First 10 patients dosed in 77 patient randomized, double blind, placebo controlled Phase 2 Clinical Trial at Shaare Zedek Medical Center in Jerusalem, Israel
Data from randomized, placebo controlled, open label Phase 1b trial in 27 hospitalized COVID-19 patients supports dose selection for the Phase 2 Clinical Trial
Company to include its proprietary 3CL protease enzymatic assay (“TolloTest™) as exploratory theranostic biomarker
Haemonetics Corporation (NYSE: HAE) ("Haemonetics" or the "Company"), a global medical technology company focused on delivering innovative medical solutions to drive better patient outcomes, today announced that CSL Plasma, Ltd. ("CSL") has informed Haemonetics of its intent not to renew its Supply Agreement with Haemonetics for the use of PCS2® Plasma Collection System devices and the purchase of disposable plasmapheresis kits in the U.S. following the expiration of the current term in June 2022. Haemonetics was informed that the decision was based on changes in CSL's internal strategy and was not related to product or service quality.
This notice of intent not to renew is specific to Haemonetics' plasmapheresis equipment and disposables Supply Agreement for CSL's U.S. plasma collection centers. In fiscal year 2020, Haemonetics revenue under this Supply Agreement was $117 million, or 11.8% of total Company revenue, with a gross margin similar to total Company adjusted gross margin. The Company expects to incur an approximately $25 million one-time impairment relating to disposables manufacturing equipment and an estimated $7 million in additional expenses in the fourth quarter of fiscal 2021 in relation to this announcement. Haemonetics remains committed to supporting CSL in other geographies and capacities, representing approximately 1% of total Company revenue in fiscal year 2020, and will continue to support CSL's plans to roll out NexSys PCS® plasmapheresis devices in Europe under the recently executed agreement with CSL.
"We have a long-standing relationship with CSL and while we are disappointed by this decision we appreciate the advance notice," said Chris Simon, Haemonetics' President and CEO. "We have taken a series of actions over the past five years to strengthen Haemonetics' financial health and believe that our organization has the agility to navigate these changes. We are confident in our ability to continue to generate positive cash flow as we pursue our strategies to deliver shareholder value."
Haemonetics continues to believe in the value proposition of its NexSys PCS® and Persona® technologies, supported by real world data, and remains committed to delivering these technologies to its customers and pursuing additional innovation to further improve plasma collection. The Company also reaffirms its expectation of 8-10% average long term growth in the U.S. source plasma collections market.
As previously noted, the current term of the Supply Agreement expires on June 30, 2022. The Supply Agreement also provides CSL the right to extend the agreement until June 30, 2023 with notice of renewal to be given no later than December 31, 2021.
The Company intends to provide additional details about this announcement on its fourth quarter and fiscal year 2021 earnings call in May 2021.
https://finance.yahoo.com/news/haemonetics-provides-u-plasma-business-100000499.html
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced it has engaged Dr. Ben Carson, Sr., a world-renowned neurosurgeon and the 17th Secretary of the U.S. Department of Housing and Urban Development, as a special consultant to assist with development of the Company’s galectin-3 inhibitor, belapectin, as a treatment for NASH cirrhosis and in combination with immunotherapy for the treatment of cancers.
The Company engaged Dr. Carson to increase awareness of Galectin Therapeutics including its ongoing Phase 2b/3 NAVIGATE clinical trial in NASH cirrhosis, its continuing research in combination with cancer immunotherapy, and its potential in addressing other fibrotic diseases. Dr. Carson will also assist in the formation of a scientific advisory committee for the Company, recruit potential members of the committee, and identify potential strategic commercial and/or academic partners for the Company.
The Company also announced that it has entered into a $10 million convertible debt financing with Richard E. Uihlein, the Company’s Chairman and largest individual stockholder. The $10 million convertible debt financing is unsecured and bears interest at a rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if the debt and interest are converted into shares of the Company’s common stock, at Mr. Uihlein’s option, on or prior to maturity, which is four years from the date of the loan. The conversion price of the debt and interest is fixed at $5.00 per share of common stock.
https://finance.yahoo.com/news/world-renowned-neurosurgeon-dr-ben-120000795.html
Rain Therapeutics, a Phase 3-ready biotech developing in-licensed therapies for cancer, announced terms for its IPO on Monday.
The Newark, CA-based company plans to raise $125 million by offering 7.4 million shares at a price range of $16 to $18. At the midpoint of the proposed range, Rain Therapeutics would command a fully diluted market value of $457 million.
Rain's lead candidate, RAIN-32, is a small molecule oral inhibitor of MDM2 in-licensed in September 2020 based on the results of a Phase 1 trial, which demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors. The company anticipates commencing a pivotal Phase 3 trial in LPS in the 2H21, a Phase 2 tumor-agnostic basket trial in certain solid tumors in the 2H21, and a Phase 2 trial in intimal sarcoma by early 2022.
Rain Therapeutics was founded in 2017 and plans to list on the Nasdaq under the symbol RAIN. Goldman Sachs, Citi, Piper Sandler, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of April 19, 2021.
GoodRx, Inc. (NASDAQ: GDRX), America’s leading resource for healthcare savings, today announced the closing of the acquisition of HealthiNation as part of the company’s continued investment in vital health information and consumer resources to help Americans navigate the complex world of healthcare. HealthiNation offers a comprehensive library of thousands of premium videos on a wide range of health topics that provide a platform for pharmaceutical manufacturers to reach targeted audiences and high-intent consumers. Through this acquisition, GoodRx furthers its commitment to delivering high-quality content and information to consumers, as well as expands its offering to pharmaceutical manufacturers.
Millions of consumers and healthcare professionals come to GoodRx every month looking for information and savings options for brand-name prescriptions. As part of its Manufacturing Solutions business, GoodRx works with manufacturers to deliver affordability solutions such as co-pay cards, patient assistance programs, and other savings options directly to consumers. In turn, GoodRx provides manufacturers with a targeted and efficient way to connect their brands with millions of high-intent consumers. With the extensive video library, editorial expertise, and resources of HealthiNation, GoodRx will be able to provide manufacturers with new ways to reach large audiences contextually relevant to their drugs.
https://finance.yahoo.com/news/goodrx-expands-manufacturer-solutions-offering-130000459.html
Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, today announced positive data from the Phase 1b portion of ZUMA-19 evaluating the efficacy and safety of lenzilumab in patients treated with CAR-T in diffuse large B-cell lymphoma (DLBCL). At the recommended Phase 2 dose of lenzilumab, the ORR was 100% and no patient experienced severe cytokine release syndrome (CRS) or severe neurotoxicity (NT).
ZUMA-19 was a clinical study designed to evaluate the efficacy and safety of lenzilumab and CAR-T (axicabtagene ciloleucel, Axi-Cel) in patients with relapsed or refractory DLBCL.
"These encouraging results from ZUMA-19 provide further proof of concept that lenzilumab may break the linkage between efficacy and toxicity (CRS and NT) widely-associated with CAR-T, and may improve durability of response," said Dale Chappell, MD, MBA, Chief Scientific Officer, Humanigen. "We believe these data warrant a larger study involving multiple CAR-T therapies."
Humanigen will initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in DLBCL. The study plans to enroll approximately 150 patients and the protocol is being submitted to FDA.
Humanigen has terminated the clinical collaboration agreement with Kite related to ZUMA-19 and both parties will collaborate to wind down current study activities.
"Humanigen is pleased to be in a position to proactively develop lenzilumab across the CAR-T landscape and further expand its pipeline," said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. "We thank Kite for their sponsorship and contribution that has allowed Humanigen to progress to this exciting point."
https://finance.yahoo.com/news/humanigen-reports-positive-data-lenzilumab-110000711.html
Ublituximab demonstrated superiority versus teriflunomide in reducing annualized relapse rates and MRI brain lesions
Ublituximab was generally well tolerated, with no unexpected safety signals
BLA submission targeted in Q3 2021
https://finance.yahoo.com/news/tg-therapeutics-announces-positive-results-113000006.html
