Alnylam (ALNY - Analyst Report) , focused on developing novel therapeutics based on RNA interference (RNAi), saw its shares slump on its decision to discontinue the development of a late-stage pipeline candidate. Meanwhile, several biotech companies were present at the congress of the European Society for Medical Oncology (ESMO) with data on their cancer treatments.
Recap of the Week’s Most Important Stories
Alnylam Plunges on Revusiran Discontinuation: Alnylam suffered a major blow related to the development of one its phase III candidates. The company said that it will not be continuing with the development of a late-stage pipeline candidate, revusiran. The data monitoring committee for the phase III ENDEAVOUR study conducted a review following reports of new onset or worsening peripheral neuropathy in some revusiran phase II OLE patients. While no conclusive evidence for a drug-related neuropathy signal was found in the ENDEAVOUR study, the committee found that the benefit-risk profile for revusiran no longer supported continued dosing. Alnylam’s shares slumped 48.5% on the news and touched a 52-week low as well.
Revusiran, an investigational RNAi therapeutic, was being developed for the treatment of hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM). Alnylam said that the discontinuation of revusiran will not affect its other RNAi programs including patisiran, currently in late-stage development for the treatment of hATTR amyloidosis with polyneuropathy (hATTR-PN). Top-line data from this study is expected in mid-2017 (Read more: Alnylam Discontinues Phase III Study on Revusiran).
TESARO PARP Inhibitor Data Impresses: TESARO’s (TSRO - Snapshot Report) shares shot up 18.8% and hit a 52-week high on the presentation of data on its PARP inhibitor, niraparib, for recurrent ovarian cancer at ESMO. The candidate fared well in the study cohorts – median progression free survival (PFS) in the gBRCAmut cohort was 21 months compared to 5.5 months (niraparib versus control), 9.3 months compared to 3.9 months in the non-gBRCAmut cohort (niraparib versus control) and 12.9 months compared to 3.8 months (niraparib versus control) in the non-gBRCAmut cohort for patients with HRD-positive tumors. The results are encouraging – with ovarian cancer being the fifth most frequent cause of cancer death among women, there is significant need for new therapeutic options that prolong response.
TESARO has started the rolling NDA submission for niraparib with the submission expected to complete in the fourth quarter and the European submission is also planned for the fourth quarter.
Clovis & Incyte Also Present Data at ESMO: Clovis (CLVS - Analyst Report) , which is focused on bringing cancer treatments to market, was also present at ESMO with efficacy and safety data on rucaparib. Rucaparib is currently under priority review in the U.S. (monotherapy treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations who have been treated with two or more chemotherapies) with a response expected on Feb 23, 2017.
Meanwhile, Incyte (INCY - Analyst Report) presented additional phase I data from the ECHO-202 study in treatment-naïve patients with advanced or metastatic melanoma who were treated with Incyte’s selective IDO1 enzyme inhibitor epacadostat plus Merck’s anti-PD-1 therapy Keytruda. While median PFS is yet to be reached, the updated data showed that the combination led to PFS rates of 74% and 57% at 6 months and 12 months, respectively.
An increase in the complete response (CR) rate (26%) was also observed while the objective response rate (ORR) and disease control rate (DCR) remained consistent with the previously published abstract data, at 58% and 74%, respectively. Incyte is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Sarepta Declines on DMD Drug Coverage News: Sarepta’s (SRPT - Analyst Report) shares declined on news that health insurer Anthem, Inc. said that the use of the company’s recently launched Duchenne muscular dystrophy (DMD) drug, Exondys 51, is considered investigational and not medically necessary for all indications, including but not limited to the treatment of DMD.
Sarepta had previously said that it expects Exondys 51’s net annual cost to be about $300,000 taking into account the weight-based dosing in the product label and the typical expected patient age and weight over time.
Medical - Biomedical and Genetics Industry Price Index
The NASDAQ Biotechnology Index declined 3.8% over the last five trading days. All major biotech stocks recorded a decline with Vertex (VRTX - Analyst Report) declining 5.5% and Gilead 4.4%. Over the last six months, Biogen (BIIB - Analyst Report) was up 12.5% while Gilead lost 22.9% (See the last biotech stock roundup here: Summit Soars on Sarepta Deal, Regeneron Presents Data).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates from biotech companies.
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