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Tuesday, September 3, 2019

Castle Biosciences EPS misses by $0.57, beats on revenue

Castle Biosciences (NASDAQ:CSTL): Q2 GAAP EPS of -$1.05 misses by $0.57.
Revenue of $10.74M (+169.2% Y/Y) beats by $3.26M.

China says has only ‘limited’ cooperation with U.S. on fentanyl

China and the United States have only “limited” cooperation in stopping fentanyl smuggling, a Chinese narcotics official was quoted as saying on Tuesday, after complaints China isn’t doing enough to help fight an opioid crisis in the United States.
U.S. officials say China is the main source of illicit fentanyl and fentanyl-related substances that are trafficked into the United States, much of it through international mail. China denies that most of the illicit fentanyl entering the United States originates in China.
U.S. President Donald Trump last month accused Chinese President Xi Jinping of failing to meet his promises to crack down on the deluge of fentanyl and fentanyl analogues flowing into the United States. China labeled that “blatant slander”.
Fentanyl is a cheap, relatively easy-to-synthesize opioid painkiller 50 times more potent than heroin that has played a major role in a devastating U.S. opioid crisis.
Liu Yuejin, Vice Commissioner of the China National Narcotics Control Commission, told a news conference that China was cracking down on illicit fentanyl production, state television reported.
“The National Narcotics Control report states that looking at cases, counter-narcotics law enforcement departments from China and the United States have for many years maintained a good cooperative relationship,” the report cited Liu as saying.
“But cooperation on investigating and prosecuting fentanyl-related substances is extremely limited.”
Since 2012, the United States has only reported “clues” on six fentanyl-related smuggling cases to China, with only three of these cases successfully cracked, the report added.
Since May 1 of this year, when China tightened controls on fentanyl-related substances, China has not yet discovered a single fentanyl-related smuggling case, Liu said.
Liu reiterated previous government denials that China is the source of most of the fentanyl smuggled into the United States.
China has told the United States it needs to get its house in order when it comes to tackling fentanyl abuse, and should do more to reduce demand.
The U.S. Treasury last month imposed sanctions on three Chinese men accused of illegally trafficking fentanyl, acting three weeks after Trump accused China of reneging on pledges to stem the flood of the highly addictive synthetic opioid into the United States.
The National Institute of Drug Abuse reported earlier this year that 130 people die every day in the United State after overdosing on opioids, which include prescription pain relievers, heroin and synthetic drugs like fentanyl.
The dispute over fentanyl comes as the United States is in the middle of a major trade dispute with China.

ShockWave Medical down 10% on bearish Cliffside report, lockup expiration

ShockWave Medical (SWAV -10.4%) is down on a 7x surge in volume in apparent response to a report from Cliffside Research that rates the stock a Strong Sell with a $23 (39% downside risk) price target citing its  heady valuation and the expiration of the lockup period today.

Zealand Pharma advances BI 456906 to mid-stage clinical test in obesity/diabetes

Boehringer Ingelheim plans to initiate Phase 2 development of the GLP-1/glucagon dual agonist BI 456906, which was in-licensed from Zealand Pharma (NASDAQ:ZEAL).
The dual agonist BI 456906 is a part of Boehringer Ingelheim’s pipeline portfolio in the obesity and diabetes disease areas.
The Phase 2 trial for BI 456906 is expected to be initiated in late 2019 and will trigger a €20M milestone payment to Zealand Pharma out of total outstanding potential milestone payments of €365M and high single to low double digit royalties on future sales.

Amarin up as European CV groups include Vascepa in practice guidelines

The European Society of Cardiology and European Atherosclerosis Society have updated their clinical practice guidelines for managing dyslipidemias to include finding from the REDUCE-IT study, including the recommendation that Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl), 2g twice daily, be considered for high-risk patients with cardiovascular (CV) disease with triglyceride levels between 135 mg/dL and 499 mg/dL despite treatment with statins.

Aridis Pharma’s AR-105 flunks mid-stage study

Ultra-thinly traded micro cap Aridis Pharmaceuticals (NASDAQ:ARDS) slumps 27% premarket on light volume in reaction an unsuccessful Phase 2 clinical trial evaluating candidate AR-105, a fully human IgG1 monoclonal antibody, for the treatment of ventilator-associated pneumonia caused by Gram-negative Pseudomonas aeruginosa.
AR-105 failed to sufficiently separate from placebo in terms of clinical cure rate at day 21. There were also statistically significant imbalances in all-cause mortality and serious adverse events (SAEs) between the treatment and placebo arms, although no SAE or death was determined to be related to AR-105.
The company will not allocate any further resources to development.

IGM Bio sets IPO terms

IGM Biosciences (IGMS) plans to offer 7,812,500 common shares at $15 – 17 in its IPO. Gross proceeds should be $125M.