Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up by more than 200% and provided supportive data for an NDA filing planned for early 2026. The company’s president and CEO, Marcio Souza, said more than 200,000 people wanted to participate in the Essential3 program, which enrolled 473 patients in Study 1 and 238 patients in Study 2, reflecting the large unmet need for a disruptive condition that current therapies are unable to control. In Study 1, ulixacaltamide hit the primary endpoint, with patients treated showing a mean improvement of 4.3 points from baseline in the Modified Activities of Daily Living 11 at week eight. Treated patients also showed a statistically significant superior maintenance of effect over placebo during the randomized-withdrawal phase, the Study 2 primary endpoint, and the small-molecule inhibitor of T-type calcium channels hit numerous secondary endpoints and was well-tolerated. Praxis shares (NASDAQ:PRAX), which reached their 52-week high of $205.89 on Oct. 16, were trading midday at $179.47.

Leads Biolabs joins a $1B development deal with Dianthus

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co., Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor for treating autoimmune disorders. The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties. Dianthus gets the exclusive development and commercialization rights outside of greater China. Dianthus stock (NASDAQ:DNTH) popped about 10% upward before the market opened but had settled to a more modest 1% gain at midday, with shares about $36 each.

Aimedbio’s solid tumor ADC asset goes to Boehringer in $1B deal

Antibody-drug conjugate (ADC) specialist Aimedbio Inc. announced Oct. 16 the signing of a potential $991 million deal with Boehringer Ingelheim GmbH to license out its novel preclinical ADC asset targeting solid tumors, including KRAS mutations, which is set to enter phase I study next year. Specific financial terms, including those on milestone payments, were not disclosed. The $991 million was inclusive of an up-front payment, development, regulatory and commercial milestones, along with separate royalty payments on net sales. The near $1 billion deal sheet is expected to be a boost for the privately held biotech, which has been preparing for a Kosdaq listing by the end of 2025.

Adcytherix raises $122M series A to develop novel ADCs

A year and half from its inception, Adcytherix SAS has raised a €105 million (US$122 million) series A, enabling it to take the lead antibody-drug conjugate (ADC) program into clinical development next year. Applications to conduct a trial of ADCX-020 will be filed before the end of 2025, with the first patient expected to be treated in Australia in 2026. To date, Adcytherix has disclosed few details of its technology, but the company says its aim is to expand the reach of ADCs to tumors that currently are unresponsive, or respond poorly to this form of therapy, and to overcome resistance mechanisms that occur with current payloads.

Aicuris to file pritelivir NDA after positive phase III data in herpes infections

Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients. The phase III met the primary endpoint of superiority in complete lesion healing rate compared to standard of care, after treatment for up to 28 days. Statistical superiority was further increased when patients in the trial who had not responded, or had partially responded at 28 days, were dosed for a further two weeks.

ECNP 2025: Endocannabinoids have metabolic role in mental health

In the U.S., cannabis is currently a Schedule I substance under the Controlled Substances Act, meaning that in the eyes of the government, it has a high potential for abuse and no current accepted medical use. However, both parts of that classification look set to change. President Trump has hinted he will reclassify cannabis as a Schedule III substance, which would mean it has a moderate to low potential for dependence. And researchers are gaining insights into the endocannabinoid system – the receptors that are responsible for cannabis’ effects – that could ultimately lead to their pharmaceutical targeting.

USPTO proposes limits on administrative patent challenges

The U.S. Patent and Trademark Office has proposed to apply limits on the use of administrative challenges to patents when the patent in dispute is already the subject of litigation in district court proceedings. While this proposal would force would-be litigants to choose one venue rather than challenge a patent in parallel proceedings, this change may reduce the time and cost of patent litigation, a change that many in the life sciences might see as an improvement over the current hyper-litigious environment.

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