The biotech sector has been in focus in the past week with some important pipeline and regulatory updates. Acquisition news has also grabbed the spotlight in the week.
Recap of the Week’s Most Important Stories:
Nektar Plunges on Deal Termination
: Shares of
Nektar Therapeutics
NKTR
plunged
significantly after the company and partner
Bristol Myers Squibb
BMY
announced the joint decision to end the global clinical development program for bempegaldesleukin (BEMPEG) in combination with the latter’s blockbuster immuno-oncology drug Opdivo (nivolumab). The decision was based on disappointing results from pre-planned analyses of two late-stage clinical studies of bempegaldesleukin in combination with Opdivo in renal cell carcinoma (RCC) and bladder cancer. Nektar and Bristol Myers collaborated in 2018 to evaluate the combination. The companies have now decided to discontinue these studies and all others in the program.
The pre-planned analysis of phase III PIVOT-09 study evaluating BEMPEG plus Opdivo in patients with previously untreated advanced RCC demonstrated that the combination regimen failed to meet the pre-specified boundary for statistical significance for objective response rate (ORR) compared to a tyrosine kinase inhibitor (TKI) therapy in the comparator-arm of the study. The final analysis of the phase II PIVOT-10 study showed that the BEMPEG and Opdivo doublet therapy did not reach an efficacy threshold for ORR to support continuing evaluation of the regimen in patients with locally advanced or metastatic urothelial cancer or bladder cancer.
Updates From Regeneron
:
Regeneron Pharmaceuticals, Inc
.
REGN
announced that the FDA has extended the review of the biologics license application (BLA) for antibody cocktail REGEN-COV (casirivimab and imdevimab) by three months.
The regulatory body extended the review due to ongoing discussions on pre-exposure prophylactic use for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The agency considers the submission of these additional data to be a major amendment to the BLA and has extended the target action date to Jul 13, 2022. On a positive note, the FDA has not requested any new studies to complete its review of the current BLA at this time.
Regeneron also announced that it will acquire clinical-stage biopharmaceutical
Checkmate Pharmaceuticals, Inc
.
CMPI
for $10.50 per share or $250 million, which fueled the share price of the latter. The acquisition will add investigational candidate vidutolimod to its pipeline. Vidutolimod is a potential best-in-class TLR9 agonist, with demonstrated clinical responses observed in PD-1 refractory melanoma as monotherapy. The transaction is expected to close in mid-2022. The acquisition should strengthen Regeneron’s portfolio of diverse and combinable immuno-oncology candidates.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Axsome Soars on Update
: Shares of
Axsome Therapeutics, Inc
.
AXSM
surged after the company announced that it has received and agreed to Postmarketing Requirements/Commitments proposed by the FDA with respect to the new drug application (NDA) for its investigational candidate AXS-05. The NDA is seeking approval of the candidate for the treatment of major depressive disorders (MDD). Consequently, Axsome anticipates the potential approval of the candidate in the second quarter of 2022. AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for MDD, Alzheimer’s disease agitation and smoking cessation.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 0.59% in the past four trading sessions. Among the biotech giants, Biogen has gained 7.19% during the period. Over the past six months, shares of Moderna have lost 54.22%. (See the last biotech stock roundup here:
Biotech Stock Roundup: SRRA Surges on GSK Buyout, HALO Offers Update & More
)
Image Source: Zacks Investment Research
What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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