Biotech Stock Roundup: Biogen Gains on Q2 Results, Agios Gets FDA Nod For Leukemia Drug

While the last week was pretty low key for the biotech sector, with a few regulatory updates, the sector is back in focus as bigwig Biogen, Inc. BIIB reported better-than-expected second-quarter results and also upped its guidance. Key regulatory updates include Gilead Sciences, Inc.’s GILD collaboration with Gadeta and Agios Pharmaceuticals, Inc. AGIO obtaining FDA approval for its leukemia drug.

Recap of Important Stories:

Biogen Gains on Better-Than-Expected Q2 Results: Shares of Biogen, Inc. gained 4% after the company reported better-than-expected results for the second quarter. The company topped both sales and earnings estimates on strong sequential growth for key drugs. In particular, sales were strong for Biogen’s newest drug Spinraza (spinal muscular atrophy) as the company experienced a 20% increase in the number of adult Spinraza patients in the United States compared to last quarter. Additionally, the company raised its annual guidance thereby boosting investor sentiment.

Moreover, investors will also look forward to detailed results on Alzheimer's disease candidate, BAN2401, expected later today.  Earlier in the month, Biogen and partner Eisai announced positive topline results of the final analysis at 18 months of the phase II study on BAN2401, a monoclonal antibody that targets amyloid beta aggregates, in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key secondary endpoints evaluating Alzheimer’s Disease Composite Score and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).

Gilead Collaborates With Gadeta, Positive Data on Truvada:  Gilead announced that it has entered into a collaboration with privately-held company Gadeta B.V. for the discovery and development of novel cancer immunotherapies based on gamma delta T cell receptors (TCRs). Per the terms of the agreement, Kite will provide research and development (R&D) funding for the collaboration. In return, Gadeta will be eligible to receive future payments upon achievement of certain regulatory milestones. Moreover, Kite will make an upfront purchase of equity in Gadeta from Gadeta’s shareholders and may acquire additional equity in Gadeta upon achievement of certain R&D milestones. Kite will also have the exclusive option to acquire Gadeta.

Additionally, Gilead also announced results of a retrospective nationwide analysis of the impact of HIV drug Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets) for pre-exposure prophylaxis (PrEP) use across all 50 U.S. states and the District of Columbia. The data demonstrated that the States with highest use of Truvada for PrEP had experienced a significant decline in new HIV infections. The data were presented at the 22ndInternational AIDS Conference (AIDS 2018) in Amsterdam. We note that Gilead is now banking on its HIV franchise to maintain its top-line growth given the persistent decline in HCV infections.

Gilead currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Agios Gets FDA Nod for Leukemia Drug Tibsovo: Agios Pharmaceuticals, Inc. (AGIO) received a major boost when the FDA approved its second drug Tibsovo for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. Per the company, Tibsovo, an oral, targeted inhibitor of the IDH1 enzyme, is the first and only FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Tibsovo is the second IDHm inhibitor approved in less than a year for the company. Agios’ first IDHm inhibitor, Idhifa, was approved by the FDA last August for the treatment of patients with relapsed or refractory AML and an IDH2 mutation. Idhifa was developed in collaboration with Celgene. (Read more: Agios  Secures FDA Approval for Leukemia Drug Tibsovo).

Reata Soars On Positive Data On Kidney Disease Trial: Shares of Reata Pharmaceuticals, Inc. RETA skyrocketed after the company announced positive results from two studies, CARDINAL and PHOENIX, on bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD).   The company reported positive one-year results for the phase II portion of CARDINAL, a study of bardoxolone in patients with CKD due to Alport syndrome. The results showed significantly increased estimated glomerular filtration rate (eGFR) at Week 48 from baseline (n=25) of 10.4 mL/min/1.73 m2 (p<0.0001) in patients treated with bardoxolone. The data demonstrated that one year of bardoxolone treatment can improve kidney function in Alport syndrome patients that have had progressive loss of kidney function while on standard of care. 

The company also reported positive final results for the phase II autosomal dominant polycystic kidney disease (ADPKD) cohort of PHOENIX wherein statistically significant improvement in kidney function was observed in ADPKD patients after 12 weeks of treatment. The data from the study showed significantly increased eGFR at Week 12 from baseline, which was the primary endpoint of the study, in bardoxolone treated patients.  The observed 9.3 mL/min/1.73 m2 improvement after 12 weeks of treatment with bardoxolone represents a recovery of approximately two years of average eGFR loss. The results show the potential of bardoxolone treatment to prevent or delay kidney failure in rare forms of chronic kidney disease.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

 

Medical - Biomedical and Genetics Industry 5YR % Return

 

The NASDAQ Biotechnology Index lost 0.30% over the last five trading sessions. Among the major biotech stocks, Biogen has gained 5.03%. Over the past six months, Celgene has lost 15.5% while Alexion has gained 8.2%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN Resubmits Evenity BLA, Advaxis Soars, Regulatory Updates)

 

What's Next in Biotech?

Stay tuned for Q2 results from bigwigs like Amgen, Gilead, and Celgene among others along with other regulatory updates and pipeline development news.

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