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Biotech Stock Roundup: BIIB's Gain on Alzheimer's Data, Regulatory Updates & More

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Positive data released by bigwig Biogen, Inc. (BIIB - Free Report) from a mid-stage study for the treatment of Alzheimer’s disease created a stir in the biotech sector last week. Among other news, Celgene Corporation (CELG - Free Report) reported positive data on a key pipeline candidate from a late-stage study while Axovant (AXON - Free Report) gained on yet another licensing deal.

Recap of Important Stories:

Biogen Soars on Positive Alzheimer’s Study Results: Shares of Biogen soared after the company reported encouraging top-line results from a mid-stage study on pipeline candidate BAN2401 for the treatment of early Alzheimer’s disease (AD). BAN2401, an anti-amyloid beta protofibril antibody, was being evaluated in a phase II study for AD. Biogen is developing BAN2401, a humanized beta amyloid antibody, in collaboration with Japan’s Eisai Co., Ltd. The candidate is being investigated to see whether it can slow the progression of memory problems associated with amyloid. Top-line results of the final analysis of the phase II study (n=856) demonstrated statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) of BAN2401 as compared to placebo. Meanwhile, treatment with this high dose for 18 months also led to reduction of amyloid beta accumulated in the brain. (Read more: Biogen's Alzheimer Disease Candidate Succeeds in Phase II).

The positive results gave investors much reason to cheer as AD has always been a challenging market given the spate of study failures in recent times. So, the abovementioned results are deemed as important breakthrough by Biogen and Eisai in the AD market, raising hopes for a possible cure. 

Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celgene Reports Positive Data on Thalassemia Drug From Late-Stage Study: Celgene Corporation and partner Acceleron Pharma Inc. (XLRN - Free Report) reported positive results from a second randomized, double-blind, multi-center clinical phase III study, BELIEVE, on pipeline candidate, luspatercept. The results show that luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33% reduction from baseline in red blood cell (RBC) transfusion burden with a reduction of at least 2 units during the protocol-defined period of 12 consecutive weeks (from week 13 to week 24) compared to placebo. Moreover, luspatercept also met all key secondary endpoints of demonstrating statistically significant improvements in RBC transfusion burden from baseline of at least a 33% reduction during the period from week 37 to week 48.  Notably, this is the second positive phase III study for the candidate. Last month, both companies announced positive results from another phase III study, MEDALIST, wherein luspatercept met the primary and key secondary endpoints compared to placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anaemia. A third study, BEYOND, is also ongoing and evaluating luspatercept in non-transfusion dependent beta-thalassemia. (Read more: Celgene, Acceleron Report Positive Data on Thalassemia Drug).

Meanwhile, Celgene also announced positive results from a phase III study, IMpassion130, wherein the experimental combination of Roche’s immuno-oncology drug Tecentriq plus Abraxane by the former compared with Abraxane monotherapy, significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced triple negative breast cancer. 

Axovant Gains on Yet Another Gene Therapy Deal: Axovant Sciences’ shares gained after it announced a licensing agreement with Benitec Biopharma. Per the agreement, Axovant licensed exclusive global rights to an experimental Silence-and-Replace gene therapy program from Benitec Biopharma for the treatment of oculopharyngeal muscular dystrophy (OPMD). Axovant will obtain rights to AXO-AAV-OPMD, which will utilize proprietary Silence-and-Replace technology. AXO-AAV-OPMD is an adeno-associated viral (AAV) vector gene therapy delivered via a one-time intramuscular administration, which both silences the mutant PABPN1 gene and replaces it with a functional copy. It is currently in preclinical development stage. Axovant plans to initiate a placebo-controlled clinical study in 2019. The candidate enjoys orphan drug status in both the United States and Europe for the treatment of OPMD.  Both companies have also entered into a research collaboration for the development of five additional gene therapy products in neurological disorders.  The agreement with Benitec will bolster Axovant’s pipeline of innovative gene therapies for serious neurological diseases. (Read more: Axovant, Benitec Gain on Licensing Deal for Gene Therapy)

Idera Announces Termination of Merger Agreement With BioCryst: Idera Pharmaceuticals, Inc. (IDRA - Free Report) announced that the merger agreement with BioCryst Pharmaceuticals has been terminated as the stockholders of the latter voted against the same in a special meeting. Consequently, BioCryst will reimburse Idera $6 million in connection with the termination. Both companies had entered into a merger agreement in January 2018. While BioCryst gained on the news, shares of Idera slumped as the majority of Idera’s stockholders voted in favor of the adoption of the merger agreement.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

 

 

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 4.09% over the last four trading sessions. Among the major biotech stocks, Biogen has gained 15.4%. Over the past six months, Celgene has lost 19.82% while Vertex has gained 11.27%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD's Positive CHMP Nod, Regulatory Updates & More)

 

What's Next in Biotech?

Stay tuned for regulatory updates and pipeline development news.

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