Biotech Stock Roundup: BIIB Tops, MACK Plunges, REGN's Asthma Drug Gets FDA Nod
It was a busy week for the biotech sector as quite a few companies came out with data on key drugs while bigwig Biogen BIIB announced third-quarter results. Regeneron REGN won FDA nod for a label expansion. However, Merrimack Pharmaceuticals, Inc. MACK plunged on disappointing data from one of its pipeline candidates.
Recap of the Week’s Top Stories:
Biogen Tops Earnings & Sales Estimates in Q3: Biogen reported strong results for the third quarter wherein both earnings and sales beat estimates. Sales came in at $3.44 billion, up 12% from the year-ago period and surpassed the Zacks Consensus Estimate of $3.33 billion, primarily driven by higher sales of Spinraza and higher contribution from biosimilars and Ocrevus royalties. Earnings per share of $7.40 beat the Zacks Consensus Estimate of $6.80.
Separately, Biogen and partner UCB announced disappointing top-line results from a phase IIb study evaluating the safety and efficacy of dapirolizumab pegol (DZP) in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants. The study failed to meet the primary endpoint of showing a dose response at 24 weeks on the BILAG-Based Composite Lupus Assessment (BICLA) composite index.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
FDA Approves Regeneron’s Dupixent for Asthma: Regeneron and partner Sanofi SNY announced FDA approval for Dupixent’s label expansion. The FDA approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Consequently, Dupixent is now approved in the United States for two important groups of uncontrolled asthma patients — those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma.
Dupixent reduced severe exacerbations and oral corticosteroid use and improved lung function in clinical trials. We note that Dupixent is already approved in the United States for the treatment of adults suffering from moderate-to-severe atopic dermatitis. Both the companies are working on expanding the drug’s label. Dupixent is currently under regulatory review for moderate-to-severe asthma in several other countries, including Japan and in the European Union (EU). The company recently announced positive phase III results in chronic rhinosinusitis with nasal polyps.
Merrimack Plunges on Study Termination: Shares of Merrimack Pharmaceuticals plunged after the company announced the termination of SHERLOC study. The randomized open-label phase II study was evaluating MM-121 in combination with docetaxel in patients with heregulin positive non-small cell lung cancer (NSCLC). MM-121 did not improve progression free survival (PFS) in patients. The decision was made in agreement with the Chair of the independent Data Safety Monitoring Board following an interim analysis that was triggered by the occurrence of 75% of events required for trial completion. The decision comes as a blow to Merrimack as it has limited pipelines candidates.
Incyte Announces Data on Pipeline Candidates: Incyte INCY announced positive results from the GEOMETRY mono-1 trial on pipeline candidate, capmatinib. The experimental MET inhibitor was evaluated in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon-14 skipping mutations. The study results showed an overall response rate (ORR) of 72% in treatment-naive patients and 39.1% (95% CI: 27.6-51.6) in previously treated patients. ORR was assessed by blinded independent review committee (BIRC). The safety profile was consistent with studies.
Incyte has a collaboration agreement with Novartis for capmatinib. Incyte also announced updated data from its ongoing phase II FIGHT-202 trial evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer) who failed at least one previous treatment.
Interim study results demonstrated an overall response rate (ORR) of 40%, the primary endpoint, and a median progression free survival (PFS) of 9.2 months, a key secondary endpoint in patients with FGFR2 translocations who were followed for at least eight months.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 5.01% over the last five trading sessions. Among the major biotech stocks, Biogen lost 6.63% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 21.9% while Celgene lost 10.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD, BIIB Present Data, VTGN Gains on Fast Track Status).
What's Next in Biotech?
Stay tuned for more earnings reports as industry bigwigs are scheduled to release results later in the week.
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Sanofi (SNY) : Free Stock Analysis Report
Incyte Corporation (INCY) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
Merrimack Pharmaceuticals, Inc. (MACK) : Free Stock Analysis Report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
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