It was a busy week for the biotech sector. While the fourth-quarter earnings season continues, other pipeline and regulatory updates were also in focus.

Recap of the Week’s Most Important Stories:

MRNA’s Q4 Results

Moderna MRNA reported a loss of $2.50 per share in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $2.69. In the year-ago period, the company had reported earnings of 55 cents per share.

Revenues declined 64% year over year to $966 million, primarily due to the declining sales of its COVID-19 vaccine and the soft sales performance of its recently launched RSV vaccine.

MRNA recorded $923 million in Spikevax sales for the fourth quarter of 2024 compared with $2.8 billion in the year-ago quarter.

Moderna reiterated its total revenue guidance for 2025, which was issued last month. It expects total revenues to be in the range of $1.5-$2.5 billion, mainly from product sales of its COVID-19 and RSV vaccines. Owing to the seasonality of its business, management expects to generate around $0.2 billion in revenues in the first half of the year.

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

GILD’s HIV Prevention Treatment Application Accepted

Gilead Sciences, Inc. GILD announced that the FDA has accepted its new drug application (NDA) submissions for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV as pre-exposure prophylaxis (PrEP).

The regulatory body will review the applications under priority review and has assigned a target action date of June 19, 2025.

The NDAs are based on data from the late-stage PURPOSE 1 and PURPOSE 2 studies.  Data from the PURPOSE I study showed twice-yearly lenacapavir demonstrated zero infections in the lenacapavir group and 100% risk reduction and superiority compared to background HIV incidence for the investigational use of HIV prevention in cisgender women.

The PURPOSE 2 study showed that there were two HIV infections in the lenacapavir group, demonstrating 99.9% of participants in the lenacapavir group did not acquire HIV infection, a 96% risk reduction in HIV infections, and superiority compared to bHIV among a broad and geographically diverse range of cisgender men and gender-diverse people.  

Gilead also recently submitted applications for lenacapavir for PrEP to the European Medicines Agency that will be reviewed under accelerated assessment review timeline.

SEPN Stock Plunges on Trial Update

Septerna, Inc. SEPN announced that it will discontinue the phase I single and multiple-ascending dose (SAD/MAD) clinical trial of pipeline candidate SEP-786 in healthy volunteers. SEP-786 is an oral small-molecule agonist of the parathyroid hormone 1 receptor (PTH1R) being developed for the treatment of hypoparathyroidism.

Shares of this clinical-stage biotechnology company plunged 47% on the news.

SEPN decided to discontinue the study following the observation of two unanticipated severe (Grade 3) events of elevated unconjugated bilirubin in the MAD portion of the phase I study, both of which were without elevations in ALT, AST and GGT liver enzyme levels. Dosing was discontinued for both study participants, and the bilirubin elevations were reversible.

SLDB Up on Study Data

Solid Biosciences Inc. SLDB announced positive initial data from the phase I/II INSPIRE DUCHENNE trial evaluating SGT-003, a next-generation gene therapy product candidate intended for the treatment of Duchenne muscular dystrophy (Duchenne). Interim biopsy data reported in the first three participants at day 90 showed an average microdystrophin expression of 110%, as measured by western blot, and improvements in multiple biomarkers that are indicators of muscle health and resilience.

Data also showed encouraging early signals of potential cardiac benefit. SGT-003 has been well-tolerated by the six participants dosed as of Feb. 11, 2025, with no serious adverse events observed.

Enrollment is ongoing, and the company expects to dose approximately 20 participants by the fourth quarter of 2025. SLDB plans to request an FDA meeting in mid-2025 to discuss a potential accelerated approval pathway for SGT-003.

Shares of SLDB were up following the announcement. Solid Biosciences Inc. also announced the pricing of an underwritten offering of 35,739,810 shares of its common stock at a price of $4.03 per share.

Performance

The Nasdaq Biotechnology Index has gained 3.08% in the past four trading sessions and MRNA’s shares have gained 15.6%. In the past six months, shares of MRNA have plunged 60.26%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Up on Q4 Results, VRTX, AXSM Gain on Drug Approval)

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What's Next in Biotech?

Stay tuned for more pipeline updates.




 

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