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BioNTech SE BNTX announced that it has entered into a definitive agreement to acquire China-based biotech, Biotheus, to strengthen its oncology pipeline.
With the acquisition, BNTX will gain full global rights to BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A, which is currently being developed in mid-to-late-stage studies for various oncological indications.
The transaction is expected to be closed in the first quarter of 2025, subject to the fulfillment of customary closing conditions, including regulatory approvals.
Shares of BioNTech were up 4.9% on Nov. 13 following the announcement of the news. The stock has risen 5.6% so far this year against the industry’s decline of 3.8%.
More on BNTX's Latest Deal
We remind investors that in November 2023, Germany-based BioNTech signed an exclusive license and collaboration agreement with Biotheus. The agreement granted BNTX the rights to develop, manufacture and commercialize BNT327/PM8002 worldwide, excluding Greater China.
With the acquisition of Biotheus, BioNTech gets full global rights to the candidate
The latest deal is likely to help BNTX expand its footprint in China, adding a local research and development center for conducting clinical studies.
Per the deal, BioNTech will make an upfront payment of $800 million to acquire all the issued share capital of Biotheus. The payment will be mainly in cash, with a small portion in American depositary shares (“ADS”).
BNTX will also make additional performance-based contingent payments of up to $150 million upon the achievement of certain milestones. Also, more than 300 employees of Biotheus will join BioNTech following the closure of the acquisition.
BNTX's Lucrative Oncology Strategy
The above deal is likely to boost BioNTech’s oncology pipeline by adding BNT327/PM8002 and strengthening its capabilities to develop and commercialize next-generation bispecific antibodies and novel treatment combinations.
BioNTech and Biotheus plan to initiate multiple registrational studies evaluating the combo of BNT327/PM8002 plus chemotherapy targeting various solid tumor indications like small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer later in 2024 and 2025.
Additional clinical studies evaluating BNT327/PM8002 as combination therapies are expected to begin later in 2024 and 2025.
Per the company, if successfully developed, BNT327/PM8002 has the potential to replace current checkpoint inhibitor standard-of-care treatments for various oncology indications.
Developing bispecific antibodies that target two proteins, namely PD-1 and VEGF, has been one of the lucrative areas in the treatment of cancer of late.
Companies like Summit Therapeutics SMMT and Instil Bio TIL are already engaged in developing their respective PD-1/VEGF targeting antibody candidates, namely ivonescimab and SYN-2510.
While SMMT’s therapy is ahead in terms of clinical development, the BNTX and TIL candidates are not too far away. They are in early-stage or mid-stage development across multiple solid tumors.
Besides, Instil Bio’s SYN-2510 has shown the potential to block both VEGF-A and VEGF-B compared to Summit’s ivonescimab, which blocks only VEGF-A.
BNTX's Zacks Rank & Key Pick
BioNTech currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Castle Biosciences, Inc. CSTL, carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 47.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
Zacks Investment Research
Shares of Avidity Biosciences RNA rose more than 12% on Wednesday after the company announced that it is expanding its current RNA-based pipeline of rare muscle disorders to explore a new therapeutic area — precision cardiology.
Avidity Enters the Cardio Space With Two New Drugs
The company has decided to advance two new wholly-owned pipeline drugs, AOC 1086 and AOC 1072, targeting two rare genetic cardiomyopathies, PLN cardiomyopathy and PRKAG2 syndrome, respectively.
There is currently no FDA-approved therapy for PLN cardiomyopathy and PRKAG2 syndrome, which are caused by mutations in the PLN and PRKAG2 genes, respectively. An excess build-up of these genes can lead to arrhythmias, sudden cardiac arrest, heart failure and other complications.
Per management, both AOC 1086 and AOC 1072 have been designed to address the root causes of the genetic diseases. Based on preclinical studies conducted by Avidity, both drugs have demonstrated robust delivery of siRNA (a type of RNA molecule) against targets in the heart and reduced the number of disease-causing genes by nearly 80%.
Avidity plans to present preclinical data from the AOC 1072 study at the American Heart Association Scientific Sessions 2024 on Nov. 16.
RNA Shares Glimpse of Innovations in RNA Space
Avidity also shared the first look at next-generation technology innovations in the RNA space, including modifications in siRNA delivery and advanced antibody engineering.
In preclinical studies, these advancements have shown up to a 30-fold increase in siRNA delivery to skeletal muscle and extended durability, achieving sustained target inhibition for three months. Based on these improvements, management believes that there is an opportunity to explore less frequent dosing options and enhance patient convenience.
RNA Stock Performance
Following the news, shares of Avidity hit an all-time high of $55.98. Wall Street has been paying a lot of attention to the stock, thanks to the impressive clinical performance of its rare muscle disorder pipeline. Per management, Avidity was the first company to successfully deliver siRNA to skeletal muscles. Preclinical studies showed that it has achieved a similar success against targets in the heart.
With this latest announcement, investors were likely impressed as the company is not just limiting itself to one segment but also exploring other medication areas like cardiology, which have shown immense commercial potential over the years.
Year to date, Avidity’s shares have skyrocketed 480% against the industry’s 3.8% decline.
Factors Driving RNA Stock’s Rally
With no marketed drugs in its portfolio, Avidity Biosciences highly depends on its pipeline drugs for growth. This upside in RNA stock is being driven by the encouraging clinical development of its three rare neuromuscular programs — del-desiran for myotonic dystrophy type 1 (DM1), del-brax for facioscapulohumeral muscular dystrophy (FSHD) and del-zota for Duchenne muscular dystrophy (DMD).
The most advanced candidate in Avidity’s pipeline is del-desiran. Last month, the FDA removed a partial clinical hold on the drug placed in 2022 following news of a patient experiencing a serious adverse event in a phase I/II study. Removing the clinical hold provides a re-assurance for the drug’s safety profile. Del-desiran has been granted breakthrough therapy, orphan drug and fast track designations by the FDA in DM1 indication. Earlier this year, management started the late-stage HARBOR study on the drug in DM1 patients. The study is currently enrolling participants.
The other two candidates, del-brax and del-zota, are being evaluated in separate phase I/II studies for FHSD and DMD indications, respectively. Earlier this year, management reported encouraging initial data from these studies that demonstrate the potential of Avidity’s candidates in both indications.
Earlier in June, management reported encouraging initial data from the del-brax study that showed significant reductions in DUX4-regulated genes, the underlying cause of FHSD. Currently, there is no approved therapy for FHSD.
In August, RNA reported data from the del-zota study which showed that treatment with the drug for four months led to statistically significant increase of 25% of normal in dystrophin production and 37% rise in exon 44 skipping in DMD patients who are amenable to this skipping.
RNA’s Zacks Rank
Avidity currently carries a Zacks Rank #3 (Hold).
Avidity Biosciences, Inc. Price
Avidity Biosciences, Inc. price | Avidity Biosciences, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Castle Biosciences CSTL and Biogen BIIB. While CSTL currently sports a Zacks Rank #1 (Strong Buy), BIIB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 51.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Biogen’s 2024 EPS have increased from $16.12 to $16.38. EPS estimates for 2025 have improved from $17.09 to $17.16. Year to date, shares of Biogen have lost 35%.
Biogen’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 9.99%.
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