BIIB Tops, MACK Plunges, REGN’s asthma drug gets FDA approval

BIIB Tops, MACK Plunges, REGN’s asthma drug gets FDA approval

It was a busy week for the biotech sector, as several companies released data on key drugs, while bigwig Biogen BIIB announced third-quarter results. Regeneron REGN has won FDA approval for label expansion. However, Merrimack Pharmaceuticals, Inc. MACK pounced on the disappointing data from one of its candidates.

Summary of the week’s top stories:

Biogen tops Q3 revenue and sales estimates: Biogen reported strong third-quarter results, with both revenue and sales beating estimates. Sales were $3.44 billion, up 12% from the year-ago period and beating the Zacks Consensus Estimate of $3.33 billion, primarily due to 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 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 care. treatment such as corticosteroids, antimalarials 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) index.

Biogen currently has a Zacks Rank #3 (Hold). You can see full 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 label extension. The FDA has approved Dupixent as adjunctive maintenance therapy in patients 12 years of age and older with moderate to severe asthma with an eosinophilic phenotype or asthma dependent on oral corticosteroids. Consequently, Dupixent is now approved in the United States for two important groups of patients with uncontrolled asthma—those who are moderate to severe with an eosinophilic phenotype or those with asthma dependent on oral corticosteroids.

Dupixent reduced severe exacerbations and the use of oral corticosteroids and improved lung function in clinical trials. We note that Dupixent is already approved in the United States for the treatment of adults with moderate to severe atopic dermatitis. Both 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 the European Union (EU). The company recently announced positive phase III results in chronic rhinosinusitis with nasal polyps.

Merrimack sinks at graduation: Shares of Merrimack Pharmaceuticals fell after the company announced the end of the SHERLOC trial. The randomized, open-label phase II study evaluated 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 Committee following an interim review that was triggered by the occurrence of 75% of the events required to complete the study. The decision comes as a blow to Merrimack, as it has limited pipeline candidates.

Incyte Announces Data on Pipeline Candidates: Incyte INCY announced positive results from the GEOMETRY mono-1 study of its pipeline candidate, capmatinib. The experimental MET inhibitor was evaluated in 94 adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET-14 exon deletion mutations. The study results showed an overall response rate (ORR) of 72% in treatment-experienced patients and 39.1% (95% CI: 27.6-51.6) in treatment-naïve patients. The ORR was assessed by a blinded independent review committee (BIRC). The safety profile was consistent with the studies.

Incyte has a collaboration agreement with Novartis for capmatinib. Incyte also announced updated data from its ongoing Phase II FIGHT-202 study evaluating pemigatinib (INCB54828), its selective fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced/metastatic cholangiocarcinoma or surgically unresectable (bile duct cancer) that have 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 industry – biomedical and genetics 5 years % return

Medical industry – biomedical and genetics 5 years % return

The NASDAQ Biotechnology Index lost 5.01% in the last five trading sessions. Among major biotech stocks, Biogen has lost 6.63% over the past five trading sessions. Over the past six months, Biogen shares have risen 21.9%, while Celgene has lost 10.8%. (See the latest summary of biotech stocks here: Biotech Stock Roundup: GILD, BIIB Current Data, VTGN Earnings on Fast Track Status).

What’s next in biotechnology?

Stay tuned for more earnings reports as industry bigwigs are scheduled to release results later in the week.

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