This week's life sciences industry news includes a Malvern firm's $6 million direct stock offering, approval of a study of a new use for a Philadelphia company's drug being developed for Parkinson's disease, a Montgomery County organization's effort to improve cancer care in Taiwan, and more.
Here's the roundup:
NRx Pharmaceuticals
The Radnor biopharmaceutical company closed a $6.28 million raise through a direct stock offering on Friday.
NRx (NASDAQ: NRXP) said it has entered into definitive agreements with undisclosed purchasers who are buying 9.67 million shares of the company's common stock at 65 cents per share. In a concurrent private placement, NRx will also issue unregistered warrants to the buyers to purchase an identical number of common stock shares, at a price of 65.25 cents per share, that will be exercisable six months following issuance for five years following the initial exercise date.
H.C. Wainwright & Co. was the exclusive placement agent for the offering.
NRx intends to use the net proceeds from the offering for working capital and general corporate purposes, and may use the net proceeds to initiate research into the use of its new drug candidate NRX-101 for the treatment of post-traumatic stress disorder and chronic pain.
Earlier this week, NRx entered into a licensing deal valued at up to $345 million for NRX-101, which is being developed initially as a treatment for treatment-resistant bipolar depression. Under the terms of the deal, Lotus Pharmaceuticals of Taiwan will acquire worldwide rights for NRX-101 for suicidal treatment-resistant bipolar depression and will be responsible for commercialization of NRX-101 in markets outside the United States. Alvogen of Morristown, New Jersey, through its central nervous system-focused Almatica division, will be responsible for the U.S. commercialization of NRX-101.
Enterin
The Philadelphia biopharmaceutical company said the Food and Drug Administration has accepted an investigator-sponsored investigational new drug application that will test Enterin's new drug candidate ENT-01 in a patient with prodromal multisystem atrophy.
Prodromal multisystem atrophy is a rare condition, similar to Parkinson's disease, that causes gradual damage to nerve cells in the brain. There is no existing treatment which halts the progression of the disease.
Dr. Robert Hauser, the treating physician for the study, is director of the Parkinson’s Disease and Movement Disorders Center of the University of South Florida.
Dr. Denise Barbut, co-founder, president and chief medical officer of Enterin, said the study marks the first time that any compound is being used to prevent the progression of multisystem atrophy and is "a milestone in the development of ENT-01 for both treatment and prevention of other neurodegenerative disorders.”
ENT-01 has been used to treat close to 200 patients with Parkinson’s disease in mid-stage clinical testing. Enterin is making preparations for a Phase 3 clinical trial.
The company has a second compound, ENT-03, that it is developing as a potential treatment of diabetes, obesity, and Alzheimer’s disease. Phase 1 clinical trials in subjects with obesity and diabetes are set to begin this month.
NCCN
The Plymouth Meeting-based National Comprehensive Cancer Network has signed a memorandum of understanding with Vietnam National Cancer Hospital and the Vietnam Cancer Association to work together to improve standards for cancer care throughout the country.
The goal of the collaboration will be to "develop and validate Vietnamese harmonizations, and subsequent translations," of NCCN guidelines, according to Dr. Robert W. Carlson, NCCN's CEO.
“We can improve outcomes and quality of life for patients with cancer throughout the country by standardizing practices and addressing language barriers," Carlson said.
NCCN currently has a library of more than 80 guidelines containing the latest evidence-based expert consensus recommendations for treating nearly every type of cancer, plus screening, prevention and supportive care. There are currently more than 250 translations of the NCCN guidelines and clinical resources across 69 languages.
Madrigal Pharmaceuticals
The Conshohocken biopharmaceutical company this week launched a new disease education campaign and website for patients called “Taking on Fatty Liver and NASH.”
NASH, an acronym for nonalcoholic steatohepatitis, is a serious metabolic disorder characterized by the accumulation of liver fat in people who drink little or no alcohol.
The TakingOnFattyLiver.com website, created by Madrigal (NASDAQ: MDGL) on the sixth International NASH Day that took place on June 8, was designed to "educate, inform, and inspire" people with at-risk NASH to find the right care team, understand their risk, and manage their liver health. The site provides information about NASH disease progression, noninvasive testing options and community resources from patient advocacy groups.
Madrigal expects to file a new drug application for its experimental NASH treatment, resmetirom, this month.
Quick Hits
Berwyn-based Annovis Bio (NYSE: ANVS) said its Phase 3 study of its lead compound buntanetap for Parkinson's disease has reached full enrollment of 520 patients nine months after it began. Results from the clinical trial are expected by the end of the year. … Orchestra BioMed (NASDAQ: OBIO) of New Hope appointed Bill Little to the newly created position of executive vice president of corporate development and strategy and Andrew Taylor as chief financial officer. Little was previously chief operating officer of Neovasc. Taylor, previously CFO of Motus GI Holdings Inc., succeeds former Orchestra CFO Michael Kaswan, who will continue as a consultant to the company during a transition period. … Ocugen (NASDAQ: OCGN) established a business advisory board to assist the Malvern biotechnology company in establishing public/private partnerships with governments around the world; pursuing business collaborations, partnerships, and licensing opportunities; and creating awareness of its capabilities. Among the members of the board are former Pennsylvania Sen. Pat Toomey and Joseph W. Westphal, the global senior fellow at the Joseph H. Lauder Institute of Management and International Studies at The Wharton School of The University of Pennsylvania and the former U.S. Ambassador to the Kingdom of Saudi Arabia.
