Dr. Reddy’s (NYSE: RDY) partner halts TACTI-004 Phase III Eftilagimod alfa trial
Rhea-AI Filing Summary
Dr. Reddy’s Laboratories reports that its partner Immutep has halted the TACTI-004 Phase III trial of Eftilagimod alfa in first-line non-small cell lung cancer. An independent data monitoring committee recommended discontinuation after a planned interim futility analysis reviewing safety and efficacy data.
Enrollment in the study will stop and Immutep will wind down the trial while following patients and closing sites. Dr. Reddy’s subsidiary, which holds exclusive rights to develop and commercialize Eftilagimod alfa in many territories outside North America, Europe, Japan and Greater China, has so far made only the upfront payment under the collaboration and is in discussions with Immutep on the path forward.
Positive
- None.
Negative
- TACTI-004 Phase III futility and discontinuation: The independent data monitoring committee recommended stopping the Phase III Eftilagimod alfa trial in first-line non-small cell lung cancer for futility, halting enrollment and triggering trial wind-down, which materially clouds this partnered indication’s commercial and milestone potential for Dr. Reddy’s.
Insights
Key partnered lung cancer trial for Eftilagimod alfa is discontinued after futility review, creating uncertainty for Dr. Reddy’s program.
The disclosure explains that the independent committee for the TACTI-004 Phase III lung cancer study recommended stopping the trial for futility after reviewing safety and efficacy data. This effectively halts development for this specific first-line non-small cell lung cancer indication.
Dr. Reddy’s subsidiary holds rights to Eftilagimod alfa across several major ex-US and ex-Europe territories, but notes it has only paid the upfront amount to date. This limits sunk costs, yet future milestones and potential revenues from this indication are now uncertain while Immutep reassesses data and next steps.
Immutep will wind down the study and conduct a comprehensive data review, while stating continued focus on its broader pipeline, including Eftilagimod alfa. Any revised development strategy emerging from this review would be expected to appear in subsequent company communications and regulatory updates.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13A-16 OR 15D-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
March, 2026
Commission File Number 1-15182
DR. REDDY’S LABORATORIES LIMITED
(Translation of registrant’s name into English)
8-2-337, Road No. 3, Banjara Hills
Hyderabad, Telangana 500 034, India
+91-40-49002900
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ______
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
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Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to registrant in connection with Rule 12g3-2(b): 82-________.
EXHIBITS
Exhibit |
| Description of Exhibits |
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99.1 | Intimation dated March 13, 2026 |
| 2 |
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, thereunto duly authorized.
| DR. REDDY’S LABORATORIES LIMITED (Registrant) | |
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Date: March 13, 2026 | By: | /s/ K Randhir Singh |
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| Name: K Randhir Singh |
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| Title: Company Secretary |
| 3 |
Exhibit 99.1
| Dr. Reddy's Laboratories Ltd. 8-2-337, Road No. 3, Banjara Hills Hyderabad – 500 034, Telangana, India
CIN: L85195TG1984PLC004507 Tel: + 91 40 4900 2900 Fax: + 91 40 4900 2999 Email: mail@drreddys.com |
Web: www.drreddys.com |
March 13, 2026
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY)
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Dear Sir/ Madam,
Ref: | Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (“SEBI Listing Regulations”) |
This is in furtherance to our intimation dated December 8, 2025, wherein we had informed that Dr. Reddy’s Laboratories SA (“Dr. Reddy’s SA”), a wholly-owned subsidiary of Dr. Reddy’s Laboratories Limited, had entered into a strategic collaboration and exclusive licensing agreement with Immutep SAS, a wholly-owned subsidiary of Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep”), to develop and commercialize Eftilagimod Alfa in all countries outside North America, Europe, Japan, and Greater China.
The Company would like to inform that Immutep has announced on March 13, 2026, that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III evaluating Eftilagimod alfa (“efti”) in patients in firstline non-small cell lung cancer study has recommended the discontinuation of the trial following a planned interim futility analysis, in accordance with the study protocol. This recommendation followed a review of the available safety and efficacy data.
In response to the IDMC’s recommendation, enrolment in the study will be halted and Immutep will implement an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations. Immutep has communicated that it is undertaking a comprehensive review of the available data to better understand the results and determine the appropriate next steps for the program.
Further, Dr Reddy’s SA has, to date, made only the upfront payment to Immutep and continues to engage with Immutep on the appropriate way forward. Immutep remains focused on advancing its pipeline of innovative therapies including Eftilagimod Alpha.
This is for your information and records.
Thanking you.
Yours faithfully,
For Dr. Reddy’s Laboratories Limited
K Randhir Singh
Company Secretary, Compliance Officer & Head-CSR
FAQ
What did Dr. Reddy’s Laboratories (RDY) disclose about the TACTI-004 Phase III trial?
Why was the Eftilagimod alfa TACTI-004 trial discontinued according to Dr. Reddy’s (RDY)?
What territories does Dr. Reddy’s subsidiary cover for Eftilagimod alfa under its Immutep deal?
How much has Dr. Reddy’s paid Immutep so far under the Eftilagimod alfa collaboration?
What actions will Immutep take following the TACTI-004 Phase III futility decision?
Does Immutep plan to continue developing Eftilagimod alfa after stopping TACTI-004?
Filing Exhibits & Attachments
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