The FDA approves Immunomedics’ (IMMU +1.2%) Trodelvy (sacituzumab govitecan) for the treatment of triple-negative breast cancer patients who have received at least two prior lines of therapy.
The agency’s nod is early. Its action date was June 2.
The approval is a big win for the company. It received a CRL over a year ago in response to its first filing.
Nasdaq has not yet posted a time for the resumption of trading.
Management will host a conference call today at 5:00 pm ET to discuss the approval.
Germany’s Paul-Ehrlich Institut has signed off on a Phase 1/2 clinical trial evaluating BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine program, BNT192, for the prevention of the respiratory infection, the first such study there.
The dose escalation portion will enroll ~200 subjects aimed at determining the optimal dose for further studies and assessing initial safety and immunogenicity. The trial will also evaluate the effects of repeat immunization for three of the four vaccine candidates that use uRNA or modRNA. Patients with higher risk of developing severe COVID-19 infection will be included in the second part.
A U.S.-based trial should launch shortly.
Pfizer (NYSE:PFE) is the company’s development partner.
BNTX will host a conference call tomorrow, April 23, at 8:00 am ET to discuss the study.
BNTX is up 50% premarket and PFE is up 6%, both on modest volume.
“Some of these companies, I tell you, this is ethically very questionable to get out with this stuff,” Roche (OTCQX:RHHBY) CEO Schwan told reporters after scrutinizing some existing products.
“It’s a disaster. These tests are not worth anything, or have very little use,” he added.
Roche plans to offer its own blood tests by early May to identify those who had been infected with the coronavirus and plans by June to boost production to “high double-digit millions” per month.
Nano cap Neon Therapeutics (NASDAQ:NTGN) jumps 32% premarket on increased volume in concert with planned acquirer BioNTech (NASDAQ:BNTX) which is up 33% premarket on the heels of the expected start of a clinical trial in Germany for its COVID-19 vaccines candidates..
Under the terms of the merger, expected to close this quarter, NTGN shareholders will receive 0.063 of a BNTX ADS, each whole ADS representing one BNTX ordinary share, for each NTGN common share owned.
Neon’s top candidate is a neoantigen T cell therapy called NEO-PTC-01, in preclinical development for second-line melanoma, second-line ovarian cancer, RAS-positive pancreatic cancer and other undisclosed solid tumors.
Mallinckrodt (NYSE:MNK) is up 8% premarket on light volume in reaction to its announcement that the FDA has accepted for review its marketing application seeking approval to use terlipressin to treat hepatorenal syndrome type 1 (HRS-1), a type of progressive kidney failure in people with severe liver damage, most commonly by cirrhosis.
The agency’s action date is September 12.
Terlipressin is an analogue of vasopressin which is used to treat low blood pressure.
