Author: Frank Vinluan

Xconomy Editor Frank Vinluan is a business journalist with experience covering technology and life sciences. Based in Raleigh, he was a staff writer at the Triangle Business Journal covering technology, biotechnology and energy before joining MedCityNews.com as North Carolina bureau chief. Prior to moving to North Carolina’s Research Triangle in 2007 he held business reporting positions at The Des Moines Register and The Seattle Times.

No Charm: PTC’s Duchenne Drug Rejected by FDA for Third Time

The FDA on Wednesday rejected a Duchenne muscular dystrophy drug from PTC Therapeutics, marking the third time that the regulator has quashed the company’s attempts to bring its drug to the market. Early this year, South Plainfield, NJ-based PTC (NASDAQ: [[ticker:PTCT]]) invoked a little-used rule to force an FDA decision. That strategy looked ill-advised last … Continue reading “No Charm: PTC’s Duchenne Drug Rejected by FDA for Third Time”

Five Prime Therapeutics Promotes Aron Knickerbocker to CEO

Five Prime Therapeutics (NASDAQ: [[ticker:FPRX]]) did not have to go far to find its next CEO. Aron Knickerbocker, currently the chief operating officer of the South San Francisco, CA, biotech, has been named its new CEO. Knickerbocker will succeed Lewis “Rusty” Williams, who will become executive chairman. The change will become effective Jan. 1. Knickerbocker … Continue reading “Five Prime Therapeutics Promotes Aron Knickerbocker to CEO”

Bruno Lucidi Appointed CEO of AgenTus Therapeutics

Bruno Lucidi has been named CEO of AgenTus Therapeutics, a subsidiary of Lexington, MA, cancer drug developer Agenus (NASDAQ: [[ticker:AGEN]]). AgenTus is also developing cancer treatments, but it will focus specifically on cell therapies. Lucidi’s industry experience includes senior roles at GlaxoSmithKline (NYSE: [[ticker:GSK]]), Johnson & Johnson (NYSE: [[ticker:JNJ]]), and Bristol-Myers Squibb (NYSE: [[ticker:BMY]]).

Arsanis Eyes IPO to Support Clinical Testing of Pneumonia Drug

Arsanis is joining the IPO queue, filing for a stock offering that would raise cash to support a drug that combines two monoclonal antibodies with the goal of preventing pneumonia infections. The filing comes seven months after the Waltham, MA, company raised $45.5 million in a Series D investment round to finance Phase 2 studies … Continue reading “Arsanis Eyes IPO to Support Clinical Testing of Pneumonia Drug”

Boston Biomedical Brings on Board Edgar Braendle as Head of R&D, CMO

Boston Biomedical has appointed Edgar Braendle to serve as executive vice president, head of research and development, and chief medical officer. Before joining the Boston-based cancer drug developer, Braendle was president and CEO of ARUP Laboratories in Salt Lake City. He also previously worked at Novartis (NYSE: [[ticker:NVS]]), where he was global head of the … Continue reading “Boston Biomedical Brings on Board Edgar Braendle as Head of R&D, CMO”

Merck’s Mark DiNubile Joins BioAegis as Chief Medical Officer

Mark DiNubile has joined BioAegis Therapeutics as chief medical officer. DiNubile previously spent 16 years at Merck (NYSE: [[ticker:MRK]]), where his work focused on infectious diseases and vaccines. North Brunswick, NJ-based BioAegis is a clinical stage company developing treatments for inflammation and infection. The company’s lead drug is in Phase 2 studies as a potential … Continue reading “Merck’s Mark DiNubile Joins BioAegis as Chief Medical Officer”

Bio Roundup: Kite’s CAR-T Approved, Obamacare Fix & Lilly mRNA Deal

Kite Pharma wasn’t expecting a regulatory decision for its non-Hodgkin lymphoma treatment until November, but this week, the company got the FDA’s O.K. The approval of axicabtagene ciloleucel (Yescarta) marks the second time in the two months that the FDA has given the nod to a CAR-T therapy, a treatment made from a patient’s own … Continue reading “Bio Roundup: Kite’s CAR-T Approved, Obamacare Fix & Lilly mRNA Deal”

For Key Study, UniQure Allowed to Swap Hemophilia Gene Therapies

UniQure is trying to get to the finish line for a hemophilia B gene therapy by switching horses mid-race—and it says it has the blessing from regulators to make the unusual change. The company had been testing a gene therapy candidate called AMT-060 in early-stage clinical trials, with good data to show for it. But … Continue reading “For Key Study, UniQure Allowed to Swap Hemophilia Gene Therapies”

Eli Lilly to Pursue mRNA Cancer Vaccines with CureVac Pact

[Updated, 10/19/17, 3:17 pm. See below.] Eli Lilly is getting a foothold in messenger RNA (mRNA) cancer vaccines through a deal with CureVac that could develop up to five new therapies. Indianapolis-based Lilly (NYSE: [[ticker:LLY]]) will pay CureVac, headquarted in Germany, $50 million up front, plus make an equity investment in the company valued at … Continue reading “Eli Lilly to Pursue mRNA Cancer Vaccines with CureVac Pact”

Vir Biotech Vies for Global Approach to Tackling Infectious Disease

Vir Biotechnology CEO George Scangos aims to develop new infectious disease drugs that can treat people in the U.S. and other developed countries. But he also wants to make these therapies available to the developing world, where the need is great but the financial means to pay for medicine is scarce. To accomplish both goals, … Continue reading “Vir Biotech Vies for Global Approach to Tackling Infectious Disease”

After FDA Nod, TransEnterix Preps to Bring Surgical Robot to Market

TransEnterix now has regulatory clearance to bring its surgical robot to the market, but don’t expect to see surgeries performed with the technology in U.S. hospitals for at least a year, perhaps longer. Hospitals need four to six quarters to work through purchasing decisions for new capital equipment, says CEO Todd Pope. In the meantime, … Continue reading “After FDA Nod, TransEnterix Preps to Bring Surgical Robot to Market”

Gemini Reels In $42M to Target Root Causes of Age-Related Blindness

One of the biggest risk factors for vision loss is age. As people grow old, the central part of the retina can become damaged, leading patients to lose the central part of their vision in a condition called age-related macular degeneration (AMD). In recent years, scientists have found genetic factors associated with the eye damage … Continue reading “Gemini Reels In $42M to Target Root Causes of Age-Related Blindness”

Synlogic Taps Andrew Gengos for Chief Operating Officer Post

Andrew Gengos has been named chief operating officer and head of corporate development for Cambridge, MA, biotech Synlogic (NASDAQ: [[ticker:SYBX]]). Gengos was most recently president and CEO of Westlake Village, CA-based ImmunoCellular Therapeutics (NYSE MKT: [[ticker:IMUC]]). Synlogic, which genetically engineers microbes for therapeutic applications, went public earlier this year in a reverse merger.

SutroVax Appoints Alan Kimura Chief Medical Officer

Alan Kimura is joining Foster City, CA, vaccine developer SutroVax as chief medical officer. Kimura’s experience includes senior positions at Translate Bio, Novartis (NYSE: [[ticker:NVS]]) and Shire (NASDAQ: [[ticker:SHPG]]). Earlier this year, SutroVax raised $64 million in financing to start clinical testing of its vaccine candidate for pneumococcal infections. In other moves, SutroVax named Durga … Continue reading “SutroVax Appoints Alan Kimura Chief Medical Officer”

Join Xconomy in December for What’s Hot in Bay Area Biotech

The earlier a disease is spotted, the sooner it can be treated. New diagnostic approaches are promising ways for physicians to detect cancer earlier from a small blood sample. Advances are also reaching consumers, who now have new ways to learn what their genes or microbiomes can say about their health. Xconomy is bringing together … Continue reading “Join Xconomy in December for What’s Hot in Bay Area Biotech”

Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote

An experimental Spark Therapeutics gene therapy intended to treat rare eye diseases that lead to blindness has won the unanimous backing of an advisory panel to the FDA. Following a daylong hearing that included presentations from Philadelphia-based Spark (NASDAQ: [[ticker:ONCE]]), FDA staff, ophthalmologists, and patients, the panel of independent eye experts voted 16-0 on the … Continue reading “Spark’s Gene Therapy to Restore Vision Wins Unanimous FDA Panel Vote”

OrthoPediatrics IPO Raises $52M for Medical Implants and Instruments

OrthoPediatrics is making its stock market debut today in a $52 million IPO that will support the company’s lineup of medical devices developed specifically for children. Warsaw, IN-based OrthoPediatrics priced its offering of 4 million shares at $13 each, the midpoint of its projected $12 to $14 range. Underwriters of the offering have the option … Continue reading “OrthoPediatrics IPO Raises $52M for Medical Implants and Instruments”

Merck Abandons Plans to Seek FDA Approval of Cholesterol Drug

Merck is pulling the plug on a cholesterol-lowering drug that met its main goal in a clinical trial but still raised questions about whether it would benefit patients. Kenilworth, NJ-based Merck (NYSE: [[ticker:MRK]]) said Wednesday that it won’t seek regulatory approval for anacetrapib, a drug that inhibits a protein called cholesterolylester transfer protein (CETP). By … Continue reading “Merck Abandons Plans to Seek FDA Approval of Cholesterol Drug”

Zafgen Names Hatfield CEO, Former Chief Exec Hughes Shifts to CSO

Zafgen (NASDAQ: [[ticker:ZFGN]]) has named Jeffrey Hatfield CEO of the Boston-based drug developer. Thomas Hughes, who has been Zafgen’s CEO since 2008, will continue as president and take on the newly created position of chief scientific officer. Both Hatfield and Hughes will serve on the company’s board of directors. Hatfield was most recently CEO of … Continue reading “Zafgen Names Hatfield CEO, Former Chief Exec Hughes Shifts to CSO”

Armo BioSciences Appoints Joseph Leveque Chief Medical Officer

Joseph Leveque has joined Armo BioSciences as chief medical officer. Leveque will oversee the late-stage clinical testing of Armo’s lead cancer immunotherapy candidate, as well as the rest of the Redwood City, CA, company’s pipeline. Before Armo, Leveque held executive and senior management roles at EMD Serono, Merck Group, Bristol-Myers Squibb (NYSE: [[ticker:BMY]]), Onyx Pharmaceuticals, … Continue reading “Armo BioSciences Appoints Joseph Leveque Chief Medical Officer”

KalVista, Merck Partnership on Blindness Drug Sends Shares Skyward

KalVista Pharmaceuticals has inked a partnership with pharmaceutical giant Merck for its lead drug, an experimental treatment for a complication of diabetes that can lead to blindness. According to the deal announced Tuesday, Merck (NYSE: [[ticker:MRK]]) will pay Cambridge, MA-based KalVista (NASDAQ: [[ticker:KALV]]) $37 million up front. Merck gains the option to acquire the diabetic … Continue reading “KalVista, Merck Partnership on Blindness Drug Sends Shares Skyward”

Eli Lilly Drug Fails in Lung Cancer, Stalling Oncology Strategy

A cancer drug that Eli Lilly was positioning as a challenger to similar drugs from rivals Pfizer and Novartis has failed a late-stage clinical trial in lung cancer. Indianapolis-based Lilly (NYSE: [[ticker:LLY]]) said Tuesday that its drug, abemaciclib (Verzenio), did not meet the Phase 3 study’s main goal of improving overall survival in patients who … Continue reading “Eli Lilly Drug Fails in Lung Cancer, Stalling Oncology Strategy”

Ag Secretary Perdue Hears Startups Call for More Research Support

U.S. Secretary of Agriculture Sonny Perdue’s visit to North Carolina this week put him on stage among entrepreneurs and academics that his office chose for the occasion, and they used the opportunity to bend his ear. Joy Parr Drach, a farmer who is also CEO of Advanced Animal Diagnostics, told him about the challenges facing … Continue reading “Ag Secretary Perdue Hears Startups Call for More Research Support”

Rhythm Pharma IPO Pops to the Tune of a $120M Upsized Offering

Rhythm Pharmaceuticals is in step with other life science companies going public, raising $120 million in its own upsized IPO. The Boston company priced its stock offering late Wednesday at $17, topping the $14 to $16 per share range it had previously set. Rhythm sold just over 7 million shares, nearly 400,000 more shares that … Continue reading “Rhythm Pharma IPO Pops to the Tune of a $120M Upsized Offering”

Fresenius Medical’s Angelo Moesslang Joins InGeneron as CEO

Regenerative medicine company InGeneron has appointed Angelo Moesslang CEO. Before joining Houston-based InGeneron, Moesslang was CFO of Fresenius Medical Care North America, part of German company Fresenius Medical Care. Earlier this year, InGeneron raised $20 million to support clinical testing of a stem cell-based system meant to aid recovery from wounds and orthopedic injuries.

Amicus Therapeutics’ Pompe Drug Data Show Improved Muscle Movement

[Updated 10/5/17, 3:35 pm. See below.] Amicus Therapeutics has its sights set on a second approved drug after reporting that its Pompe disease treatment helped patients reduce the muscle-wasting effects of the genetic disease. The results were from a small, 20-patient study, however, and the Amicus drug will have to pass muster in a larger … Continue reading “Amicus Therapeutics’ Pompe Drug Data Show Improved Muscle Movement”

Ultragenyx Sweetens Offer, Dimension Tx Agrees to $151M Acquisition

Two weeks after making a surprise bid for Dimension Therapeutics, Ultragenyx Pharmaceutical is now set to acquire the gene therapy company in a deal valued at $151 million. Ultragenyx (NASDAQ: [[ticker:RARE]]) announced Tuesday that it has reached an agreement to acquire Cambridge, MA-based Dimension (NASDAQ: [[ticker:DMTX]]) for $6 per share. The Novato, CA-based rare disease … Continue reading “Ultragenyx Sweetens Offer, Dimension Tx Agrees to $151M Acquisition”

Cullinan Oncology Emerges with $150M to Build Cancer Drug Portfolio

It’s no secret that discovering and developing cancer drugs is an expensive and risky endeavor. But Cullinan Oncology is betting that a financial approach, rather than a purely scientific one, can improve the odds, and it has raised $150 million to test its approach. The Series A investment for Cambridge, MA-based Cullinan was co-led by … Continue reading “Cullinan Oncology Emerges with $150M to Build Cancer Drug Portfolio”

Genomics Startup Sema4 Appoints Jamie Coffin President and COO

Jamie Coffin has been appointed president and chief operating officer of Stamford, CT-based health IT startup Sema4. Before joining Sema4, Coffin was the CEO of Birmingham, AL-based Source Medical Solutions. His experience also includes senior management posts at Dell and IBM (NYSE: [[ticker:IBM]]). Sema4 spun out of the Icahn School of Medicine at Mount Sinai … Continue reading “Genomics Startup Sema4 Appoints Jamie Coffin President and COO”

Arvinas Promotes John Houston to President and CEO

John Houston has been named president and CEO of Arvinas. He will also join the board of directors of the New Haven, CT, drug developer. Houston initially joined Arvinas in January as president of research and development and chief scientific officer. Before Arvinas, Houston spent 18 years in various roles at Bristol-Myers Squibb (NYSE: [[ticker:BMY]]). … Continue reading “Arvinas Promotes John Houston to President and CEO”

Endocyte Adds Phase 3-Ready Prostate Cancer Drug with ABX Deal

Four months after two Endocyte drug candidates stumbled in early-stage studies, sparking a corporate shakeup, the company has signed a deal landing an experimental prostate cancer treatment that it says is ready for Phase 3 clinical trials. West Lafayette, IN-based Endocyte (NASDAQ: [[ticker:ECYT]]) says it paid $12 million up front to German biochemicals company ABX … Continue reading “Endocyte Adds Phase 3-Ready Prostate Cancer Drug with ABX Deal”

Bio Roundup: Graham-Cassidy, Axovant Fail, SpringWorks Launches & More

After drug pricing, count drug shortages among the hot button issues sparking patient ire. Last year, the FDA says, 23 drug shortages were reported, down from 26 the previous year (and 251 in 2011). But Hurricane Maria’s direct strike on Puerto Rico might put the progress made on reducing shortages to the test. The Pharmaceutical … Continue reading “Bio Roundup: Graham-Cassidy, Axovant Fail, SpringWorks Launches & More”

Deciphera IPO Drums Up $128M for Cancer Drug Studies

Three life sciences companies went public late Wednesday and raised more than $300 million combined. They were headlined by Deciphera Pharmaceuticals, which pulled in $127.5 million in an upsized IPO. The Waltham, MA-based cancer drug developer priced its shares at $17 apiece, which was on the high end of the $15 to $17 range it … Continue reading “Deciphera IPO Drums Up $128M for Cancer Drug Studies”

GSK’s Chris Carpenter Joins Rubius as Chief Medical Officer

Chris Carpenter has been appointed chief medical officer of Cambridge, MA-based Rubius Therapeutics. Carpenter was most recently senior vice president and head of the cancer epigenetics department at GlaxoSmithKline (NYSE: [[ticker:GSK]]). His experience also includes posts at Merck (NYSE: [[ticker:MRK]]) and Harvard Medical School. Earlier this year, Rubius raised $125 million to bring its engineered … Continue reading “GSK’s Chris Carpenter Joins Rubius as Chief Medical Officer”

Health IT Startup Aetion Names Carolyn Magill CEO

Aetion has named Carolyn Magill CEO of the New York-based company. Magill most recently served as CEO of Darien, CT-based Remedy Partners. Aetion, a health IT startup, has developed software that analyzes clinical and financial activity to find evidence supporting the efficacy and value of treatments. In March, Aetion raised $11 million in a Series … Continue reading “Health IT Startup Aetion Names Carolyn Magill CEO”

A4L Lands $25M for Imaging Tech that Reads Heart’s Electric Signals

Electricity regulates the beats of a healthy human heart, telling its chambers when to contract. Though the role of electrical signals in heartbeats is well understood, Analytics 4 Life says they can offer much more. The startup has closed $25 million in financing to test a medical device meant to read the heart’s electrical activity … Continue reading “A4L Lands $25M for Imaging Tech that Reads Heart’s Electric Signals”

Indigo Harvests $156M to Boost Agtech R&D, Harness Crop Microbes

In the past year, Indigo Ag has brought to the market five microbial seed treatments that help plants hold up to crop stresses, such as drought. The company now has its sights set on developing more products for more applications, and it has raised $156 million to support that work. New investors Baillie Gifford and … Continue reading “Indigo Harvests $156M to Boost Agtech R&D, Harness Crop Microbes”

Sarepta Therapeutics Names Basi Chief Scientific Officer

Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]) has a new chief scientific officer. Guriqbal Basi has been appointed to the post, where he will oversee the Cambridge, MA, company’s rare disease drug pipeline. Basi’s 30 years of pharmaceutical industry experience includes several leadership roles at the former Ireland-based drug company Elan, now part of Perrigo (NYSE: [[ticker:PRGO]]).

Third Rock’s Barbara Weber Appointed CEO of Tango Therapeutics

Barbara Weber, the Third Rock Ventures partner who has been serving as interim CEO of Tango Therapeutics, is now formally the company’s chief executive. Weber will also continue as a partner at Third Rock, the venture capital firm that incubated the cancer drug developer. Cambridge, MA-based Tango spun out of Third Rock in March, backed … Continue reading “Third Rock’s Barbara Weber Appointed CEO of Tango Therapeutics”

Low-Hanging Fruit Gone, Ag & Food Tech Investors Pay More for Deals

[Updated 9/25/17, 5:18 pm. See below.] Food delivery startups are catching on with more consumers, and that demand is whetting investor appetites. The $400 million that grocery delivery startup Instacart raised in March marked the largest deal for a U.S. food technology company in the first half of the year, according to new data from … Continue reading “Low-Hanging Fruit Gone, Ag & Food Tech Investors Pay More for Deals”

Landos Joins Garabedian’s Bio Startup Accelerator Xontogeny, Gets $10M

Xontogeny, the Boston-based biotech startup accelerator formed by one-time Sarepta Therapeutics CEO Chris Garabedian, has taken on its first company. The firm has helped secure a $10 million investment for a Blacksburg, VA, startup, Landos Biopharma, that is developing drugs for inflammatory bowel disease. New York life sciences investment firm Perceptive Advisors is the sole … Continue reading “Landos Joins Garabedian’s Bio Startup Accelerator Xontogeny, Gets $10M”

Disarm Launches With $30M From Atlas, AbbVie to Battle Neuro Disease

The available drugs for neurodegenerative conditions like multiple sclerosis (MS) can only treat symptoms, or at best slow the disease’s march forward. But recent research has uncovered a new approach that could potentially address what causes nerves to break down in the first place. Startup Disarm Therapeutics aims to turn that research into new drugs … Continue reading “Disarm Launches With $30M From Atlas, AbbVie to Battle Neuro Disease”

Ultragenyx Makes Competing Bid for Gene Therapy Biotech Dimension Tx

[Updated 9/19/17, 10:39 am. See below.] A bidding war has erupted for gene therapy developer Dimension Therapeutics. Ultragenyx Pharmaceutical (NASDAQ: [[ticker:RARE]]) announced Monday that it is ready to pay $5.50 per share in cash, or approximately $136 million, to acquire Cambridge, MA-based Dimension (NASDAQ: [[ticker:DMTX]]). The non-binding proposal from Novato, CA-based Ultragenyx is a 358 … Continue reading “Ultragenyx Makes Competing Bid for Gene Therapy Biotech Dimension Tx”

How Bayer and Ginkgo Teamed Up in a $100M Synthetic Biology Bet

Nitrogen is essential for plant growth and photosynthesis, but plants can’t pull it directly from air. They rely on bacteria on their roots to convert the gas into a usable form. Many major food crops don’t have these bacteria but Bayer wants to change that. The multinational company is teaming up with Boston startup Ginkgo … Continue reading “How Bayer and Ginkgo Teamed Up in a $100M Synthetic Biology Bet”

Halozyme Inks $105M Bristol-Myers Partnership, Expands Roche Deal

Halozyme Therapeutics has turned a method of delivering a drug more conveniently into partnerships with several large pharmaceutical companies that want to see their infusible drugs delivered via injections instead. The San Diego biotech company’s list of alliances is now getting longer. Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) announced Thursday that it will pay $105 million up … Continue reading “Halozyme Inks $105M Bristol-Myers Partnership, Expands Roche Deal”

BridgeBio Bags $135M For “Hub and Spoke” Rare Disease Drug R&D

Thousands of diseases have been traced to genetic origins, but the vast majority have no treatment at all. BridgeBio wants to reduce that unmet need with an unusual model for developing drugs to treat rare genetic diseases, and it now has $135 million in new funding. Palo Alto, CA-based BridgeBio says new investor Viking Global … Continue reading “BridgeBio Bags $135M For “Hub and Spoke” Rare Disease Drug R&D”