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Friday, January 3, 2020

Can-Fite up on encouraging Namodenoson data

Nano cap Can-Fite BioPharma (NYSEMKT:CANF) is up 25% premarket on average volume in response to encouraging preclinical data on Namodenoson (CF102).
Studies performed at Hadassah Medical Center in Jerusalem on fat mouse and diabetic rat models showed Namodenoson induced weight loss and normalized glucose levels.
The company has filed a patent application through the World Intellectual Property Organization for the use of Namodenoson as an anti-obesity drug.
Topline results from a Phase 2 study in patients with nonalcoholic fatty liver disease (NAFLD), with or without NASH, should be available this quarter.
A Phase 3 trial in certain liver cancer patients should launch soon.

Endo Pharma gains after Piper upgrade

“Broadly Maligning This Group No Longer Warranted,” goes the title of a note on specialty pharma from Piper Jaffray.
“Can a specialty pharma deep value idea really work in 2020,” asks the team. “We think so,” they answer themselves, upgrading Endo Pharmaceuticals (NASDAQ:ENDP) to Overweight, with $7 price target (56% upside).
Notable Calls notes this is the first upgrade for Endo in two years, and this “coiled spring” could see something nearing a $5 handle today.
Shares are higher by 2% premarket to $4.59

Applied Genetic Tech up ahead key data readouts

Applied Genetic Technologies (AGTC +0.5%) shrugs off broad market selling in early trade (albeit on very light volume). Shares have rallied 56% since December 18 ahead of two expected data readouts this month.
Interim six-month data from the expansion group in a Phase 1/2 study evaluating its recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations.
Interim six-month dose-escalation data from Phase 1/2 studies evaluating gene therapy AGTC-402 in CNGA3 achromatopsia and CNGB3 achromatopsia (color blindness).
The company plans to present comprehensive data on all the trials at its R&D Day on Tuesday, January 28.

Leap Therapeutics up 60% on BeiGene deal

Leap Therapeutics (LPTX +59.5%) is up on a healthy 44x surge in volume after announcing an exclusive option and license agreement with BeiGene (NASDAQ:BGNE) for the development and commercialization of lead candidate DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap will retain exclusive rights to DKN-01 for the rest of the world.
Under the terms of the agreement, Leap will receive $3M upfront and will receive an additional payment if BeiGene exercises its option to develop and commercialize DKN-01. If so, it will be eligible to receive up to $132M in milestones and tiered royalties on net sales.
BeiGene will also make a $5M equity investment in Leap as part a $27M equity deal with two institutional investors.
DKN-01 is a humanized IgG4 monoclonal antibody that binds to Dickkopf-1 (DKK1), a protein associated with a poor prognosis in a range of cancers. Specifically, it inhibits a pathway called canonical Wnt/Beta-catenin which plays a key role in embryonic development, cell proliferation and differentiation. The company says patients with confirmed Wnt pathway alterations experience a greater duration of clinical benefit from DKN-01.

Allergan settles Bystolic patent dispute with Ajanta

Allergan (AGN -0.4%) has settled patent infringement litigation with would-be generic competitor Maharashtra, India-based Ajanta Pharma Limited related to hypertension med Bystolic (nebivolol).
Ajanta will be prohibited from selling its generic version in the U.S. until the patent expires in December 2021 unless granted a non-exclusive license or the patent is invalidated.
Bystolic generated $431M in U.S. sales during the first three quarters of 2019.

Thursday, January 2, 2020

Judge blocks California law on dialysis clinics

A federal judge on Monday blocked enforcement of a California law aimed at preventing increased billing costs at dialysis clinics.
There is “a dire public interest” in granting a preliminary injunction that would bar enforcement for months while a lawsuit against it proceeds through the courts, Judge David O. Carter said.
If Assembly Bill 290 is permitted to take effect before it is reviewed, “thousands of California HIPP recipients—who number among the poorest and most medically vulnerable of all Californians—may not be able to afford the dialysis treatments that keep them alive (or may be forced to dedicate all of their scant financial resources to medical care) and may face further delays in receiving a transplant,” Carter wrote.
HIPP refers to the Health Insurance Premium Program run by the not-for-profit American Kidney Fund. The program, paid for by dialysis clinics, covers insurance premiums for low-income patients with kidney disease who need dialysis.
California passed the law this year in an effort to deter dialysis clinics from encouraging patients to enroll in health plans that give them higher reimbursement rates.
But the lawsuit contends the law will force the American Kidney Fund to close down the program, which helps about 3,700 patients in the state.
The fund has said the law creates requirements in California that conflict with federal laws the program must follow.
State lawmakers contended that two large dialysis clinics in California were contributing to the fund’s program, which in turn covered their patients’ premiums with private insurers that paid higher reimbursement rates back to the clinics.
The state passed the law after a ballot measure to cap dialysis clinics’ profits failed in 2018.

Vaping-Associated Lung Injury Riskier for Older Patients

Patients who were rehospitalized or who died after being treated for EVALI (e-cigarette or vaping product use–associated lung injury) were more likely to have been older and to have had at least one chronic illness, the Centers for Disease Control and Prevention (CDC) reports.
In response to these findings, the CDC has issued interim guidance recommending confirmation of patients’ medical stability for 24 to 48 hours prior to discharge, outpatient follow-up of patients within 48 hours after discharge, and follow-up with a pulmonologist within 2 to 4 weeks after discharge.
According to the CDC, 2561 cases of EVALI and 55 deaths have been reported as of January 2, 2020, and numbers continue to rise.
These findings underscore the need for incorporating measures that “might minimize EVALI patients’ risk for rehospitalization and death, especially among patients with chronic conditions,” the authors write.
Christina A. Mikosz, MD, and colleagues from the CDC’s Lung Injury Response Epidemiology/Surveillance Task Force partnered with state health departments to develop a voluntary reporting service to collect data “on confirmed and probable hospitalized or deceased EVALI patients.”
Using data reported to the CDC as of December 10, 2019, they compared the clinical characteristics of patients with EVALI who were rehospitalized or died after hospital discharge with those of patients with EVALI who were neither rehospitalized nor died after hospital discharge (comparator group). The findings were published online January 2 in Morbidity and Mortality Weekly Report.
Data from 2409 cases that required hospitalization were evaluated, including 52 deaths. The researchers found that among the 1139 patients discharged before October 31, 2019, 31 (2.7%) were rehospitalized, and seven (13.5%) died following discharge. The median interval from discharge to readmission and from discharge to death was 4 days and 3 days, respectively. The comparator group included 768 patients with EVALI who were also discharged before October 31, 2019, but who were not rehospitalized and who did not die.
Mikosz and colleagues found that 70.6% of those who were rehospitalized and 83.3% of those who died had one or more chronic conditions, compared with 25.6% of patients in the comparator group. Chronic conditions included cardiac disease, chronic pulmonary disease (eg, chronic obstructive pulmonary disease and obstructive sleep apnea), and diabetes.
Further, patients who died following their initial visit were more likely to be older (median age, 54 years). All required intubation and mechanical ventilation during their initial hospital visit. Duration of initial hospitalization and use of corticosteroids or antibiotics were similar for all three groups.
Given that most rehospitalizations occurred within 2 to 4 days following initial discharge, the authors suggest “that ensuring clinical stability before discharge as well as postdischarge follow-up optimally within 48 hours might minimize risk for rehospitalization and death, especially among patients with chronic conditions.”
Findings Prompt New Guidance
In response to the finding by Mikosz and colleagues, the CDC, in consultation with the Lung Injury Response Clinical Working Group, has provided updated interim guidance for the management of patients with EVALI. These new recommendations include the following:
  • Confirmation of stable vital signs for at least 24 to 48 hours prior to discharge;
  • Follow-up within 48 hours of discharge (previous recommendation was within 2 weeks of discharge);
  • Focused management of comorbidities and coordination of posthospitalization specialty care; and
  • Ensuring access to mental and behavioral health services post discharge.
The authors have disclosed no relevant financial relationships.
MMWR. Published online January 2, 2019. Full text