The past week was busy for the biotech sector with quite a few data releases. Biogen BIIB and Conatus CNAT crash on study setbacks while the FDA refused to approve Lexicon’s diabetes candidate. Meanwhile, Gilead’s GILD HIV drug was approved in Japan.
Recap of the Week’s Top Stories:
Biogen Crashes on Alzheimer's Study Failure: Shares of Biogen declined after the company and its Japan-based partner Eisai announced the discontinuation of two late-stage studies, evaluating the joint Alzheimer’s disease candidate, aducanumab. The decision was taken following a futility analysis conducted by an independent data monitoring committee (IDMC). The analysis showed that the studies are unlikely to achieve their primary goals. However, there were no safety issues. Both companies were evaluating aducanumab in two phase III studies, namely ENGAGE and EMERGE in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s indication, dementia. The companies will also halt a phase II study — EVOLVE — and the long-term extension of PRIME phase Ib, which were examining aducanumab. The initiation of the phase III secondary prevention study depends on the further evaluation of data from ENGAGE and EMERGE studies.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Conatus Tumbles as NASH Study Fails: Shares of Conatus Pharmaceuticals Inc. tanked 50.8% in after-hours trading after the company announced dismal top-line results from the phase IIb ENCORE-NF study. The randomized, double-blind ENCORE-NF program was initiated in the first quarter of 2016 on patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis. The study enrolled and treated 318 patients with biopsy-confirmed NASH Clinical Research Network (CRN) fibrosis stages F1-F3 at baseline. Patients enrolled in the study were randomized 1:1:1 to receive 5 mg of emricasan, 50 mg of emricasan or placebo twice daily for 72 weeks. The program was conducted across 87 U.S. and EU sites. Its primary endpoint was a ≥1 CRN fibrosis stage improvement without the worsening of steatohepatitis as compared to placebo at week 72. However, the candidate did not meet its primary endpoint as it lacked the desired effect on the earlier-stage NASH fibrosis patients. Nevertheless, the candidate is also being evaluated in more advanced-stage NASH cirrhosis patients.
Lexicon Falls on CRL to Diabetes Candidate: Shares of Lexicon Pharmaceuticals, Inc. LXRX plunged following a complete response letter (CRL) to the company’s new drug application (NDA), seeking an approval for its lead pipeline candidate, Zynquista (sotagliflozin). Lexicon is developing the candidate in collaboration with Sanofi (SNY). Zynquista is a dual SGLT1 and SGLT2 inhibitor, evaluated in combination with insulin for the treatment of type I diabetes in adult patients. In January, the FDA advisory committee was divided in opinion on supporting the approval for Zynquista. There were concerns about whether the candidate’s overall benefits outweigh the risks. The issuance of a CRL signifies that the FDA cannot accept the NDA in its current form. Further, evaluations or more detailed data may be required for considering the nod for the candidate. Lexicon and Sanofi plan to work with the FDA and determine the future path of development.
Gilead’s Biktarvy Gets Approval in Japan: Gilead Sciences announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy, a once-daily single tablet regimen (STR), for the treatment of HIV-1 infection. The nod was based on data from the four phase III studies, which showed that no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. Bikatarvy is already approved in the United States as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history.
DMC Recommends Amgen to Continue Study on Heart Failure Drug: Amgen, Inc. AMGN, partner Cytokinetics, Incorporated CYTK and Servier announced that the Data Monitoring Committee (DMC) for the phase III study — GALACTIC-HF — recently completed the first planned interim analysis. The study is evaluating if treatment with omecamtiv mecarbil, when added to the standard of care, reduces the risk of the heart failure events (heart failure hospitalization and other urgent treatment for heart failure) and cardiovascular (CV) death in patients suffering chronic heart failure with reduced ejection fraction. The analysis included consideration of pre-specified criteria for futility. The DMC reviewed data from the study and recommended that the study should continue without changes to its conduct.
Alexion Announces Collaborations on Pipeline Development: Alexion Pharmaceuticals, Inc. ALXN announced a collaboration deal with Zealand Pharma A/S to discover and develop the novel peptide therapies for complement-mediated diseases. The agreement provides the company with exclusive worldwide licenses as well as the development and commercial rights for up to four targets within the complement pathway.
Zealand will lead the joint discovery and research efforts through the preclinical stage while Alexion will be in charge of the developmental efforts beginning with an IND filing and the phase I studies. Alexion will make an immediate upfront payment of $25 million to Zealand for the first target along with a $15-million equity investment in the latter. The contract also provides for development-related milestone fees of up to $115 million and up to $495 million in sales-related milestones besides the potential for high single- to low double-digit royalty payments. Alexion also announced a partnership with Affibody AB to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index declined 3.16% in the past five trading sessions. Among the major biotech biggies, Biogen lost 28.1% of value. Over the past six months, shares of Regeneron have rallied 3.60% while the Gilead stock has declined 15.1%. (See the last biotech stock roundup here:Biotech Stock Roundup: REGN Gets FDA Nod for Dupixent & Other Pipeline News)
What's Next in Biotech?
Stay tuned for regular pipeline updates.
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