The biotech sector continues to be in focus with the development of antibodies and vaccines for COVID-19. Other pipeline and regulatory updates also grabbed the spotlight.
Recap of the Week’s Most Important Stories
:
Pipeline & Regulatory Updates From Regeneron
:
Regeneron Pharmaceuticals, Inc
.
REGN
and partner
Sanofi
SNY
announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for asthma drug, Dupixent (dupilumab). The sBLA is seeking a label expansion of the drug as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
Dupixent is currently approved for the same for patients aged 12 years and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date is Oct 21, 2021, and the European Union (EU) regulatory submission for the same is planned later in the quarter.
Meanwhile, Regeneron announced changes to the phase III study assessing investigational COVID-19 antibody cocktail, REGEN-COV (casirivimab with imdevimab), in non-hospitalized patients (“outpatients”) with COVID-19, following recommendations from the Independent Data Monitoring Committee (IDMC). The committee found clear clinical efficacy in reducing the rate of hospitalization and death with both 1,200 mg and 2,400 mg doses of REGEN-COV compared to placebo.
Hence, it recommended stopping enrollment in the placebo group, which Regeneron will immediately follow. The trial will continue to enroll patients into both the 1,200 mg and 2,400 mg REGEN-COV treatment groups.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the COVID-19 antibody cocktail to treat confirmed COVID-19 in patients who do not require supplemental oxygen and those at high risk of progressing to severe COVID-19.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Vir Plunges on COVID-19 Study Data
: Shares of
Vir Biotechnology, Inc
.
VIR
were down 27.6% after the company and partner
Glaxo
provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program phase III study.
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. While VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit.
The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed for enrollment while the data mature. The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.
KemPharm Surges on Drug Approval
: Shares of
KemPharm, Inc
.
KMPH
surged
significantly after the FDA approved its New Drug Application (NDA) for Azstarys, a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. KemPharm has a collaboration and license agreement with Corium, Inc., a portfolio company of Gurnet Point Capital (“GPC”), for the commercialization of Azstarys.
Per the deal, Corium will lead the commercialization of Azstarys, which is expected to hit the U.S. market as early as the second half of this year. KemPharm has earned a regulatory milestone payment following the FDA’s approval of Azstarys, per the agreement. The company may be eligible to receive up to $468 million in regulatory and sales-based milestone payments, as well as tiered royalties on the product’s net sales.
Pipeline Updates from Incyte
:
Incyte
INCY
and partner
Eli Lilly and Company
LLY
announced positive top-line results from a phase III study, BRAVE-AA2, evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.
Both doses of baricitinib met the primary efficacy endpoint at week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. Baricitinib is approved under the brand name Olumiant in the United States as a treatment for adults with moderate to severe active rheumatoid arthritis (RA). It is also approved in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis (AD).
Earlier, Incyte announced the validation of its Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on or are intolerant of platinum-based chemotherapy. The validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.
ASLAN Jumps on Study Data
: Shares of clinical-stage, immunology-focused biopharmaceutical company,
ASLAN Pharmaceuticals
ASLN
, jumped after it announced positive data on pipeline candidate, ASLAN004. The interim unblinded data from the three dose cohorts of its ongoing randomized, double-blind, placebo-controlled, multiple ascending dose study of ASLAN004 for the treatment of moderate to severe AD showed that the candidate was well tolerated across all doses and demonstrated improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated, novel treatment for AD. The positive data supports the company’s plan to advance the candidate in a phase IIb study (expected to be initiated later in the year).
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 6.51% in the last five trading sessions. Among the biotech giants, Biogen lost 5.71% during the period. Over the past six months, shares of Alexion have surged 32.88%. (See the last biotech stock roundup here:
Biotech Stock Roundup: Regulatory Updates From REGN, INCY, & Other Updates
)
What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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