ChemoCentryx Inc. ( CCXI Quick Quote CCXI - Free Report) reported a second-quarter 2021 loss of 56 cents per share, wider than the Zacks Consensus Estimate of a loss of 55 cents. The company had reported earnings of 29 cents per share in the year-ago period.
It recorded revenues of $1.8 million, which missed the Zacks Consensus Estimate of $5 million and decreased from $49.4 million in the year-ago quarter.
Shares of the company have plunged 76.4% year to date compared with the
industry’s decline of 11.3%. Ima ge Source: Zacks Investment Research Quarter in Detail
Collaboration and license revenues from related parties were $1.7 million in the reported quarter compared with $49.3 million in the year-ago quarter.
The company recorded grant revenues of $0.1 million during the quarter.
Research & development (R&D) expenses were $20.8 million, up from $18.8 million in the year-ago quarter, primarily attributable to the manufacture of commercial drug supply in anticipation of the launch of avacopan for the treatment of Antineutrophil Cytoplasmic Autoantibody (ANCA) vasculitis. R&D expenses also increased due to higher research and drug discovery expenses, including those associated with the development of CCX559, its orally-available small molecule checkpoint (PD-1/PD-L1) inhibitor.
ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal phase III study in ANCA-associated vasculitis or AAV and is in late-stage clinical development for the treatment of severe Hidradenitis Suppurativa and C3 glomerulopathy (C3G). A new drug application on avacopan is under review in the United States.
General and administrative expenses were $19.7 million, up from $10.3 million in the year-ago quarter.
The company had $402.6 million in cash, cash equivalents and investments as of Jun 30, 2021.
In May 2021, ChemoCentryx announced the outcome of the FDA Arthritis Advisory Committee on avacopan for the treatment of AAV. The Committee was split 9-9 on the first question whether the efficacy data supports the drug approval, 10-8 on the second question whether the safety profile of avacopan is adequate to support approval and 10-8 on the final question whether the benefit-risk profile is adequate to support the drug’s approval at the proposed dose of 30 mg twice daily.
In July 2021, the company announced the filing of additional information to its NDA submission, which the FDA deemed to be a major amendment. The PDUFA review period for avacopan in the treatment of AAV was extended. The agency set a new PDUFA goal date of Oct 7, 2021. The company’s filing followed the outcome of the meeting of the FDA’s Arthritis Advisory Committee.
During the second quarter, the company initiated phase I clinical development of CCX559, a novel, orally-administered, PD-1/PD-L1 checkpoint inhibitor.
ChemoCentryx plans to meet with the FDA to discuss the phase III development of avacopan in patients with Hurley Stage 3 (severe) Hidradenitis Suppurativa (HS) with the goal of initiating a phase III study in those patients.
ChemoCentryx plans to initiate clinical development of avacopan in patients with lupus nephritis in the first half of 2022.
The company also plans to schedule a meeting later this year with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of avacopan in the very rare disorder C3G.
Zacks Rank and Stocks to Consider
ChemoCentryx currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are
Horizon ( HZNP Quick Quote HZNP - Free Report) , Vertex Pharmaceuticals ( VRTX Quick Quote VRTX - Free Report) and Repligen, Inc. ( RGEN Quick Quote RGEN - Free Report) . While Repligen carries a Zacks Rank #2 (Buy), Horizon and Vertex sport a Zacks Rank #1 (Strong Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Earnings estimates for Horizon for 2021 have moved up 43 cents in the past seven days. The stock is up 43.6% year to date.
Earnings estimates for Vertex for 2021 have moved up 20 cents in the past seven days.
Earnings estimates for Repligen for 2021 have gone up 43 cents in the past 30 days. The stock is up 33.8% year to date.