Shares of Myovant Sciences GmbH (NASDAQ:MYOV) were trading midday at $27.69, up $4.94, or 21% on word of a potential $4.2 billion deal with Pfizer Inc. focused on recently approved Orgovyx (relugolix), to be developed in oncology and women’s health in the U.S. and Canada. Orgovyx is approved as the first and only, once-daily oral GnRH antagonist for adults with advanced prostate cancer. Pfizer will promote the compound with a sales force already pushing Xtandi (enzalutamide), the androgen receptor inhibitor partnered with Tokyo-based Astellas Pharma Inc. that was first given the FDA’s nod in the summer of 2012 for late-stage, castration-resistant PC.

Aprea's lead candidate fails in phase III MDS trial

Shares of Aprea Therapeutics Inc. (NASDAQ:APRE) fell 76.2% to just north of its cash balance by midday after a phase III trial of its lead candidate, eprenetapopt, failed to significantly differentiate a combination of the candidate with azacitidine (AZA) from AZA alone in the treatment of people with TP53 mutant myelodysplastic syndromes (MDS). Data on the p53 reactivator, which has breakthrough, orphan and fast track designations in MDS, will continue to be evaluated, the company said. Trials of the asset in other cancers are also underway.

Australians pay less for drugs but wait twice as long for access

PERTH, Australia – Although Australians pay less for their drugs than patients in many other countries, Australia is falling behind when it comes to reimbursement for newer, targeted therapies, according to a report launched by Medicines Australia that assessed the timelines for registration and reimbursement of new medicines in Australia compared to 10 other Organisation for Economic Co-operation and Development (OECD) countries.

China approves NDA for CNBG COVID-19 vaccine, Sinovac delays data release

HONG KONG and BEIJING – Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine last week even as the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine. On Dec. 24, the NMPA accepted an NDA for a traditional inactivated whole virus vaccine candidate developed by CNBG’s Beijing Institute of Biological Product. CNBG is part of China National Pharmaceutical Group (Sinopharm). Just three days earlier, the NMPA had announced that a 60-day review would be waved for COVID-19 vaccines and would, instead, be approved and marketed right away. The first COVID-19 vaccines are now expected to hit the market by the end of this year or in January. CNBG’s vaccine was approved in the United Arab Emirates and Bahrain earlier this month.

CMS: 505(b)(2) path a gaming opportunity

Although it held off on a proposed rule change to close down a gaming opportunity for drug manufacturers in the U.S., the Centers for Medicare & Medicaid Services (CMS) pressed its reasoning for including some 505(b)(2) drugs in multiple source codes for reimbursement, which could force them to compete with generics on price. Permitting the payment of all 505(b)(2) drugs, especially injectable drugs administered by providers, “as single source drugs could continue to incentivize the development of minimally modified, high-priced products,” CMS said in its 2021 Physician Fee Schedule published in the Dec. 28 Federal Register.

Holiday notice

BioWorld’s offices were closed in observance of Christmas. No issues were published Thursday, Dec. 24 or Friday, Dec. 25.

Also in the news

Aim Immunotech, Algernon, Alligator, Allogene, Altimmune, Amryt, Aprea, Arch Biopartners, Arctic Vision, Astrazeneca, Audentes, Aurobindo, Beigene, Biontech, Bridgebio, Bristol Myers Squibb, Cara, Chiesi Global Rare Diseases, Covaxx, Cullinan Oncology, Elevar, Entheon Biomedical, Evaxion, Foresee, Gannex, GBS, Gritstone Oncology, IMV, Inceptua, Innocare, Innovent, Inotrem, Inovio, Janssen, Lysogene, Novadip, Novavax, Oasmia, Orphazyme, Palvella, Pfizer, Proteostasis, Recce, Revive, Roche, Soligenix, Sumitomo Dainippon, Tarsus, TLC, Tonix, United, Verrica, Vincera, Y-mabs, Yumanity, Zai Lab