Mergers and acquisitions grabbed the spotlight in the biotech sector this week after Jazz Pharmaceuticals JAZZ announced an agreement to acquire Chimerix CMRX. Meanwhile, other pipeline and regulatory updates were in focus.

The Week’s Most Important Biotech Stocks Stories:

CMRX Stock Surges on JAZZ Acquisition Bid

Shares of clinical-stage biotech Chimerix skyrocketed following an acquisition agreement from Jazz Pharmaceuticals for $8.55 per share in cash, aggregating to nearly $935 million.

The offer price reflects an approximately 72% premium based on CMRX’ closing price on Tuesday.

The acquisition will add CMRX’s lead pipeline drug, dordaviprone, to Jazz’s pipeline. This drug is currently under review by the FDA under the accelerated approval pathway as a potential treatment for adult and pediatric patients with recurrent H3 K27M-mutant diffuse glioma. A final decision is expected by Aug. 18, 2025.

Chimerix has another clinical candidate, ONC206, which is being evaluated in early-stage, dose-escalating studies for adult and pediatric patients with advanced central nervous system tumors.

The transaction has been approved by both companies and is expected to be closed in the second quarter of 2025.

The addition of Chimerix’s drug could help Jazz expand its oncology portfolio and further diversify its revenue stream.

MRNA Stock Pops on Updates

Shares of Moderna MRNA gained after a couple of SEC filings showed that two board members bought shares on the open market. Moderna’s CEO Stephane Bancel and director Paul Sagan acquired common stock worth $6 million.

MRNA also secured a legal victory in a patent dispute against Pfizer and BioNTech. A German court ruled that Pfizer and BioNTech infringed Moderna's COVID-19 vaccine patent. The ruling required both Pfizer and BioNTech to compensate the company, though the final amount will be determined in further proceedings.

Regulatory Update From GSK

GSK plc GSK announced that the FDA accepted its biologics license application (BLA) for pipeline candidate, depemokimab, in two indications.

The BLA is seeking approval of the candidate as an add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium to high-dose inhaled corticosteroids (ICS) plus another asthma controller. GSK is also looking to get the candidate approved as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

The regulatory body has set a target action date of Dec. 16, 2025.

The BLA is based on data from positive SWIFT and ANCHOR trials. SWIFT-1 and -2 showed depemokimab reduced exacerbation and hospitalization rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo. ANCHOR-1 and 2 showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo.

REGN’s MM Drug Gets Positive CHMP Opinion

Regeneron Pharmaceuticals, Inc. REGN obtained a positive opinion for its pipeline candidate, linvoseltamab, from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”).

The CHMP recommended conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. A final decision is expected in the coming months.

Last month, the FDA accepted the BLA for linvoseltamab for review and set a target action date of July 10, 2025.

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

Biotech Stocks Performance

The Nasdaq Biotechnology Index has increased 2.62% in the past five trading sessions and MRNA’s shares increased 4.85%. In the past six months, shares of MRNA have plunged 52.06%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE Down on Update, News From GILD, TRDA)

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What's Next in Biotech?

Stay tuned for more pipeline updates.


 

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This article originally published on Zacks Investment Research (zacks.com).

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