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4 Biotech Stocks With Key Clinical Readouts Expected This Fall
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Key Takeaways
KOD expects phase III DAYBREAK data on Zenkuda and KSI-501 for wet AMD this month.
CLDX and RAPP expect late-stage readouts for barzolvolimab and RAP-219 in CSU and bipolar mania, respectively.
PCVX expects to report phase III data on VAX-31, its 31-valent pneumococcal vaccine, in October.
Clinical readouts are among the most important catalysts for biotechnology stocks, as study results can materially shift investor expectations about a drug candidate’s efficacy, safety, regulatory prospects and commercial potential. Positive or negative data can therefore lead to sharp stock-price moves as investors reassess the value of a company’s pipeline.
The impact can be especially significant for clinical-stage biotech companies without marketed products, since their valuations are driven largely by the perceived potential of their development programs rather than established product sales. As a result, upcoming phase II and phase III study data readouts can serve as major valuation inflection points and are closely watched by investors.
Against this backdrop, Kodiak Sciences (KOD - Free Report) , Celldex Therapeutics (CLDX - Free Report) , Rapport Therapeutics (RAPP - Free Report) and Vaxcyte (PCVX - Free Report) are worth watching this fall. The companies are approaching potentially important mid- to late-stage readouts spanning ophthalmology, immunology, neuroscience and vaccines, with outcomes that could influence the development and commercial prospects of their respective pipelines. While CLDX, RAPP and PCVX carry a Zacks Rank #3 (Hold) each, KOD has a Zacks Rank #4 (Sell) at present.
Kodiak is on track to report top-line data this month from the phase III DAYBREAK study evaluating Zenkuda (tarcocimab tedromer) and KSI-501 for treatment-naïve wet age-related macular degeneration (wet AMD). The study is testing both candidates against Regeneron’s Eylea (aflibercept), with the one-year primary endpoint assessing non-inferiority in change in visual acuity from baseline. Zenkuda is an anti-VEGF antibody-biopolymer conjugate designed to combine rapid activity with extended durability, with individualized dosing ranging from every four weeks to as long as six months. KSI-501 adds anti-IL-6 activity to VEGF inhibition and is intended to address both angiogenesis and inflammation. Kodiak identifies the opportunity across retinal vascular diseases as targeting a roughly $15-billion anti-VEGF market.
Kodiak has several additional late-stage opportunities that could extend the impact of its retinal portfolio. KSI-101 is being evaluated in the phase III PEAK and PINNACLE studies for macular edema secondary to inflammation, with PEAK top-line data expected in December 2026. Meanwhile, KOD has initiated enrolment in the phase III ALTO study of KSI-501 versus Eylea for diabetic macular edema. The company is also advancing earlier ABCD-platform programs aimed at retinal diseases, including glaucoma and geographic atrophy.
Celldex Therapeutics
Celldex expects a September/October 2026 top-line data readout from its phase III EMBARQ-CSU1 and EMBARQ-CSU2 studies evaluating barzolvolimab in adults with chronic spontaneous urticaria (CSU), including patients who remain symptomatic despite antihistamines and advanced therapies. The humanized monoclonal antibody targets the KIT receptor, which is critical for mast-cell survival and function, thereby directly reducing mast-cell activity. This distinguishes barzolvolimab mechanistically from established approaches such as antihistamines and IgE-directed therapy. With 1,939 patients enrolled, the late-stage CSU program is designed to support a planned regulatory submission for the candidate in 2027.
Barzolvolimab also remains in phase III development for cold urticaria and symptomatic dermographism, where Celldex says no advanced therapies are approved. Separately, a phase II study is also evaluating the candidate for moderate-to-severe atopic dermatitis, with top-line data expected in late 2026. The company is additionally advancing CDX-622, an early-stage bispecific antibody targeting soluble stem cell factor and TSLP in mild-to-moderate asthma, aiming to combine mast-cell depletion with inhibition of type II inflammation.
Rapport Therapeutics
Rapport is targeting October 2026 to report top-line results from its phase II study of RAP-219 for bipolar mania. RAP-219 is a TARPγ8-specific AMPA receptor negative allosteric modulator designed to selectively influence AMPA signaling in brain regions such as the hippocampus and neocortex. The company believes this neuroanatomical specificity could differentiate RAP-219 from broader-acting neuroscience medicines. A successful readout would provide an important clinical validation for RAP-219 beyond epilepsy and could support discussions with the FDA on a potential phase III program for bipolar mania.
The RAP-219 franchise has multiple additional development paths. Rapport recently initiated the phase III FOCUS 1 and FOCUS 2 studies of the candidate for focal onset seizures and plans to initiate a phase III program for primary generalized tonic-clonic seizures in the first half of 2027. The company is also developing a long-acting injectable formulation of RAP-219, with phase I pharmacokinetic data expected in 2027. Beyond RAP-219, Rapport is advancing RAP-641, an α6β4 nicotinic acetylcholine receptor agonist, through clinical development-enabling studies as a potential non-opioid, non-CNS treatment for chronic pain and migraine.
Vaxcyte
Vaxcyte expects to report top-line safety, tolerability and immunogenicity data from the phase III OPUS-1 study of VAX-31, a 31-valent next-generation pneumococcal conjugate vaccine (PCV) for the prevention of invasive pneumococcal disease and pneumonia in adults, by the end of October 2026. OPUS-1 is a pivotal noninferiority study directly comparing VAX-31 with Prevnar 20 and Capvaxive. VAX-31 uses Vaxcyte’s carrier-sparing, site-specific conjugation approach and is designed to cover 31 serotypes, potentially broadening protection beyond current standard-of-care PCVs. Vaxcyte says the candidate is designed to cover approximately 95% of invasive pneumococcal disease and 88% of pneumococcal pneumonia in U.S. adults aged 50 and older.
The OPUS-1 readout is part of Vaxcyte’s broader VAX-31 franchise. The company is also evaluating VAX-31 in the phase III OPUS-2 study in pneumococcal vaccine-naïve adults receiving a seasonal influenza vaccine and the phase III OPUS-3 study in adults previously vaccinated against pneumococcal disease, with data from both studies expected in the first half of 2027. Separately, a phase II study is evaluating VAX-31 in healthy infants for the prevention of invasive pneumococcal disease, with data from the primary immunization series and booster expected by the end of the first half of 2027. Results from the adult phase III program, together with a manufacturing consistency study, are expected to support a planned regulatory submission.
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4 Biotech Stocks With Key Clinical Readouts Expected This Fall
Key Takeaways
Clinical readouts are among the most important catalysts for biotechnology stocks, as study results can materially shift investor expectations about a drug candidate’s efficacy, safety, regulatory prospects and commercial potential. Positive or negative data can therefore lead to sharp stock-price moves as investors reassess the value of a company’s pipeline.
The impact can be especially significant for clinical-stage biotech companies without marketed products, since their valuations are driven largely by the perceived potential of their development programs rather than established product sales. As a result, upcoming phase II and phase III study data readouts can serve as major valuation inflection points and are closely watched by investors.
Against this backdrop, Kodiak Sciences (KOD - Free Report) , Celldex Therapeutics (CLDX - Free Report) , Rapport Therapeutics (RAPP - Free Report) and Vaxcyte (PCVX - Free Report) are worth watching this fall. The companies are approaching potentially important mid- to late-stage readouts spanning ophthalmology, immunology, neuroscience and vaccines, with outcomes that could influence the development and commercial prospects of their respective pipelines. While CLDX, RAPP and PCVX carry a Zacks Rank #3 (Hold) each, KOD has a Zacks Rank #4 (Sell) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Kodiak Sciences
Kodiak is on track to report top-line data this month from the phase III DAYBREAK study evaluating Zenkuda (tarcocimab tedromer) and KSI-501 for treatment-naïve wet age-related macular degeneration (wet AMD). The study is testing both candidates against Regeneron’s Eylea (aflibercept), with the one-year primary endpoint assessing non-inferiority in change in visual acuity from baseline. Zenkuda is an anti-VEGF antibody-biopolymer conjugate designed to combine rapid activity with extended durability, with individualized dosing ranging from every four weeks to as long as six months. KSI-501 adds anti-IL-6 activity to VEGF inhibition and is intended to address both angiogenesis and inflammation. Kodiak identifies the opportunity across retinal vascular diseases as targeting a roughly $15-billion anti-VEGF market.
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. price-consensus-chart | Kodiak Sciences Inc. Quote
Kodiak has several additional late-stage opportunities that could extend the impact of its retinal portfolio. KSI-101 is being evaluated in the phase III PEAK and PINNACLE studies for macular edema secondary to inflammation, with PEAK top-line data expected in December 2026. Meanwhile, KOD has initiated enrolment in the phase III ALTO study of KSI-501 versus Eylea for diabetic macular edema. The company is also advancing earlier ABCD-platform programs aimed at retinal diseases, including glaucoma and geographic atrophy.
Celldex Therapeutics
Celldex expects a September/October 2026 top-line data readout from its phase III EMBARQ-CSU1 and EMBARQ-CSU2 studies evaluating barzolvolimab in adults with chronic spontaneous urticaria (CSU), including patients who remain symptomatic despite antihistamines and advanced therapies. The humanized monoclonal antibody targets the KIT receptor, which is critical for mast-cell survival and function, thereby directly reducing mast-cell activity. This distinguishes barzolvolimab mechanistically from established approaches such as antihistamines and IgE-directed therapy. With 1,939 patients enrolled, the late-stage CSU program is designed to support a planned regulatory submission for the candidate in 2027.
Celldex Therapeutics, Inc. Price and Consensus
Celldex Therapeutics, Inc. price-consensus-chart | Celldex Therapeutics, Inc. Quote
Barzolvolimab also remains in phase III development for cold urticaria and symptomatic dermographism, where Celldex says no advanced therapies are approved. Separately, a phase II study is also evaluating the candidate for moderate-to-severe atopic dermatitis, with top-line data expected in late 2026. The company is additionally advancing CDX-622, an early-stage bispecific antibody targeting soluble stem cell factor and TSLP in mild-to-moderate asthma, aiming to combine mast-cell depletion with inhibition of type II inflammation.
Rapport Therapeutics
Rapport is targeting October 2026 to report top-line results from its phase II study of RAP-219 for bipolar mania. RAP-219 is a TARPγ8-specific AMPA receptor negative allosteric modulator designed to selectively influence AMPA signaling in brain regions such as the hippocampus and neocortex. The company believes this neuroanatomical specificity could differentiate RAP-219 from broader-acting neuroscience medicines. A successful readout would provide an important clinical validation for RAP-219 beyond epilepsy and could support discussions with the FDA on a potential phase III program for bipolar mania.
Rapport Therapeutics, Inc. Price and Consensus
Rapport Therapeutics, Inc. price-consensus-chart | Rapport Therapeutics, Inc. Quote
The RAP-219 franchise has multiple additional development paths. Rapport recently initiated the phase III FOCUS 1 and FOCUS 2 studies of the candidate for focal onset seizures and plans to initiate a phase III program for primary generalized tonic-clonic seizures in the first half of 2027. The company is also developing a long-acting injectable formulation of RAP-219, with phase I pharmacokinetic data expected in 2027. Beyond RAP-219, Rapport is advancing RAP-641, an α6β4 nicotinic acetylcholine receptor agonist, through clinical development-enabling studies as a potential non-opioid, non-CNS treatment for chronic pain and migraine.
Vaxcyte
Vaxcyte expects to report top-line safety, tolerability and immunogenicity data from the phase III OPUS-1 study of VAX-31, a 31-valent next-generation pneumococcal conjugate vaccine (PCV) for the prevention of invasive pneumococcal disease and pneumonia in adults, by the end of October 2026. OPUS-1 is a pivotal noninferiority study directly comparing VAX-31 with Prevnar 20 and Capvaxive. VAX-31 uses Vaxcyte’s carrier-sparing, site-specific conjugation approach and is designed to cover 31 serotypes, potentially broadening protection beyond current standard-of-care PCVs. Vaxcyte says the candidate is designed to cover approximately 95% of invasive pneumococcal disease and 88% of pneumococcal pneumonia in U.S. adults aged 50 and older.
Vaxcyte, Inc. Price and Consensus
Vaxcyte, Inc. price-consensus-chart | Vaxcyte, Inc. Quote
The OPUS-1 readout is part of Vaxcyte’s broader VAX-31 franchise. The company is also evaluating VAX-31 in the phase III OPUS-2 study in pneumococcal vaccine-naïve adults receiving a seasonal influenza vaccine and the phase III OPUS-3 study in adults previously vaccinated against pneumococcal disease, with data from both studies expected in the first half of 2027. Separately, a phase II study is evaluating VAX-31 in healthy infants for the prevention of invasive pneumococcal disease, with data from the primary immunization series and booster expected by the end of the first half of 2027. Results from the adult phase III program, together with a manufacturing consistency study, are expected to support a planned regulatory submission.