13 Biotech Stocks Charging Ahead With New 52-week Highs - Will Near-term Catalysts Drive More Gains?

Mineralys Therapeutics

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(RTTNews) - "All there is to investing is picking good stocks at good times and staying with them as long as they remain good companies", said Warren Buffet, reminding us that patience and discipline are key to successful investing. Stocks quietly climbing to new 52-week highs could be a sign that the market is recognizing consistent performance, strong fundamentals, or upcoming catalysts.

The following are some of the stocks that hit new 52-week highs yesterday. Do you already own any of them? Are any on your watchlist? And are there near-term catalysts that could keep the momentum going?

Let's take a closer look.

Cogent Biosciences Inc. (COGT)

Cogent Biosciences is planning to file its first New Drug Application for its lead drug candidate Bezuclastinib in the indication of non-advanced systemic mastocytosis by the end of 2025.

Bezuclastinib is a type of tyrosine kinase inhibitor (TKI), which is being evaluated as a potential treatment for non-advanced systemic mastocytosis, gastrointestinal stromal tumors, and advanced systemic mastocytosis.

A phase III clinical trial comparing Bezuclastinib in combination with Pfizer's approved drug Sutent (Sunitinib) against Sutent alone in people with Gastrointestinal Stromal Tumors, dubbed PEAK, is underway, with top-line results due in the second half of 2025.

In the indication of Advanced Systemic Mastocytosis, Bezuclastinib is under a phase II trial, dubbed APEX. Topline results from this study are also anticipated in the second half of 2025.

COGT was featured on our site on July 2, 2025, when it was trading at $7.25. The stock touched a 52-week high of $16.99 during intraday trading yesterday.

Assembly Biosciences Inc. (ASMB)

Assembly Biosciences is steadily advancing its four key development programs - ABI-4334, ABI-5366, ABI-1179, and ABI-6250.

The company expects to move ABI-5366 into longer-duration phase 2 clinical studies in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes in mid-2026.

A Phase 1b study of ABI-1179, another long-acting HSV helicase-primase inhibitor candidate, is ongoing, with interim data due in the fall of this year.

ABI-6250, the company's orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate, is under a phase 1a clinical trial in healthy participants. Interim data from this study were reported in August of this year.

As for ABI-4334, it delivered positive topline results from a Phase 1b study in participants with chronic hepatitis B virus (HBV) infection, demonstrating favorable efficacy, safety, and pharmacokinetic (PK) profiles in July of 2025.

When we profiled ASMB on May 5, 2025, it was trading at $14.53. The stock touched a 52-week high of $28 during intraday trading yesterday.

Compass Therapeutics Inc. (CMPX)

Compass Therapeutics has a key clinical trial catalyst to watch related to its lead investigational drug Tovecimig, which is being evaluated in a phase 2/3 study in patients with advanced biliary tract cancer, dubbed COMPANION-002.

Analyses of the secondary endpoints, including Overall Survival and progression-free survival (PFS), from the COMPANION-002 study are expected to occur in Q1, 2026. In April 2025, the company announced that Tovecimig met the primary endpoint in the ongoing Phase 2/3 COMPANION-002 study. Tovecimig plus paclitaxel significantly improved the overall response rate compared to paclitaxel alone.

CMPX was featured on our site on January 28, 2025, when it was at $2.91. The stock touched a 52-week high of $4.39 during intraday trading yesterday.

NewAmsterdam Pharma Company N.V. (NAMS)

NewAmsterdam Pharma is developing Obicetrapib, an oral, low-dose and once-daily cholesteryl ester transfer protein ("CETP") inhibitor, as the preferred LDL-C lowering therapy to be used in patients at risk of cardiovascular disease for whom existing therapies are not sufficiently effective or well-tolerated.

In July of this year, the company announced encouraging full data from its BROADWAY trial, demonstrating statistically significant reductions in key Alzheimer's disease biomarkers.

BROADWAY is a 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter trial that evaluated the efficacy and safety of 10 mg Obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with atherosclerotic cardiovascular disease ("ASCVD") and/or heterozygous familial hypercholesterolemia ("HeFH") whose LDL-C is not adequately controlled.

The company has also completed another two phase III trials of Obicetrapib, dubbed BROOKLYN and TANDEM.

The Marketing Authorization Applications for Obicetrapib 10 mg monotherapy and 10 mg Obicetrapib plus 10 mg ezetimibe fixed-dose combination ("FDC") for patients with primary hypercholesterolemia, both heterozygous familial ("HeFH") and non-familial or mixed dyslipidemia were accepted for review by the European Medicines Agency (EMA) in August of this year. The EMA submission was based on data from BROOKLYN, TANDEM and BROADWAY Phase 3 trials.

NAMS was featured on our site on July 10, 2025, when it was trading at $21.56. The stock touched a 52-week high of $39.76 during intraday trading yesterday.

Mineralys Therapeutics Inc. (MLYS)

Mineralys' lead drug candidate is Lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) & resistant hypertension (rHTN), chronic kidney disease, and obstructive sleep apnea (OSA).

In a pivotal phase III trial, dubbed Launch-HTN, the primary endpoint that evaluated the efficacy and safety of Lorundrostat for the treatment of participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as add-on therapy, who fail to achieve blood pressure (BP) control on their existing medications, was achieved. A pre-NDA meeting with the FDA is scheduled to take place this quarter.

A phase II trial evaluating the safety and efficacy of Lorundrostat in the treatment of overweight and obese participants with moderate-to-severe OSA and uHTN or Rhtn, dubbed Explore-OSA, is ongoing. The company anticipates reporting topline results from this trial in 1H 2026.

When we alerted readers to MLYS on February 5, 2025, it was trading at $10.34. The stock hit a 52-week high of $43.88 during intraday trading yesterday.

Kymera Therapeutics Inc. (KYMR)

Kymera had a data-rich first half of the year, marked by key milestones that build on its scientific progress and further validate the potential of its oral immunology pipeline.

The company is on track to report data from its phase I trial of KT-621 in adult male and female patients with moderate to severe atopic dermatitis, dubbed BroADen, this quarter. Two parallel Phase 2b studies of KT-621 in atopic dermatitis and asthma patients are planned to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively.

When we alerted readers to KYMR on June 2, 2025, it was trading at $40. The stock touched a 52-week high of $60 during intraday trading yesterday.

Insmed Inc. (INSM)

Insmed is a biopharmaceutical company that has two approved drugs and a diverse portfolio of mid- to late-stage investigational medicines. Its flagship asset is Arikayce, an antibacterial drug, which secured accelerated approval from the FDA in September 2018, for the treatment of a serious lung disease caused by a group of bacteria, Mycobacterium avium complex, in adults who have limited or no alternative treatment options. The second drug, BRINSUPRI, an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older, was approved as recently as August 12, 2025.

A phase 3 trial of Arikayce in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics, dubbed ENCORE, is underway, with topline readout due in the first half of 2026.

BRINSUPRI is also being explored in a phase 2b study in patients with chronic rhinosinusitis without nasal polyps, dubbed BiRCh, with topline data anticipated by the end of 2025.

When we alerted readers to INSM on July 21, 2024, it was at $76.54. The stock touched a high of $166.54 during intraday trading yesterday.

Adaptive Biotechnologies Corp. (ADPT)

Adaptive Biotechnologies is a commercial-stage biotechnology company that operates through two primary businesses: the Minimal Residual Disease (MRD) business and the Immune Medicine (IM) business.

The MRD business centers around its flagship clonoSEQ diagnostic test, which is FDA-authorized for the detection and monitoring of minimal residual disease in patients with multiple myeloma, B-cell acute lymphoblastic leukemia, and chronic lymphocytic leukemia. Additionally, clonoSEQ is available as a CLIA-validated laboratory-developed test for other lymphoid cancers, including diffuse large B-cell lymphoma and mantle cell lymphoma. The IM business is focused on the discovery and development of immune-based therapies for cancer and autoimmune diseases.

For the full year 2025, the company expects revenue for the MRD business to be between $190 million and $200 million compared to $145.5 million in 2024. No revenue guidance is provided for the Immune Medicine business.

The financial results for the quarter ended September 30, 2025, are expected to be released during the second week of next month.

We last alerted readers to ADPT on May 5, 2025, when it was trading at $9.80. The stock touched a 52-week high of $15.94 during intraday trading yesterday.

BridgeBio Pharma Inc. (BBIO)

BridgeBio has a couple of clinical trial catalysts to watch in the coming months, with topline results expected from both the FORTIFY and CALIBRATE studies in Fall 2025.

FORTIFY is a phase 3 trial of drug candidate BBP-418 for limb-girdle muscular dystrophy type 2I/R9 while CALIBRATE is a phase III trial of Encaleret for autosomal dominant hypocalcemia type 1 (ADH1).

The company's marketed drug is Attruby, which secured FDA approval for the treatment of patients with transthyretin amyloid cardiomyopathy (ATTR-CM), last November. The drug generated net product revenue of $108 million in the first half of 2025.

We featured BBIO on our site on August 29, 2024, when it was at $25.10. The stock touched a 3-year high of $56.24 during intraday trading yesterday.

Tarsus Pharmaceuticals Inc. (TARS)

Tarsus Pharma, which marked the second anniversary of its XDEMVY launch in August, believes its peak potential is even greater than initially expected at launch.

Xdemvy is the first and only FDA-approved therapy for the treatment of Demodex blepharitis, a disease caused by the infestation of Demodex mites, the most common ectoparasite found on humans. It is characterized by eyelid inflammation, redness, and irritation.

The net product sales of Xdemvy were $102.7 million in Q2, 2025, compared to $40.8 million for the same period in 2024.

The financial results for the third quarter of 2025 are scheduled to be reported during the first week of next month.

When we alerted readers to TARS on July 29, 2024, it was at $25.01. The stock touched an all-time high of $70.15 during intraday trading yesterday.

Palvella Therapeutics Inc. (PVLA)

Palvella has a key clinical trial event to watch in mid-December.

The company's lead product candidate is QTORIN rapamycin, currently under development for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and other serious, functionally debilitating skin diseases driven by the overactivation of the mTOR pathway. The mTOR signaling pathway is a key regulator of cell growth, proliferation, survival, and metabolism.

A phase 2 trial of QTORIN 3.9% rapamycin anhydrous gel for the treatment of cutaneous venous malformations, dubbed TOIVA, is underway, with top-line data expected in mid-December 2025.

We featured PVLA on our site on March 10, 2025, when it was trading at $25. The stock touched a 52-week high of $76.76 during intraday trading yesterday.

Merus N.V. (MRUS)

Merus agreed to be acquired by Genmab A/S (GMAB) for $97 per share in an all-cash transaction representing a transaction value of roughly $8.0 billion, last month. The deal is anticipated to close by early in the first quarter of 2026.

The company's lead asset Bizengri was granted accelerated approval by the FDA on December 4, 2024, for the treatment of NRG1 fusion-positive non-small cell lung cancer (NSCLC) and NRG1 fusion-positive pancreatic adenocarcinoma in patients who have had disease progression during or after prior systemic therapy. Merus has exclusively licensed to Partner Therapeutics, Inc. the right to commercialize BIZENGRI for the treatment of NRG1+ cancer in the U.S.

The most advanced drug candidate in the pipeline is Petosemtamab, a human IgG1 Biclonics designed to bind to cancer cells expressing epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G protein-coupled receptor 5 (LGR5).

When we alerted readers to MRUS on January 17, 2025, it was at $39.71.

Nephros Inc. (NEPH)

Nephros, which reported strong results for the second quarter of 2025, marking its third consecutive quarter of profitability, is optimistic about maintaining its upward trajectory in both growth and financial performance.

This commercial-stage company develops and markets high-performance water filtration solutions, with a core focus on medical-grade water filtration. For the second quarter of 2025, whose results were reported in August, net revenue was $4.4 million and net income was $237,000. This compared with a net revenue of $3.3 million and a net loss of $289,000 in the second quarter of 2024.

The company is scheduled to report financial results for the third quarter ended September 30, 2025, during the first week of next month.

When we alerted readers to NEPH on May 27, 2025, it was trading at $2.93. The stock touched a 52-week high of $5.98 during intraday trading yesterday.