Enanta Pharmaceuticals Inc. hit the mark that Wall Street hoped for, and details rolled out in top-line results from the first-in-pediatrics phase II study evaluating once-daily, oral zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
Voyager Therapeutics Inc.’s recent selection of a lead development candidate, VY-1706, for its tau silencing gene therapy program in Alzheimer’s disease brought renewed attention to the target, which continues to intrigue a substantial lineup of developers. Bellwether data rolled out this fall from UCB SA and Roche AG at the Clinical Trials in Alzheimer’s Disease meeting in Madrid.
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
Although head-to-head results on tolerability were missing from the company’s data release, Eli Lilly and Co. said its U.S. FDA-approved weight-loss drug Zepbound (tirzepatide) beat the also-cleared Novo Nordic A/S compound Wegovy (semaglutide) in a phase IIIb study comparing the two.
Janux Therapeutics Inc. CEO David Campbell said the firm will be talking with the U.S. FDA about “what we may or may not be able to do [in order to get JANX-007] to patients more rapidly,” though he noted that the agency has “primarily been focused on overall survival” in considering prostate cancer drugs, so more work on that endpoint may be required. “We’ll keep that in mind,” he said.
PTC Therapeutics Inc. said a “highly competitive process with several parties involved” led to the deal centered on the firm’s Huntington’s disease program with Novartis AG, an arrangement that brings $1 billion up front along with as much as $1.9 billion in development, regulatory, and sales milestone rewards.
Outlook Therapeutics Inc. is forging onward with plans to resubmit the BLA for ONS-5010, an ophthalmic version of Avastin (bevacizumab, Roche AG), after a missed endpoint in phase III with the VEGF binder for wet age-related macular degeneration (AMD).
Wall Street began comparing and contrasting what’s available after Amgen Inc. rolled out phase II data with weight loss candidate Maritide – a disclosure that led shares of the biotech heavyweight (NASDAQ:AMGN) to close Nov. 26 at $280.01, down $13.99.
The Alzheimer’s disease (AD) space took another blow along with the shares of Cassava Sciences Inc. (NASDAQ:SAVA), which plummeted by 83.8%, or $22.19, to end Nov. 25 at $4.30 after the firm unveiled top-line data from the phase III Rethink-Alz study with simufilam. The study tested simufilam in mild to moderate AD, where results fell short of each of the prespecified co-primary, secondary and exploratory biomarker endpoints.
President-elect Donald Trump’s nomination of Robert F. Kennedy Jr. as U.S. Secretary of Health and Human Services (HHS) grabbed headlines globally, but the political jostling to come will determine whether Kennedy can secure the seat.
