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Biotech Roundup: Novartis on Hold, AMAG Vote, Neuro News & More

Xconomy National — 

The brain has stymied many efforts to develop new neuroscience drugs, leading a number of big pharmaceutical companies to pull back on such R&D work. This week, Amgen joined them.

Amgen (NASDAQ: AMGN) is ending its research and early development programs in neuroscience, the company announced during a conference call to discuss third-quarter financial results. Exempt from the decision is neuroinflammation research, as well as Amgen’s drug erenumab (Aimovig), which last year became the first approved FDA-drug in a new class of migraine-prevention medicines.

Going forward, Amgen will focus on areas such as oncology and cardiovascular disease, where CEO Bob Bradway says the company stands the best chance for success. Amgen’s decision follows the neuroscience retreat of Pfizer (NYSE: PFE), GlaxoSmithKline (NYSE: GSK), and AstraZeneca (NYSE: AZN), among others. But as big pharma steps back from neuro R&D, some smaller biotechs are stepping up, including a startup that this week revealed how its approach targeting the brain protein tau could treat neurodegeneration. In other news this week, an FDA panel voted to withdraw a drug from the market, a gene therapy study was put on hold, and Wall Street welcomed two more biotechs. Let’s get to those stories and more in this week’s roundup.

DRUG DEVELOPMENTS

—The FDA placed a partial clinical hold on a Novartis (NYSE: NVS) clinical trial testing the gene therapy, Zolgensma, after safety issues from an animal study surfaced.

—Biogen (NASDAQ: BIIB) and Alkermes (NASDAQ: ALKS) won FDA approval for multiple sclerosis (MS) drug diroximel fumarate (Vumerity). The drug is expected to become a successor to Biogen’s MS pill Tecfidera.

—An FDA advisory committee voted 9-7 to recommend that the agency pull an AMAG Pharmaceuticals (NASDAQ: AMAG) drug for preterm birth from the market. The injectable treatment, hydroxyprogesterone caproate (Makena), failed to beat a placebo in a post-marketing study.

—The UK’s Competition and Markets Authority dinged the $1.2 billion Illumina (NASDAQ: ILMN) and PacBio (NASDAQ: PACB) tie-up, saying in provisional findings that the merger would unfairly reduce competition in the industry. The companies extended the deadline for the deal.

—Cancer drug developer Mirati Therapeutics (NASDAQ: MRTX) saw its share price jump 17 percent Tuesday after it released encouraging Phase 1/2 data for MRTX849, which is being tested in patients with solid tumors that carry a KRAS G12C mutation.

CASH GRABS & NEW STARTS

Cancer drug developer Nuvation Bio closed $275 million in Series A financing and unveiled a team led by former Medivation CEO David Hung.

Pinteon Therapeutics raised $17 million for early-stage tests of drug that targets the brain protein tau as a way of treating neurodegenerative disorders.

—The Cystic Fibrosis Foundation is building on its earlier efforts to invest in promising CF therapies with a new plan to allocate up to $500 million over the next five years for drug research that could lead to a cure.

— Disc Medicine, a new biotech that aims to treat anemia caused by a variety of blood disorders, launched with $50 million. The company is developing drugs to impact hepcidin, a liver hormone that helps the body regulate iron absorption.

—Tmunity Therapeutics, a University of Pennsylvania developing next-generation T cell cancer therapies in Philadelphia, raised a $75 million Series B financing round led by Andreessen Horowitz.

Wisconsin’s Venture Investors, the oldest venture firm in Wisconsin, has raised a sixth fund totaling $75 million.  In a departure from its broader focus with previous funds, the new fund will invest only in early-stage life sciences and healthcare startups.

LET’S MAKE A DEAL

Roche agreed to pay $200 million up front for rights to a Dicerna Pharmaceuticals (NASDAQ: DRNA) RNA interference drug currently in Phase 1 testing for hepatitis B virus infection.

Pandion Therapeutics joined forces with Astellas Pharma in a partnership focused on treatments for type 1 diabetes and other autoimmune diseases affecting the pancreas. Cambridge, MA-based Pandion could receive up to $45 million in upfront and R&D payments, plus more depending on the progress of the programs.

—Pear Therapeutics and Ironwood Pharmaceuticals (NASDAQ: [[ticker: IRWD]]) are teaming up to develop digital therapeutics for gastrointestinal disorders. No financial terms were disclosed.

—Roche, which agreed to acquire gene therapy maker Spark Therapeutics (NASDAQ: ONCE) in February for $4.8 billion, has extended the merger agreement plan to Nov. 25 to allow more time for US and UK regulators to complete antitrust investigations.

—Google parent company Alphabet (NASDAQ: GOOGL) has offered to acquire Fitbit (NYSE: FIT), a maker of fitness trackers and smartwatches, Reuters reported.

—Amgen is paying $2.7 billion for a 20.5 percent stake in Beijing-based BeiGene (NASDAQ: BGNE). The companies will work together to commercialize Amgen’s drugs in China.

THIS WEEK IN IPOS

—Cancer and inflammatory diseases drug developer RAPT Therapeutics (NASDAQ: RAPT) joined the public markets with a $36 million IPO. The South San Francisco company priced its IPO at $12 per share, which was the low end of its projected price range.

—Oyster Point Pharma (NASDAQ: OYST) raised $80 million from its IPO, which priced at $16 per share—the low end of its targeted price range. The Princeton, NJ, company will use the cash to continue development and prepare for commercialization of its lead product candidate, a nasal spray that treats dry eye disease.

—Shanghai, China-based I-Mab filed paperwork to list shares on a US stock exchange. The cancer and autoimmune disorders drug developer set a preliminary $100 million figure for its IPO.

PEOPLE ON THE MOVE

—Editas Medicine (NASDAQ: EDIT) appointed Judith Abrams chief medical officer… Mirum Pharmaceuticals (NASDAQ: MIRM) appointed Ed Tucker chief medical officerThomas Russo left Gilead Sciences to become chief financial officer of Assembly Bio (NASDAQ: ASMB)… Genmab (NASDAQ: GMAB) CFO David Eatwell will retire in February… Matthew Sause was appointed president and CEO of North America operations for Roche Diagnostics… José Octávio Costa Filho left Servier Pharmaceuticals to become chief medical officer of Rafael Pharmaceuticals… Bicycle Therapeutics (NASDAQ: BCYC) named Nigel Crockett chief business officer… Richard Morris left Context Therapeutics to become Passage Bio’s CFO… Joanne Schindler joined IMV (NASDAQ: IMV) as chief medical officer… and Scout Bio appointed Anne Traas chief development officer.

Sarah de Crescenzo contributed to this report.

Photo by Flickr user Dave Winer via a Creative Commons license.