The biotech sector continues to be in focus with pipeline and regulatory updates. Earnings updates from
Regeneron ( REGN Quick Quote REGN - Free Report) and Moderna ( MRNA Quick Quote MRNA - Free Report) also grab the spotlight. : Recap of the Week’s Most Important Stories : Biotech giant, Regeneron Pharmaceuticals, Inc., Regeneron’s Q1 Earnings reported strong growth in earnings and sales in the first quarter of 2021 on broad-based portfolio growth. Earnings of $9.89 per share comfortably beat the Zacks Consensus Estimate of $8.79. Total revenues in the reported quarter increased 38% year over year to $2.52 billion but missed the Zacks Consensus Estimate by 1.96%. Demand for Eylea revived and Dupixent maintained its strong performance. Incremental contribution from REGEN-COV boosted the top line and should propel sales as the pandemic continues.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Moderna, Inc. announced initial data from its mid-stage study on COVID-19 vaccine, mRNA-1273. The data from the phase II study showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). Booster dose of mRNA-1273.351, a strain-matched candidate, achieved higher titers against B.1.351 than a booster dose of mRNA-1273. Moderna Announces Booster Data Against SARS-CoV-2 Variants
The company also beat on earnings in the first quarter owing to the success of its COVID-19 vaccine, mRNA-1273.
: Shares of Minerva Surges on Schizophrenia Study Minerva Neurosciences, Inc. ( NERV Quick Quote NERV - Free Report) surged after it announced results from the 40-week open-label extension (OLE) of its phase III study of roluperidone for the treatment of negative symptoms (NS) of schizophrenia. The OLE followed the 12-week double-blind, placebo-controlled portion of this study.
In the study, 333 patients participated, of whom 166 received the 32 mg dose and 167 patients received the 64 mg dose over the 40-week OLE period. The continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS) was observed over a year (12-week double-blind and 40-week open-label periods) in patients receiving both 64 mg and 32 mg doses. The mean improvement in negative symptoms was 6.8 points in the 32 mg arm and 7.5 points in the 64 mg arm. PSP total score improved by a mean of 12.3 points in the 32 mg arm and 14.5 points in the 64 mg arm, suggesting functional improvement.
The encouraging data should also support a new drug application (“NDA”) to the FDA following the completion of a bioequivalence study and to address FDA’s comments during a Type C meeting held in November last year.
: Amgen’s Application for Otezla Accepted Amgen ( AMGN Quick Quote AMGN - Free Report) announced that the FDA has accepted for review the supplemental New Drug Application (sNDA) for Otezla (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy.
The sNDA was submitted in February 2021. It was based on positive data from the phase III ADVANCE study, a multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla in adults with mild-to-moderate plaque psoriasis. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of Dec 19, 2021.
: Biogen to Exercise Option for Candidate Biogen ( BIIB Quick Quote BIIB - Free Report) and TMS Co., Ltd. announced that the former exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, from the latter. The decision was based on positive data from a phase IIa study, which met its primary safety objective with no incidence of symptomatic intracranial hemorrhage (sICH) and demonstrated positive impacts on both blood vessel reopening in the brain and patient functional recovery. Biogen will make a one-time $18-million payment as part of the acquisition. TMS is also eligible to receive up to an additional $335 million in potential post-acquisition development and commercial payments if TMS-007 achieves certain developmental milestones and sales thresholds. Performance
The Nasdaq Biotechnology Index declined 1.57% in the last five trading sessions. Among the biotech giants, Regeneron gained 3.33% during the period. Over the past six months, shares of Alexion have surged 34.31%. (See the last biotech stock roundup here:
). Biotech Stock Roundup: BIIB, AMGN’s Q1 Earnings Updates & Other Pipeline News What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
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