Biotech Stock Roundup: AMGN Resubmits Evenity BLA, Advaxis Soars, Regulatory Updates

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It was a low-key week for the dynamic biotech sector, with just a few regulatory updates. Bigwig Amgen AMGN was in the news for resubmiting its BLA for Evenity. Meanwhile, shares of Advaxis ADXS soared after the FDA lifted its clinical hold on the mid-stage study.

Recap of Important Stories :

Amgen Resubmits BLA For Evenity : Amgen and partner UCB announced that they have resubmitted their Biologics License Application ("BLA") to the FDA for pipeline candidate Evenity. The candidate is an investigational monoclonal antibody, which is being evaluated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Evenity treats osteoporosis by increasing bone mineral density ("BMD") and reduces the risk of fracture. The marketing applications for Evenity are currently in review in Europe and Japan. We remind investors that the first BLA seeking approval of Evenity for the same indication in the United States was issued a complete response letter ("CRL") by the FDA in July 2017. The BLA included data only from the FRAME study. However, the FDA then requested a resubmission of the application with additional data from the ARCH and the BRIDGE studies. Hence, the second BLA now includes data from the ARCH and BRIDGE studies. (Read more: Amgen Resubmits BLA to FDA for Osteoporosis Candidate Evenity)

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

Advaxis Soars As FDA Lifts Clinical Hold On Oncology Trial : Shares of late-stage biotechnology company Advaxis soared as it announced that the FDA has lifted the clinical hold on its Investigational New Drug ("IND") application for its phase I/II study of axalimogenefilolisbac ("AXAL") in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. The hold was put in place in March 2018 after the company reported of a patient death to the FDA. A patient died on Feb 27, post-dosing, involving acute respiratory failure after nine months of combination therapy. Consequently, new guidelines for the early detection and treatment of such rare events were agreed to with the FDA and will be implemented for this combination study.

Array BioPharmaGets NCCN Recommendation : Array Biopharma ARRY reported that the National Comprehensive Cancer Network ("NCCN") has updated the Clinical Practice Guidelines in Oncology for Melanoma to include BraftovI in combination with Mektovi as a Category 1 first-line and second-line treatment option for patients with BRAF or BRAF-mutant metastatic or unresectable melanoma. The FDA had approved the combination in June 2018 for the treatment of patients with unresectable or metastatic melanoma with the above-mentioned mutations. A Category 1 recommendation indicates that, based on high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

Akcea Gets Approval OfTegsed in Europe : Akcea Therapeutics, Inc. AKCA , an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. IONS , announced that the European Commission has approved Tegsedi for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). An approval was in the cards as the Committee for Medicinal Products for Human Use ("CHMP") of European Medicines Agency ("EMA") had given a positive opinion on the same. Tegsedi is under review in the United States, with a Prescription Drug User Fee Act (PDUFA) date on Oct 6, 2018. We note that Akcea licensed the worldwide rights to commercialize Tegsedi from Ionis in April. Following EC's approval, Ionis will receive a $40 million milestone payment from Akcea.


Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 1.45% over the last five trading sessions. Among the major biotech stocks, Vertex has gained 4.27%. Over the past six months, Celgene has lost 15.8% while Vertex has gained 16.3%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB's Gain on Alzheimer's Data, Regulatory Updates & More )

What's Next in Biotech?

Stay tuned for regulatory updates and pipeline development news. Investors will also be gearing up for Q2 results as a few biotech bigwigs report results next week.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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