Sanofi: Second positive Phase 3 Dupixent® (dupilumab) trial

 Second positive Phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis

• Dupixent is the first and only medicine to demonstrate positive Phase 3 results in prurigo nodularis, confirming the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to address itch and skin lesions

• Data confirm results from first Phase 3 trial, with 60% of Dupixent patients meeting the primary endpoint of itch reduction compared to 18% of placebo at 24 weeks

• Additionally, nearly three times as many Dupixent patients experienced reduced skin lesions

• Data continue to support well-established safety profile of Dupixent

• Data to be submitted to regulatory authorities starting in H1

https://finance.yahoo.com/news/second-positive-phase-3-dupixent-060000982.html

Mainz Biomed Engages Support for Study of mRNA Biomarkers for ColoAlert

 Results of European study potentially incorporated into U.S. regulatory strategy for FDA approval

Opportunity for ColoAlert to become the gold standard at-home screening test for colorectal cancer

Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has formally contracted with DCN Dx, a leading international developer of point-of-care diagnostics, and provider of comprehensive product development services. An integral part of the engagement will be the role of Emily Friedland, Vice President of Clinical Research at DCN Dx, who will spearhead the preparation and initiation of Mainz’s European centric clinical study to evaluate the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer. This suite of biomarkers which were in-licensed from Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) in early January 2022, have demonstrated the unique ability to detect pre-cancerous lesions including advanced adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC). The study is on track to commence in the first half of 2022.

https://finance.yahoo.com/news/mainz-biomed-engages-dcn-dx-080100019.html

Leap Therapeutics: Combo Regime Shows Efficacy In Gastric Cancer

 Leap Therapeutics Inc (NASDAQ: LPTX) will present updated data from the DisTinGuish Phase 2a study of DKN-01, in combination with tislelizumab in gastric or gastric gastroesophageal junction cancer (G/GEJ).

• Data will be shared at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium.

• Tislelizumab is BeiGene Ltd's (NASDAQ: BGNE) anti-PD-1 antibody.

• In first-line patients treated with DKN-01 combo therapy showed overall preliminary median progression-free survival (PFS) of 10.7 months.

• The preliminary median duration of response (DoR) was 10.7 months in DKK1-high patients, compared to 7.9 months in DKK1-low patients.

• Median overall survival has not been reached.

• Among patients who received a full first cycle of DKN-01 (modified intent to treat, n=22), the objective response rate (ORR) was 68%, including one complete response (CR) and 14 partial responses (PR).

• The Company will also share initial findings from the still-enrolling Part B of the trial, studying DKN-01 + tislelizumab in second-line advanced G/GEJ patients with high tumoral DKK1 expression.

• DKN-01 + tislelizumab was well tolerated at both 300mg and 600mg DKN-01 doses.

• Among evaluable patients (n=20), the ORR was 25%, including 5 PRs and 4 stable disease (SD). One additional patient has had an irPR by iRECIST criteria.

• The study is ongoing and enrolling in the 600mg DKN-01 cohort.

https://finance.yahoo.com/news/leap-therapeutics-says-dkn-01-110706752.html

Cross Country Healthcare Updated Guidance for Fourth Quarter 2021

 Throughout 2021, Cross Country Healthcare has delivered strong revenue and improved profitability driven by solid execution as it continues to grow its number of professionals on assignment. As a result, the Company is raising the fourth quarter 2021 guidance for revenue, adjusted EBITDA and adjusted EPS from the prior guidance on November 3, 2021.

"As one of the largest healthcare staffing and workforce solutions providers in the country, we remain focused on growth and sustainable profitability. We look forward to our earnings announcement in late February and building long-term value for our shareholders," said Clark. He continued, "We are entering 2022 on a very strong trajectory and I am excited about the prospect of achieving another year of historic performance. Though we anticipate an eventual softening of bill rates, demand for our services has remained robust and as a result rates have continued to remain elevated."

	Q4 2021 Range		Year-over-Year		Sequential
			Change		Change
Revenue	$630 million - $640 million		192% - 197%		68% - 71%
Adjusted EBITDA*	$77 million - $82 million		570% - 613%		156% - 172%
Adjusted EPS*	$1.32 - $1.42		$1.13 - $1.23		$0.71 - $0.81
https://finance.yahoo.com/news/cross-country-healthcare-announces-co-134500285.html

Ginkgo Bioworks to Acquire Mass. COVID-19 Testing Provider

 Acquisition to enable Ginkgo to bolster its growing biosecurity platform and provide expanded COVID-19 testing options to communities in Massachusetts and beyond

Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the acquisition of Project Beacon COVID-19 LLC (Project Beacon), a Boston-based social benefit organization focused on helping to increase the capacity, availability, accessibility and affordability of COVID-19 testing. Under the terms of the deal, Ginkgo acquired Project Beacon's assets and will assume responsibility for Project Beacon's ongoing operations, providing COVID-19 monitoring tools to communities in Massachusetts and other areas.

"As we embark on a new wave of the pandemic and grapple with the spread of the Omicron variant, large-scale testing will be critical to help keep kids in schools and mitigate the spread of COVID-19," said Matt McKnight, Chief Commercial Officer at Ginkgo Bioworks, who is leading Ginkgo's public health and biosecurity efforts. "Integrating Project Beacon's capabilities with our Concentric by Ginkgo offering will enable us to further empower communities in Massachusetts and beyond with the tools they need to make important public health decisions.

Throughout the pandemic, Ginkgo has supported widespread COVID-19 monitoring through its biosecurity and public health initiative, Concentric by Ginkgo. Today, Concentric provides COVID-19 monitoring services for over 280,000 individuals per week through its programs in K-12 schools, correctional facilities, airports, and other community settings. Concentric conducted over 3 million tests in the second half of 2021.

Concentric and Project Beacon share a common goal of making COVID-19 testing accessible to the communities that need it the most. With this acquisition, Concentric will integrate Project Beacon's partner and customer relationships, digital platform, and several key personnel into its broader efforts.

https://finance.yahoo.com/news/ginkgo-bioworks-announces-acquisition-massachusetts-120000584.html

United Therapeutics : FDA Acknowledges Acceptance of Tyvaso DPI Application

 United Therapeutics Corp. said the U.S. Food and Drug Administration has acknowledged acceptance of its new drug application for its Tyvaso DPI lung-disease treatment.

The Silver Spring, Md., biotechnology company said the FDA has accepted the application for review as a class 1 response with a user fee goal date in February.

The company is seeking approval of the drug for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, to improve exercise capacity.

The FDA in October had turned away the application, citing a single deficiency related to an open inspection issue at a third-party testing plant.

United Therapeutics said at the time that it believed the issue would be resolved quickly, paving the way for FDA approval of Tyvaso DPI by the summer of 2022. In December, it refiled its application.

https://www.marketscreener.com/quote/stock/UNITED-THERAPEUTICS-CORPO-11262/news/United-Therapeutics-FDA-Acknowledges-Acceptance-of-Tyvaso-DPI-Application-37573392/

Antares Gets FDA Fast-Track Designation for Adrenal Crisis Rescue

 Antares Pharma Inc. said the U.S. Food and Drug Administration granted fast-track designation for ATRS-1902 for adrenal crisis rescue.

The development program for ATRS-1902 supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, the company said.

A drug candidate that receives fast-track designation is eligible for more-frequent communication with the FDA throughout the drug-development process and a rolling or priority review of its marketing application.

"We look forward to working closely with the agency as we advance our development of ATRS-1902 with an upcoming pivotal clinical study and an additional human factor study that we anticipate will support our 505(b)(2) NDA submission by the end of the year," Chief Medical Officer Peter Richardson said.

https://www.marketscreener.com/quote/stock/ANTARES-PHARMA-INC-2956189/news/Antares-Gets-FDA-Fast-Track-Designation-for-ATRS-1902-for-Adrenal-Crisis-Rescue-37574211/