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It was a busy week in the biotech sector, marked by significant regulatory and pipeline updates. Among these, shares of Corcept Therapeutics Incorporated CORT skyrocketed after a late-stage study met its primary goal. On the other hand, Axsome Therapeutics’ AXSM shares declined after announcing results from a study on major depressive disorder (MDD).
Recap of the Week’s Most Important Stories:
CORT Stock Soars on Study Data
Shares of Corcept Therapeutics Incorporated surged on March 31 after the company announced the success of the late-stage ROSELLA study.
The phase III ROSELLA study evaluated its pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer.
The ROSELLA study met its primary endpoint of improved progression-free survival (PFS), as assessed by a blinded independent central review (PFS-BICR).
Data from the study showed that treatment with relacorilant plus nab-paclitaxel reduced the risk of disease progression by 30% compared to patients treated with nab-paclitaxel alone. Patients who were treated with relacorilant plus nab-paclitaxel achieved a median PFS-BICR of 6.5 months compared to 5.5 months in those who received nab-paclitaxel alone.
Patients treated with the combo of relacorilant plus nab-paclitaxel had a significant improvement in overall survival (OS), with the median OS being 16 months versus 11.5 months for those receiving nab-paclitaxel alone, at an interim analysis of OS. The combo of relacorilant plus nab-paclitaxel improved PFS and OS without increasing the side effect burden.
Corcept plans to submit a new drug application in the United States in the third quarter of 2025, with a marketing authorization application in Europe likely to follow shortly.
AXSM Stock Down on Study Data
Axsome Therapeutics announced top-line data from the phase III PARADIGM study, which evaluated solriamfetol for the treatment of major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).
Patients were randomized to receive solriamfetol (300 mg) or a placebo for six weeks. In the overall patient population, treatment with solriamfetol failed to demonstrate a statistically significant change on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo — the study’s primary endpoint.
Nonetheless, in the prespecified subgroup of patients with severe EDS, treatment with solriamfetol led to greater improvements in depressive symptoms versus placebo. In patients without severe EDS, there was no meaningful difference versus placebo on the study endpoints.
Based on this outcome, Axsome plans to initiate a phase III study on solriamfetol in MDD patients with EDS later in 2025. Axsome stock was down following the announcement.
Treatment with solriamfetol was generally safe and well-tolerated in the PARADIGM study.
Axsome currently markets solriamfetol as Sunosi for treating narcolepsy.
Exelixis’ Cabometyx Label for Neuroendocrine Tumors
Exelixis EXEL announced that the FDA has approved the label expansion of its lead drug Cabometyx (cabozantinib).
The regulatory body approved Cabometyx for the treatment of adult and pediatric patients 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET).
Simultaneously, the drug was approved for adult and pediatric patients (12 years and older) with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET (epNET).
The approval came ahead of the target action date of April 3, 2025. The latest FDA approval is based on results from the phase III CABINET study, which evaluated Cabometyx compared to placebo in two cohorts of patients with previously treated NET — advanced pNET and advanced epNET.
Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo.
EXEL currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Updates From BMY’s Opdivo
Bristol Myers Squibb BMY announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of Opdivo (nivolumab) for another indication.
The CHMP recommended approval of Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.
The positive CHMP opinion was based on results from the CheckMate -77T trial. Results from this study showed a significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo, followed by surgery and adjuvant placebo.
BMY also obtained positive CHMP opinion for the subcutaneous formulation of Opdivo across multiple solid tumor indications.
Nivolumab for subcutaneous use, co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
The CHMP recommendation is based on results from the CheckMate-67T trial, as well as additional data demonstrating comparable pharmacokinetics and safety profiles between subcutaneous use of Opdivo and the intravenous formulation.
BLUE Surges on Merger Deal
Shares of bluebird bio BLUE surged after the company announced that it has received an acquisition proposal from Ayrmid.
Ayrmid proposed to acquire bluebird for an upfront cash payment of $4.50 per share and a one-time contingent value right of $6.84 per share, payable upon achievement of a net sales milestone. bluebird was previously engaged in discussions with Ayrmid as part of its comprehensive review of strategic alternatives. Ayrmid did not submit any proposal to bluebird as part of that process.
In February 2025, bluebird entered into a definitive acquisition agreement with funds managed by global investment firms Carlyle and SK Capital Partners, LP for $3.00 per share in cash and a one-time contingent value right of $6.84 per share, payable upon achievement of a net sales milestone.
bluebird is reviewing the Ayrmid Proposal in consultation with its legal and financial advisors and will provide further updates later.
Performance
The Nasdaq Biotechnology Index has lost 6.47% in the past five trading sessions and MRNA’s shares have lost 19.76%. In the past six months, shares of MRNA have plunged 57.52%. (See the last biotech stock roundup here: Biotech Stock Roundup: SAVA Dives on Setback, ALNY Up on Update & More)
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What's Next in Biotech?
Stay tuned for more pipeline updates.
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