Earnings took centerstage for the biotech sector this week, with quite a few bigwigs like Gilead Sciences (GILD - Free Report) , Vertex Pharmaceuticals (VRTX - Free Report) and Celgene (CELG - Free Report) coming up with fourth-quarter results. Apart from these, regular pipeline updates and data read outs were also in the news.
Recap of the Week’s Top Stories:
Celgene, Alexion Beat, Gilead Disappoints in Q4: Earnings were in focus in the week as quite a few bigwigs were out with their Q4 results. Celgene reported better-than-expected results for the fourth quarter of 2018, led by an increase in psoriasis drug sales, Otezla. Lead drug, Revlimid too maintained momentum for the company. Alexion beat on both earnings and sales driven by increased sales of Soliris, Strensiq and Kanuma. However, results were mixed for Gilead Sciences, Inc. as the company missed on earnings but beat on sales. Vertex too beat on earnings.
Celgene currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes Down as FDA Refuses to Approve Drug: Shares of Alkermes, plc (ALKS - Free Report) were down after the FDA issued a Complete Response Letter (“CRL”) related to its new drug application (“NDA”) for ALKS 5461. The NDA sought approval for the candidate as an adjunctive treatment of major depressive disorder (“MDD”). The regulatory authority refused to approve the drug due to lack of evidence supporting efficacy of the oral medication. Moreover, the FDA requested for additional clinical data to demonstrate substantial evidence of the effectiveness of ALKS 5461 for the proposed indication. The company is planning to meet with the FDA to discuss the issues raised in the CRL and future steps related to the development of ALKS 5461.
AVEO Oncology Crashes On Delayed NDA: Shares of AVEO Oncology (AVEO - Free Report) plunged after the company announced that it will delay submission (“NDA”) seeking approval for its kidney cancer drug, Fotivda. The company decided not to submit a NDA in the United States after the FDA expressed its dissatisfaction with the preliminary overall survival (“OS”) data reported along with the topline TIVO-3 study data on progression-free-survival in November 2018. The phase III TIVO-3 study is evaluating Fotivda in highly refractory advanced or metastatic renal cell carcinoma (“RCC”) patients compared to Nexavar. The FDA informed the company that the preliminary OS data was not sufficient to alleviate the concerns related to potential detriment in OS raised in the complete response issued earlier in 2013 for similar application. The FDA’s recommendation indicates that it required additional data for approving the drug.
Alexion Collaborates With Caelum Biosciences: Alexion Pharmaceuticals, Inc. announced a collaboration to develop CAEL-101 for light chain (AL) amyloidosis to diversify its clinical-stage rare hematology portfolio. A first-in-class amyloid fibril targeted therapy, CAEL-101, is designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis. Per the terms, Alexion will acquire a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on phase II data for pre-negotiated economics. In exchange, Alexion will make payments to Caelum totaling up to $60 million, including the purchase price for the equity and milestone-dependent development funding payments. The collaboration also provides for potential additional payments of up to $500 million, including the upfront and regulatory and commercial milestone payments, in the event Alexion exercises the acquisition option. Both companies will collaborate on the design of the ongoing development program for CAEL-101. Caelum will be responsible for conducting the development program through the end of phase II and for manufacturing CAEL-101.
CHMP Positive for Label Expansion of Praluent: Regeneron (REGN - Free Report) and partner Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the label expansion of Praluent (alirocumab) Injection. The committee recommended a new indication to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors in adults with established atherosclerotic cardiovascular disease (ASCVD). The recommendation was based on data from a phase III cardiovascular outcomes trial, ODYSSEY OUTCOMES, which evaluated the effect of Praluent in 18,924 patients, who had an ACS between 1-12 months (median 2.6 months) before enrolling in the trial. A decision from the EC is expected in the coming months. Meanwhile, data from ODYSSEY OUTCOMES has also been submitted to the FDA with a target action date of Apr 28, 2019. We note that Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or ASCVD who require additional lowering of LDL-C.
The NASDAQ Biotechnology index gained 2.49% in the last five trading sessions. Among the major biotech stocks, Gilead lost 2.74%. Over the past six months, shares of Regeneron have rallied 7.95%, while Gilead has dropped 11.7% (See the last biotech stock roundup here: Biotech Stock Roundup: Amgen, Vertex Get EC Nod for Label Expansion of Drugs)
What's Next in Biotech?
Stay tuned for more earnings updates.
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