Cellectis Amends $20 M Convertible Note Under Collaboration Agreement with Cytovia

 Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today that it has amended certain financial terms of the $20 million convertible note issued by its partner, Cytovia Therapeutics, LLC (“Cytovia”) in payment of the upfront collaboration consideration provided for pursuant to the research collaboration and non-exclusive license agreement between Cellectis and Cytovia.

The amended and restated note provides for automatic conversion into common stock of Cytovia in the case of certain fundamental transactions pursuant to which Cytovia becomes a public reporting company and for conversion at Cellectis’ option in connection with certain financing transactions, upon a company sale and at final maturity. In each case such conversion is subject to a 9.9% ownership cap, with the balance issuable in the form of pre-funded warrants. Among other changes, the amended and restated note increased the applicable interest rate of the note to 10% per annum, subject to a 10% step up upon the occurrence and continuation of an event of default, provided for the repayment of 50% of the outstanding amount on April 30, 2023 and extended the final maturity date for the repayment of the remaining outstanding amount to June 30, 2023.

https://finance.yahoo.com/news/cellectis-amends-20-million-convertible-213000877.html

Ideaya starts Phase 2 of eye melanoma trial

 Initiated Phase 2 clinical trial evaluating Darovasertib as neoadjuvant treatment of uveal melanoma prior to primary interventional treatment of enucleation or radiation therapy

-  Clinical protocol includes neoadjuvant treatment with Darovasertib to maximum benefit up to 6 months, primary treatment, then up to 6 months of follow-up adjuvant therapy

-  Neoadjuvant endpoints include eye preservation, reducing radiation and vision preservation; adjuvant endpoints include relapse free survival and useful vision

-  UM represents an unmet medical need and potential clinical expansion opportunity with annual incidence of approximately 8,700 patients in the US and EU

-  Targeting clinical data update for Darovasertib / Crizotinib Combination in MUM in 2023, including overall survival (OS) data

https://finance.yahoo.com/news/ideaya-announces-darovasertib-phase-2-110000420.html

BioCryst Selects Swixx BioPharma as Commercial Partner for ORLADEYO in Central, Eastern Europe

  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the company has entered into a collaboration with Swixx BioPharma AG to commercialize ORLADEYO® (berotralstat) in Central and Eastern Europe (CEE).

“We continue to build partnerships with companies that have deep expertise in commercializing rare disease therapies as we advance our mission of bringing ORLADEYO to patients living with hereditary angioedema around the world. The team at Swixx is highly skilled at launching rare disease therapies in Central and Eastern Europe, and we are thrilled to work alongside them to bring our oral, once-daily prophylactic treatment for HAE to patients in this region,” said Charlie Gayer, chief commercial officer of BioCryst.

https://finance.yahoo.com/news/biocryst-selects-swixx-biopharma-commercial-120000271.html

Morphic reveals that Janssen has terminated agreement

 Waltham, Massachusetts, USA-based biotech Morphic Therapeutic announced I a Securities and Exchange Commission (SEC) filing that Johnson & Johnson (NYSE: NJN) subsidiary Janssen Pharmaceuticals has elected to terminate the research collabora/tion and option agreement between the companies dated December 30, 2020, and as further expanded and amended.

The termination will be effective within 60 days of January 13, 2023.

https://www.thepharmaletter.com/article/morphic-reveals-that-janssen-has-terminated-agreement

Asensus Surgical Receives CE Mark for Expanded Machine Vision Capabilities

 Expanded Intelligent Surgical Unit™ (ISU™) capabilities include 3D measurement, digital tagging, image enhancement, and enhanced camera control, for our European customers

The Senhance Surgical System

The Senhance Surgical System is powered by the Intelligent Surgical Unit, enabling real-time surgical image analytics and machine vision-driven control of the camera.

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced receipt of CE Mark for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™). With this CE Marking, the expanded ISU capabilities are now commercially available across all of the Company’s key geographies, including the European Union, Japan, and the U.S. In addition, this approval included a review of the Senhance® Surgical System platform, making Senhance one of the first robotic surgical systems to be approved through the new, more rigorous EU Medical Device Regulation, or MDR, process.

https://finance.yahoo.com/news/asensus-surgical-receives-ce-mark-115500581.html

Mallinckrodt: Data on Hepatorenal Syndrome Reversal at Critical Care Congress

 Findings from a retrospective analysis suggest that patients with baseline acute-on-chronic liver failure (ACLF) grade ≤2 treated with TERLIVAZ^® plus albumin had a higher incidence of HRS reversal than those treated with placebo plus albumin¹

Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from a retrospective analysis of three North American-centric, Phase III, randomized, placebo-controlled studies comparing the incidence of hepatorenal syndrome (HRS) reversal with baseline acute-on-chronic liver failure (ACLF) grade in adults with rapid reduction in kidney function² treated with TERLIVAZ^® plus albumin versus those treated with placebo plus albumin. Investigators will present the findings during an oral presentation at the SCCM 2023 Critical Care Congress on January 22, taking place in San Francisco, CA from January 21-24.

https://www.biospace.com/article/releases/mallinckrodt-presents-new-terlivaz-terlipressin-for-injection-data-on-hepatorenal-syndrome-hrs-reversal-at-the-society-of-critical-care-medicine-sccm-2023-critical-care-congress/

NYU Langone Health exits diabetes vaccine trial

 Researchers from New York City-based NYU Langone Health departed from a trial investigating a tuberculosis vaccine's potential as a pediatric Type 1 diabetes vaccine, The New York Times reported Jan. 20. 

The tuberculosis vaccine, Bacillus Calmette-Guerin, is more than 100 years old and isn't widely used in the U.S., according to the CDC. Boston's Massachusetts General Hospital is leading the study and has been researching the vaccine's prospects for other uses, such as COVID-19.

NYU Langone officials told the Times the researchers were withdrawing from the phase 2 study after reviewing more information about the BCG vaccine but said the decision "will not affect the safety of enrolled participants."

Of the 150 children enrolled in the study, the NYU Langone team has administered the vaccine in at least 18 participants, according to the Times. These patients will continue to see the hospital's physicians for diabetes care, university officials said. 

The decision to leave the trial drew criticism from Massachusetts General Hospital leaders and patients alike, but the yearslong effort to study the tuberculosis vaccine for other uses has been wobbling in uncertainty. In 2018, the American Diabetes Association and JDRF, a nonprofit that funds Type 1 diabetes research, said the tentative link between BCG and a diabetes vaccine "must be interpreted with caution."

https://www.beckershospitalreview.com/pharmacy/nyu-langone-health-exits-diabetes-vaccine-trial.html