Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.

Counterx Therapeutics Inc. has executed an exclusive licensing agreement with the University of Minnesota and the University of Washington for a portfolio of novel monoclonal antibody and vaccine candidates targeting fentanyl and opioid overdose.

Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.

Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary objectives.

As soon as Dianthus Therapeutics Inc. disclosed its early “go” decision on claseprubart in chronic inflammatory demyelinating polyneuropathy (CIDP), Wall Street set about comparing the phase III monoclonal antibody (mAb) to other prospects in the space, with particular focus on Sanofi SA’s riliprubart (SAR-455088).

Shortly after Amgen Inc. walked away from its partnership with Kyowa Kirin Co. Ltd., the Tokyo-based company said it is discontinuing all ongoing clinical trials for rocatinlimab due to safety concerns.

Boehringer Ingelheim GmbH is stopping development of OSE Immunotherapeutics SA’s BI-770371 in metabolic dysfunction-associated steatohepatitis (MASH), after the SIRPα antagonist failed to show efficacy in a phase II study. Codevelopment of BI-770371 will continue for oncology indications, however, which was the initial target of the duo’s €1.4 billion (US$1.6 million) partnership in 2018.

Generate Biomedicines Inc. proved that enthusiasm hasn’t waned for TSLP as a target by pricing an IPO selling 25 million shares at $16 each for proceeds of $400 million. Generate’s lead compound is phase III-stage TSLP-targeting antibody GB-0895 and the company’s assigned Nasdaq ticker is GENB. The offering is expected to close on March 2.

Slate Medicines Inc. has launched with $130 million in series A financing and a focus on advancing next-generation therapeutics for migraine and other headache disorders.

Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the brain and the central nervous system, has opened up new targeting possibilities, and Vesalic is now working on in vivo studies to demonstrate preclinical proof of concept.