental New Drug Application (sNDA) for Fanapt^® seeking approval as a maintenance treatment of schizophrenia in adults.

Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt^®.

The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.

About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visitwww.vandapharma.com.

About Fanapt^®
Fanapt^® is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt^® to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt® slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.

IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in elderly patients with dementia-related psychosis; QT prolongation; neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia and diabetes mellitus; weight gain; seizures; orthostatic hypotension and syncope; leukopenia, neutropenia and agranulocytosis; hyperprolactinemia; body temperature regulation; dysphagia; suicide; priapism; potential for cognitive and motor impairment.

COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT^® (>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.

For full U.S. Prescribing Information, including Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, without limitation, statements regarding the target completion date of the FDA’s review of the sNDA, are “forward-looking statements” under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties, including, without limitation, risks that the FDA will not complete its review of the sNDA by the user fee goal date or that the FDA may not ultimately approve the sNDA. Important factors that could cause actual results to differ materially from those reflected in Vanda’s forward-looking statements are set forth in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vanda’s annual report on Form 10-K for the fiscal year ended December 31, 2014 and quarterly report on Form 10-Q for the quarter ended June 30, 2015, which are on file with theSEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Vanda’s annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda’s results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Corporate Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

Media Contact:
Laney Landsman
Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com

SOURCE Vanda Pharmaceuticals Inc.

Conference Call Today at 8:30 a.m. ET

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2016 (GLOBE NEWSWIRE) — Portola Pharmaceuticals(Nasdaq:PTLA) today provided a corporate update and reported its financial results for the fourth quarter and year ended December 31, 2015.

“During the fourth quarter of 2015, we executed on several milestones that we expect will make 2016 a year of unprecedented progress. We plan to commercially launch andexanet alfa and report pivotal Phase 3 results from our APEX study that, if positive, will support the global approval of betrixaban,” saidBill Lis, chief executive officer of Portola. “Both have the potential to benefit the patients and transform the field in the multibillion dollar thrombosis market. Additionally, our R&D pipeline continues to progress with our ongoing Phase 1/2 study with cerdulatinib, our oral, dual syk/JAK inhibitor in refractory/relapsed hematologic cancer patients.”

Recent Achievements, Upcoming Events and Milestones

Betrixaban – an FDA-designated Fast Track oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients.

• Plan to report topline results from the 7,514-patient pivotal Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study in early April.
• Plan to submit a New Drug Application to the FDA in the second half of 2016, subject to positive APEX data.

Andexanet alfa – an FDA-designated Breakthrough Therapy Factor Xa inhibitor antidote in development for reversal of anticoagulation in patients treated with a Factor Xa inhibitor and who are admitted to the hospital with uncontrolled bleeding or need urgent surgery.

• The FDA accepted the Biologics License Application (BLA) for filing February 16, 2016. The BLA was granted a priority review under an Accelerated Approval pathway, and assigned a PDUFA date of August 17, 2016. We plan to launch andexanet alfa commercially in the U.S. in the second half of 2016, subject to FDA approval.
• The full data set from the ANNEXA-R study with rivaroxaban was presented in a Late-Breaking Clinical Trial Session at the American Heart Association’s Scientific Sessions 2015 and simultaneously published in the New England Journal of Medicine.
• Licensed development and commercial rights in Japan to Bristol-Myers Squibb Company andPfizer Inc. Separately, entered into a clinical collaboration agreement with Bayer HealthCare to include its Factor Xa inhibitor rivaroxaban in the development program in Japan.
• Continue to enroll patients in ANNEXA-4, a Phase 4 confirmatory study of patients receiving apixaban, rivaroxaban, edoxaban or enoxaparin who present to the hospital with an acute major bleed.
• Plan to present data from the Phase 2 proof-of-concept andexanet study with betrixaban in healthy volunteers at a medical conference in 2016 The study was designed to evaluate safety and define the dose of andexanet required to reverse the anticoagulant effect of betrixaban.
• Plan to complete FDA pre-approval inspection of the initial (Generation 1 2,500 liter scale at CMC Biologics).  Generation 1 validation batch runs at the 6 x 2,000 liter scale are ongoing.
• Completed two Generation 2 engineering batches manufactured by Lonza at the 10,000 liter scale, with target yields achieved.  Expect commercial validation batches to begin in the second half of 2016.

Cerdulatinib – an oral, dual Syk/JAK kinase inhibitor in development to treat resistant or relapsed hematologic cancer patients.

• Presented three abstracts at the 2015 ASH Annual Meeting on cerdulatinib’s preclinical activity in chronic lymphocytic leukemia; clinical and pharmacodynamic results of a Phase 1/2 study with relapsed/refractory B cell malignancies; and pharmacokinetic modeling of cerdulatinib plasma concentrations in patients with relapsed/refractory B cell malignancies.
• Continue to dose-escalate for clinical activity and tolerability in the ongoing Phase 1/2 study in patients with relapsed/refractory B-cell malignancies. Plan to initiate enrollment in expansion cohorts this year.

 
Corporate

• Raised $162.7 million in net proceeds from an underwritten public offering of common stock inDecember 2015.

Fourth Quarter and Year-End Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee’s Pharmaceutical was $4.4 million for the fourth quarter of 2015 compared with $2.4 million for the fourth quarter of 2014. Collaboration revenue for the year ended December 31, 2015, was $12.1 million compared with $9.6 million for the year ended December 31, 2014.

Total operating expenses for the fourth quarter of 2015 were $70.7 million compared with $41.7 millionfor the same period in 2014. Total operating expenses for the fourth quarter of 2015 included $6.8 millionin stock-based compensation expense compared with $2.5 million for the same period in 2014. Total operating expenses for the year ended December 31, 2015, were $239.2 million compared with $147.2 million for 2014. Total operating expenses for the full year ended December 31, 2015, included $22.9 million in stock-based compensation expense compared with $9.3 million for 2014. Research and development expenses were $200.4 million for the year ended December 31, 2015, compared with$123.6 million for 2014, as the Company continued to support its manufacturing scale-up of andexanet alfa in preparation for the BLA submission and commercial launch and work on its larger-scale Generation 2 manufacturing process at Lonza, its Phase 3 and Phase 4 ANNEXA studies of andexanet alfa, completing enrollment in the Phase 3 APEX Study of betrixaban, and its Phase 1/2a clinical study of cerdulatinib. Selling, general and administrative expenses for the fourth quarter of 2015 were $10.9 million compared with $7.0 million for the same period in 2014. Selling, general and administrative expenses for the year ended December 31, 2015, were $38.9 million compared with $23.6 million for 2014, as the Company increased headcount to support its growth and increased pre-commercial launch activities, including hiring key regional sales directors and national account managers and further developing medical affairs.

For the fourth quarter of 2015, Portola reported a net loss of $66.1 million, or $1.23 net loss per share, compared with a net loss of $39.3 million, or $0.82 net loss per share, for the same period in 2014. Net loss for the year ended December 31, 2015, was $226.5 million, or $4.36 net loss per share, compared with a net loss of $137.1 million, or $3.19 net loss per share, for the same period in 2014.

Cash, cash equivalents and investments at December 31, 2015, totaled $460.2 million compared with cash, cash equivalents and investments of $392.3 million as of December 31, 2014.

Conference Call Details
To access the live conference call today, February 26, 2016, at 8:30 am Eastern Time via phone, please dial (844) 452-6828 from the United States and Canada or +1 (765) 507-2588 internationally, and use the passcode 48937755. Please dial in 10 minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company’s website at http://investors.portola.com. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary. A replay of the webcast will be available on the Company’s website for 30 days following the live event.

About Portola Pharmaceuticals, Inc.

Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing its three wholly-owned programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success. These programs include betrixaban, an oral, once-daily Factor Xa inhibitor being evaluated in the APEX Phase 3 study for prophylaxis of venous thromboembolism; andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola’s partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visitwww.portola.com and follow the Company on Twitter @Portola_Pharma.

Portola Forward-looking Statement
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and ability to achieve the milestones and events described under the section “Recent Achievements, Upcoming Events and Milestones,” our goal of becoming a fully commercialized biopharmaceutical company, the projected timing of our product launches, the occurrence and timing of planned filings with the FDA and the timing of our reporting of clinical data. Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtainFDA approval for one or more of our product candidates, our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the pace of enrollment in our clinical trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K, which we expect to file on February 29, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Unaudited Condensed Statements of Operations
(In thousands, except share and per share data)
	Three Months Ended												Twelve Months Ended
	December 31,												December 31,
	2015						2014						2015						2014
Collaboration and license revenue	$		4,414				$		2,412				$		12,070				$		9,625
Operating expenses:
Research and development			59,814						34,722						200,376						123,639
Selling, general and administrative			10,881						6,950						38,869						23,552
Total operating expenses			70,695						41,672						239,245						147,191
Loss from operations			(66,281	)					(39,260	)					(227,175	)					(137,566	)
Interest and other income (expense),net			(190	)					5						305						441
Net loss attributable to common stockholders	$		(66,471	)			$		(39,255	)			$		(226,870	)			$		(137,125	)
Income tax benefit			365						–						365						–
Net loss	$		(66,106	)			$		(39,255	)			$		(226,505	)			$		(137,125	)
Net loss attributable to Noncontrolling interest (VIE)			–						–						–						–
Net loss attributable to Portola	$		(66,106	)			$		(39,255	)			$		(226,505	)			$		(137,125	)
Shares used to compute net loss per share attributable to common stockholders:
Basic and diluted			53,623,313						48,153,468						51,981,463						42,997,463
Net loss per share attributable to common stockholders:
Basic and diluted	$		(1.23	)			$		(0.82	)			$		(4.36	)			$		(3.19	)

 

Unaudited Condensed Balance Sheet Data
(In thousands)
	December 31,			December 31,
	2015			2014
	(Unaudited)
Cash, cash equivalents and investments	$	460,161		$	392,303
Prepaid research and development		16,976			1,686
Total current assets		465,577			315,077
Property and equipment, net		6,243			2,776
Intangible assets		3,151			–
Total assets		502,924			416,495
Accounts payable		10,279			14,084
Accrued research and development		24,195			12,545
Accrued compensation and other liabilities		8,285			4,933
Deferred revenue (current portion and long-term)		27,016			36,585
Total current liabilities		51,146			41,131
Total liabilities		72,601			68,693
Total Portola stockholders’ equity		427,396			347,802
Noncontrolling interest (VIE)		2,927			–
Total liabilities and stockholders equity		502,924			416,495

 

Investor Contact:
Ana Kapor
Portola Pharmaceuticals
ir@portola.com

Media Contact:
Julie Normart
W2O Group
jnormart@w2ogroup.com

Portola Pharmaceuticals, Inc.

CORALVILLE, Iowa, March 14, 2016 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ:KMPH) today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP, its lead investigational drug candidate for the short-term management of acute pain.

KP201/APAP is a combination of KP201, KemPharm’s prodrug of hydrocodone (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is being developed as an abuse-deterrent immediate release prodrug of hydrocodone bitartrate/APAP.  The Company’s NDA for KP201/APAP was accepted and granted priority review by the FDA in early February 2016.  The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.

“The Advisory Committee meeting is an important step forward in the review process for KP201/APAP,” saidTravis C. Mickle, Ph.D., President and CEO of KemPharm. “We look forward to discussing the data submitted as part of our NDA filing with the Advisory Committee members and continuing to work with the FDA through the review process.”

About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.

Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements regarding the expected timing of approval, if at all, of KP201/APAP by the FDA.  These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm’s financial resources and whether they will be sufficient to meet KemPharm’sbusiness objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results; the protection and market exclusivity provided by KemPharm’s intellectual property; risks related to the drug discovery and the regulatory approval process; the impact of competitive products and technological changes; and the FDA approval process under the Section 505(b)(2) regulatory pathway, including without limitation any timelines for related approval. KemPharm’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm’s Periodic and Current Reports filed with the Securities and Exchange Commission.  KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com

Media Contact:
Jim Heins
Cooney Waters Unlimited
212-886-2221
jheins@cooneywatersunlimited.com

KemPharm