Shares of Viking Therapeutics Inc. (NASDAQ:VKTX) were trading midday at $67.35, up $28.87, or 75%, as Wall Street greeted top-line results from the phase II study called Venture with VK-2735, a dual agonist of the glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide receptors in development for metabolic disorders including obesity. The study hit the primary and all secondary endpoints. VK-2735 yielded significant body weight reductions at all doses compared to placebo, San Diego-based Viking said.

Janux surges on strong efficacy, safety for its T-cell engagers

Strong early data of Janux Therapeutics Inc.’s tumor-activated T-cell engager (TRACTr) compounds JANX-007 and JANX-008 sent the San Diego-based company’s shares soaring by 210%, indicating enthusiasm for their best-in-class potential and the possibility of tapping into multibillion-dollar prostate cancer and solid tumor markets. T-cell engagers are “clearly an exciting class of compounds,” said Janux President and CEO David Campbell, who presented the data in a webcast after market close on Feb. 26. Phase Ia data of JANX-007 showed that 83% of patients (5/6) with late-stage metastatic castration-resistant prostate cancer achieved PSA50, a decline of 50% in prostate specific antigen (PSA) levels, with the first step dose of at least 0.2 mg, while 56% (10/18) achieved PSA50 declines with a first dose of at least 0.1 mg. There were no cytokine release syndrome events greater than grade 2 in any cohort. JANX-008 showed similar signs of efficacy and safety in a phase Ia trial, specifically in a non-small-cell lung cancer patient and a renal cell carcinoma patient. Shares (NASDAQ:JANX) were trading midday Feb. 27 at $46.77, up $31.67.

Curve adds £40.5M series A for small-molecule oncology work

Curve Therapeutics Ltd. has raised £40.5 million (US$51.2 million) in a series A round to take two lead programs toward the clinic over the next three years. Since its formation in 2019, Curve has applied its Microcycle intracellular screening platform to discover a pipeline of small molecules against oncology targets that have evaded conventional approaches. The lead assets generated by the technology are both first in class: a dual inhibitor of hypoxia-inducible factors 1 and 2 that the company says will block survival mechanisms in more than half of solid tumors; and an inhibitor of ATIC dimerization that is designed to prevent the homodimer from catalyzing de novo purine biosynthesis.

FDA unconvinced, issues CRL for Minerva’s schizophrenia drug

In the end, Minerva Neurosciences Inc.’s NDA submission wasn’t able to overcome the U.S. FDA’s concerns regarding data for dual 5-HT2A/sigma 2 antagonist roluperidone. The agency issued a complete response letter (CRL) for the application, which had been seeking approval as the first treatment specifically targeting negative symptoms of schizophrenia. Shares of Minerva (NASDAQ:NERV) were trading down 60% at midday.

BIO CEO 2024: Policy impact on election year will linger

The Inflation Reduction Act and drug pricing are playing outsized roles in the dynamics of the November election, creating turbulence for drug companies and for patients that will extend years after the votes are counted. During a Tuesday morning session on drug pricing trends during an election year at the BIO CEO & Investor Conference in New York, key opinion leaders spoke about their concerns, including tighter formularies as fewer drugs are covered by insurance, the powerful impact of the Inflation Reduction Act and the need to explain drug-pricing rationale to voters and patients in plain terms.

Baseimmune raises $11.3M to advance mutation-resistant vaccines

Baseimmune Ltd. has raised $11.3 million through a series A to accelerate the development of its deep learning AI technology for predicting future pathogen mutations to generate a series of longer-lasting, multistrain vaccines. The financing was co-led by new investors MSD Global Health Innovation Fund and IQ Capital, as well as existing investors, including Hoxton Ventures, Creator Fund, Beast Ventures and Maki.vc. In addition to further advancing its technology, the London-based company plans to use the capital to expand its team, boost the number of programs in development – it currently has two human vaccines in preclinical stages – and create new vaccine programs.

Allecra’s Exblifep crosses finish line first with FDA nod in UTIs

Allecra Therapeutics GmbH secured U.S. FDA approval for its beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, Exblifep (cefepime/enmetazobactam), in complicated urinary tract infections, including pyelonephritis, in patients 18 years and older, the news coming only days after a potentially competing BL/BLI combo from Venatorx Pharmaceuticals Inc. earned a complete response letter from the agency.

Global radiopharma market poised to top $13B over next decade

Global interest in radiopharmaceuticals is soaring, and the global radiopharma market is expected to grow 10% over the next decade to $13.67 billion by 2032, according to a new report by Precedence Research. The global radiopharma industry was estimated to be worth $5 billion in 2017. North America holds most of the market at roughly 44%, and Asia is expected to grow the fastest over the next decade.

PBM study, reforms languishing despite prioritization

More than a year and a half after the U.S. FTC launched its investigation into how pharmacy benefit manager (PBM) practices and consolidation impact patients’ ability to access and afford their prescription drugs, the six biggest PBMs in the country have yet to fully comply with the agency’s June 2022 order to provide data and documents pertaining to certain business practices. Recognizing the urgency of completing the study, FTC Lina Khan said the commission can take the PBMs to court, if necessary, to compel compliance. Meanwhile, patience is wearing thin among U.S. lawmakers who have pushed several PBM reforms through congressional committees only to have them languish with no floor vote.

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