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Tuesday, May 5, 2020

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/

Prospect of rebound in orders lifts Siemens Healthineers

Shares in Siemens Healthineers gained on the prospect of medical imaging and diagnostics orders bouncing back later this year, even as it abandoned its full-year profit guidance citing uncertainties from the COVID-19 pandemic.
The German group will likely not achieve its previous outlook for the year through September for growth in adjusted earnings per share of 6% to 12%, but revenue growth should return some time before June, Healthineers said on Tuesday.
“The focus on COVID-19 patients made customers delay purchasing decisions, which should show up as pent-up demand in the future,” Chief Executive Bernd Montag said.
Sales of diagnostic products and reagents are slipping as patients avoid check-ups for conditions not related to the virus and Montag said hospitals were in no mind now to purchase big-ticket items such as MRI scanners, predicting lower sales in the April-to-June quarter.
“When it comes to orders, I am optimistic … it will come back to normal,” he added.
The German maker of x-ray, ultrasound and MRI scanners said its adjusted earnings before interest and tax (EBIT) edged 6% higher to 659 million euros ($718 million) in the January-March period, beating the average estimate of 563 million in an analyst survey posted on the company’s website.
That was helped by growth in the CT scanner business and demand for other molecular imaging machines.
Shares in Healthineers were up 5.8% at 42.06 euros by 0837 GMT, after jumping as much as 8.5% to a three-month high.
“We are encouraged that management expects a period of abnormally high growth out of the recovery owing to pent-up demand,” Scott Bardo, an analyst at Berenberg Bank, said.
Healthineers laid out plans last month to launch an antibody test to identify past coronavirus infections, eyeing output of more than 25 million tests per month from June as it competes with rivals Roche and Abbott.
Berenberg’s Bardo said that would likely lift earnings, after Healthineers said in an analyst call that the tests would be priced at a “low single-digit dollar amount” apiece.

https://www.marketscreener.com/news/Prospect-of-rebound-in-orders-lifts-Siemens-Healthineers-shares–30538380/?countview=0

Catalent EPS beats by $0.01, beats on revenue

Catalent (NYSE:CTLT): Q3 Non-GAAP EPS of $0.50 beats by $0.01; GAAP EPS of $0.08 misses by $0.21.
Revenue of $760.6M (+23.2% Y/Y) beats by $64.5M.
https://seekingalpha.com/news/3569002-catalent-eps-beats-0_01-beats-on-revenue

Mallinckrodt Q1 Acthar Gel sales down 25%

Mallinckrodt (MNK) Q1 results:
Revenues: $665.8M (-15.8%); Acthar Gel: $167.6M (-25.1%); INOmax: $141.7M (-6.2%); Ofirmev: $74.9M (-21.7%).
Net loss: ($56.7M) (-136.5%); loss/share: ($0.67) (-136.6%); non-GAAP Net Income: $138.3M (-15.9%); non-GAAP EPS: $1.64 (-15.5%).
CF Ops: $53.7M (-67.4%).
https://seekingalpha.com/news/3568983-mallinckrodt-q1-acthar-gel-sales-down-25

Regeneron and Sanofi’s Libtayo shows benefit in skin cancer

Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi (NASDAQ:SNY) announce positive topline results from a single-arm open-label Phase 2 study evaluating Libtayo (cemiplimab) in patients with the most common type of skin cancer called basal cell carcinoma (BCC) who progressed on or were intolerant of prior hedgehog pathway inhibitor therapy.
The objective response rate (ORR) at week 93 was 29%. 85% of responders experienced an estimated duration of response (DOR) greater than one year. The disease control rate (DCR) (responders + stable cancer for at least six months) was 60%.
In patients with metastatic BCC, the ORR was 21% while 83% of responders experiencing a DOC of at least a year. The DCR was 46%.
No new safety signals were observed.
Marketing applications are next up.
The FDA approved the PD-1 inhibitor in September 2018 for cutaneous squamous cell carcinoma (second most common type of skin cancer).
https://seekingalpha.com/news/3568922-regeneron-and-sanofis-libtayo-shows-benefit-in-skin-cancer