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Biotech Stock Roundup: FDA Gives Nod to Amgen's Drugs, EU Approves Exelixis' Cabometyx

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The Biotech space remained a key area of investors’ focus with label expansion of a few prominent drugs and pipeline updates on a few others. While Amgen obtained the FDA approval for Prolia and Repatha, Exelixis also obtained approval for its lead drug Cabometyx for the first-line treatment of kidney cancer in Europe.

Recap of Important Stories

Label Expansion of Amgen’s Drugs: It is raining approvals at Amgen (AMGN - Free Report) . The FDA approved the label expansion of Prolia for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. 

Notably, this is the fifth indication for Proloa in men and women at high risk of fracture receiving systemic glucocorticoid therapy. The approval was based on positive data from a phase III study, which showed that patients on glucocorticoid therapy who received Prolia had greater gains in bone mineral density (BMD) compared with those who received active comparator (risedronate).

Last week, Amgen obtained approval for a label expansion of Repatha in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels in Europe.  Amgen and partner Novartis also obtained the FDA approval of migraine drug, Aimovig (erenumab). (Read more:  Amgen's Label Expansion Application for Prolia Gets FDA Nod, Amgen's Repatha Gains EU Nod to Include Outcomes Data).

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

Exelixis Gets EU Approval For Cabometyx: Exelixis (EXEL - Free Report) announced that its partner Ipsen has obtained approval from the European Commission (EC) for kidney cancer drug, Cabometyx (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union.

The approval will broaden the geographic reach of the drug as the market potential is significant for the first-line treatment of kidney cancer. The approval also triggered a milestone payment of $50 million to Exelixis from Ipsen of which approximately $46 million was recognized as collaboration revenue in the first quarter of 2018. The payment will be made by Ipsen within the next 70 days. (Read more: Exelixis' Cabometyx Gets EU Nod for First-Line Kidney Cancer)

Regeneron Announces Data on Dupixent: Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that a pivotal phase III trial evaluating Dupixent for the treatment of moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met its primary and key secondary endpoints. The results show that Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures.

The New England Journal of Medicine (NEJM) also published detailed results from two phase III trials (QUEST and VENTURE) on Dupixent for the treatment of moderate-to-severe asthma. The results showed that Dupixent significantly reduced the risk of severe asthma attacks (exacerbations), improved lung function and reduced dependence on oral corticosteroids (OCS).

The drug also demonstrated significant improvements in the key primary and secondary endpoints across the overall populations in both QUEST and VENTURE studies. Patients with more severe type 2 inflammatory asthma experienced the greatest benefit. (Read more: Sanofi Eczema Drug Dupixent Succeeds in Adolescents Study)

Both the companies also announced that data evaluating cemiplimab as a potential treatment for advanced non-small cell lung cancer (NSCLC) from a phase I will be shared at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

Lexicon/Sanofi’s Drug Accepted by FDA: Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) and partner Sanofi announced that the FDA has accepted the New Drug Application (NDA) for diabetes drug Zynquista (sotagliflozin). Zynquista is an investigational oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose), resulting in improved glucose control and additional clinical benefits.

The FDA action date is expected to be Mar 22, 2019 under the Prescription Drug User Fee Act (PDUFA). Earlier in 2018, Sanofi also submitted a regulatory application to the European Medicines Agency.

Nabriva Therapeutics Announces Positive Data on Lefamulin: Nabriva Therapeutics plc (NBRV - Free Report) announced positive top-line results from the phase III trial, LEAP (Lefamulin Evaluation Against Pneumonia) 2, on lefamulin. The trial evaluated the safety and efficacy of five days of oral lefamulin compared with seven days of oral moxifloxacin in adult patients with moderate community-acquired bacterial pneumonia (CABP).

Lefamulin met the FDA primary endpoint of non-inferiority compared with moxifloxacin for early clinical response (ECR) assessed 72-120 hours following initiation of therapy with the intent to treat (ITT) patient population. The company plans to file a New Drug Application with the FDA in the fourth quarter of 2018. However, the stock fell as investors were wary of the rate of treatment-emergent adverse events observed in the lefamulin arm.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index lost 0.74% over the last five trading sessions. Among the major biotech stocks, Gilead gained 0.41%. Over the past six months, Celgene lost 27.15%, while Alexion gained 10.60% (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN, VRTX Post Solid Results, GILD Disappoints in Q1).

 

What's Next in Biotech?

Stay tuned for regulatory updates and pipeline development news.

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