It was a busy week for the biotech sector, with lots of regulatory and pipeline updates amid fears of a global recession sparked by the ongoing global trade war. Most bigwigs came out with important updates. Among these, Pacira Biosciences, Inc. PCRX was up on a positive patent settlement agreement, while Edgewise Therapeutics EWTX stock plunged on study data.

PCRX Stock Up on Patent Settlement

Shares of Pacira Biosciences gained after the company announced settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals and eVenus Pharmaceuticals Laboratories, related to patents for pain management drug Exparel (bupivacaine liposome injectable suspension).

Following the settlement, which resolves the patent litigation brought by Pacira BioSciences against the companies, Consent Judgments will be filed in multiple courts, preventing Fresenius, like the others, from marketing generic bupivacaine liposome injectable suspension before the relevant patents expire, except as outlined in the agreement.

As part of the settlement, Pacira Biosciences granted Fresenius a license to its patents, allowing limited-volume sales of generic bupivacaine liposome injectable suspension in the United States starting early 2030. This license permits market entry of generic versions before the final patent for Exparel expires on July 2, 2044.

Fresenius will initially distribute a high-single-digit percentage of the total U.S. market supply and gradually increase each year, reaching the low thirties by 2033. It will continue to rise modestly over the following two years before peaking in the high thirties during the agreement’s final three years. Additionally, Pacira has granted Fresenius a license to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the United States, beginning no earlier than 2039.

Exparel is PCRX’s lead drug, and patent settlement regarding the same bodes well for the company.

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

SRPT Stock Down on Setback

Shares of Sarepta Therapeutics SRPT declined after the EMA placed a clinical hold on all studies evaluating Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD).

This hold has been placed in response to a patient’s death post-treatment with Elevidys, which was reported in March. Though the death was due to acute liver failure, Sarepta believes that the patient’s recent cytomegalovirus infection might have contributed to the outcome. Investigation is still ongoing.

Sarepta has a collaboration with Roche for Elevidys. Sarepta and Roche are pausing enrollment and dosing of study participants in three studies evaluating the therapy at the EU study sites. This hold will remain ‘until the analysis into the cause of death is complete.’

The paused studies include Sarepta-sponsored phase III ENVISION study (in boys aged 8-17 years), the Roche-sponsored phase II ENVOL study in infants and newborns, and Sarepta’s early-stage study in boys aged 4 to 9 years with pre-existing antibodies to a specific serotype. Roche has also paused enrolment and dosing for the ENVOL study being conducted at the U.K. study sites.

AMGN’s Drug Label Expansion

Amgen AMGN obtained FDA approval for the label expansion of its rare disease drug, Uplizna (inebilizumab), for a new indication. The regulatory body has now approved Uplizna for the treatment of adults living with immunoglobulin G4-related disease (IgG4-RD), a rare immune-mediated inflammatory condition. The FDA had previously granted Uplizna a breakthrough therapy designation for the treatment of IgG4-RD.

This marks the second approved indication for the drug. Uplizna is already approved in the United States for treating adults with a rare autoimmune disease called neuromyelitis optica spectrum disorder.

The latest FDA approval for the expanded use of Uplizna in IgG4-RD was based on data from the phase III MITIGATE study, which showed that treatment with Uplizna led to an 87% reduction in the risk of flares compared to placebo.

Amgen is also evaluating Uplizna for treating generalized myasthenia gravis, another immune-mediated disease.

Updates From BMY

Bristol Myers Squibb BMY announced that it has obtained FDA approval for the label expansion of Opdivo (nivolumab) plus Yervoy (ipilimumab).

The regulatory body approved Opdivo plus Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).

Please note that Opdivo , as a single agent or in combination with Yervoy, was previously granted accelerated approval in MSI-H/dMMR CRC in adult and pediatric patients (12 years and older) who have progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.

The latest FDA approval converts this second-line indication to full approval for Opdivo monotherapy and expands the indication for Opdivo plus Yervoy into the first-line setting.

The combination demonstrated a reduction in the risk of disease progression or death by 79% as compared to chemotherapy in the first-line setting and by 38% versus Opdivo monotherapy across all lines of therapy.

Bristol Myers obtained this approval more than two months ahead of the target action date of June 23, 2025.

EWTX Stock Plummets on Study Data

Edgewise Therapeutics stock plunged last week, likely due to safety concerns for its investigational candidate, EDG-7500, in patients with obstructive or nonobstructive hypertrophic cardiomyopathy (HCM), despite positive mid-stage study results.

EWTX is evaluating EDG-7500 in the ongoing phase II CIRRUS-HCM study. In patients with obstructive HCM, Edgewise Therapeutics reported that treatment with EDG-7500 demonstrated meaningful, dose-dependent reductions in left ventricular outflow tract gradient (LVOT-G), both at rest and post-Valsalva. At the 100 mg dose, patients experienced a 71% reduction in resting gradients and a 58% reduction in provokable gradients without significant changes in left ventricular ejection fraction (LVEF).

Additionally, Edgewise Therapeutics announced that NT-proBNP levels, a key heart failure biomarker, showed a 62% mean reduction.

However, it reported that adverse events related to treatment with the candidate were mostly mild to moderate in severity, but two patients experienced serious adverse events of atrial fibrillation that required cardioversion. Additionally, one participant discontinued treatment due to moderate dizziness.

Nonetheless, Edgewise Therapeutics is optimizing its dosing strategy in Part D of the CIRRUS-HCM study in patients with obstructive and nonobstructive HCM. Initial Part D data readout is expected in the second half of 2025. The company is also planning to initiate a late-stage study of EDG-7500 for the HCM indications in the first half of 2026.

Performance

The Nasdaq Biotechnology Index has lost 9.70% in the past five trading sessions and BIIB’s shares have lost 13.62%. In the past six months, shares of MRNA have plunged 57.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: CORT Up on Study Data, Updates From AXSM, BMY, EXEL & More)

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What's Next in Biotech?

Stay tuned for more pipeline updates.

 

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Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report

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