Today's top gainers include Tango Therapeutics, following encouraging pancreatic cancer trial data; Aspire Biopharma, ahead of upcoming milestones; Alvotech, after FDA acceptance of its interchangeable biosimilar to Entyvio for review; and Zevra Therapeutics, on actions strengthening exclusivity for MIPLYFFA, among others.
Read on…
Tango Puts Its Best Foot Forward
Tango Therapeutics Inc. (TNGX) led the pack of gainers on Monday, with shares jumping more than 50%, following positive initial data from its ongoing Phase 1/2 combination study of Vopimetostat in pancreatic cancer.
The phase 1/2 trial is a combination study of Vopimetostat with RAS(ON) multi-selective inhibitor Daraxonrasib or RAS(ON) G12D-selective inhibitor Zoldonrasib (both investigational drugs from Revolution Medicines, RVMD), in patients with previously treated, MTAP-deleted, RAS-mutant pancreatic and lung cancer.
According to the initial results, patients with second and third-line pancreatic ductal adenocarcinoma (PDAC) treated with Vopimetostat and Daraxonrasib showed a 6-month progression-free survival (PFS) rate of 90% (median PFS not yet reached), suggesting durability of clinical benefit.
Based on the encouraging data, Tango intends to rapidly advance the combination of Vopimetostat and Daraxonrasib into Phase 3 development for patients with MTAP-deleted pancreatic cancer.
TNGX closed Monday's trading at $30.93, up 52.97%.
Aspire To File NDA by Year-end
Aspire Biopharma Holdings Inc. (ASBP), a biopharmaceutical company developing multi-faceted patent-pending drug delivery technology, soared more than 24% on no specific news.
The company remains on track to file its New Drug Application (NDA) for its lead candidate, a high-dose sublingual aspirin, via the 505(b)(2) pathway by the end of 2026.
In April of this year, Aspire announced a binding letter of intent to acquire 100% of Dura Driver Control Systems (DCS) for $30 million in cash. DCS reported revenue of over $200 million and Adjusted EBITDA (unaudited) of more than $22 million in 2025.
A one-for-thirty (1:30) reverse stock split was implemented by Aspire on May 11, 2026, to regain compliance with Nasdaq's minimum bid price requirement.
ASBP closed Monday's trading at $6.65, up 24.53%.
Alvotech Takes AVT16 One Step Closer to FDA Approval
Alvotech's (ALVO) Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio lyophilized vial for intravenous administration, has been accepted for review by the FDA.
Entyvio, developed by Takeda, is an integrin receptor antagonist used to treat Crohn's disease and ulcerative colitis, and is approved for intravenous (IV) and subcutaneous (SC).
AVT16 is being developed under a strategic partnership between Alvotech and Teva, with Alvotech overseeing development and manufacturing and Teva responsible for commercialization.
ALVO closed Monday's trading at $4.24, up 19.77%.
Incannex On Watch
Incannex Healthcare Inc. (IXHL) was also one of the top gainers on Monday, with shares rising more than 16%.
The company is developing combination medicines for chronic conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. Its pipeline includes three clinical-stage product candidates IHL-42X, IHL-675A, and PSX-001.
Last month, the company launched DReAMzz clinical study evaluating IHL-42X for the treatment of obstructive sleep apnea (OSA). The DReAMzz study is designed as a crossover dose optimization study intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase 3 development program.
IHL-675A, under development to alleviate inflammatory conditions, such as rheumatoid arthritis, is under a phase 2 program.
PSX-001, cleared for Phase 2 clinical development, is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder.
IXHL closed Monday's trading at $3.40, up 16.44%.
Zevra Rises on Orange Book Listing for MIPLYFFA
Zevra Therapeutics Inc. (ZVRA) jumped more than 13% on Monday, following the Orange Book Listing of a U.S. patent, strengthening exclusivity for MIPLYFFA. The patent expires on November 19, 2041.
MIPLYFFA is an orally delivered treatment for Niemann-Pick disease type C, an ultra-rare, progressive, and neurodegenerative disorder.
The Orange Book lists patents and regulatory exclusivities associated with brand-name drugs, which dictates when generic competitors can legally enter the market.
A patent term extension application for another patent related to MIPLYFFA remains under review by the U.S. Patent and Trademark Office, and if granted, could extend protection beyond its current 2029 expiry date.
MIPLYFFA generated net revenue of $87.4 million for full-year 2025, up from $10.1 million in 2024.
ZVRA closed Monday's trading at $12.09, up 13.95%.
Oscar In Good Health
Oscar Health Inc. (OSCR), which touched a new 52-week high on Monday, closed the day's trading - gaining more than 11%.
This healthcare technology company offers health plans through the Affordable Care Act (ACA), serving individuals, families, and employees.
Last month, the company announced strong first-quarter results, highlighted by significant year-over-year improvements across its core metrics, reaffirmed its full-year guidance, and reiterated its expectation of meaningful margin expansion and profitability in 2026.
OSCR closed Monday's trading at $27.39, up 11.75%.
IDEAYA Turns Heads on Wall Street
Shares of IDEAYA Biosciences Inc. (IDYA), a precision medicine oncology company, gained more than 11% on Monday.
The company's New Drug Application (NDA) for Darovasertib in combination with Crizotinib for patients with first-line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) is being reviewed under the Oncology Center of Excellence Real-time Oncology Review (RTOR) program.
The Real-time Oncology Review (RTOR) program allows applicants to submit portions of an NDA before the complete application is filed, allowing the FDA to begin reviewing clinical data earlier and potentially accelerate access to safe and effective treatments for patients.
IDEAYA completed its first pre-submission under the RTOR program this May and expects to complete the NDA filing in the second half of 2026.
After the bell, the company announced a public offering to raise up to $300 million through the sale of common stock and pre-funded warrants, with underwriters having the option to purchase an additional $45 million of common stock.
IDYA closed Monday's trading at $31.48, up 11.28%.
Calendar Marked for FDA Pre-IND Meeting
NewcelX Ltd. (NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, was one of the top gainers on Monday, with shares registering over a 10% gain.
Last month, the company announced a Pre-Investigational New Drug briefing package to the FDA to support the proposed First-In-Human clinical trial of NCEL-101 in combination with tegoprubart, an investigational immunomodulatory agent being developed by Eledon Pharmaceuticals (ELDN).
A Type B pre-IND meeting has been scheduled with the FDA for the last week of June. NewcelX plans to discuss NCEL-101 manufacturing, the preclinical (safety/toxicology study) development plan and FIH clinical trial design.
NCEL closed Monday's trading at $3.24, up 10.58%.
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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.