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Tenaya Therapeutics (NASDAQ: TNYA) trims Q1 loss, lands Alnylam deal

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Tenaya Therapeutics reported first quarter 2026 results and a broad pipeline update. Collaboration revenue was $225,000, total operating expenses were $20.3 million, and net loss narrowed to $19.3 million, or $0.09 per share, compared with a $26.9 million loss a year earlier.

Cash and cash equivalents were $80.9 million as of March 31, 2026, and together with a $10.0 million upfront payment from a new Alnylam collaboration are expected to fund operations into the second half of 2027. The company highlighted upcoming 2026 data readouts for gene therapies TN-201 and TN-401, preclinical progress for TN-301, and design-stage work on gene editing candidate TN-501.

Positive

  • None.

Negative

  • None.

Insights

Tenaya pairs tighter spending with new collaboration funding while advancing multiple cardiology programs.

Tenaya reduced first quarter 2026 operating expenses to $20.3M from $27.5M, narrowing net loss to $19.3M. R&D and G&A both declined, while collaboration revenue of $0.2M appeared for the first time, reflecting new partnership activity.

A multi-target research collaboration with Alnylam brought an upfront payment of $10.0M and potential milestones of up to $1.1B, alongside research cost reimbursement. This non-dilutive funding helps support development of gene therapies TN-201 and TN-401, HDAC6 inhibitor TN-301, and gene-editing candidate TN-501.

The company now expects existing cash plus the Alnylam upfront to fund operations into the second half of 2027, extending runway while it pursues key 2026 readouts from the MyPEAK-1 and RIDGE-1 Phase 1b/2 studies and prepares TN-301 for patient trials.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Collaboration revenue $225,000 Three months ended March 31, 2026
R&D expenses $14.8M Q1 2026 vs $21.1M in Q1 2025
G&A expenses $5.4M Q1 2026 vs $6.5M in Q1 2025
Net loss $19.3M Q1 2026 vs $26.9M in Q1 2025
Net loss per share $0.09 Basic and diluted loss per share, Q1 2026
Cash and cash equivalents $80.9M As of March 31, 2026
Alnylam upfront payment $10.0M Received April 2026 under research collaboration
Potential Alnylam milestones $1.1B Future development, regulatory and sales-based milestones
Phase 1b/2 medical
"RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC"
Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.
HDAC6 inhibitor medical
"TN-301, the company’s highly selective HDAC6 inhibitor, with givinostat"
An HDAC6 inhibitor is a drug that blocks the activity of the HDAC6 enzyme, which helps control how cells manage certain proteins and switch genes on or off. Think of HDAC6 as a combination of a light switch and a cleaning crew inside cells; inhibiting it can change cell behavior and reduce harmful protein buildup. Investors care because this mechanism underlies potential treatments for cancers, neurodegenerative and inflammatory diseases, so it shapes clinical risk, development timelines and market opportunity.
Rare Pediatric Disease Designation regulatory
"TN-301 was granted both Rare Pediatric Disease Designation and Orphan Drug Designation"
A rare pediatric disease designation is an official regulatory status given to a drug or therapy that targets a serious or life‑threatening condition primarily affecting children and is uncommon in the population. It matters to investors because the status often brings financial and development perks — such as tax credits, reduced fees, faster review and periods of market protection — which can lower costs, speed approval and improve the commercial outlook; think of it as a VIP pass that makes bringing a scarce, child‑focused treatment to market easier and potentially more profitable.
Orphan Drug Designation regulatory
"Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of DMD"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
arrhythmogenic right ventricular cardiomyopathy medical
"TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)"
A hereditary heart condition in which muscle in the right pumping chamber is gradually replaced by fat or scar tissue, disrupting the heart’s electrical signals and causing abnormal rhythms that can lead to fainting or sudden cardiac arrest. Investors should care because it drives demand for diagnostics, devices (like implanted defibrillators), drugs and long-term care, affects clinical trial size and regulatory risk, and can influence healthcare costs and market opportunities for related companies.
gene editing therapeutic candidate medical
"TN-501, a gene editing therapeutic candidate intended for the treatment of PLN-R14del-associated"
Collaboration revenue $225,000 $225,000 vs $0 in Q1 2025
R&D expenses $14.8M $14.8M vs $21.1M in Q1 2025
G&A expenses $5.4M $5.4M vs $6.5M in Q1 2025
Net loss $19.3M $19.3M vs $26.9M in Q1 2025
Net loss per share $0.09 $0.09 vs $0.24 in Q1 2025
Guidance

Tenaya expects existing cash plus a $10.0M Alnylam upfront payment to fund planned operations into the second half of 2027.

false000185884800018588482026-05-062026-05-06

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 06, 2026

 

 

Tenaya Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40656

81-3789973

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

171 Oyster Point Boulevard

Suite 500

 

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 825-6990

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

TNYA

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 2.02 Results of Operations and Financial Condition.

On May 6, 2026, Tenaya Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026 (“Earnings Press Release”). The full text of the Earnings Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit
No.

 

Description

 

 

99.1

 

Press Release of Tenaya Therapeutics, Inc., dated May 6, 2026

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

TENAYA THERAPEUTICS, INC.

 

 

 

By:

 

 

/s/ Jennifer Drimmer Rokovich

 

 

 

 

Jennifer Drimmer Rokovich

 

 

 

 

General Counsel and Secretary

Date: May 6, 2026

 

 

 

 

 

 


Exhibit 99.1

img92481827_0.jpg

Tenaya Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update

 

One-Year Cohort 1 Data and Initial Cohort 2 Data from RIDGE™-1 Phase 1b/2 Trial of TN-401 for PKP2-Associated ARVC to be Presented at ASGCT 2026

 

New Data from Both Cohorts of the MyPEAK™-1 Phase 1b/2 Trial of TN-201 for Adults with MYBPC3-Associated HCM Expected in the Second Quarter 2026

 

Preclinical Data at MDA 2026 Highlighted TN-301’s Activity in Duchenne Muscular Dystrophy Disease Models; Distinct Mechanism of HDAC6 Inhibition Supportive of TN-301’s Potential in Multiple Indications

 

Entered Research Collaboration with Alnylam to Identify and Validate Genetic Targets for Cardiovascular Conditions

 

SOUTH SAN FRANCISCO, Calif., May 6, 2026 – Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.

 

“We are entering a catalyst-rich period for Tenaya, with multiple clinical milestones expected across our lead gene therapy programs throughout 2026. Building on the encouraging initial readouts we reported in 2025, we believe the additional data expected this year from both TN-201 and TN-401 may support alignment on registrational pathways for these novel gene therapies,” said Faraz Ali, Chief Executive Officer of Tenaya.

 

Mr. Ali continued, “While our focus remains on the advancement of TN-201 and TN-401 for patients suffering from these genetic cardiomyopathies, we also announced meaningful steps in the direction of our next horizon of opportunities to address unmet patient needs and to create value for stockholders. We presented new preclinical data for TN301, our clinical-stage small molecule candidate, in Duchenne muscular dystrophy adding to the body of compelling preclinical evidence for the broad clinical utility of this molecule in multiple prevalent and rare cardiac and cardiac-adjacent indications. Advancing TN301 toward a trial in patients reflects our commitment to building a diversified portfolio grounded in mechanistic insight and translational rigor. The recently announced collaboration with Alnylam also reinforces the strength of Tenaya's innovation engine and expands the reach and impact of our modality-agnostic research capabilities.”

 

Business and Program Updates

 

TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM)

 

On May 9, 2026, at the upcoming European Society of Cardiology (ESC) Heart Failure Conference, in Barcelona, Spain, Milind Desai, M.D., Director of the Hypertrophic Cardiomyopathy Center, Vice Chair of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, and principal investigator for the MyPEAK-1 clinical trial, will present insights that

emerged early in the trial that enabled reductions in the cumulative dose and duration of immune suppressive medications, even when TN-201 is administered at the higher dose.
o
Per the MyPEAK-1 protocol, sirolimus and prednisone are administered prophylactically in patients receiving TN-201 gene therapy, accompanied by post dose tapering in conjunction with monitoring of liver enzyme levels – an early indicator of potential complement system activation. Investigators found that minor adjustments, including administering sirolimus earlier, reducing the starting dose of prednisone and monitoring patients weekly, led to faster tapering and an overall decrease in the burden of immunosuppression.
o
The ESC-HF presentation offers more detail on the immunosuppressive regimen results previously reported in November 2025 and includes safety data for the first seven patients enrolled in MyPEAK-1. The optimized regimen and monitoring protocols that were successfully deployed in MyPEAK-1 are also being utilized in the RIDGE-1 clinical trial of TN-401.
o
Tenaya expects to report interim MyPEAK-1 data for Cohort 2 (6E13 vg/kg) and updates from Cohort 1 (3E13 vg/kg) in the second quarter of 2026.
 
In January, Tenaya resumed enrollment and screening in MyPEAK-1 following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input.
At the American Society of Gene and Cell Therapies (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, MA, Tenaya will present results from a survey exploring parental perceptions of gene therapy treatment for children with cardiomyopathies. This work was conducted by Tenaya in partnership with DDC Clinic and Children’s Cardiomyopathy Foundation. The poster presentation is scheduled for May 12, 2026.

 

TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

 

Data from the ongoing RIDGE-1 Phase 1b/2 clinical trial of TN-401 in adults with ARVC due to variants in the PKP2 gene have been accepted as a late-breaking presentation at the upcoming ASGCT Annual Meeting. The presentation, scheduled for Friday, May 15, is expected to include one-year data for Cohort 1 (3E13 vg/kg) and initial Cohort 2 (6E13 vg/kg).
o
Tenaya management plans to conduct a webcast conference call on Friday, May 15, 2026, at 10:30 a.m. EDT / 7:30 am PDT following the Late Breaker Session. The webcast conference call, including an accompanying slide presentation, will be accessible from the Investor section of the Tenaya website at www.tenayatherapeutics.com.
In January, the RIDGE-1 data and safety monitoring board (DSMB) reviewed all available data for the six patients that have received TN-401 gene therapy. The DSMB determined that TN-401 had an acceptable safety profile and endorsed continued enrollment of patients in RIDGE-1 expansion cohorts at either dose.

 

TN-301 – Small Molecule HDAC6 Inhibitor for the Potential Treatment of Heart Failure with Preserved Ejection Fraction (HFpEF) and Related Cardiac, Metabolic, or Muscular Diseases

 

In March 2026, Tenaya presented encouraging preclinical data comparing TN-301, the company’s highly selective HDAC6 inhibitor, with givinostat, an approved pan-HDAC inhibitor, in well-established preclinical models of Duchenne muscular dystrophy (DMD) at the Muscular Dystrophy Association’s 2026 Clinical and Scientific Congress.
Results of the study showed that:
o
TN-301 treatment at doses as low as 3 mg/kg improved grip strength to wild-type levels within five weeks, whereas mdx mice treated with givinostat (10 mg/kg, approximating clinical exposures) failed to reach wild-type performance.

o
TN-301-mediated functional improvements were accompanied by reductions in circulating creatine kinase and favorable changes in gene expression, indicating reduced muscle cell injury.
o
In cardiomyocytes derived from human DMD-induced pluripotent stem cells, TN-301 corrected calcium handling abnormalities and mitochondrial dysfunction, while givinostat exacerbated these established drivers of DMD cardiomyopathy.
TN-301 was granted both Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of DMD from U.S. Food and Drug Administration.
In 2026, Tenaya plans to advance TN-301 toward clinical trials in patients in order to generate proof-of-activity data, with HFpEF and DMD being among the most promising potential indications identified to date.

 

Research

In March 2026, Tenaya entered into a multi-target research collaboration with Alnylam Pharmaceuticals to identify and validate novel genetic targets aimed at treating cardiovascular disease.
o
Under the terms of the collaboration agreement, in April 2026, Tenaya received an upfront payment of $10.0M and may be eligible for future development, regulatory and sales-based milestones totaling up to $1.1 billion, in addition to reimbursement of associated research costs.
Updated results of preclinical studies characterizing TN-501, a gene editing therapeutic candidate intended for the treatment of PLN-R14del-associated dilated cardiomyopathy (DCM) will be presented at ASGCT on Thursday, May 14, 2026. TN-501 is designed to specifically inactivate the pathogenic phospholamban (PLN) R14del allele while preserving healthy function.

 

First Quarter 2026 Financial Highlights

Cash: As of March 31, 2026, cash and cash equivalents were $80.9 million. Tenaya expects that such resources, along with the $10.0 million upfront payment from the Alnylam collaboration, will be sufficient to fund planned operations into the second half of 2027.
Research & Development (R&D) Expenses: R&D expenses were $14.8 million for the first quarter of 2026, compared to $21.1 million for the same period in 2025. Non-cash stock-based compensation included in R&D expense was $1.2 million for the first quarter of 2026 compared to $2.0 million for the same period in 2025.
General & Administrative (G&A) Expenses: G&A expenses were $5.4 million for the first quarter of 2026 compared to $6.5 million for the same period in 2025. Non-cash stock-based compensation included in G&A expense was $1.0 million for the first quarter of 2026 and $1.7 million for the same period in 2025.
Net Loss: Net loss was $19.3 million, or $0.09 loss per share, for the first quarter ended March 31, 2026, compared to a net loss of $26.9 million, or $0.24 per share, for the same period in 2025.

 

About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM); TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC); and TN-301, a highly specific small molecule HDAC6 inhibitor with broad potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction (HFpEF) and Duchenne muscular dystrophy (DMD). Tenaya has employed a suite of integrated internal capabilities including modality agnostic target discovery and validation, generate a portfolio of novel medicines based on genetic insights, aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com.


 

Forward Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “expected,” “believe,” “may,” “focused,” “commitment,” “will,” “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, planned timing for sharing data from RIDGE-1 and MyPEAK-1 and the expected content of such data releases; the potential for additional data from Tenaya’s TN-201 and TN-401 programs to support regulatory alignment on registrational pathways; Tenaya’s focus on the advancement of TN-201 and TN-401; Tenaya’s commitment to the building a diversified portfolio and advance TN-301 toward clinical trials; the potential for Tenaya to receive development, regulatory and sales-based milestone payments, as well as research reimbursement under the collaboration with Alnylam; planned presentation for TN-501; the sufficiency of Tenaya’s cash resources to fund the company into the second half of 2027; and statements made by Tenaya’s chief executive officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of data at the referenced times; the timing and progress of Tenaya’s clinical trials; unexpected concerns that may arise as a result of the occurrence of adverse safety events in Tenaya’s clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; the potential for the FDA to conclude at any time that Tenaya’s clinical programs may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s ability to achieve the expected benefits from the collaboration with Alnylam; the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration with Alnylam; Tenaya’s continuing compliance with applicable legal and regulatory requirements; regulatory developments in the United States and foreign countries; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to comply with specified operating covenants and restrictions in its loan agreement; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates and platform technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Tenaya Contacts

Michelle Corral
VP, Corporate Communications and Investor Relations
IR@tenayathera.com

 

Investors

Anne-Marie Fields
Precision AQ
annemarie.fields@precisionaq.com

 

Media
Wendy Ryan
 


Ten Bridge Communications
wendy@tenbridgecommunications.com

 


TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Revenue

 

 

 

 

 

 

Collaboration revenue

 

$

225

 

 

$

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

14,843

 

 

 

21,076

 

General and administrative

 

 

5,447

 

 

 

6,462

 

Total operating expenses

 

 

20,290

 

 

 

27,538

 

Loss from operations

 

 

(20,065

)

 

 

(27,538

)

Other income, net:

 

 

 

 

 

 

Interest income

 

 

793

 

 

 

635

 

Other income, net

 

 

 

 

 

39

 

Total other income, net

 

 

793

 

 

 

674

 

Net loss before income tax expense

 

 

(19,272

)

 

 

(26,864

)

Income tax expense

 

 

 

 

 

 

Net loss

 

$

(19,272

)

 

$

(26,864

)

Net loss per share, basic and diluted

 

$

(0.09

)

 

$

(0.24

)

Weighted-average shares used in computing net loss per share, basic and diluted

 

 

216,883,164

 

 

 

109,869,278

 

 

 

 

Condensed Balance Sheet Data

(In thousands)

(Unaudited)

 

 

 

March 31,

 

 

December 31,

 

 

 

2026

 

 

2025

 

Cash and cash equivalents

 

$

80,887

 

 

$

100,547

 

Total assets

 

$

135,070

 

 

$

146,921

 

Total liabilities

 

$

28,881

 

 

$

23,656

 

Total liabilities and stockholders’ equity

 

$

135,070

 

 

$

146,921

 

 

 

 


FAQ

How did Tenaya Therapeutics (TNYA) perform financially in Q1 2026?

Tenaya reported a Q1 2026 net loss of $19.3 million, or $0.09 per share, improving from a $26.9 million loss in 2025. Total operating expenses fell to $20.3 million as both R&D and G&A spending declined year over year.

What is Tenaya Therapeutics’ (TNYA) cash runway after Q1 2026?

Tenaya ended March 31, 2026 with $80.9 million in cash and cash equivalents. Together with the $10.0 million upfront payment from its Alnylam collaboration, the company expects these resources to fund planned operations into the second half of 2027.

What are the key clinical milestones Tenaya Therapeutics (TNYA) expects in 2026?

Tenaya expects new 2026 data from its TN-201 MyPEAK-1 and TN-401 RIDGE-1 Phase 1b/2 trials, including updated Cohort 1 and interim Cohort 2 results. Additional TN-201 and TN-401 data may help support discussions on potential registrational pathways for these gene therapies.

What is the Alnylam collaboration announced by Tenaya Therapeutics (TNYA)?

In March 2026, Tenaya entered a multi-target research collaboration with Alnylam Pharmaceuticals to identify and validate genetic targets for cardiovascular disease. Tenaya received a $10.0 million upfront payment and may earn up to $1.1 billion in potential milestone payments plus research cost reimbursement.

How is Tenaya Therapeutics (TNYA) progressing TN-301, its HDAC6 inhibitor program?

Tenaya presented preclinical data showing TN-301 improved grip strength, reduced creatine kinase, and corrected cardiomyocyte abnormalities in Duchenne muscular dystrophy models. TN-301 received Rare Pediatric Disease and Orphan Drug designations for DMD, and Tenaya plans to advance it toward patient trials in 2026.

What designations has Tenaya Therapeutics (TNYA) received for its DMD program?

The FDA granted TN-301 both Rare Pediatric Disease Designation and Orphan Drug Designation for treating Duchenne muscular dystrophy. These programs can offer incentives such as priority review vouchers and market exclusivity if the candidate ultimately achieves regulatory approval.

Filing Exhibits & Attachments

2 documents