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Wednesday, July 15, 2020

Organogenesis sees Q2 revenue above consensus

Organogenesis Holdings (NASDAQ:ORGO) expects Q2 net revenue between $68M – $68.6M vs. consensus of $48.25M and net revenue from PuraPly products between $27.7M – $28.1M, down 5% to 7% Y/Y.
Advanced Wound Care revenue between $59.7M and $60.1M.
Surgical & Sports Medicine revenue between $8.3M and $8.5M.
Q2 results will be out after the market closes on August 10, 2020.
Shares up 29.8% premarket.

Cytokinetics to update on CV pipeline at investor event today

Cytokinetics (NASDAQ:CYTK) will host a Virtual Analyst & Investor Event today starting at 8:30 am ET during which it will update on its cardiovascular (CV) pipeline and strategies to build a commercial franchise. Key points:
Results expected in Q4 from a Phase 3 clinical trial, GALACTIC-HF, evaluating omecamtiv mecarbil in heart failure patients with reduced ejection fraction [collaborating with Amgen (NASDAQ:AMGN)]. Results from previous studies will also be presented.
Cardiac myosin inhibitor CK-3773274: review of Phase 1 data and discussion of development plans for CV diseases associated with hypercontractility. A Phase 2 study, REDWOOD-HCM, in patients with hypertrophic cardiomyopathy has resumed enrollment after being suspended due to the pandemic.
Management will review its commercialization plan for omecamtiv mecarbil including leveraging its corporate partnerships.


Mid-stage study underway on BridgeBio’s infigratinib for bone growth disorder

July 15, 2020

The first subject has been dosed in a Phase 2 clinical trial, PROPEL 2, evaluating BridgeBio Pharma’s (NASDAQ:BBIO) infigratinib (BBP-831) in children with achondroplasia, a bone growth disorder characterized by dwarfism.
The primary efficacy measure is the change from baseline in annualized height velocity up to month 18.
The estimated primary completion date is October 2021.
Achondroplasia is caused by mutations in a gene called FGFR3 which causes the FGFR3 protein to be overly active. Orally available infigratinib is designed to reduce the activity of FGFR3.

Florida Health Dept.: Some labs have not reported negative COVID-19 results

After FOX 35 News noticed errors in the state’s report on positivity rates, the Florida Department of Health said that some laboratories have not been reporting negative test result data to the state.
Countless labs have reported a 100 percent positivity rate, which means every single person tested was positive. Other labs had very high positivity rates. FOX 35 News found that testing sites like one local Centra Care reported that 83 people were tested and all tested positive. Then, NCF Diagnostics in Alachua reported 88 percent of tests were positive.
How could that be? FOX 35 News investigated these astronomical numbers, contacting every local location mentioned in the report.
The report showed that Orlando Health had a 98 percent positivity rate. However, when FOX 35 News contacted the hospital, they confirmed errors in the report. Orlando Health’s positivity rate is only 9.4 percent, not 98 percent as in the report.

The report also showed that the Orlando Veteran’s Medical Center had a positivity rate of 76 percent. A spokesperson for the VA told FOX 35 News on Tuesday that this does not reflect their numbers and that the positivity rate for the center is actually 6 percent.
FOX 35 News went on to speak with the Florida Department of Health on Tuesday. They confirmed that although private and public laboratories are required to report positive and negative results to the state immediately, some have not. Specifically, they said that some smaller, private labs were not reporting negative test result data to the state.
“The Department immediately began working with those labs to ensure that all results were being reported in order to provide comprehensive and transparent data,” a spokesperson for the Florida Department of Health said. “As the state continues to receive results from various labs, the Department will continue educating these labs on proper protocol for reporting COVID-19 test results.”

Florida is currently experiencing a surge in COVID-19 cases, reporting the state’s daily reported cases have gone from about 2,000 a day a month ago to over 12,000. Then, on Tuesday, state health officials reported the largest single-day increase in deaths yet, as 132 more were announced.
Doctors had been predicting that a surge in deaths would follow Florida’s jump in daily reported cases. The growing caseload is partly driven by increased testing, but a larger percentage of tests are coming back positive, jumping from 6 percent a month ago to more than 18 percent.
Almost all people infected with coronavirus survive, but those who do succumb usually die two or more weeks after they are first diagnosed.
While Florida has broken national records for jumps in cases, the state’s death toll is nowhere near the national record. When COVID-19 was ravaging New York three months ago, it recorded 799 deaths on April 9 and had a top seven-day average of 763 deaths on April 14. New York now has one of the nation’s lowest death rates per capita, recording 10 per day over the last week.

Novocure teams up with Merck in lung cancer study

Novocure (NASDAQ:NVCR) will collaborate with Merck (NYSE:MRK) on a Phase 2 pilot study evaluating the concomitant use of Tumor Treating Fields and Keytruda (pembrolizumab) in PD-L1-positive non-small cell lung cancer (NSCLC) patients in a first-line setting.
Enrollment in the 66-subject trial should launch in H2. The primary endpoint will be objective response rate (ORR). Secondary endpoints include overall survival, progression-free survival, duration of response and disease control rate.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

Schein to distribute Radic8 air purifiers in North America

Medical products distributor Henry Schein (NASDAQ:HSIC) inks an agreement with UK-based Radic8 to sell its air purifier devices in the U.S. and Canada. Financial terms are not disclosed.
The Radic8 VirusKiller air purifier is currently being marketed for emergency use in the U.S. during the COVID-19 pandemic.

Feds commit to buy Becton, Dickinson rapid COVID-19 test system

Becton, Dickinson and Company (NYSE:BDX) announces that the U.S. Department of Health and Human Services (HHS) has committed to purchase 2K BD Veritor Plus Systems and 750K rapid SARS-CoV-2 antigen test kits for use on the portable instruments.
Distribution will commence next week.
BDX plans to ramp up production to 2M tests per week by the end of September. It expects to produce up to 10M total tests from now until then.