Biovie Inc.’s buyout of the assets from Neurmedix Inc. provides phase III-ready NE-3107, an oral small-molecule therapy designed to inhibit insulin resistance in Alzheimer’s disease. The compound may have utility in other indications such as Parkinson’s disease, multiple myeloma and prostate cancer. Biovie is providing a modest up-front payment in cash and shares, but the deal brings plenty more later, including $1.2 billion if the FDA approves NE-3107’s NDA. Shares of Biovie (NASDAQ:BIVI) were trading midday at $17.58, down $3.92, or 18%.

ODAC votes to continue Keytruda’s accelerated approval in bladder cancer

In its first session of the day April 28, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for patients with advanced or metastatic urothelial carcinoma who are not eligible for cisplatin and carboplatin chemotherapy. Panelists on both sides of the vote noted how difficult it was given the unmet need for patients who aren’t eligible for platinum-based chemotherapy. Later in the day, ODAC will consider next steps for the Roche Group’s Tecentriq (atezolizumab) accelerated approval for the same indication.

Protalix shares tumble on CRL for Fabry disease therapy

Shares of Protalix Biotherapeutics Inc. (NYSE:PLX) lost nearly 40% of their value by midday Wednesday after the company reported receiving an FDA complete response letter in answer to its BLA for pegunigalsidase alfa, a galactosidase enzyme replacement therapy it has long advanced for the potential treatment of Fabry disease. Protalix said it’s working with its U.S. commercial partner, Chiesi Farmaceutici SpA, to assess “the most expedient regulatory approach to reach an understanding with the FDA on additional actions required to obtain approval” for the candidate.

Head to head: Beigene’s BTK inhibitor yields solid data against Imbruvica

Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), stood solid in a head-to-head phase III trial with Imbruvica (ibrutinib) in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Results from the study’s interim analysis show Brukinsa hit the primary endpoint by showing noninferiority in objective response rate (ORR) by investigator and independent review committee assessments. The small-molecule BTK inhibitor also showed a superior ORR by a statistically significant improvement in ORR for Brukinsa vs. ibrutinib. The market applauded the results as Cambridge, Mass., and Beijing-based Beigene shares (NASDAQ:BGNE) had surged 8% in midday trading.

Business development in neurological diseases heating up

The significant risks and high costs associated with neurological R&D has tended to keep companies and investors on the sidelines over the past few years. However, thanks to research progress and the development of new technologies, business development and investing in the space is heating up once again. This activity has yet to fully translate to the public markets, with the BioWorld Neurological Diseases index, a price-weighted index of public biopharmaceutical companies that are focused on developing therapies to treat neurological diseases, still underwater this year.

Canbridge inks deal for Logicbio’s gene therapy candidates

HONG KONG - Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $581 million, gaining global rights to develop, manufacture and commercialize gene therapy candidates from Logicbio Therapeutics Inc. for the treatment of Fabry and Pompe diseases. The candidates are based on Logicbio’s adeno-associated virus (AAV) sL65, which are the first produced from its Saavy capsid development platform. According to the companies, AAV sL65 has unique liver-targeting properties, the potential to overcome limited potency and immunogenicity issues, and is more efficient to manufacture, potentially resulting in higher yields.

KOSDAQ simplifies listing rules to attract more biopharma startups

HONG KONG – South Korea’s securities exchange operator, Korea Exchange Inc., has relaxed the procedure for tech companies, including biopharma firms, to list on its KOSDAQ board. Under the simplified listing standard, companies with a market capitalization of ₩500 billion (US$449.26 million) and above will now need to submit only one assessment, with a result of “A” or higher, from a professional evaluation agency. Those with a market capitalization of ₩1 trillion or higher are exempt from the assessments altogether. “We simplified the technology company’s listing standard to eliminate inconveniences for those companies with high market capitalizations, while also trying to encourage more unicorn companies in the platform and bio industries to list on the KOSDAQ board,” said Won Il Lee, KOSDAQ market listing rules and regulations team head at the Korea Exchange.

Also in the news

Akari, Aldeyra, Alpha-9 Theranostics, Amgen, Amplyx, Arrowhead, Bayer, Beigene, Benitec, Biomarin, Boundless, Calliditas, Cardiol, Chiesi, Compass Pathways, Dermtech, EMD Serono, Essa, Exscientia, Flexion, G1, Grifols, Homology, Hope, Ico, Inmed, Innovation, Lilly, Lutris, Neuraly, Nkarta, Novaliq, Nymox, Ocugen, Okyo, Organicell, Pfizer, Point, Protalix, Provention, Realta, Redx, Resverlogix, Reveragen, Roche, Santhera, Silence, Soligenix, Sorrento, Takeda, Tarus, Tetra, Trillium, Triplet, Turn, Twist, VBI, Vertex, Vifor, Vivlion, Y-mabs