Biotech Stock Roundup: Eleven Bio Slumps on Eye Drug Data …

Biotech Stock Roundup: Eleven Bio Slumps on Eye Drug Data …

Eleven Biotherapeutics (EBIOSnapshot Report) suffered a huge setback with its lead pipeline candidate failing in a late-stage study. Meanwhile, companies like bluebird (BLUESnapshot Report), Agios (AGIOSnapshot Report) and Acceleron (XLRNSnapshot Report) all got encouraging news on the regulatory front. Achillion (ACHNSnapshot Report) struck a collaboration agreement with Johnson & Johnson for its hepatitis C virus (HCV) candidates.

Recap of the Week’s Most Important Stories

1. Eleven Biotherapeutics saw its shares plunging 69.2% on disappointing data from a pivotal late-stage study on its lead pipeline candidate, EBI-005. EBI-005 was being evaluated for the treatment of moderate to severe dry eye disease in the study – the candidate failed to meet either of the two co-primary endpoints (Read more: Eleven Biotherapeutics Tanks after Eye Drug Fails Study).

2. Achillion entered into a collaboration with Johnson & Johnson’s Janssen worth up to $1.1 billion in the form of development, regulatory and sales milestone payments as well as a separate equity investment. The agreement is related to the development and commercialization of one or more of Achillion’s lead hepatitis C virus (HCV) assets which include ACH-3102, ACH-3422, and sovaprevir.

All development as well as commercialization costs will be funded by Janssen. Moreover, Achillion will be entitled to tiered royalties between mid-teens and low-twenties on global sales.

3. bluebird, a clinical stage biotech company focused on the development of transformative gene therapies for severe genetic and rare diseases, could well gain accelerated approval both in the U.S. and the EU for one of its most advanced pipeline candidates, LentiGlobin BB305. The company made this announcement following discussions with regulatory authorities regarding development plans which could lead to accelerated approvals. LentiGlobin BB305 is being developed for the treatment of beta-thalassemia major. Shares were up on the announcement.

Meanwhile, Intercept, focused on the development of treatments for chronic liver diseases, announced its plans for an international phase III study (REGENERATE) to be conducted on its lead pipeline candidate, obeticholic acid (OCA). OCA is being developed for the treatment of patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The study design has been finalized following discussions with the FDA and EMA and could lead to initial approval based on the interim 72-week histology endpoint (approximately 1,400 patients). Full approval would be based on the liver-related outcomes endpoint. OCA has breakthrough designation in the U.S. for this patient population. The study is expected to start next quarter.

4. Celgene (CELGAnalyst Report) saw a couple of its partnered products gain fast track designation from the FDA. While luspatercept is partnered with Acceleron Pharma, AG-120 is partnered with Agios Pharmaceuticals. Luspatercept got fast track status for two indications – the treatment of patients with transfusion dependent beta-thalassemia and the treatment of patients with non-transfusion dependent beta-thalassemia (Read more: Celgene/Acceleron’s Luspatercept Granted Fast Track Status).

Meanwhile, Agios’ AG-120 got fast track status for the treatment of patients with acute myelogenous leukemia (AML) that harbor IDH1 mutations (Read more: Agios Gains on Fast Track Status for Leukemia Drug AG-120). Fast track designation is granted to fasten the development and review of new drugs targeting serious or life-threatening conditions and which have the potential to address unmet medical needs.

5. Regeneron (REGNAnalyst Report) and Sanofi announced positive interim data from a mid-stage study evaluating their experimental asthma treatment, dupilumab. The results were encouraging and the companies said that this phase IIb study could be treated as one of two pivotal efficacy studies needed for filing a biologics license application (BLA) in asthma.

Dupilumab is also being evaluated in a phase III study in patients with uncontrolled persistent asthma – this study will be treated as the second pivotal efficacy study for filing the BLA (Read more: Regeneron/Sanofi Announce Positive Data on Dupilumab).

Performance

Over the last five trading days, Regeneron recorded the highest gain (5.16%) among major biotechs. Biogen saw its shares declining slightly (0.03%) during this period. Biogen, however, was the highest gainer (30.16%) over the last six months. Alexion lost 15.63% during this period.

The NASDAQ Biotechnology Index gained 2.58% over the last five trading days (See the last biotech stock roundup here: Alexion to Buy Synageva, FDA Panel Backs Vertex’s Orkambi).

Company
Last Week
last 6 Months
AMGN
3.36%
1.60%
BIIB
-0.03%
30.16%
GILD
4.74%
8.03%
CELG
2.88%
9.23%
REGN
5.16%
21.41%
ALXN
0.55%
-15.63%
VRTX
3.41%
13.75%

What’s Next in the Biotech World?

With first quarter earnings season coming to an end, watch out for the usual pipeline updates and data presentations from biotech companies.

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Biotech Stock Roundup: Eleven Bio Slumps on Eye Drug Data …

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