Cambridge, MA's Seres Therapeutics won the FDA's coveted breakthrough-therapy designation for its lead microbiome treatment, promising the company a speedy regulatory review as it prepares to go public.
A group of FDA advisers backed GlaxoSmithKline's latest asthma treatment for use in adults but balked at recommending it for adolescents, setting the stage for a likely approval in the fall.
Agios Pharmaceuticals' lead cancer drug extended its streak of promising clinical results, racking up remissions in an expanded Phase I trial as the company prepares for late-stage testing.
FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the week's biggest news in biopharma, including the ongoing squabble between Teva and Mylan, the debate over a new class of cholesterol treatments, and the regulatory saga of a long-delayed female libido drug.
In this week's EuroBiotech Report, Biotie Therapies, Cosmo Pharmaceuticals, Targovax and Pieris Pharmaceuticals are all advancing plans to raise cash from public investors. Biotie and Pieris are following the well-trodden path to Nasdaq, although the latter is going by the circuitous route of an OTCQB listing on its way to a $35 million (€31 million) IPO on the main market. And more.
San Diego's BioAtla has raised $30 million in equity from undisclosed Chinese investors, cash that will help push its pipeline of large-molecule treatments.
Vivek Ramaswamy may not know anything about biotech and even less about treating Alzheimer's, but he just provided a master class on the current state of public investing and executing IPOs in the field.
Hot on the heels of executing a $645 million deal to work with Seattle Genetics on a portfolio of antibody-coupled T-cell receptor programs, Cambridge, MA-based Unum Therapeutics has taken the wraps off a whopping $65 million crossover round aimed at fueling their drive into the clinic with their next-gen approach to CAR-T.
Genmab has moved a step closer to seeing daratumumab approved in double refractory multiple myeloma. A rolling submission for the breakthrough cancer therapy is now underway, raising hopes that the product will be on the market early next year.
Johnson & Johnson today took the wraps off its latest collection of collaborations aimed at everything from setting up new "asset-centric" drug development operations with a partner in China to exploring ways to prevent Type 1 diabetes with investigators at Washington University. Its latest tally of 17 new deals and developments also includes a new Innovation hub in Sweden and brings its global total for its deal teams to more than 200 projects over two years running.
Targovax is to merge with fellow Nordic biotech Oncos Therapeutics to create an immuno-oncology player with the critical mass to get noticed in the congested and fiercely fought field. The merged company will fuel the first-phase of its ambitions through a private placement, with an IPO in Oslo to follow within the next 12 months.
The infants and young children who suffer from rare cases of spinal muscular atrophy, or SMA, don't live long. But Isis Pharmaceuticals says that the latest update on the infants enrolled in their mid-stage program for ISIS-SMNrx shows that toddlers with the most severe form of the disease have been getting progressively stronger and living longer while taking this drug.
After spending the last four years germinating an idea for a new biotech company with some top scientists, the partners at Polaris have allied with New Enterprise Associates and a trio of biotech investors to launch XTuit, jumping out of stealth mode with a $22 million A round and a new take on fighting cancer and liver disease.
Amgen won the support of FDA advisers with its potentially game-changing new cardiovascular treatment, but the agency panel cautioned against widespread use of the injection until its long-term safety is better understood.
Two weeks after GlobeImmune conceded that its Gilead-partnered hepatitis B vaccine had flunked out of a key Phase II study, the Louisville, CO-based biotech said it laid off "the majority" of its staff.
Pieris Pharmaceuticals has filed to step up to Nasdaq from OTCQB and add $35 million (€31 million) to its bank balance in the process. The listing would end Pieris' short stay on OTCQB, which began when it acquired Marika in a reverse merger late last year and allowed it to raise $13.5 million in a private placement from investors including OrbiMed Advisors.
Cosmo Pharmaceuticals is pushing ahead with plans to spin out its dermatology assets and list the resulting company on the SIX Swiss Exchange. To get the project underway, Cosmo and its shareholders have clubbed together for a €49.9 million ($56.5 million) capital increase, giving the spinout the cash it needs to wrap up a Phase III trial of its lead candidate.
Biotie Therapies has become the latest European biotech to ratchet up its Nasdaq IPO plans after gauging interest in the offering. But proceeds for the CNS specialist are due to stay at the same level, with the 12% rise in the overall haul coming from UCB's decision to sell its stake for around $7.7 million (€6.8 million).
A rash of unnamed-source reports claim Receptos has shaken off multibillion-dollar advances from some of the world's biggest drugmakers, sending the San Diego biotech's shares ever higher as it advances its autoimmune treatment.