It was a busy week for the biotech sector as the fourth-quarter earnings season kicked in. While Regeneron REGN gained following the announcement, Amgen AMGN was in the red. Meanwhile, other pipeline and regulatory updates were also in focus.

Recap of the Week’s Most Important Stories:

Regeneron, Amgen’s Q4 Results

Regeneron reported earnings per share (EPS) of $12.07, which beat the Zacks Consensus Estimate of $11.62. The company recorded an EPS of $11.86 in the year-ago period. The upside in the bottom line can be attributed to higher revenues. Total revenues increased 10% year over year to $3.79 billion, fueled by increased collaboration revenues from Sanofi for Dupixent, and higher Eylea HD and Libtayo sales. Revenues marginally beat the Zacks Consensus Estimate of $3.78 billion.

Regeneron also announced the initiation of a quarterly cash dividend program and declared a dividend of $0.88 per share. The dividend is payable on March 20, 2025, to shareholders of record as of Feb. 20, 2025. The board also authorized an additional $3.0 billion share repurchase program, bringing the total current capacity to approximately $4.5 billion.

Shares gained 4.5% in response to better-than-expected results and the initiation of a quarterly dividend program.

Amgen reported fourth-quarter 2024 adjusted earnings of $5.31 per share, which beat the Zacks Consensus Estimate of $5.03. Earnings rose 13% year over year as higher revenues were partially offset by higher operating costs.

Total revenues of $9.1 billion also beat the Zacks Consensus Estimate of $8.9 billion. Total revenues rose 11% year over year.

Along with the earnings release, Amgen announced that the FDA has put a clinical hold on a phase I study on its obesity candidate, AMG 513. Shares were trading down post the results due to this setback.

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

VRTX Stock up on FDA Nod for Drug

Vertex VRTX obtained FDA approval for its oral, non-opioid, highly selective NaV1.8 pain signal inhibitor, suzetrigine, for the treatment of adults with moderate-to-severe acute pain. The pain drug will be marketed under the name Journavx. Shares of VRTX gained following the release.

Subsequent to the nod, Journavx has become the first and only non-opioid oral pain signal inhibitor and the first new class of pain medicine to be approved by the FDA in more than 20 years.

Per the company, Journavx has the potential to transform the treatment paradigm of acute pain.

Vertex believes that Journavx, a non-opioid drug, is an effective and well-tolerated medicine for use in all types of moderate-to-severe acute pain.

BIIB Stock Down on Regulatory Update

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD, collectively known as early AD, in the EU.

In November 2024, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) rendered a positive opinion recommending marketing approval for Leqembi for early AD.

Biogen and Eisai announced that the European Commission (EC) had requested the CHMP to reassess new safety data that emerged after the positive opinion and determine if any updates are needed. Additionally, the CHMP will review the clarity of risk minimization measures in its opinion to ensure proper implementation. These discussions are scheduled for an upcoming CHMP meeting later this month.

Biogen and Eisai stated that the safety profile of lecanemab observed in clinical studies across the United States, Japan and other countries aligns with its approved labels, with no new safety concerns identified. Given the clarity and sufficiency of the available information, the companies believe that existing data will address the EC’s requests, which the CHMP will review.

AXSM Stock Up on Migraine Drug Approval

Axsome Therapeutics, Inc. AXSM announced that the FDA has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.

According to the company, Symbravo, a novel oral medicine, offers a multi-mechanistic approach to treating migraines. It targets multiple pathways underlying a migraine attack.

The FDA's approval of Symbravo was based on data from a comprehensive clinical program that included multiple phase III studies, including the MOMENTUM study, INTERCEPT and the phase III MOVEMENT long-term open-label safety study.

Data from the phase III MOMENTUM and INTERCEPT studies showed that 77% and 85% of patients who were treated with Symbravo, respectively, did not require rescue medication within 24 hours after the dose.

AXSM expects to launch Symbravo in the United States in about four months.
Shares of AXSM gained on the news.

Performance

The Nasdaq Biotechnology Index has gained 0.4% in the past five trading sessions and MRNA’s shares have lost 23.97%. In the past six months, shares of MRNA have plunged 59.20%. (See the last biotech stock roundup here: Biotech Stock Roundup: SAGE Up on Declining BIIBs Offer, CYTK, AKRO Up on Updates)

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What's Next in Biotech?

Stay tuned for more pipeline updates.


 

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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

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