Bio Roundup: Fast FDA Approvals, Biogen Delays, ORIC’s IPO & More

Xconomy National — 

COVID-19’s spread has clamped down on a lot of economic activity, including the work of developing and testing new medicines. But the FDA isn’t showing signs of slowing down, at least when it comes to drugs filed for accelerated approval. The regulator signed off on three such drugs in the past week.

These approvals are for cancers that have few, if any, treatment options. The FDA says it is committed to expediting the review of such drugs, even under COVID conditions. But can the agency keep up the pace? Politico’s AgencyIQ division notes that while the pandemic has not yet affected drug approvals, regulatory submissions are reviewed over timelines spanning many months. That means that the pandemic’s impact on drug reviews will likely happen in the months to come.

In other news this week, an Alzheimer’s disease drug is delayed, questions emerged around a closely watched experimental COVID-19 therapy, and another biotech squeaked through the IPO window. Let’s get to those stories and more in this week’s news roundup.


—Seattle Genetics (NASDAQ: SGEN) received its third FDA approval, winning the agency’s OK for tucatinib (Tukysa) in combination with two chemotherapies for patients with HER2-positive breast cancer that can’t be surgically removed or has spread.

—Incyte (NASDAQ: INCY) won an FDA nod for pemigatinib (Pemazyre), the first drug approved for cholangiocarcinoma, a rare cancer affecting the bile ducts.

—The FDA approved Immunomedics (NASDAQ: IMMU) drug sacitizumab govitecan (Trodelvy) for patients whose metastatic triple negative breast cancer hasn’t responded to two earlier treatments. It’s the Morris Plains, NJ, company’s first product to clear the regulatory bar.


—Biogen (NASDAQ: BIIB), which expected to have finalized its FDA submission for Alzheimer’s disease drug aducanumab by now, delayed to the third quarter its estimate of when the filing would be complete. The company cited the complexity of the data and impacts from COVID-19.

—Cara Therapeutics (NASDAQ: CARA) reported that its pruritus drug difelikefalin (Korsuva) met the main goal of a second Phase 3 study and the Stamford, CT-based drug developer plans to file for regulatory approvals in the US and Europe later this year.

—Esperion (NASDAQ: ESPR) licensed Japanese rights to its two cholesterol-lowering drugs to Otsuka Pharmaceutical. Ann Arbor, MI-based Esperion received $60 million up front and could earn up to $450 million in milestone payments pegged to the progress of those drugs in Japan.

—Scynexis (NASDAQ: SCYX) is preparing to file for FDA review of ibrexafungerp after reporting early Phase 3 data showing its experimental anti-fungal candidate beat a placebo in treating vaginal yeast infections.

—Xconomy reported on the progress of microbiome research from the perspective of panelists speaking at the recent BioEurope conference.


—Venture capital flowed to life sciences companies in the first quarter. But according to a report from the National Venture Capital Association and PitchBook, early-stage deals aren’t likely to continue apace as investors focus their attention on their portfolio companies.

Affinivax raised $120 million in Series B financing to support R&D of its bacterial vaccines technology in applications including healthcare-associated infections, cancer, and COVID-19.

—San Franciso startup Unlearn raised $12 million to advance its clinical trial enablement software, which aims to use proprietary machine learning tools to add “digital twins” created from past patient records as control patients.

—ORIC Pharmaceuticals raised $120 million in an initial public offering, cash the company says it will use to test its drug-resistant cancer therapies.

—Norfolk, VA-based ReAlta Life Sciences raised $14 million to advance its lead program, a treatment for a severe birth complication called hypoxic ischemic encephalopathy that affects newborns. The fresh cash, a second tranche of Series A financing, brings its total to $26 million.


—Novartis (NYSE: NVS) acquired Amblyotech, an Atlanta startup developing a digital therapy for amblyopia, also known as “lazy eye.” No financial terms were disclosed.

—Gilead Sciences (NASDAQ: GILD) subsidiary Kite signed a three-year cancer immunotherapy research collaboration with Australian biotech oNKo Innate to discover and develop of treatments focused on natural killer cells. The approach is considered a potential complement to T cell immunotherapies. Terms weren’t disclosed.

—Antibiotics developer Melinta Therapeutics emerged from its Chapter 11 bankruptcy restructuring as a privately held firm owned by Deerfield Management.

—Asklepios BioPharmaceutical of Research Triangle Park, NC, added to its pipeline with the acquisition of BrainVectis, a France-based company developing a Huntington’s disease gene therapy. No financial terms were disclosed.

—Nearly two years after emerging with technology and cash to develop drugs based on RNA-modifying proteins, Lexington, MA-based Accent Therapeutics added more money from a $63 million Series B round of funding.

—San Francisco-based biotech Nitrome Bio raised $38 million to get its preclinical Parkinson’s disease treatment ready for human testing. The venture arm of AbbVie (NASDAQ: ABBV) participated in the financing.


—Rick Bright, who has headed the Biomedical Advanced Research and Development Authority (BARDA) since 2016, left the position for a role at the National Institutes of Health. Bright said the move was involuntary, and retaliation for his stance on the broad use of chloroquine and hydroxychloroquine, which President Trump has promoted as a treatment for COVID-19 without scientific evidence.

—Novartis (NYSE: NVS) said it would run a Phase 3 trial evaluating the use of hydroxychloroquine in patients hospitalized with COVID-19 disease. The pharma giant plans to enroll about 440 patients at more than a dozen US sites.

—Companies pursuing COVID-19 vaccines need to balance speed and efficacy in the face of a pandemic situation, including selecting the most promising candidates, the FDA’s Peter Marks emphasized in a talk on vaccine development amid the outbreak.

—A World Health Organization draft document stated that experimental COVID-19 treatment remdesivir failed a clinical trial in China, according to news reports. The document has since been removed from the WHO website. The drug’s developer, Gilead Sciences, said the WHO mischaracterized the study, adding that it ended early due to low enrollment.


Laura Shawver joined Silverback Therapeutics as its CEO…Ohana Biosciences added Ramiro Castro-Santamaria as its chief medical officer…Russell Ellison was tapped as Rockwell Medical’s new president and CEO…PTC Therapeutics (NASDAQ: PTCT) promoted Matthew Klein to chief development officer and Eric Pauwels to chief business officer…C. Greg Guyer joined BioMarin Pharmaceutical (NASDAQ: BMRN) as chief technical officer and executive vice president of global manufacturing and technical operations…and Virta Health appointed Robert Ratner to serve as its chief medical officer.

Image: iStock/Sensay

Sarah de Crescenzo contributed to this report.