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Tuesday, May 5, 2020

Diffusion Pharma up 18% premarket on potential use of TSC in COVID-19

Nano cap Diffusion Pharmaceuticals (NASDAQ:DFFN) is up 18% premarket on robust volume in reaction to its announcement that the FDA will accelerate the review of its clinical development plan for using lead drug trans sodium crocetinate (TSC) to treat COVID-19 patients with severe respiratory symptoms and low oxygen levels.
The company believes that small molecule TSC’s oxygen-enhancing mechanism of action could help these patients.
https://seekingalpha.com/news/3569084-diffusion-pharma-up-18-premarket-on-potential-use-of-tsc-in-covidminus-19

Akebia up on positive vadadustat data

Akebia Therapeutics (NASDAQ:AKBA) announces positive results from the two Phase 3 clinical trials in its INNO2VATE program comparing vadadustat to darbepoetin alfa (similar to erythropoietin) in adult patients on dialysis with chronic kidney disease-related anemia.
Both studies met the primary and secondary endpoints demonstrating vadadustat’s non-inferiority to darbepoetin alfa as measured by the mean change in hemoglobin from baseline to weeks 24 – 36 (secondary evaluation period was weeks 40 – 52).
The company plans to file a U.S. marketing application “as quickly as possible.”
https://seekingalpha.com/news/3569012-akebia-up-25-premarket-on-positive-vadadustat-data

Adverum gene therapy shows positive action in macular degeneration



Adverum Biotechnologies (NASDAQ:ADVM) announces positive preliminary data from the first three cohorts in a Phase 1 dose-ranging clinical trial, OPTIC, evaluating gene therapy candidate ADVM-022, administered via intravitreal injection, in patients with wet age-related macular degeneration (wet AMD).
The company says ADVM-022 continues to show “robust” efficacy with long-durability of beyond a year from a single administration with no rescue injections in cohort 1.
On the safety front, the gene therapy continues to be well-tolerated with a favorable safety profile.
Mean gain in best corrected visual acuity (BCVA) in cohort 3 was +6.8 letters.
It plans to file an IND for ADVM-022 in diabetic retinopathy (DR) this quarter.
Key H2 milestones: Present data from all four cohorts in OPTIC and launch enrollment in Phase 1/2 study of ADVM-022 in DR.
https://seekingalpha.com/news/3569040-adverum-gene-therapy-shows-positive-action-in-wet-amd-shares-up-22-premarket

Chembio up on launch and initial orders of COVID-19 blood test

Chembio Diagnostics (NASDAQ:CEMI) announced Q1 results after the close yesterday that missed views, but investors are reacting to its update on activities related to its DPP COVID-19 IgM/IgG blood test that it recently launched. Key developments:
Selected by Stony Brook Medicine to identify COVID-19 survivors for a convalescent plasma study.
Received a $4M purchase order from Rio de Janeiro-based Bio-Manguinhos.
It also completed a reproducibility study of its DPP HIV-Syphilis test and submitted the data to the FDA.
https://seekingalpha.com/news/3569049-chembio-up-15-on-launch-and-initial-orders-of-covidminus-19-blood-test

TG Therapeutics up on positive umbralisib data

TG Therapeutics (NASDAQ:TGTX) announces positive topline results from a Phase 3 clinical trial, UNITY-CLL, comparing unbralisib plus ublituximab (U2) to obinutuzumab plus chlorambucil in patients with previously untreated relapsed/refractory chronic lymphocytic leukemia (CLL).
Based on a prespecified interim analysis by the independent Data Safety Monitoring Board, treatment with U2 resulted in a statistically significant improvement in progression-free survival (PFS). As a result, the study will be stopped early.
Management will host a conference call this morning at 8:30 am ET to discuss the results.
https://seekingalpha.com/news/3569023-tg-therapeutics-up-34-premarket-on-positive-umbralisib-data

Bangladesh’s Beximco to begin producing COVID-19 drug remdesivir – COO

One of Bangladesh largest drugmakers, Beximco Pharmaceuticals Ltd, will start production this month of the experimental antiviral drug remdesivir, which has shown promise in fighting the new coronavirus, a senior company executive said on Tuesday.
Remdesivir, a drug developed by Gilead Sciences, has grabbed attention as one of the most promising treatments for COVID-19, the respiratory disease caused by the novel coronavirus that has killed more than 250,000 people.
U.S. drug authorities granted emergency use authorisation last week, paving the way for its broader use across U.S. hospitals, after Gilead provided data showing the drug helped to improve survival rates for COVID-19 patients.
The company plans to price the drug, which is given via intravenous infusion, at between 5000 and 6000 takas per vial ($59-$71/per vial), Beximco’s Chief Operating Officer Rabbur Reza told Reuters, adding a patient might need anywhere between 5 and 11 vials.
“We will only know exactly how much a patient needs once studies are complete,” Reza said. He said production would begin this month, initially for domestic use only.
Beximco’s pricing indicates a course of remdesivir treatment could cost anywhere between $295 and $781 per patient in the south Asian country depending on the severity of the case, the number of vials required and the final pricing of the drug.
The figures are a first indication of how the potentially life-saving drug will be priced, as countries around the world struggle to control the pandemic.
Gilead has donated an initial batch of 1.5 million vials of the drug to help patients in the United States, but has yet to announce its pricing.
The Institute for Clinical and Economic Review (ICER), which assesses the effectiveness of drugs to determine appropriate prices, put the cost of producing a 10-day course of remdesivir at $10. It suggested the price could rise to $4,500 based on patient benefits shown in clinical trials.
https://www.marketscreener.com/BEXIMCO-PHARMACEUTICALS-L-46697813/news/Exclusive-Bangladesh-s-Beximco-to-begin-producing-COVID-19-drug-remdesivir-COO-30540592/

SIEMENS HEALTHINEERS: Buy rating from Berenberg

Berenberg is positive on the stock with a Buy rating. The target price continues to be set at EUR 40.
https://www.marketscreener.com/SIEMENS-HEALTHINEERS-AG-42379342/news/SIEMENS-HEALTHINEERS-Buy-rating-from-Berenberg-30540697/