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The biotech sector continues to be in focus with pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Biogen’s Gene Therapy Studies Disappoint: Biogen Inc. (BIIB - Free Report) announced disappointing results from the phase II/III XIRIUS study of investigational gene therapy, cotoretigene toliparvovec (BIIB112). It was being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa (XLRP), a rare, inherited retinal disease, in the XIRIUS study. The study did not meet its primary endpoint of demonstrating a statistically significant improvement in the proportion of treated study eyes with ≥7 dB improvement from baseline at ≥5 of the 16 central loci of the 10-2 grid assessed by Macular Integrity Assessment (MAIA) microperimetry.
The company said that though the study did not meet the primary endpoint, positive trends were observed in other pre-specified clinically relevant endpoints, such as a measure of visual acuity under low-light conditions. Biogen will decide on the next steps of the program after analyzing the final data set.
Agenus Surges on Bristol-Myers’ Deal: Shares of Agenus (AGEN - Free Report) surged after biotech bigwig Bristol-Myers Squibb Company (BMY - Free Report) entered a global exclusive license agreement with the former for its proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target. Bristol Myers will be entirely responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide. In exchange, Agenus will receive an upfront payment of $200 million and up to $1.36 billion in development, regulatory and commercial milestones, in addition to tiered double-digit royalties on net product sales. It will also retain options to conduct clinical studies under the development plan, combination studies with certain other Agenus pipeline assets, and co-promote AGEN1777 in the United States, upon commercialization.
Regeneron Resumes Enrollment in Study: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has resumed enrollment in its monotherapy studies of pipeline candidate, odronextamab, a CD20xCD3 bispecific antibody. The company resumed enrolling patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in the studies after the FDA agreed to lift the partial clinical trial hold for those patient cohorts. Regeneron paused new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in studies in December 2020, as the FDA had put a partial clinical hold. The agency requested the company to amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. As a result, Regeneron amended the trial protocols and will recommence enrollment in these patient cohorts effective immediately (trials NCT02290951 and NCT03888105).
Sarepta Surges on Positive Data: Shares of Sarepta Therapeutics, Inc. (SRPT - Free Report) surged after it announced positive data from the ENDEAVOR study on investigational gene therapy, SRP-9001, for the treatment of Duchenne muscular dystrophy. The study was conducted in partnership with Roche (RHHBY - Free Report) . Results from the first 11 participants enrolled in the 9001-103 ENDEAVOR study demonstrated robust expression of micro-dystrophin and no new safety signals from prior studies, supporting its potentially differentiated profile for the treatment of Duchenne muscular dystrophy. All patients demonstrated robust transduction, with a mean micro-dystrophin expression of 55.4% of normal, as measured by western blot. Muscle dystrophin levels demonstrated a mean of 70.5% (baseline 12.8%) muscle fibers expressing micro-dystrophin at 12 weeks with a mean intensity at the sarcolemma of 116.9% (baseline 41.0%) compared to normal biopsies, as measured by immunofluorescence.
The Nasdaq Biotechnology Index gained 1.90% in the last five trading sessions. Among the biotech giants, Regeneron gained 3% during the period. Over the past six months, shares of Alexion have surged 41.63%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Q1 Earnings Update, MRNA's Vaccine Data & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Biotech Stock Roundup: AGEN, SRPT Surge & BIIB, REGN Provide Pipeline Updates
The biotech sector continues to be in focus with pipeline and regulatory updates.
Recap of the Week’s Most Important Stories:
Biogen’s Gene Therapy Studies Disappoint: Biogen Inc. (BIIB - Free Report) announced disappointing results from the phase II/III XIRIUS study of investigational gene therapy, cotoretigene toliparvovec (BIIB112). It was being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa (XLRP), a rare, inherited retinal disease, in the XIRIUS study. The study did not meet its primary endpoint of demonstrating a statistically significant improvement in the proportion of treated study eyes with ≥7 dB improvement from baseline at ≥5 of the 16 central loci of the 10-2 grid assessed by Macular Integrity Assessment (MAIA) microperimetry.
The company said that though the study did not meet the primary endpoint, positive trends were observed in other pre-specified clinically relevant endpoints, such as a measure of visual acuity under low-light conditions. Biogen will decide on the next steps of the program after analyzing the final data set.
Agenus Surges on Bristol-Myers’ Deal: Shares of Agenus (AGEN - Free Report) surged after biotech bigwig Bristol-Myers Squibb Company (BMY - Free Report) entered a global exclusive license agreement with the former for its proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target. Bristol Myers will be entirely responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide. In exchange, Agenus will receive an upfront payment of $200 million and up to $1.36 billion in development, regulatory and commercial milestones, in addition to tiered double-digit royalties on net product sales. It will also retain options to conduct clinical studies under the development plan, combination studies with certain other Agenus pipeline assets, and co-promote AGEN1777 in the United States, upon commercialization.
Regeneron Resumes Enrollment in Study: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that it has resumed enrollment in its monotherapy studies of pipeline candidate, odronextamab, a CD20xCD3 bispecific antibody. The company resumed enrolling patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in the studies after the FDA agreed to lift the partial clinical trial hold for those patient cohorts. Regeneron paused new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in studies in December 2020, as the FDA had put a partial clinical hold. The agency requested the company to amend the trial protocols in order to further reduce the incidence of ≥Grade 3 cytokine release syndrome (CRS) during step-up dosing. As a result, Regeneron amended the trial protocols and will recommence enrollment in these patient cohorts effective immediately (trials NCT02290951 and NCT03888105).
Sarepta Surges on Positive Data: Shares of Sarepta Therapeutics, Inc. (SRPT - Free Report) surged after it announced positive data from the ENDEAVOR study on investigational gene therapy, SRP-9001, for the treatment of Duchenne muscular dystrophy. The study was conducted in partnership with Roche (RHHBY - Free Report) . Results from the first 11 participants enrolled in the 9001-103 ENDEAVOR study demonstrated robust expression of micro-dystrophin and no new safety signals from prior studies, supporting its potentially differentiated profile for the treatment of Duchenne muscular dystrophy. All patients demonstrated robust transduction, with a mean micro-dystrophin expression of 55.4% of normal, as measured by western blot. Muscle dystrophin levels demonstrated a mean of 70.5% (baseline 12.8%) muscle fibers expressing micro-dystrophin at 12 weeks with a mean intensity at the sarcolemma of 116.9% (baseline 41.0%) compared to normal biopsies, as measured by immunofluorescence.
Sarepta carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 1.90% in the last five trading sessions. Among the biotech giants, Regeneron gained 3% during the period. Over the past six months, shares of Alexion have surged 41.63%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN's Q1 Earnings Update, MRNA's Vaccine Data & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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