Galecto to Participate at Jefferies Healthcare Conference

Galecto, Inc. 

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, a clinical stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that management will be participating at the upcoming Jefferies Healthcare Conference, taking place on June 8-10 in New York City. Details for the event are as follows:

Jefferies Healthcare Conference
Date:	June 8, 2022
Time:	3:00 pm ET
Webcast:	Click HERE

A live webcast of the presentation will be available on the "News & Events" section of Galecto's Investor website at https://ir.galecto.com/news-and-events/events. A replay of the presentation will be available on this same website following the event.

About Galecto
Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 (and the galectin family generally) and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a Phase 1b/2a trial in liver cirrhosis and (iv) an orally active galectin-3 inhibitor (GB1211) in a separate planned phase 2 trial for the treatment of NSCLC in combination with atezolizumab (Tecentriq®).

Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

https://www.benzinga.com/pressreleases/22/05/g27471229/galecto-to-participate-at-jefferies-healthcare-conference

Biodesix in Research Agreement with Top US Cancer Center

 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, today announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer.

"The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement," said Scott Hutton, CEO, Biodesix.

Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR™ platform, the Bio-Rad QX600™ ddPCR™ System.

https://finance.yahoo.com/news/biodesix-announces-research-agreement-top-100000272.html

Novo Nordisk hits primary objectives of trials with once-weekly insulin icodec

 Novo Nordisk today announced headline results from the main phases of ONWARDS 1 (52 weeks) and ONWARDS 6 (26 weeks) phase 3a trials with once-weekly insulin icodec.

ONWARDS 1 (insulin naïve people with type 2 diabetes)
ONWARDS 1 is a phase 3a, 78-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin glargine U100 (insulin glargine), both in combination with non-insulin anti-diabetic treatment, in 984 insulin-naïve people with type 2 diabetes.

The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared to insulin glargine.

From an overall baseline HbA1c of 8.5% once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of -1.55% compared to -1.35% for insulin glargine (estimated treatment difference: -0.19%). Superior time in range (TIR) was also achieved for once-weekly insulin icodec compared to insulin glargine.

In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3mmol/L) with 0.30 events per patient year exposed to once-weekly insulin icodec and 0.16 events per patient-year exposed to insulin glargine. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.

https://finance.yahoo.com/news/novo-nordisk-achieves-primary-objectives-073000977.html

Bristol-Myers To Buy Turning Point Therapeutics for $4.1 B

 Bristol-Myers Squibb  (BMY) - Get Bristol-Myers Squibb Company Report said Friday it will buy Turning Point Therapeutics  (TPTX) - Get Turning Point Therapeutics, Inc. Report in a deal that values the San Diego-based oncology specialists at around $4.1 billion.

Bristol-Myers will pay $76 per share, in cash, for Turning Point Therapeutics, a 122% premium to the group's Thursday closing price on the Nasdaq, in a deal that has the group's unanimous board approval. 

Bristol-Myers said the acquisition would clip 8 cents per share from its non-GAAP earnings this year, but will begin to boost its bottom line by 2025.  

“The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset,” said Bristol-Myers CEO Giovanni Caforio. “With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile.”  

https://www.thestreet.com/markets/bristol-myers-to-buy-turning-point-in-4-1-billion-oncology-deal

Amylyx Gets PDUFA Date Extension for AMX0035 for Treatment of ALS

 Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ("Amylyx" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is September 29, 2022.

The FDA extended the PDUFA date to allow more time to review additional analyses of data from the Company’s clinical studies. The submission of this information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA goal date.

https://finance.yahoo.com/news/amylyx-pharmaceuticals-receives-notification-pdufa-110000354.html

Rapid rise in Mumbai pushes India's COVID-19 numbers to month high

 India's health ministry reported 3,712 new coronavirus infections for the past twenty four hours on Thursday (Jun 2), the highest in nearly a month, driven up by a record number cases recorded in the financial capital, Mumbai.

The city reported 739 cases on Wednesday night, more than double the number it had recorded just two days earlier, 318.

"Trend graph of Mumbai shows a silent wave, mild omicron variants. Protect vulnerables, keep close watch on hospitalization," Shashank Joshi, a member of the state government task force on COVID-19 said on Twitter late on Wednesday.

Hospitalisations in Mumbai were low, and 96 per cent of the cases reported on Wednesday were asymptomatic, the city's civic body said in its daily COVID-19 report.

"There is no rise in hospitalisations. People are quarantining themselves at home and recovering at home. There is no need to worry," state health minister Rajesh Tope told reporters on Wednesday.

Mumbai was one of the first cities to be affected in India's devastating second wave of the pandemic in 2021, but was lauded for its efficient tackling of the crisis.

India has recorded more than 43 million cases and 524,641 deaths since the pandemic began.

https://www.channelnewsasia.com/asia/rapid-rise-mumbai-india-covid-19-numbers-2722571

Omicron Sub-Variant Fuels Portugal's COVID-19 Surge

 An Omicron sub-variant has fuelled a surge in COVID-19 cases in Portugal that now has the world's second-highest infection rate, potentially threatening the tourism sector's recovery.

Portugal registered an average of 2,447 new cases per million people over the last seven days. That compares to neighbouring Spain's 449 and Britain's 70, according to tracker Our World In Data.

The rolling average has subsided slightly in the past few days and is just over a third of the Jan. 31 Omicron peak.

Portugal has the world's fifth-highest death rate from COVID-19 and hospitalisations are on the rise, but both are still far below previous peaks.

Several tourism businesses contacted by Reuters have expressed fears about the surge, but said they had had no cancellations so far. The number of foreign tourists in April was close to levels seen before the pandemic.

More than 90% of Portugal's population is fully vaccinated.

Public health institute Ricardo Jorge said in a report on Tuesday the Omicron sub-variant BA.5 represented nearly 90% of new COVID-19 infections. The BA.4 sub-variant has also been detected in Portugal.

Both drove South Africa's fifth COVID wave last month, with scientists saying they were able to dodge antibodies from earlier infection.

"Portugal is probably the European country with the highest prevalence of this sub-lineage and this partly explains the high number (of cases) we are seeing," Health Minister Marta Temido told RTP broadcaster.

The government lifted most COVID-19 restrictions, including the mandatory use of masks in most indoor public spaces, in April and has said there are no plans to reintroduce measures.

Temido said the use of masks was still recommended and authorities would continue to roll out booster vaccine doses to the most vulnerable.

https://www.usnews.com/news/world/articles/2022-06-02/omicron-sub-variant-fuels-portugals-covid-19-surge