Bio Roundup: DIY Biohacking, PCSK9 Data, Solid Setback & More

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clinical testing of a treatment for acromegaly, a rare hormone disorder.

—Humacyte closed a $75 million Series C round that the Research Triangle Park, NC, company will use to continue Phase 3 studies of its bioengineered blood vessels and to complete a bioprocessing system for manufacturing them.

—Flagship Pioneering launched Cambridge, MA-based Foghorn Therapeutics with $50 million in funding. Forbes has more on the startup, which is founded by 32-year-old Dana-Farber Cancer Institute professor Cigall Kodach and aims to develop drugs that control gene expression in cells.

—Orexigen Therapeutics (NASDAQ: OREX) filed for bankruptcy with plans to sell itself, and its weight loss pill Contrave, at an open auction in May. Orexigen was about to breach a debt deal because 2017 sales of Contrave didn’t reach $100 million.

—Ideaya Biosciences of South San Francisco, CA, raised $94 million to bring its cancer drugs into human testing. The Series B round included “crossover investors,” entities that invest in both public and private companies, laying the groundwork for a potential IPO.

DRUG DEVELOPMENTS

—In a surprise, the House of Representatives rejected a bill that would give terminally ill patients more access to experimental drugs. The so-called right-to-try movement is staunchly opposed by patient advocate groups and the drug industry, which lobbied hard against the bill.

— Norbert Bischofberger, chief medical officer of Gilead Sciences (NASDAQ: GILD), is transitioning to retirement after nearly 30 years with the Foster City, CA, company. Gilead says he’ll step away from his executive post in April and leave the company in July.

—Sanofi chose not to gain rights to an experimental Alnylam RNA interference medicine, lumisiran, for the rare kidney disease primary hyperoxaluria type 1. The two streamlined a wide-ranging alliance on a variety of RNA interference drugs in January.

—Sarepta Therapeutics (NASDAQ: SRPT) will file for accelerated approval of its second Duchenne muscular dystrophy drug, golodirsen, by the end of the year. The FDA approved Sarepta’s first drug, eteplirsen (Exondys 51) even though it hadn’t yet proven to benefit patients.

—Intra-Cellular Therapies (NASDAQ: ITCI) said after a meeting with the FDA the two have agreed “on the content and timing” of an approval filing for experimental schizophrenia drug lumateperone, which has had mixed results in clinical testing. Intra-Cellular should complete the application by mid-year.

—The FDA halted a study testing a combination of Advaxis’ (NASDAQ: ADXS) experimental cancer vaccine axalimogene filolisbac and AstraZeneca’s immunotherapy durvalumab (Imfinzi) after a patient died of respiratory failure.

—Auris Medical’s (NASDAQ: EARS) tinnitus drug Keyzilen failed a Phase 3 study, the second late-stage failure for the Switzerland-based company’s drug.

—There’s a new enzyme for the CRISPR-Cas13 gene-editing system. Arbor Biotechnologies published its discovery of Cas13d in the journal Molecular Cell, saying the enzyme could be used in RNA manipulation and highly sensitive diagnostics.

—Alexion Pharmaceuticals (NASDAQ: ALXN) announced positive preliminary results from a Phase 3 study testing its drug ALXN210 in paroxysmal nocturnal hemoglobinuria, a rare blood disorder.

Ben Fidler and Alex Lash contributed to this report.

Photo by Flickr user Brandon Giesbrecht via a Creative Commons license.

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