Biotech Rally Powers Through After-Hours Session: FDA Green Light and Pipeline Progress Drive Multiple Stock Gainers

The biotechnology and healthcare sector demonstrated strong momentum during Monday’s extended trading session, with pharmaceutical and medical device companies recording impressive advances across the board. Market participants showed particular enthusiasm for companies with recent regulatory wins and clinical milestone announcements.

FDA Approval Catalyzes Novo Nordisk’s Significant Surge

Novo Nordisk A/S (NVO) led the sector’s gains, advancing 9.48% in after-hours trading to reach $52.66—a jump of $4.56 from earlier levels. The Danish pharmaceutical giant’s rally centered on a landmark regulatory achievement: the U.S. Food and Drug Administration’s approval of Wegovy as an oral once-daily formulation, marking the first GLP-1 medicine in pill form approved for obesity management in the American market.

The newly approved treatment represents a significant therapeutic development. Wegovy oral is designated for adults with obesity or those carrying excess weight combined with obesity-related medical conditions, to be used in conjunction with calorie-restricted dietary protocols and enhanced physical activity regimens. The approval extends beyond weight management, encompassing cardiovascular protection—the medication is now cleared to mitigate the risk of major adverse cardiac events, including myocardial infarction, cerebrovascular accidents, and mortality, in obese or overweight patients with documented cardiovascular disease.

Clinical Pipeline Progress Fuels Investor Interest

IDEAYA Biosciences, Inc. (IDYA) registered a 6.49% gain to $37.81 following completion of patient enrollment in its pivotal Phase 2/3 OptimUM-02 trial. The study evaluates darovasertib combined with crizotinib (a Pfizer treatment) as therapy for metastatic uveal melanoma. Management guidance indicates progression-free survival readout is anticipated during the first quarter of 2026, potentially supporting an expedited regulatory pathway.

BioRestorative Therapies, Inc. (BRTX) climbed 6.90% to $1.24, building upon November momentum when the company disclosed FDA designation of a Type B meeting to evaluate an accelerated Biologics License Application strategy for BRTX-100. The investigational therapy targets chronic lumbar disc disease, with the regulatory consultation scheduled for mid-December—a procedural triangle instrument in advancing specialized treatments through the approval process.

RenovoRx, Inc. (RNXT) posted a 4.44% advance to $0.94 following the earlier disclosure that its abstract submission to the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium 2026 achieved acceptance. The company will present Phase III trial findings from its TIGeR-PaC program during January proceedings.

Sector Momentum and Speculative Interest

Neumora Therapeutics, Inc. (NMRA) demonstrated the session’s most pronounced advance among featured names, surging 16.02% to $2.10 for a $0.29 per-share gain. The absence of company-specific announcements suggests the move reflects broader sector enthusiasm and speculative positioning favoring the biotech complex.

Healthcare Triangle, Inc. (HCTI) advanced 6.72% to $1.43, capitalizing on its December 10 announcement regarding an Advance Agreement with Teyame AI LLC as a precursor to acquiring Spain-headquartered AI-enhanced customer experience platforms Teyame 360 SL and Datono Mediacion SL. The transaction aims to position Healthcare Triangle as a prominent provider of artificial intelligence-driven patient and customer engagement infrastructure globally.

Alphatec Holdings, Inc. (ATEC), a provider of spine surgery technology platforms, recorded more modest after-hours appreciation of 2.80%, settling at $21.28. The company released no updates during the session but continues benefiting from sustained investor confidence in its surgical device portfolio.

The coordinated strength across the biotech and healthcare segment underscores investor appetite for companies advancing novel therapeutics, securing regulatory clearances, and expanding technological capabilities in artificial intelligence-enabled healthcare delivery.

(This report represents current market observations and does not necessarily reflect the opinions of any official exchange or regulatory body.)