Target to $7 from $3
Wednesday, February 2, 2022
Thermo Fisher beat boosted by nearly $2.5 billion in COVID-19 response revenue
Shares of Thermo Fisher Scientific Inc. TMO,
Boston Scientific Tumbles On Lackluster Guidance
Early Wednesday, Boston Scientific (BSX) reported adjusted profit of 45 cents per share on $3.13 billion in sales for the fourth quarter. In response, BSX stock skidded.
On average, analysts polled by FactSet expected Boston Scientific to earn 44 cents per share on $3.11 billion in sales.
In the year-earlier period, the medical products company earned 23 cents per share and reported $2.71 billion in sales.
For the year ending in December 2022, Boston Scientific guided to 6%-8% sales growth, on both a strict as-reported and organic basis. That would fall from 20% growth in 2021. The company also expect to earn $1.73-$1.79 a share. BSX stock analysts projected adjusted profit of $1.87 per share and $12.93 billion in sales, up 9%.
https://www.investors.com/news/technology/bsx-stock-boston-scientific-earnings-q4-2021/
Logic B o Phase 1/2 Trial Put on Hold
LogicBio Therapeutics, Inc. (Nasdaq: LOGC), a clinical-stage genetic medicine company, today provided an update on the LB-001 clinical development program. The U.S. Food and Drug Administration (FDA) has notified the company that its Phase 1/2 SUNRISE clinical trial of LB-001 in pediatric patients with methylmalonic acidemia (MMA) has been placed on clinical hold. The company will host a conference call and webcast this morning to discuss this update.
To date, four patients have been dosed in the SUNRISE trial with LB-001, LogicBio's investigational, single-administration, adeno-associated virus (AAV) genome editing therapy. In accordance with the FDA-cleared protocol, the first two patients dosed were in the older age group (3 to 12 years old) and received 5 x 1013 vg/kg of LB-001. These first two patients are doing well, have not experienced drug-related serious adverse events (SAEs), and are being monitored in accordance with the protocol.
As previously disclosed, the third patient dosed in the SUNRISE trial, who received 5 x 1013 vg/kg of LB-001 and is in the younger age group (6 months to 2 years old), experienced a drug-related SAE, which was categorized as a case of thrombotic microangiopathy (TMA). TMA has been previously reported in association with other AAV genetic therapies. The patient was hospitalized and responded well to intravenous fluids and parenteral nutrition. Following this SAE, the company implemented additional safety measures in the SUNRISE trial, and reported the SAE to the FDA and the Data Safety Monitoring Board for the trial (DSMB). In December 2021, the company announced that the SAE experienced by the third patient had resolved.
In January 2022, the fourth patient dosed in the SUNRISE trial, who received 5 x 1013 vg/kg of LB-001 and is in the younger age group, experienced a drug-related SAE, which was categorized as a case of TMA. The patient is being closely followed by the patient's care team and has been steadily improving. The company reported the SAE to the FDA and the DSMB. The FDA subsequently notified the company that the SUNRISE trial has been placed on clinical hold. LogicBio will be working closely with the FDA and the DSMB to determine the next steps for the SUNRISE trial and the LB-001 program.
Conference Call and Webcast Details
LogicBio will host a conference call and webcast today, Wednesday, February 2, 2022, at 8:30 a.m. ET to discuss the program update. To listen to the conference call, please dial +1 (833) 519-1335 (domestic) or +1 (602) 585-9978 (international) using conference ID number 7545016. A live webcast of the call can be accessed via the Investors section of the company's website at https://investor.logicbio.com. A webcast replay will be available following the call and archived for approximately 30 days.
https://finance.yahoo.com/news/logicbio-therapeutics-provides-lb-001-110000095.html
Novo Nordisk shares rise on upbeat outlook
Shares in Novo Nordisk rose more than 3% on Wednesday after the Danish drug developer delivered a better-than-expected earnings outlook for 2022 despite missing fourth quarter operating profit expectations.
The world's largest diabetes drug developer expects to generate sales growth of between 6% and 10% in local currencies in 2022 and deliver operating profit growth of 4% to 8%.
"This reflects an underlying unchanged positive growth momentum for Novo Nordisk," Sydbank analyst Soren Lontoft told Reuters, adding that he would be raising his estimates.
Jefferies analysts said Novo's operating profit forecast reflected lower margin pressure than feared.
Novo reported fourth quarter operating profit of 13.63 billion Danish crowns ($2.06 billion), an increase of 16% over the corresponding period last year, but below an average of 14.36 billion forecast by analysts in a Refinitiv poll.
Higher sales and distribution costs in addition to higher research and development spending had impacted the results, Lontoft said.
"It reflects perhaps a more normalized world with increasing absence of restrictions and COVID-19, which has led to increased marketing spending," he added.
Sales for the fourth quarter, however, came in at 38.3 billion crowns, above analysts' estimates of 37.9 billion, driven by sales of new diabetes drug, Ozempic, which rose 64% to 33.7 billion in 2021.
OVERCOMING SUPPLY ISSUES
Novo was overwhelmed by the demand for its Wegovy obesity drug following its release to the U.S. market in June, leading to product shortages.
In December, a contract manufacturer halted deliveries and manufacturing temporarily after issues relating to good manufacturing practice
"Since December, we have worked hard to optimise our internal capacity," Chief Executive Lars Joergensen told reporters on Wednesday.
"Consequently, we now expect that internal capacity in the first half of 2022 will be close to the demand of around 20,000 weekly total scripts as seen in the U.S. market at the end of 2021," Joergensen added.
World's 1st trial deliberating infecting young adults with Covid found to be safe
The world's first human challenge trial in which volunteers were deliberately exposed to Covid-19 to advance research into the disease was found to be safe in healthy young adults, one of the companies running the study said on Wednesday.
The data supports the safety of this model which could theoretically provide a "plug and play" platform for testing therapies and vaccines using the original Covid-19 strain as well as variants of the virus, Open Orphan (ORPH.L), which carried out the study, said in a statement.
Open Orphan is running the project, launched a year ago, with Imperial College London, the UK government's vaccines task force and the clinical company hVIVO.
The trial infected 36 healthy male and female volunteers aged 18-29 years with the original SARS-CoV-2 strain of the virus and closely monitored them in a controlled quarantined setting. They will be followed up for 12 months after discharge from the quarantine facility.
No serious adverse events occurred, and the human challenge study model was shown to be safe and well tolerated in healthy young adults, the company said.
With the model established, it said it should be able to contract or conduct Covid-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals.
https://www.gulf-times.com/story/709138/World-s-1st-trial-deliberating-infecting-young-adu
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