Ocugen
OCGN
grabbed the headlines, courtesy of its regulatory updates. Plus, other vital information dominated the biotech sector this week.
Recap of the Week’s Most Important Stories:
Ocugen Down on Regulatory Update
: Shares of Ocugen
tanked
after it was announced that the FDA has declined to issue an Emergency Use Authorization (EUA) to its COVID-19 vaccine Covaxin. OCGN was seeking EUA for Covaxin to actively immunize COVID-19 caused by SARS-CoV-2 in individuals aged from 2 years to 18 years. As a result, OCGN stated that it will continue working with the FDA to deduce the regulatory pathway forward for vaccination of the pediatric individuals with Covaxin.
Voyager Surges on Deal With Novartis
: Shares of
Voyager Therapeutics, Inc
.
VYGR
surged after the company announced an agreement with Novartis. Per the terms of the deal, NVS receives a target-specific access to Voyager’s novel TRACER AAV capsids for potential use with three CNS targets plus options to access capsids for two additional targets. In exchange, Voyager will receive $54 million upfront and is entitled to receive up to $37.5 million of exercise fees for options related to the three initial CNS targets.
Novartis might also choose to evaluate capsids for up to two additional targets. Voyager will get $18 million upon selection of each target and a $12.5 million exercise fee for selection of a capsid for each target. Voyager is also eligible to earn up to $1.5 billion worth of potential development, regulatory and commercial milestones payments as well as mid- to high-single-digit tiered royalties based on the net sales of Novartis products incorporating the licensed capsids.
Voyager currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
BioNTech Collaborates With Regeneron:
BioNTech
BNTX
announced that it expanded its strategic collaboration with
Regeneron
REGN
. BioNTech and Regeneron plan to jointly conduct studies, evaluating FixVac candidate BNT116 in combination with Libtayo for the treatment of advanced non-small cell lung cancer (NSCLC). Both companies will share the development costs equally. The agreement follows BNTX’s existing collaboration whereby the combination of its FixVac candidate BNT111 with Libtayo is being evaluated for advanced melanoma. In addition, BNTX is investigating and sponsoring an early stage study, which evaluates the combination of Libtayo with its FixVac candidate BNT112 for prostate cancer.
Data on Gilead’s Trodelvy
:
Gilead Sciences, Inc
.
GILD
announced positive results from the phase II TROPiCS-02 study, which is evaluating its breast cancer drug Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. The trial targeted a 30% reduction in the risk of disease progression or death. The primary endpoint results were consistent with those observed in the phase I/II IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. The drug is already approved for second-line metastatic triple-negative breast cancer and second-line metastatic bladder cancer.
The study also showed a trend toward improvement in overall survival (OS), a key secondary endpoint. Final data on the OS endpoint is expected in 2024. Gilead will continue to follow up with patients for the overall survival result.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 2.95% in the past five trading sessions. Among the biotech giants, Vertex has gained 3.48% during the period. Over the past six months, shares of Vertex have rallied 24.74%. (See the last biotech stock roundup here:
Biotech Stock Roundup: MRNA’s Q4 Earnings, LXRX, KOD Down on Updates & More
)
Image Source: Zacks Investment Research
What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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