This week, the European Commission granted approval to Merck’s (MRK Quick QuoteMRK - Free Report) novel HIF-2α inhibitor, Welireg, for two indications. The FDA granted priority review to a supplemental biologics license application (sBLA) seeking approval of Sanofi (SNY Quick QuoteSNY - Free Report) and Regeneron’s (REGN Quick QuoteREGN - Free Report) blockbuster drug, Dupixent, for a new indication, bullous pemphigoid. Ionis Pharmaceuticals (IONS Quick QuoteIONS - Free Report) announced its fourth-quarter and full-year 2024 results.

Here's a recap of the week’s most important stories.

IONS’ Better-Than-Expected Q4 Results

IONS reported better-than-expected top and bottom-line numbers for the fourth quarter. Its loss of 66 cents per share was narrower than the Zacks Consensus Estimate of a loss of $1.12 per share. Total revenues of $227 million beat the Zacks Consensus Estimate of $137.5 million. However, revenues declined 30.2% year over year. Commercial revenues were $86 million in the fourth quarter, up 8.9% year over year. R&D revenues declined 42.7% year over year to $141 million.

Ionis issued fresh financial guidance for 2025. The company expects total revenues to be more than $600 million in 2025. Adjusted operating loss is expected to be less than $495 million.

EU Approval to Merck’s Welireg for Two Indications

The European Commission approved Merck’s Welireg as a monotherapy for certain previously treated patients with advanced renal cell carcinoma and certain patients with von Hippel-Lindau disease-associated tumors. Approvals for these two indications were based on data from the LITESPARK-004 and LITESPARK-005 studies. Welireg is already approved for both indications in the United States.

FDA’s Priority Tag to SNY’s Dupixent sBLA for Bullous Pemphigoid

Sanofi and Regeneron announced that the FDA has accepted and granted priority review to an sBLA seeking approval of Dupixent for treating bullous pemphigoid, a chronic, debilitating, and relapsing skin disease. The FDA’s decision on the sBLA is expected by June 20, 2025. The sBLA is based on data from a pivotal study, which demonstrated that Dupixent led to significant improvements in sustained disease remission compared to placebo in adult patients with moderate-to-severe bullous pemphigoid.

Dupixent is currently approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, chronic obstructive pulmonary disease or COPD and prurigo nodularis. If approved for bullous pemphigoid, Dupixent will become the first medicine approved for this chronic and relapsing skin disease in the United States.

MRK, REGN and IONS have a Zacks Rank #3 (Hold) each, while Sanofi has a Zacks Rank #4 (Sell).

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

The NYSE ARCA Pharmaceutical Index rose 1.4% in the past five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

 

 

 

 

 

 

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the previous five trading sessions.

Image Source: Zacks Investment Research

In the last five trading sessions, Novo Nordisk rose the most (6.2%), while Novartis declined the most (0.4%).

In the past six months, all the stocks were in the red except AbbVie, which rose 2.3%.

(See the last pharma stock roundup here: NVS, ABBV M&A Deals, FDA Nod to RHHBY, PFE Drugs)

What's Next in the Pharma World?

Watch this space for regular pipeline and regulatory updates next week.