Shares of Cincor Pharma Inc. (NASDAQ:CINC) were trading midday at $13.84, down 47.8% after the company disclosed top-line results from its completed phase II Halo trial testing the aldosterone synthase inhibitor baxdrostat in uncontrolled hypertension. Halo enrolled patients taking as many as two blood pressure medications at the maximally tolerated doses without satisfactory results. The study fell short of statistical significance on its primary endpoint evaluating change from baseline in mean seated systolic blood pressure in the intent-to-treat population, which included 249 trial participants.

Axsome strengthens with more positive Alzheimer’s data

Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating Alzheimer’s disease (AD) compared to placebo. The newly released data showed AXS-05 statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint. In a key secondary endpoint, it also statistically significantly prevented AD agitation relapse vs. placebo (p=0.018). In mid-August, ASX-05 became Auvelity when it received U.S. FDA approval to become the first new oral mechanism of action in the past 60 years for treating major depressive disorder. Axsome stock (NASDAQ:AXSM) surged by midday, with shares up 30% to about $74 each.

Countdown begins for US track-and-trace requirements

With only a year to go before 100% compliance with the U.S. Drug Supply Chain Security Act’s (DSCSA) serialization provisions will be required from the beginning to the end of the drug supply chain, most biopharma manufacturers are pretty confident they’re ready for the Nov. 27, 2023, deadline. But distributors? Not so much. And they lay the blame at the manufacturers’ feet.

C4X out-licenses preclinical NRF2 activator to Astrazeneca

C4X Discovery Holdings plc has outlicensed its once daily oral NRF2 (Nuclear factor-erythroid factor 2-related factor 2) activator to Astrazeneca plc in a deal with a potential value of $402 million. Of that, $2 million is being paid up front, with a further $14 million in preclinical milestones, which C4X CEO Clive Dix expects to trigger within the next two years.

Affirming advisers, FDA rejects Spectrum lung cancer drug with CRL

Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval. The company had sought approval to market the drug for the treatment of patients with previously treated locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations. The CRL was anticipated after a September 2022 meeting of the U.S. FDA's Oncologic Drugs Advisory Committee in which only four of 13 voting members agreed the drug showed a favorable benefit-risk profile as a second-line treatment for the indication.

Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issues were published Thursday, Nov. 24, or Friday, Nov. 25.

Also in the news

Abbvie, Allero, Alytas, Ascletis, Biomarin, Blueprint, Bright Minds, Bristol Myers Squibb, DRI Healthcare, Enveric, Escient, Farma Mondo, Gilead, Grünenthal, Hemispherian, Horizon, Hyloris, Ikena, Janssen, Kyowa Kirin, Lyvgen, Mesoblast, Newamsterdam, Novartis, Opiant, Pacylex, Sintalica, Sirona, Storm, Strand, Takeda, TC, Tevogen, UCB, Uniqure, Vaccinex, Wanbang, Xeris