LONDON (dpa-AFX) - The biotech sector continues to deliver headline-grabbing moves, with stocks surging to fresh highs and companies advancing pivotal trials, regulatory filings, and strategic offerings. For investors, the pace of innovation and volatility underscores Warren Buffett's timeless reminder: 'Price is what you pay. Value is what you get.' In a market where breakthroughs can rapidly transform valuations, discerning the difference between short-term price action and long-term value has never been more critical.
Several biotech stocks surged to fresh 52-week highs yesterday. Are any of these names already in your portfolio, on your watchlist, or poised for near-term catalysts that could sustain their momentum? Let's take a closer look.
Olema Pharmaceuticals Inc. (OLMA)
OLMA was featured on our site on September 17, 2025, when it was trading at $7.89. The stock touched a 52-week high of $27.17 during intraday trading yesterday.
The company announced its plans to commence a public offering, subject to market and other conditions, to issue and sell shares of its common stock, or for certain investors that so choose, in lieu of shares of common stock, pre-funded warrants to purchase shares of its common stock. All of the securities are being offered by Olema.
In connection with the proposed offering, Olema expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock Olema is offering plus the shares of common stock underlying the pre-funded warrants. TD Cowen is acting as book-running manager for the proposed offering.
Owlet Inc. (OWLT)
When we profiled OWLT on May 12, 2025, it was trading at $4.72. The stock touched a 52-week high of $12.44 during intraday trading yesterday.
As recently as on November 13, the company reported Q3 revenue of $32.0 million versus $22.1 million, an increase of 44.6%, primarily due to higher sales of Dream Sock and Dream Duo products. Net income was $4.1 million for the third quarter of 2025, compared to net loss of $5.6 million incurred a year ago.
Updated FY25 Outlook
For the full year 2025, the company now expect revenue in the range of $103 million - $106 million, or 32% - 36% growth year-over-year, gross margins in the range of 48% - 50% including the impact of new, increased tariff costs, and adjusted EBITDA of $1.25 million - $2 million.
Rigel Pharmaceuticals Inc. (RIGL)
RIGL was featured on our site on May 7, 2025, when it was trading at around $22.55. The stock touched a 52-week high of $46.31 during intraday trading yesterday.
Rigel Pharma announced a peer-reviewed publication in the Journal of Hematology & Oncology of the final five-year data from the pivotal cohort of the Phase 2 registrational trial evaluating REZLIDHIA (olutasidenib) for the treatment of patients with relapsed or refractory (R/R) mutant isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). REZLIDHIA is a potent, selective, oral, small-molecule inhibitor of mIDH11 that is approved for the treatment of R/R mIDH1 AML.
The publication reports the final follow-up analysis of the registrational Phase 2 trial, with an additional two years of efficacy and safety data. These five-year data further support the durable responses and manageable safety profile observed with olutasidenib in patients with R/R mIDH1 AML, including those R/R to prior venetoclax. The safety profile remained consistent with what was previously reported, with no new safety signals identified.
Jazz Pharmaceuticals plc (JAZZ)
When we alerted readers to JAZZ on June 19, 2024, it was trading around $108.39. The stock hit a 52-week high of $182.99 during intraday trading yesterday.
Most recently, the company announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra (tislelizumab), as first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction, and esophagus.
The company has planned to quickly engage the FDA and expects to submit a supplemental Biologics License Application (sBLA) in the U.S. for this indication in the first half of 2026.
This global biopharma company will participate in Citi's 2025 Global Healthcare Conference. The company's management will participate in a fireside chat on Tuesday, December 2, 2025, at 6:45 a.m. PST / 9:45 a.m. EST / 2:45 p.m. GMT.
Terns Pharmaceuticals Inc. (TERN)
We featured TERN on our site on August 6, 2025, when it was trading around $5.98. The stock touched an all-time high of 27.58 during intraday trading yesterday.
This clinical-stage oncology company recently announced that an abstract with updated data from the ongoing Phase 1 CARDINAL trial evaluating TERN-701 in patients with relapsed/refractory CML had been selected for oral presentation at the 67th ASH Annual Meeting and Exposition. The abstract reported data from the ongoing dose escalation and dose expansion parts of the CARDINAL trial.
Preclinical studies suggest that TERN-501, an oral thyroid hormone receptor-beta (THR-ß) agonist, offers a complementary mechanism to GLP-1, with the potential to deliver broader metabolic and liver benefits alongside enhanced weight loss. Terns is actively seeking a strategic partner to advance this program.
In the third quarter of 2025, Terns nominated TERN-801, an oral small-molecule GIPR antagonist as a development candidate from the TERN-800 series discovery effort. The company is also seeking a strategic partner to advance this program.
Madrigal Pharmaceuticals Inc. (MDGL)
When we alerted readers to MDGL on March 12, 2024, it was trading around $268.00. The stock touched an all-time high of $577.90 during intraday trading yesterday.
On November 10, the company announced positive two-year data from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial, evaluating the use of Rezdiffra in an advanced, difficult-to-treat patient population with no approved therapies. The F4c data, and multiple additional Rezdiffra abstracts from the Phase 3 MAESTRO program, were presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, taking place from November 7-11, 2025, in Washington, D.C.
Liquidia Corp. (LQDA)
We profiled LQDA on October 17, 2025, when it was trading around $22.59. LQDA hit an all-time high of $30.88 on November 18, 2025.
Earlier this month, this biopharmaceutical company reported a Q3 net loss of $3.5 million or $0.04 per share narrower than the prior year's loss of $31.0 million or $0.40 per share in the prior year quarter. Product sales, net, were $51.7 million, while Service revenue, net, was $2.7 million for the three months ended September 30, 2025.
Arcutis Biotherapeutics Inc. (ARQT)
We alerted this biopharmaceutical company to our readers on January 13, 2025, when it was trading around $14.99. The stock reached a new 52-week high of $27.84 during the intra-day session yesterday.
Arcutis announced the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.3%, a once-daily, advanced targeted topical phosphodiesterase-4 (PDE4) inhibitor, to expand the indication for the topical treatment of plaque psoriasis to include children 2 to 5 years old. The FDA has set a PDUFA target action date of June 29, 2026, for this application.
Insmed Inc. (INSM)
We alerted our subscribers to INSM when it was trading around $76.54 on July 21, 2024. The stock reached an all-time high of $203.65 during intraday trading yesterday.
November 18, Insmed announced that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. BRINSUPRI is a first-in-class therapy, offering the first and only approved treatment indicated for NCFB in the European Union (EU). BRINSUPRI was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health.
Insmed will engage with authorities across the EU to secure access to BRINSUPRI for eligible patients beginning in early 2026. Applications for brensocatib are currently under review with the Medicines and Healthcare products Regulatory Agency in the U.K. and the Pharmaceuticals and Medical Devices Agency in Japan.
Zenas BioPharma Inc. (ZBIO)
Our alert on ZBIO was published on December 17, 2024, when it was trading around $8.79. The stock rose to an all-time high of $37.89 during intraday trading yesterday.
The company has planned to report topline data from the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD around year-end 2025. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date.
Recently, the company announced highly positive results from the Phase 2 MoonStone trial of obexelimab in RMS. Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo (p=0.0009). The safety profile of obexelimab was consistent with that observed in prior completed trials, including cases of infections and hypersensitivity, most commonly mild injection site reactions. Zenas expects to report 24-week data from the MoonStone trial in the first quarter of 2026.
Zenas also announced that a Phase 3, global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orelabrutinib in patients with Secondary Progressive Multiple Sclerosis or SPMS is expected to initiate in the first quarter of 2026.
Tarsus Pharmaceuticals Inc. (TARS)
The stock TARS was featured on our site on November 3, 2025, when it was trading at around $68.76. TARS hit an all-time high of $78.76 in the intraday session yesterday.
Tarsus continues to execute on its category-creation strategy, advancing a robust pipeline designed to establish new treatment categories, with plans to initiate:
- A Phase 2 study of TP-04 (lotilaner ophthalmic gel) for the potential treatment of ocular rosacea (OR), a highly prevalent and underserved eye disease with no FDA-approved therapy, in December 2025, with topline data expected by year-end 2026.
- A Phase 2 study of TP-05 (lotilaner oral tablet) for the potential prevention of Lyme disease, a novel, on-demand, oral tablet designed to kill ticks before they can transmit infection, in 2026.
Axsome Therapeutics Inc. (AXSM)
AXSM recorded an all-time high of $149.38 on November 18, 2025, before closing at $147.48. We alerted our readers to AXSM on December 2, 2024 when it was trading around $97.19.
Earlier this month, Axsome announced that it has entered into an agreement to obtain exclusive global rights to AZD7325, a novel oral GABAA receptor a2,3 subtype-selective positive allosteric modulator (PAM), licensed from AstraZeneca AB (NASDAQ: AZN). AZD7325 has completed Phase 1 trials. Axsome intends to evaluate AZD7325 as a potential treatment for epilepsy and plans to begin Phase 2 trial-enabling activities in 2026.
Natera Inc. (NTRA)
NTRA was featured on our site on August 8, 2025, at $162.00. The stock reached an all-time high of $215.81 during the intraday session yesterday.
Recently, Natera and Flatiron Health announced the integration of Natera's oncology testing portfolio into OncoEMR, Flatiron's cloud-based Electronic Medical Record (EMR) platform. The integration enables seamless electronic ordering and results delivery for Natera's oncology tests directly within the clinical workflow of thousands of U.S. cancer care providers.
FY25 Guidance
While reporting Q3 results, the company said it expects 2025 total revenue to be in the range of $2.18 billion - $2.26 billion; 2025 gross margin to be about 62% - 64% of revenues; selling, general and administrative costs to be about $1.08 billion - $1.18 billion; research and development costs to be about $575 million - $625 million; and net cash inflow to be about $100 million.
Kiniksa Pharmaceuticals International plc (KNSA)
KNSA was published on April 29, 2025, when the stock was trading around $22.55. Shares of KNSA reached an all-time high of $42.30 during the intraday session yesterday.
Last month, the company said it is raising its 2025 ARCALYST net sales guidance to between $670 million and $675 million from between $625 million and $640 million.
Also, the company stated that it is on-track for data from the dose-focusing portion of the Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in the second half of 2026. Subsequently, Kiniksa plans to initiate the pivotal portion of the trial.
Kiniksa continues to plan to conduct a supplemental Phase 2 Transition to KPL-387 Monotherapy Dosing & Administration Study evaluating the efficacy and safety of the dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy.
Belite Bio Inc (BLTE)
BLTE was featured on our site on September 15, 2025, when it was trading around $69.60. The stock reached an all-time high of $125.01 during the intraday session yesterday.
As recently as on November 10, Belite Bio announced that it has completed the pivotal Phase 3 DRAGON trial in 104 adolescent patients with Stargardt disease, with topline data expected in Q4 2025. Interim results supported Breakthrough Therapy Designation from the U.S. FDA, and regulatory agencies in China and the UK have accepted applications for Tinlarebant.
The ongoing DRAGON II program includes Japanese patients and is designed to support future filings in Japan. Enrollment is underway, with efficacy focused on slowing the growth of atrophic lesions and continued assessment of safety and tolerability.
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