The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot.
New conditioning agents for hematopoietic stem cell transplant (HSCT) are in the works at a handful of companies, with Jasper Therapeutics Inc. ushering through the pipeline a candidate viewed by some on Wall Street as especially promising.
Pfizer Inc. scored a $5.29 billion deal with the U.S. government to provide 10 million courses of the company’s oral antiviral candidate Paxlovid (PF-07321332; ritonavir) for COVID-19, as Astrazeneca plc and Novavax Inc. also generated news in the space. Paxlovid, if approved or authorized, would be the first oral antiviral of its kind: a 3CL protease inhibitor specifically designed to combat SARS-CoV-2. New York-based Pfizer is seeking emergency use authorization (EUA) from the FDA. Rolling submissions have also commenced in several other countries, and the company continues to build its case for regulatory agencies around the world.
Kezar Life Sciences Inc. shares (NASDAQ:KZR) rose 37%, or $3.18, to close Nov. 16 at $11.59 on interim results from the phase II part of the study called Mission, testing KZR-616, a first-in-class selective immunoproteasome inhibitor, in patients with active, proliferative lupus nephritis (LN).
Recludix Pharma Inc. launched with a $60 million series A round to target Src homology 2 (SH2) domains, and the new money will get the San Diego-based firm to reach the IND-enabling stage, CEO Nancy Whiting told BioWorld.
Oncorus Inc. offered initial safety, tolerability and immune activation and clinical response data from its ongoing phase I trial with ONCR-177 at the Society for Immunotherapy of Cancer (SITC) meeting. In the fully enrolled and completed surface lesion, dose-escalation part of the study, single-agent ONCR-177, an oncolytic herpes simplex virus for intratumoral injection, proved well-tolerated with no dose-limiting toxicities.
Vaxxinity Inc. priced its IPO below the targeted range, selling 6 million shares (NASDAQ:VAXX) at $13 each for proceeds of $78 million, but came out of the gate impressively, closing at $16.55, up $3.55, or 27%, after reaching $22.77 during the day.
Yumanity Therapeutics Inc. CEO Richard Peters said his firm is “in the driver’s seat” with regard to partnering options or going it alone, after YTX-7739 hit the primary endpoints in a phase Ib Parkinson’s disease (PD) study. Wall Street seemed less than certain about the success, knocking shares (NASDAQ: YMTX) down $2.83, or 33.4%, to close at $5.65.
Compass Pathways plc rolled out favorable top-line findings from the largest randomized, controlled, double-blind psilocybin therapy study ever completed, showing that COMP-360 at 25 mg yielded a highly statistically significant and clinically relevant reduction in symptom severity after three weeks in patients with treatment-resistant depression (TRD)
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Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other.
