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Biotech Stock Roundup: Arena Shoots Up on Study Data, CELG Inks Immuno-Oncology Deal

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Key highlights this week include Arena’s ARNA data on its experimental pulmonary arterial hypertension (PAH) drug while Celgene CELG struck a deal with the aim of speeding up its immuno-oncology (IO) strategy in solid tumors.

Recap of the Week’s Most Important Stories

Arena Soars on Phase II Data: Arena’s shares shot up on positive mid-stage data on its investigational treatment for PAH. The company said that ralinepag showed a significant improvement in pulmonary vascular resistance while safety data was consistent with other drugs acting through the prostacyclin receptor-mediated effects. A numerical improvement in 6-minute walk distance (6MWD) was also observed. Arena’s shares were up 41.4% — ralinepag is one of the most advanced candidates in the company’s pipeline (Read more: Arena's Ralinepag Positive in Phase II PAH Study, Shares Up).

Celgene in IO Collaboration with BeiGene: Celgene is teaming up with BeiGene for the development and commercialization of BeiGene's investigational anti-PD-1 inhibitor, BGB-A317, for patients with solid tumor cancers in the U.S., Europe, Japan and rest of world outside Asia. Exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally and for solid tumors in Asia (with the exception of Japan) will be retained by BeiGene. BeiGene will also acquire Celgene's commercial operations in China and get an exclusive license to commercialize Celgene's approved therapies in China – Abraxane, Revlimid and Vidaza.

Celgene will pay upfront licensing fees totaling $263 million, and will make a $150 million equity investment in BeiGene and could also shell out up to $980 million in milestone payments and royalties on future sales of BGB-A317. With this deal, scheduled to close in 3Q, Celgene is looking to speed up its immuno-oncology strategy in solid tumors (Read more: Celgene, BeiGene Team Up For PD-1 Inhibitor in China).

Ocular Drug Gets another CRL: Ocular OCUL received another complete response letter (CRL) from the FDA for Dextenza for the treatment of ocular pain following ophthalmic surgery. The CRL pointed out deficiencies in manufacturing processes and analytical testing related to manufacture of the product for commercial use. Ocular had got an FDA Form 483 following a re-inspection of manufacturing operations that was completed in early May 2017.

The company had submitted a response to the agency regarding these issues on Jul 10, 2017 but the FDA did not get the time to review the same before issuing the CRL. This is the second CRL for Dextenza with the earlier one being received in Jul 2016. Importantly, the FDA has not asked for additional studies or pointed out any efficacy or safety concerns.

Amicus to File Migalastat NDA in 4Q: Amicus’ FOLD shares shot up 25.9% on news that it plans to seek FDA approval for its oral precision medicine migalastat for Fabry disease in the fourth quarter of 2017. The company said that it received permission from the FDA to go ahead with the submission. The NDA will be submitted under Subpart H, which allows accelerated approval and the company need not conduct an additional phase III study for gastrointestinal (GI) symptoms which had been requested earlier by the agency. We note that migalastat is approved in the EU under the trade name Galafold. Amicus’ shares are up 160% year-to-date (YTD), outperforming the Zacks-categorized Medical-Biomedical/Genetics industry which is up 6.6%.

Full FDA Approval for Amgen’s Blincyto: Amgen’s AMGN leukemia drug, Blincyto’s label now includes overall survival data. Moreover, with this inclusion, Blincyto’s accelerated approval in the U.S. has now been converted to full approval. Blincyto is approved for certain patients with relapsed or refractory acute lymphoblastic leukemia (ALL). The inclusion of the overall survival data should help boost sales. Results from a late-stage study showed that median overall survival for patients on Blincyto was 7.7 months compared to 4 months for standard of care (SOC) chemotherapy. While Amgen is a Zacks Rank #3 (Hold) stock, you can see the complete list of today’s Zacks #1 Rank stocks here.

Performance

Medical – Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 0.2% over the last five trading sessions. Among major biotech stocks, Vertex VRTX gained 3.1% while Gilead GILD lost 1.9%. Over the last six months, Vertex was up 61.3% while Biogen was down 9% (See the last biotech stock roundup here: Cara Plunges on Study Data, Regulatory Updates & More).


What's Next in the Biotech World?

Watch out for the usual pipeline updates and data presentations from biotech companies. The FDA’s Oncologic Drugs Advisory Committee will be meeting on Jul 13 to discuss Amgen’s regulatory application for its biosimilar version of Roche’s cancer drug Avastin (bevacizumab). Amgen will also get a response regarding its experimental osteoporosis drug, Evenity, by Jul 19. However, given the emergence of a new safety event, Amgen will most likely get a CRL.

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