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Infinity (INFI) at 52-Week Low on Disappointing Duvelisib Data
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Infinity Pharmaceuticals, Inc.’s shares plunged 69.2% to hit a new 52-week low, after the company announced unfavorable data from the phase II DYNAMO study on its lead candidate, duvelisib, for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL).
The DYNAMO study was evaluating the safety and efficacy of duvelisib (25 mg), administered twice daily as monotherapy, in patients with follicular lymphoma (FL), small lymphocytic lymphoma (SLL) or marginal zone lymphoma whose disease has progressed and who are refractory to Rituxan (rituximab) and to either chemotherapy or radioimmunotherapy.
Data revealed that duvelisib demonstrated an overall response rate of 46%, all partial responses and below expectations. Side effects were, however, reportedly reversible and clinically manageable.
Infinity Pharma said that it is planing to seek feedback from the FDA to determine the path forward with respect to duvelisib in the iNHL indication.
We note that Infinity Pharma has a collaboration and license agreement with AbbVie Inc. (ABBV - Free Report) for the development and commercialization of duvelisib in oncology indications. Currently, the companies are in discussions to explore the next steps for the parties' collaboration. As a result of the pending resolution, the companies have decided to halt a phase Ib/II study on duvelisib, which was evaluating the candidate in combination with Venclexta (venetoclax) for the treatment of relapsed or refractory indolent or aggressive NHL, chronic lymphocytic leukemia (CLL), or SLL.
Meanwhile, Infinity Pharma said that it will initiate a restructuring process, under which it has decided to shut down its discovery research organization. The move is estimated to impact 21% or 46 members, of the company’s workforce.
In addition, Infinity Pharma stated that its previously announced financial guidance for 2016 is no longer applicable. The company plans to provide an updated guidance, following the resolution of its strategic activities.
Our Take
The results of the DYNAMO study are highly disappointing as the company is heavily dependent on duvelisib for growth. Further, we remain concerned on the Infinity Pharma’s future alliance with AbbVie.
Note that Infinity Pharma is not new to pipeline setbacks. Earlier, the company had to discontinue the development of duvelisib in the rheumatoid arthritis indication after the candidate failed to meet the primary endpoint in the phase II ASPIRA study.
Currently, duvelisib is being evaluated for the treatment of previously treated FL (DYNAMO+R – phase III) and relapsed/refractory CLL (DUO – phase III).
Going ahead, we expect investors to focus on further details related to the development of duvelisib in other indications.
Infinity Pharma currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , both sporting a Zacks Rank #1 (Strong Buy).
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Infinity (INFI) at 52-Week Low on Disappointing Duvelisib Data
Infinity Pharmaceuticals, Inc.’s shares plunged 69.2% to hit a new 52-week low, after the company announced unfavorable data from the phase II DYNAMO study on its lead candidate, duvelisib, for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL).
The DYNAMO study was evaluating the safety and efficacy of duvelisib (25 mg), administered twice daily as monotherapy, in patients with follicular lymphoma (FL), small lymphocytic lymphoma (SLL) or marginal zone lymphoma whose disease has progressed and who are refractory to Rituxan (rituximab) and to either chemotherapy or radioimmunotherapy.
Data revealed that duvelisib demonstrated an overall response rate of 46%, all partial responses and below expectations. Side effects were, however, reportedly reversible and clinically manageable.
INFINITY PHARMA Price
INFINITY PHARMA Price | INFINITY PHARMA Quote
Infinity Pharma said that it is planing to seek feedback from the FDA to determine the path forward with respect to duvelisib in the iNHL indication.
We note that Infinity Pharma has a collaboration and license agreement with AbbVie Inc. (ABBV - Free Report) for the development and commercialization of duvelisib in oncology indications. Currently, the companies are in discussions to explore the next steps for the parties' collaboration. As a result of the pending resolution, the companies have decided to halt a phase Ib/II study on duvelisib, which was evaluating the candidate in combination with Venclexta (venetoclax) for the treatment of relapsed or refractory indolent or aggressive NHL, chronic lymphocytic leukemia (CLL), or SLL.
Meanwhile, Infinity Pharma said that it will initiate a restructuring process, under which it has decided to shut down its discovery research organization. The move is estimated to impact 21% or 46 members, of the company’s workforce.
In addition, Infinity Pharma stated that its previously announced financial guidance for 2016 is no longer applicable. The company plans to provide an updated guidance, following the resolution of its strategic activities.
Our Take
The results of the DYNAMO study are highly disappointing as the company is heavily dependent on duvelisib for growth. Further, we remain concerned on the Infinity Pharma’s future alliance with AbbVie.
Note that Infinity Pharma is not new to pipeline setbacks. Earlier, the company had to discontinue the development of duvelisib in the rheumatoid arthritis indication after the candidate failed to meet the primary endpoint in the phase II ASPIRA study.
Currently, duvelisib is being evaluated for the treatment of previously treated FL (DYNAMO+R – phase III) and relapsed/refractory CLL (DUO – phase III).
Going ahead, we expect investors to focus on further details related to the development of duvelisib in other indications.
Infinity Pharma currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , both sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>