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Biotech Stock Roundup: Q4 Results of BMY, REGN, BIIB & Other Regulatory Updates

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A host of leading biotechs came up with earnings reports this week. New drug approvals, label expansions of the existing drugs, and other pipeline and regulatory updates grabbed the spotlight.

Recap of the Week’s Most Important Stories

Earnings Updates From Biogen, Gilead Among others:  Biotech giant Biogen (BIIB - Free Report) missed on earnings in the fourth quarter but beat on sales. Revenues were, however, down year over year due to lower sales of the multiple sclerosis (MS) drug Tecfidera and the spinal muscular atrophy (SMA) drug Spinraza. Moreover, the guidance for 2021 was not impressive.

Gilead Sciences, Inc. (GILD - Free Report) reported better-than-expected results for the fourth quarter of 2020 on increased demand for Veklury to treat COVID-19 patients. However, the core virology business continues to decline due to the coronavirus pandemic. Gilead expects a gradual recovery in the underlying market dynamics starting the second quarter of 2021.

Regeneron Pharmaceuticals, Inc. (REGN - Free Report) reported better-than-expected results for the fourth quarter of 2020 wherein both earnings and sales beat estimates, driven by strong Dupixent growth, fueled by continued label expansions. Eylea too maintained a solid momentum despite the pandemic.

Bristol-Myers Squibb Company (BMY - Free Report) reported better-than-expected results for the fourth quarter of 2020 as its multiple myeloma (MM) drug Revlimid and the blood thinner Eliquis, drove growth. Another MM drug Pomalyst also led to this upside. Further, the company lifted its earnings guidance for 2021.

Incyte Corporation (INCY - Free Report) beat on sales and earnings in the fourth quarter as demand for Jakafi continues to boost sales. Moreover, the recent approval of Pemazyre, Monjuvi and Tabrecta generated additional revenues for the company.

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

Bristol-Myers’ CAR T Cell Therapy Gets FDA Nod:  Bristol-Myers obtained an FDA approval for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) after a few delays. The therapy is approved for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL resulting from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. The FDA nod for Breyanzi was based on data from the TRANSCEND NHL 001 (017001) study, in which 268 patients with R/R LBCL received Breyanzi.

Regeneron’s Libtayo Gets FDA Nod for Label Expansion: Regeneron and partner Sanofi (SNY - Free Report) announced that the FDA approved their PD-1 inhibitor Libtayo (cemiplimab-rwlc) as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma (BCC), previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. The immunotherapy was granted full approval for patients with locally advanced BCC and an accelerated approval was granted for patients with metastatic BCC. It is already approved as the first systemic treatment for adults with metastatic cutaneous squamous cell carcinoma (CSCC) in the United States.

Jazz to Acquire GW Pharma: Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that it will acquire GW Pharmaceuticals plc for $220 per American Depositary Share (ADS) in the form of $200 in cash and $20 in Jazz ordinary shares. The total consideration comes to $7.2 billion or $6.7 billion net of GW cash. The transaction is expected to close in the second quarter of 2021. GW’s lead product Epidiolex (cannabidiol) oral solution is approved for patients aged one year and older to treat seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. The combined entity will have a dominant position in the neuroscience space. The acquisition is expected to be substantially accretive within the first full year of consolidated operations.

Performance

The Nasdaq Biotechnology Index gained 4.23% in the last five trading sessions. Among the biotech giants, Bristol-Myers lost 5% during the period. Over the past six months, shares of Alexion have rallied 52.4%. (See the last biotech stock roundup here: Biotech Stock Roundup: AMGN, VRTX Q4 Results, SAVA Encouraging Drug Data & More)

 

What's Next in Biotech?

Stay tuned for more pipeline, regulatory and upcoming earnings updates.

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