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Monday, April 13, 2020

FDA accepts ANI Pharma application for relaunch of Cortrophin Gel

The FDA has accepted for review an application from ANI Pharmaceuticals (ANIP -2.9%) seeking approval to re-commercialize Purified Cortrophin Gel (repository corticotropin injection USP) 80U/mL. The agency’s action date is July 23.
The product, originally approved in the U.S. in 1954 and last used in the 1980s, will compete with Mallinckrodt’s (MNK +8.5%) Acthar Gel (repository corticotropin injection) if approved.
The company acquired the New Drug Application (NDA) from Merck in January 2016.
https://seekingalpha.com/news/3560148-fda-accepts-ani-pharma-application-for-relaunch-of-cortrophin-gel

CNS Pharma up on 2-DG action against coronavirus

Thinly traded nano cap CNS Pharmaceuticals (NASDAQ:CNSP) jumps 22% premarket on average volume in reaction to its announcement that research performed at the University of Frankfurt showed the 2-deoxy-D-glucose (2-DG) totally blocked replication of SARS-CoV-2, the virus causing COVID-19, in a cell culture model.
The findings were submitted to NatureResearch about a month ago.
The company is collaborating with WPD Pharmaceuticals (OTCPK:WCOTF) on development of WP112, a prodrug of 2-DG that may have therapeutic potential in COVID-19 since 2-DG inhibits glycolysis which prevents the coronavirus from replicating. In its normal state, though, it is metabolized too quickly to be effective. WP112 is only metabolized once it is inside the cell, enabling much higher tissue and organ concentrations of 2-DG.
https://seekingalpha.com/news/3560100-cns-pharma-up-22-premarket-on-2-dg-action-against-coronavirus

La Jolla Pharma up 4% on Giapreza for COVID-19 septic shock

La Jolla Pharmaceutical (NASDAQ:LJPC) perks up 4% premarket on light volume in reaction to its announcement that it is supplying Giapreza (angiotensin II) for COVID-19 patients with septic shock under an emergency medical program at a hospital in Belgium.
The FDA approved Giapreza in December 2017 for adults with septic shock or other distributive shock.
https://seekingalpha.com/news/3560113-la-jolla-pharma-up-4-on-giapreza-for-covidminus-19-septic-shock

Coherus Bio sees Q1 product sales shy of consensus

On a preliminary basis, Coherus BioSciences (CHRS -0.4%) expects Q1 product sales of $115.0M – 117.5M, up 213% (midpoint) from a year ago, but a bit short of $118.6M consensus.
Net income should be $33.5M – 38.0M, reflecting modest headwinds from the COVID-19.
Management says disruptions to its operations from the coronavirus pandemic should be transient with the greatest impact coinciding with the contagion’s peak effect on the U.S. medical system and personal behaviors.
https://seekingalpha.com/news/3560135-coherus-bio-sees-q1-product-sales-shy-of-consensus

Feds investigate coronavirus scam over deal for 39 million face masks

Federal authorities are investigating an international, coronavirus-related scam that conned a California healthcare union into believing it struck a deal for hospitals to buy 39 million N95 face masks, according to a report.
The FBI and prosecutors in Pennsylvania uncovered the scheme while trying to determine whether the personal protective equipment could be seized under the Defense Production Act that President Trump invoked last month, the Los Angeles Times said.
“We believe we disrupted fraud,” Pittsburgh US Attorney Scott Brady told the paper.
The Greater New York Hospital Association, which represents more than 160 hospitals and health care systems across the state, was among the organizations that planned to purchase the masks, according to an announcement that the United Health Care Workers West made late last month.
The union, which represents 97,000 hospital employees across the Golden State, and an unidentified Pittsburgh businessman were both duped by the scheme, but no money ever exchanged hands and neither is under investigation, the Times said.
The targets of the probe are a purported broker in Australia and a supplier in Kuwait, both of whom used the encrypted WhatsApp messaging service to communicate with the Pittsburgh businessman, the Times said.
The businessman, who was serving as a middleman in the phony deal, told investigators he planned to buy the masks for $3.50 each and turn a “slight profit,” which the Times said could have amounted to $9 million.
The UHW — which is part of the powerful Service Employees International Union and which organized petition drives against three hospital networks that declined to buy masks — said the safety gear would be available for $5 each and that it wouldn’t make anything for its role in arranging the sales.
But the bogus deal collapsed when employees of the Oakland-based, Kaiser Permanente managed-care company complained that they hadn’t received any mask after their employer placed an order for 6 million.
Union spokesman Steve Trossman told the Times that the UHW’s only role was connecting the Pittsburgh businessman and the hospitals.
“As far as we knew, he had legitimate masks and the people who were going to purchase those masks were going to fully vet it and check it out and do their due diligence,” he said.
Trossman also said that the union “was trying to save the lives of healthcare workers and patients” and that it was “proud of having made that attempt.”
https://nypost.com/2020/04/12/feds-investigate-coronavirus-scam-over-deal-for-39-million-face-masks/

Stryker down 2% as Barclays cuts view due to COVID-19 headwinds

Citing the market’s underappreciation of the severity and duration of revenue declines due to COVID-19 disruptions, Barclays’ Kristen Stewart has cut her rating on Stryker (NYSE:SYK) to Underperform with a $155 (15% downside risk) price target.
She cites a decline in physician office visits that could reduce future procedures and the expected slow ramp up (at some point) of elective procedures.
She also says recent reports have raised questions about a potential second wave of infections which could impact sales beyond this quarter.
Shares down 2% premarket on light volume.
https://seekingalpha.com/news/3560087-stryker-down-2-barclays-cuts-view-due-to-covidminus-19-headwinds

Teladoc sees spike in behavioral health visits; shares up

Teladoc (NYSE:TDOC) perks up 2% premarket on light volume on the heels of a note from Bank of America Global Research stating that it has experienced an upsurge in downloads of BetterHelp, its virtual behavioral health offering, amid COVID-19 from ~1,000/day in March to more than 1,800/day this month. BofA adds that download data do not tell the whole story. In its view, recent disruptions in employment have substantially raised churn levels which are likely to persist for at least 2-3 months.
Weekly downloads of its core medical mobile app last week were 54,270, down from 61,025 the week before and down ~22% from the peak of ~70K during the week of March 13 when the company announced a 50% increase in visits (100K/week).
https://seekingalpha.com/news/3560080-teladoc-sees-spike-in-behavioral-health-visits-shares-up-2-premarket