GM Stock – ACAD Down on CRL, EBS Gets Additional Order & Other Updates

The biotech sector continues to be in focus as the development of vaccines for coronavirus continues to be the key focus. Other pipeline and regulatory updates also grabbed the spotlight.

Recap of the Week’s Most Important Stories:

Acadia Plunges on CRL: Shares of Acadia Pharmaceuticals, Inc. ACAD plummeted after it received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

The CRL indicated that the regulatory body has completed its review of the application and decided that it cannot be approved in its present form as it lacks statistical significance in some of the subgroups of dementia. Moreover, there was an insufficient number of patients with certain less common dementia subtypes, which was considered as a lack of substantial evidence of effectiveness to support approval. The CRL also states that the phase II Alzheimer’s disease psychosis study, a supportive study in the sNDA filing, was found to be inadequate and not well controlled. The drug is already approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Emergent Gets Additional $23M Order for Vaccine: Emergent Biosolutions, Inc. EBS announced that it received a contract modification to increase the original task order by $23 million from the Biomedical Advanced Research and Development Authority ((BA)RDA) to support further expansion of the manufacturing capacity for Johnson & Johnson’s JNJ COVID-19 vaccine. The amount will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance to the third suite of Emergent’s Baltimore Bayview facility. In addition, Emergent plans to slow down the manufacturing of AstraZeneca’s COVID-19 vaccine bulk drug substance.

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Separately, Emergent provided an update on its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) for the treatment of hospitalized patients with COVID-19. The phase III Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial, also known as INSIGHT-013, evaluated the safety and efficacy of four immunoglobulin candidates plus standard of care versus placebo plus standard of care in hospitalized patients with COVID-19. Top-line data from the ITAC trial demonstrated that the addition of anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of Veklury, for hospitalized adult COVID-19 patients with symptoms for less than 12 days did not provide clinical benefit when compared to standard of care plus placebo. The study was sponsored and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

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

Dynavax Gains on Partner’s Results: Shares of Dynavax Technologies Corporation DVAX gained after it announced that partner Valneva SE posted positive initial results in a phase I/II study evaluating the latter’s COVID-19 vaccine candidate, VLA2001. The vaccine candidate uses Dynavax’s CpG 1018 adjuvant. Based on the initial data from the study, Valneva is planning to start a phase III study on the candidate by the end of this month, subject to regulatory approval. The adjuvant is also used in Dynavax’s marketed vaccine, Heplisav-B, for the prevention of hepatitis B in the United States. Valneva reported that VLA2001 was generally safe and well tolerated across all dose groups tested and was highly immunogenic with a seroconversion rate for S-protein binding IgG antibodies of 100% in the high dose group. The IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay.

Gilead’s Kite Submits sBLA for Tecartus: Gilead Sciences’ GILD Kite announced that it has submitted a supplemental biologics license application (sBLA) to the FDA for chimeric antigen receptor (CAR) T-cell therapy, Tecartus (brexucabtagene autoleucel). The sBLA is seeking approval of the therapy for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The sBLA is supported by the data from the phase I/II ZUMA-3 trial. Tecartus was granted accelerated approval in July 2020 by the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on the overall response rate and durability of response.

Performance

Medical – Biomedical and Genetics Industry 5YR % Return

Medical – Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology Index gained 3.27% in the last four trading sessions. Among the biotech giants, Incyte gained 3.68% during the period. Over the past six months, shares of Alexion have surged 32.16%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE/BMY’s CAR T Therapy Nod, KLDO’s COVID-19 Study News & More)

What’s Next in Biotech?

Stay tuned for more pipeline and regulatory updates.

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Johnson & Johnson (JNJ) : Free Stock Analysis Report

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