Biotech Stock Roundup: GILD's Positive CHMP Nod, Regulatory Updates & More

It’s been a pretty low-key week for the biotech sector, with not too many major updates. Among the key news, Gilead’s GILD CAR-T therapy won CHMP positive opinion, while Keryx Biopharmaceuticals KERX plunged on merger news.

Recap of Important Stories:

Gilead’s CAR-T Therapy Gets Positive CHMP Opinion: Gilead announced that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion on the company’s Marketing Authorization Application ("MAA") for CAR T therapy, axicabtagene ciloleucel, as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ("DLBCL") and primary mediastinal large B-cell lymphoma ("PMBCL"), after two or more lines of systemic therapy. Axicabtagene ciloleucel, a chimeric antigen receptor T cell (CAR T) therapy, modifies a patient’s own T cells to recognize and attack cancer cells.

The agency had granted PRIME status to axicabtagene ciloleucel in May 2016. A tentative approval is in the cards as the EMA generally takes the CHMP recommendation into account while reviewing any MAA. We note that axicabtagene ciloleucel was approved by the FDA in October 2017 as Yescarta.

An approval in Europe will boost the growth prospects of the therapy, given the market potential. Per the information provided by the company, there are estimated 7,700 patients with DLBCL, who are refractory to or have relapsed after two or more lines of the therapy and may be eligible for CAR T therapy in Europe. (Read more: Gilead's CAR T Therapy Gets Positive CHMP Opinion)

Amgen Announces Results on Remicade Biosimilar and Migraine Drug: Amgen, Inc. AMGN announced results from a phase III study, which evaluated the efficacy and safety of biosimilar candidate ABP 710 to branded drug Remicade. The results confirm ABP 710 was non-inferior compared to Remicade based on its primary endpoint, which was an assessment of ACR20 at week 22.

The ACR (American College of Rheumatology) criteria are used to measure the effectiveness of various arthritis medicines in clinical studies.  An ACR20 score means that a person's RA has improved by 20%. Remicade is approved for the treatment of moderate-to-severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate-to-severe Crohn's disease, moderate-to-severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis. We note that Amgen has a broad portfolio of 10 biosimilars, of which two are approved in the United States and three are approved in the European Union.

In addition, Amgen announced encouraging results from two open-label extension (OLE) studies on migraine drug, Aimovig. Results from a one-year study in chronic migraine patients reinforced the established safety and efficacy profile of Aimovig in long-term use. Moreover, a three-year interim analysis from an ongoing five-year study of episodic migraine patients also reinforced the long-term safety and tolerability of Aimovig.

Amgen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celgene Reports Positive Data on Luspatercept: Celgene Corporation CELG and partner Acceleron Pharma XLRN announced positive top-line results from a phase III, multi-center study (MEDALIST) which evaluated the efficacy and safety of luspatercept versus placebo in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent (ESA), ring sideroblast-positive and require frequent red blood cells (RBC)  transfusions.

The study showed that luspatercept achieved a highly statistically significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least eight consecutive weeks during the first 24 weeks compared to placebo. The candidate also met the key secondary endpoint of demonstrating a highly statistically significant improvement in RBC transfusion independence of at least 12 consecutive weeks during the first 24 weeks.

The study also achieved modified hematologic improvement-erythroid (IWG mHI-E), a meaningful secondary endpoint. Regulatory submissions are planned in the United States and Europe in the first half of 2019.  (Read more: Celgene's Luspatercept Meets Primary Endpoint in the Study)

Keryx Plunges on Merger Deal with Akebia: Shares of Keryx Biopharmaceuticals, Inc. plunged following announcement of a definitive merger agreement with Akebia Therapeutics, Inc. AKBA. Both companies have agreed to combine in an all-stock merger and form a new, fully integrated company focused on chronic kidney diseases (or CKD) called Akebia Therapeutics.

The deal is expected to close by the end of 2018. While Keryx already has an FDA approved drug Auryxia in its kitty, Akebia has a late-stage candidate in its pipeline. However, investors were not much impressed with the merger news and shares of both companies fell. (Read more: Keryx Inks Merger Deal With Akebia, Shares Fall)

Cara Therapeutics Rallies On Positive Results: Shares of Cara Therapeutics, Inc. CARA soared after the company announced positive top-line data from the adaptive phase II/III trial of intravenous (IV) CR845 in patients undergoing abdominal surgeries. The IV form of CR845 achieved statistical significance for the study’s primary endpoint of pain relief over the 0 to 24-hour (AUC 0-24) period post-surgery for combined surgeries at the 1.0 mcg/kg dose (p=0.032).

In addition, the treatment with the same also resulted in statistically significant reductions in the secondary endpoint of incidence of nausea and vomiting at 24-hours post-surgery for both the 0.5 and 1.0 mcg doses (p=0.006; p<0.0001 respectively). The data demonstrate the overall benefit of CR845 in both providing pain relief across surgery types up to 24 hours post-surgery and reducing post-operative nausea and vomiting, a significant medical need in the post-operative setting. The brand name for the drug is Korsuva.

The company had earlier inked a licensing deal with Vifor Fresenius Medical Care Renal Pharma Ltd. whereby it licensed worldwide rights, to commercialize Korsuva (CR845/difelikefalin) injection for the treatment of chronic kidney disease.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 1.10% over the last five trading sessions. Among the major biotech stocks, Vertex has gained 10.7%. Over the past six months, Celgene has lost 27.94% while Vertex has gained 10.34%. (See the last biotech stock roundup here: Biotech Stock Roundup: PBYI Soars, MACK Crashes, GILD's Biktarvy Gets EC Nod).

What's Next in Biotech?

Stay tuned for regulatory updates and pipeline development news.

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