Two months to the day before its Dec. 24 PDUFA date, Xofluza (baloxavir marboxil, previously S-033188, RG-6152), gained a nod from the FDA to treat acute uncomplicated influenza in individuals 12 and older who became symptomatic within the previous 48 hours.

Maybe those Pfizer Inc. neuroscience assets weren't so lackluster after all. The New York-based pharma and deep-pocketed partner Bain Capital LP placed a portfolio of eight disclosed preclinical and clinical central nervous system (CNS) candidates into the newco Cerevel Therapeutics LLC and backed them with $350 million in committed capital from funds associated with Bain Capital Private Equity and Bain Capital Life Sciences

Shares of Proteostasis Therapeutics Inc. (NASDAQ:PTI) roared Thursday, spiking to an 18-month high of $10.38, following an update on three cohorts covering 21 patients from the company's ongoing phase I study of combination doublet, PTI-801/PTI-808, in individuals with cystic fibrosis (CF). The stock closed at $10.35 for a gain of $8.46, or 447.6 percent. Volume of nearly 92.6 million shares was some 580 times the company's three-month moving average.

New Leaf Venture Partners, which led the $54.5 million series A by startup Curasen Therapeutics Inc., got in on the ground floor of a previous venture by company co-founders Anthony Ford, named CEO, and Kathleen Sereda Glaub, executive chair. Their former effort, Afferent Pharmaceuticals Inc., went to Merck & Co. Inc. in a 2016 buyout worth up to $1.25 billion for the orally administered P2X3 antagonist AF-219 to treat refractory chronic cough and idiopathic pulmonary fibrosis with cough. 

Immunicum AB raised SEK351 million (US$39.5 million) through a directed issue of approximately SEK178 million to institutional investors and a fully guaranteed rights issue of approximately SEK173 million to existing holders of the company's shares, which trade on Nasdaq Stockholm. The twofold goal was to bring Swedish institutions into the company's fold and to secure sufficient funding to move lead candidate ilixadencel – a vaccine based on allogeneic dendritic cells from healthy individuals that's designed to prime the immune system against solid tumors – into phase Ib/II studies in head and neck, non-small-cell lung (NSCLC) and stomach cancers.

Less than three years after inking a potential $500 million cell therapy partnership with SQZ Biotechnologies Co., Roche Holding Co. is going back for seconds in an expanded deal that could more than triple the economics. SQZ is set to receive $125 million in up-front and near-term milestones and could earn up to $250 million in clinical, regulatory and sales milestones for each product that emerges from the expanded collaboration. In addition, the Watertown, Mass.-based company may receive development milestone payments exceeding $1 billion. Moreover, the five-year-old biotech could share commercial rights with Roche, of Basel, Switzerland, for certain approved products.

Members of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) on Friday seemed to have more questions about Dsuvia for Acelrx Pharmaceuticals Inc. than did FDA reviewers, who followed up their mostly positive briefing document by observing the company had submitted "the kinds of information" needed to resolve last year's complete response letter (CRL) for the opioid analgesic.

Not unlike the zeal of trainspotters, the allure of chimeric antigen receptor T cell (CAR T) therapy continues to attract devoted fans. And biopharma investors clearly expect the former management team at Kite Pharma Inc. to keep that train rolling down the track.

Roche Holding AG issued a vote of confidence in partner Ionis Pharmaceuticals Inc. by tapping the Carlsbad, Calif.-based company for a second alliance, focused on the treatment of complement-mediated diseases. The companies will collaborate on the development of IONIS-FB-LRx, targeting factor B (FB), in a broad range of diseases, beginning with geographic atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD).

Rgenix Inc. tapped existing investors Novo Holdings A/S, Sofinnova Partners, Alexandria Venture Investments LLC and the Partnership Fund for New York City's Innovate NY Fund for its $40 million series C, but the round was led by new investor Lepu Medical Technology Co. Ltd., of Beijing, a publicly traded medical device maker that is expanding its footprint in therapeutic development – immuno-oncology (I-O), in particular. Oceanpine Capital and Wuxi Apptec's Corporate Venture Fund also joined the syndicate.