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Takeda (TAK) Hematology Candidate Fails in Late-Stage Study

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Takeda Pharmaceutical Company Limited (TAK - Free Report) announced that a phase III study evaluating its pipeline candidate, pevonedistat, in hematological disorders failed to reach its primary endpoint. The study evaluated a combination of the candidate with chemotherapy drug, azacitidine, as a first-line treatment for patients with higher-risk myelodysplastic syndromes (“MDS”), chronic myelomonocytic leukemia (“CMML”), and low-blast acute myeloid leukemia (“AML”).

The study’s primary endpoint was improvement in event-free survival (“EFS”) of pre-defined statistical significance, following treatment with pevonedistat plus azacytidine compared to azacytidine alone in study participants. The study defined an event as the first occurrence of death or transformation to AML in participants with higher-risk MDS or CMML, and death in participants with AML.

Shares of Takeda have declined 8.1% so far this year compared with the industry’s decrease of 10.3%.

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The company has a diverse oncology pipeline with multiple candidates targeting hematologic malignancies, other blood cancers, and novel immuno-oncology targets.

The company’s Ninlaro received approval in Japan in May this year as a first-line treatment for multiple myeloma without prior stem cell transplant. Another drug, Alunbrig is approved as a treatment for first-line non-small cell lung cancer (NSCLC) with the ALK fusion gene positive determined by Roche’s (RHHBY - Free Report) companion diagnostic ALK fusion protein kit, Ventana OptiView. Takeda’s third drug, Iclusig is approved for treating certain chronic myeloid leukemia or acute lymphoblastic leukemia patients. Other drugs in the company’s commercial portfolio include Takhzyro and Vonvendi.

The company is seeking label expansion of Vonvendi as a potential prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with von Willebrand disease. A decision is expected early next year.

Meanwhile, a new drug application (NDA) seeking approval for TAK-788 as a potential treatment for metastatic NSCLC is under review in the United States. A decision from the FDA is expected in October 2021. A regulatory application seeking approval of the candidate for a similar indication is also under review in China.

Apart from oncology, the company is also focused on commercializing and developing drugs for treating rare diseases and neurological disorders.

Takeda is seeking approval for its pipeline candidate TAK-620, as a potential treatment for Cytomegalovirus infection, a rare disease. An NDA is under review with the FDA. The company is also developing TAK-994 as a potential treatment for excessive daytime sleepiness, a chronic neurological disorder.

The company is also developing treatments for short bowel syndrome and a vaccine for dengue.

Although the company failed in the late-stage study evaluating the pevonedistat combination regimen, the successful development of other pipeline candidates and potential approval to new drugs will likely boost Takeda’s top line.

Zacks Rank & Stocks to Consider

Takeda currently carries a Zacks Rank #2 (Buy). A couple of other top-ranked stocks in the healthcare space include Repligen Corp. (RGEN - Free Report) and Ironwood Pharmaceuticals (IRWD - Free Report) . While Ironwood currently sports a Zacks Rank #1 (Strong Buy), Repligen carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Ironwood have moved up 18% for 2021 and 45.8% for 2020 in the past 60 days. The stock has gained 50.8% so far this year.

Earnings estimates for Repligen have moved up 22.1% for 2021 and 18% for 2020 in the past 60 days. The stock has gained 50.8% so far this year.