Three companies that began trading on Nasdaq on July 16 are contributing to this year’s record-setting pace of biotech IPOs. Erasca Inc., which is looking to raise $300 million, led the pack with shares (NASDAQ:ERAS) ending the day at $17.43, an 8.94% rise from the opening asking price of $16.
Private biopharma investment in 2021 continues to outpace that of the past two years as two gene therapy companies, Shape Therapeutics Inc. and Kriya Therapeutics Inc., posted series B financings this week totaling more than $200 million.
Following November’s equity investment that brought it a 14% ownership in Protomer Technologies Inc., Eli Lilly and Co. has acquired the privately held company engineering protein and peptide therapeutics that sense molecular activators. If development and commercial milestones are met, the deal could be worth more than $1 billion.
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share.
Novo Nordisk A/S has acquired a clinical-stage humanized monoclonal antibody and transthyretin amyloidosis (ATTR) program in a deal that could bring Prothena Corp. plc potential development and sales milestone payments of up to $1.2 billion. Also in the agreement, Dublin-based Prothena brings in $100 million in up-front and near-term clinical milestones payments as Novo gets full worldwide rights to the intellectual property and related rights of Prothena’s ATTR amyloidosis business and pipeline.
In an exclusive licensing agreement, Astrazeneca plc will get the global rights to research, develop and commercialize protein stimulator of interferon genes, STING inhibitor compounds, from F-star Therapeutics Inc. Astrazeneca is responsible for currently preclinical STING inhibitor compounds from F-star, which retains rights to all its STING agonists in clinical development for treating cancer.
Following battles over its price and accelerated approval, Biogen Inc. and Eisai Co. Ltd.’s Aduhelm (aducanumab) now has newly approved prescribing information from the FDA that limits the patient population and sales along with it. The updated Indications and usage now reads that the anti-amyloid beta monoclonal antibody should be used only in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. That’s the patient population in which treatment was initiated in clinical trials that led to approval. The company said the new wording “clarifies the indication.” The original FDA-approved language cleared the drug for much broader use in Alzheimer’s.
A collaboration between Oncosec Medical Inc. and Merck and Co. that yielded positive phase II study data has paved the way for a phase III study between the two companies. Oncosec’s DNA-plasmid interleukin-12 (IL-12) Tavo (tavokinogene telseplasmid) will be combined with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a randomized, global phase III study for treating late-stage metastatic melanoma.
Arrivent Biopharma Inc. has raised a series A financing worth up to $150 million to in-license compounds from China and bring them to the rest of the world. Arrivent’s focus is in oncology and its first in-licensed asset is furmonertinib, a third-generation EFGR tyrosine kinase inhibitor from Shanghai-based Allist Pharmaceuticals Co. Ltd.
Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.
