It was a busy week for the biotech sector with updates from most majors in the space. Biogen BIIB reported better-than-expected second-quarter results. Apart from this, other regulatory and pipeline updates were also in the spotlight.
Recap of the Week’s Most Important Stories:
Biogen’s Earnings Beat Estimates in Q2: Biotech giant Biogen reported encouraging second-quarter 2020 results amid the coronavirus pandemic. Earnings per share of $10.26 easily beat the Zacks Consensus Estimate of $7.99. Sales came in at $3.68 billion, up 2% from the year-ago quarter.
Higher sales of its multiple sclerosis (MS) drug, Tecfidera, and one-time licensing revenues in the quarter offset lower sales of Tysabri and spinal muscular atrophy (SMA) drug, Spinraza, as well as biosimilar products. The company also raised its earnings guidance for the year while slightly lowering its sales expectations.
Earlier, Biogen announced that it plans to initiate a global phase IV study, RESPOND, to evaluate the clinical benefit and assess the safety of Spinraza in infants and children with SMA who still have unmet clinical needs following treatment with gene therapy, Zolgensma.
Incyte Reports Positive Data on Jakafi: Incyte INCY announced that the late-stage study, REACH3, evaluating Jakafi in patients with moderate or severe steroid-refractory or steroid dependent chronic graft-versus-host disease (GVHD) met its primary endpoint of superior overall response rate (ORR) at week 24 compared to best available therapy (BAT). In addition, the study met both key secondary endpoints, significantly improving failure-free survival (FFS) and patient-reported symptoms assessed by the modified Lee chronic GVHD symptom scale (mLSS).
The drug is already approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Data from the REACH3 study will be submitted to the FDA seeking approval to treat patients with steroid-refractory or steroid dependent GVHD.
Bristol-Myers’ Application Gets EMA Validation: Bristol-Myers BMY announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for its experimental candidate, lisocabtagene maraleucel (liso-cel).
Liso-cel, an experimental CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is being evaluated for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies.
The validation of the application confirms that the submission is complete and the EMA will begin its centralized review process.
The application was based on results from TRANSCEND NHL 001, the largest study in third-line or greater R/R large B-cell lymphoma (LBCL), and additional data from the TRANSCEND WORLD study. The studies evaluated patients with R/R LBCL and included patients with a broad range of histologies and high-risk disease as well as those who received liso-cel in the outpatient setting.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead to Acquire Stake in Immunotherapy Developer: Gilead Sciences, Inc. GILD announced that it will invest $300 million to acquire a 49.9% equity interest in privately-held Tizona Therapeutics, Inc., which is developing first-in-class cancer immunotherapies. Gilead will also obtain an exclusive option to acquire the remainder of Tizona for up to an additional $1.25 billion, including an option exercise fee and potential future milestone payments.
Gilead can exercise this option following the readout of a phase Ib study of Tizona’s investigational antibody, TTX-080, or earlier. TTX-080 is a potential first-in-class medicine that targets HLA-G, a novel and emerging immune checkpoint expressed across multiple tumor types.
Acadia Plunges on Depression Study: Shares of ACADIA Pharmaceuticals Inc. ACAD declined after it announced disappointing results from the phase III CLARITY study. The study did not achieve statistical significance on the primary endpoint. The phase III CLARITY study combined two identical, double-blind, placebo-controlled studies evaluating the efficacy, safety and tolerability of pimavanserin as an adjunctive treatment for major depressive disorder (MDD).
The combined efficacy and safety analysis was pre-specified prior to data unblinding, following feedback from the FDA. The study did not achieve statistical significance on the primary endpoint, which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week 5. Pimavanserin 34 mg, given once-daily as an adjunctive treatment to standard antidepressant therapy, was associated with a mean reduction of 9.0 in HAMD-17 total score compared to 8.1 for placebo as an adjunctive treatment.
Performance
The Nasdaq Biotechnology index lost 0.38% in the last five trading sessions. Among the biotech giants, Amgen gained 1.45% during this period. Over the past six months, shares of Regeneron have gained 78.78%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD, MRNA Give Coronavirus Treatment Updates & More)
What’s Next in Biotech?
Stay tuned for more pipeline updates along with earnings updates.
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