Merrimack Pharma up 6% on $6.7M special dividend

Thinly traded nano cap Merrimack Pharmaceuticals (MACK +6.1%) is up on almost 30% higher volume, albeit on turnover of only 66K shares, on the heels of its announcement that it has received a $5M milestone payment from Ipsen S.A. (OTCPK:IPSEY) triggered by the latter's decision to advance the ongoing clinical trial evaluating Onivyde (irinotecan liposome injection) in small-cell lung cancer patients.

As a result, Merrimack's board has authorized and declared a $6.7M special cash dividend to shareholders of record on December 16 (ex-dividend date is December 13). The payout will be ~$0.50 per share.

Ipsen acquired the company's oncology assets almost three years ago for $575M in cash plus potential payments for new indications of Onivyde.

https://seekingalpha.com/news/3523396-merrimack-pharma-up-6-on-6_7m-special-dividend

Trump officials unveil program for free HIV prevention drugs for uninsured

The Trump administration on Tuesday announced a program to provide free HIV-prevention medication to uninsured people, part of President Trump’s effort to end the HIV epidemic.

Secretary of Health and Human Services Alex Azar said the move is “a historic expansion of access to HIV prevention medication and a major step forward in President Trump’s plan to end the HIV epidemic in America.”

Trump announced in his State of the Union address earlier this year a goal of cutting new HIV infections by 75 percent in five years and 90 percent by 2030.

The program announced Tuesday will allow uninsured people to get free HIV prevention drugs, known as PrEP.

The program uses a donation from the drug company Gilead announced in May of medication for up to 200,000 people per year. Officials said that is more than enough to provide medication for all the uninsured people who need it. The government will be picking up remaining costs of distributing the drugs, with help from a donation from CVS, Walgreens, and Rite Aid to waive pharmacy costs.

Azar said he is pushing for Congress to appropriate money for the program, which he said he expected based on bipartisan support among lawmakers. If Congress simply continues current funding levels with a continuing resolution, though, Azar said he would work with the White House to try to find additional funding to shift to the program.

“We really do need Congress to act,” he said.

There is also a tense background to the announcement given that in November the Trump administration sued Gilead, alleging the company was infringing on government patents for these HIV drugs.

Azar said the lawsuit is separate from Tuesday’s announcement. “This is not related in any way” to the lawsuit, he said.

https://thehill.com/policy/healthcare/472789-trump-officials-unveil-program-for-free-hiv-prevention-drugs-for-uninsured

BioCorRx up 8% on encouraging data on opioid overdose candidate

Ultra-thinly traded nano cap BioCorRx (OTCQB:BICX +7.7%) is up, albeit on only 700 shares, in reaction to encouraging preclinical data on VDM-001, its candidate for the reversal of opioid overdose that it says is an alternative to naloxone.

The company cites early preclinical data that supports the potential ability of VDM-001 to completely prevent the effects of fentanyl, an opioid that is up to 100x as potent as morphine that is commonly found in illicitly manufactured oxycodone and responsible for many overdose deaths.

The candidate, being developed by subsidiary BioCorRx Pharmaceuticals and VDM Biochemicals, is a 100% synthetic antagonist that BioCorRx says should be easier and quicker to make than naloxone (whether an injectable or nasal spray formulation is not provided).

Naloxone-related tickers: Aurobindo Pharma (OTC:ARBQY), Adamis Pharmaceuticals (ADMP -3.2%), Emergent BioSolutions (EBS -0.1%), Opiant Pharmaceuticals (OPNT -2%), Amphastar Pharmaceuticals (AMPH +0.4%)

https://seekingalpha.com/news/3523364-biocorrx-up-8-on-encouraging-data-on-opioid-overdose-candidate

Immunomedics refiles U.S. application for TNBC candidate

Immunomedics (IMMU +1.3%) bucks the broad market selloff, albeit on below-average volume, with its resubmission of a U.S. marketing application seeking accelerated approval to use antibody-drug conjugate sacituzumab govitecan to treat patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior lines of therapy.

The company received a CRL in January in response to its initial filing.

https://seekingalpha.com/news/3523378-immunomedics-refiles-u-s-application-for-tnbc-candidate-shares-up-1

Lexicon Pharma up 6% on advancement of biliary cancer candidate

Lexicon Pharmaceuticals (LXRX +5.7%) is up, albeit on below-average volume, on the heels of a safety review of the initial run-in cohort in a Phase 2 clinical trial, TELE-ABC, evaluating telotristat ethyl, combined with first-line chemo, for the treatment of patients with advanced biliary tract cancer.

The company says data on first six participants who completed at least one 21-day treatment cycle, combined with cisplatin and gemcitabine, support continued enrollment with no adjustments in the dosing regimen.

Six-month progression-free survival data on the first 20 patients should be available in 2020.

Telotristat ethyl, an oral typtophan hydroxylase inhibitor branded as Xermelo, was approved in the U.S. in February 2017 for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors (combined with somatostatin analog therapy).

Related ticker: Ipsen S.A. (OTCPK:IPSEY) (owns commercialization and licensing rights ex-U.S. and Japan).

https://seekingalpha.com/news/3523381-lexicon-pharma-up-6-on-advancement-of-biliary-cancer-candidate

Protagonist down 26% on interim PTG-300 data in beta thalassemia

Investors appear disappointed that Protagonist Therapeutics (PTGX -25.5%) did not announce more definitive results from a Phase 2 clinical trial, TRANSCEND, evaluating PTG-300 in patients with transfusion-dependent beta thalassemia, a blood disorder characterized by chronic anemia and iron overload.

The company says preliminary data showed dose-related drug exposure and reductions in serum iron and transferrin saturation levels from baseline for the 40 mg and 80 mg weekly doses. There were some clinical responders as measured by reductions in transfusion burden, but “continued evaluation at higher doses will be required” to definitively assess the rate and durability of the effects. Additional data, including results from longer follow-up periods and additional dosing regimens, should be available in 2020.

On the safety front, the most frequent treatment-related adverse event was transient erythema (reddening of the skin) (12%, n=4/33).

PTG-300 is an injectable hepcidin mimetic peptide. Hepcidin is a peptide hormone that plays a key role in regulating iron absorption, recycling and utilization. It has Orphan Drug and Fast Track status in the U.S. for the indication.

https://seekingalpha.com/news/3523356-protagonist-down-26-on-interim-ptgminus-300-data-in-beta-thalassemia

Walmart Starts Distributing DarioHealth Digital Diabetes Management System

 DarioHealth Corp. (NASDAQ: DRIO) announced today the launch of the Dario-powered digital diabetes program on Walmart.com.

Walmart is the largest retailer in the world and is the second largest e-commerce retailer in the U.S. It is also an innovator in healthcare, piloting several initiatives such as opening its own Walmart Health centers and creating a Home Health Care section on Walmart.com.

The Dario digital diabetes app is among the most downloaded and highest rated healthcare apps, with a 4.9/5.0 star rating and over 8,000+ reviews on the Apple store. Its Net Promoter Score (NPS), a measure of willingness of customers to recommend a company’s products or services to others, is +77, considered “world class” and the highest in its category, on a -100 – +100 scale.

“Walmart strives to offer its shoppers health solutions that will help them manage their own health in the most efficient way possible. We are excited to access Walmart’s online distribution channel given the extremely high volume of annual visitors. We will offer Walmart’s consumers MyDario™, our complete digital solution to manage diabetes, hypertension, nutrition and exercise. Our system is affordable and supported by a large body of clinical evidence that we believe demonstrates that Dario significantly and quickly improves the health and wellness of its users. We believe that the positive results seen while using our system reinforces engagement and are part of the reason why users rate Dario as one of the best solutions for managing chronic conditions,” said Olivier Jarry, DarioHealth’s President and Chief Commercial Officer.

https://finance.yahoo.com/news/walmart-starts-distributing-dariohealth-digital-132700837.html