Xconomy news

Turning Point Therapeutics, which is developing targeted cancer drugs for patients whose tumors resist other precision therapies, has outlined plans for an IPO.

The company, which started operations in 2014, has raised nearly $148 million since inception. It is headed by Athena Countouriotis, who joined the company in May as its chief medical officer, then was promoted to chief executive in September.

The San Diego biotech is developing what it describes as a “next-generation” drug as a treatment for cancers associated with genetic variations that alter the enzymes ALK, ROS1, and TRK. Drugs already exist for some cancers associated with those... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

One group of people in dire need of medical relief got good news this week. The first drug for postpartum depression was approved. With its complicated logistics, side effects, and potential high cost, it won’t be for everyone who experiences the condition—1 of every 9 U.S. women giving birth. But at least it’s an option. That’s more than Alzheimer’s patients and their doctors can say about aducanumab, the latest high-profile, high-cost failure in that frustrating field.

We reported on both those stories and a lot more, including clinical ups and downs and new fundings. Also this week: Reports from... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Another once-promising drug for Alzheimer’s disease has failed. And the news is devastating for the drug’s developer, Biogen (NASDAQ: BIIB), which went all in on a high-stakes gamble that its treatment, aducanumab, might succeed where so many others haven’t.

This morning, Biogen reported that it is stopping two parallel, highly anticipated Phase 3 studies in Alzheimer’s called “Engage” and “Emerge” because they are likely to fail. The news sent Biogen’s shares into a tailspin, falling by more than 27 percent, to $234 apiece—levels the Cambridge, MA, firm’s stock hasn’t traded at since 2013.

As a result of the news,... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

The high-stakes race to use CRISPR gene editing technology to create medicines and fix diseases has been underway for years now, and human trials are just starting. But the idea of using CRISPR as a tool to detect and diagnose a disease has been gaining traction, too, and the launch of a new startup today called Sherlock Biosciences marks the latest step.

Sherlock has been formed around technologies licensed from the Broad Institute of MIT and Harvard University, dubbed “SHERLOCK” and “INSPECTR,” respectively, that use CRISPR-based systems to detect foreign invaders within the body. The startup is co-founded by Feng... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

A Chicago-based private equity firm has tapped the former head of NuVasive and finance chief of GreatCall to start a new healthcare company in San Diego.

The company, Corza Health, is headed by Greg Lucier, most recently CEO at NuVasive, and backed by the PE firm, GTCR, with money from its $5.25 billion Fund XII. Lucier is also making a “substantial” investment in Corza, according to a statement from GTCR on Wednesday.

Creating new companies helmed by experienced leaders is part of a longstanding GTCR practice, which it calls its Leaders Strategy. Corza says it is on the hunt for life... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

A decade ago, Kevin Conroy took the CEO job at Exact Sciences, a cancer diagnostic firm on the brink of death. Five years later, the FDA greenlit the company’s first product, Cologuard, which marked the first non-invasive, stool-based DNA screening test approved for detecting colorectal cancer.

In the five years since then, Exact (NASDAQ: EXAS) says it has screened 2 million patients for the disease. The Madison, WI-based company has grown to more than 1,600 employees and almost $500 million in annual revenue, and it currently sports a market value of more than $11 billion.

“Looking back,... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Hsiao Lieu has been appointed senior vice president and chief medical officer of NGM Biopharmaceuticals. Lieu is joining South San Francisco, CA-based NGM from Genentech, where he was vice president of early clinical development. NGM has a five-year research partnership with Merck (NYSE: MRK), which recently exercised its option to acquire rights to an experimental NGM treatment for nonalcoholic steatohepatitis (NASH) and type 2 diabetes. On Wednesday, the partners announced that they are extending the collaboration to 2022. NGM’s wholly-owned lead drug, NGM282, is in Phase 2 testing in NASH.

Reprints | Share:          

Finistere Ventures has appointed Bayer veteran Adrian Percy to serve as chief technology officer of the San Diego-based venture capital firm. Percy, the former head of research and development for Bayer’s crop science division, will be based in a new Finistere office opening in the Research Triangle Park region of North Carolina. Finistere also said Percy will also join the boards of two of its portfolio companies, Hi-Fidelity Genetics and BioLumic.

Reprints | Share:          

Pfizer this morning added to its methodical push into the gene therapy field, paying $51 million for a 15 percent stake in Vivet Therapeutics and the option to buy the Parisian biotech in the future.

Vivet is developing an experimental gene therapy, VTX-801, for the rare genetic disorder Wilson’s disease, which causes a potentially deadly buildup of copper in the liver and other organs. In a statement, Pfizer (NYSE: PFE) noted that the current available medicines for the disease—drugs like trientine (Spyrine) taken chronically to suppress the buildup of copper—have “sub-optimal efficacy or significant side effects” for many patients. The... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Flagship Pioneering, one of the Boston area’s top biotech company creators, has closed a new $824 million fund to help fuel the growth of its startups.

The new fund—Special Opportunities Fund II—will complement the cash the firm uses to start its companies, much like the $285 million “Special Opportunities” fund the firm announced in 2016. In a statement, Flagship CEO Noubar Afeyan said the fund will provide “new capital to grow platform companies”—that is, startups based not on a single asset, but a technological platform that can produce several drugs. (Similarly, in January, another Cambridge, MA, biotech VC firm, Atlas Venture... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

The FDA has just made brexanolone (Zulresso) the first medicine approved specifically for post-partum depression, a potentially devastating disorder that afflicts roughly one in every seven new mothers in the U.S., according to the American Psychological Association

Now the drug’s owner, Sage Therapeutics (NASDAQ: SAGE), of Cambridge, MA, must convince doctors to prescribe and new mothers to accept the treatment, which acts fast but requires a 60-hour continuous infusion in a health facility. The approval comes with other “black box” warnings about side effects.

Sage’s list price for brexanolone is $7,450 per vial, and it estimates a total course of... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Urovant Sciences says its experimental drug for overactive bladder could offer advantages compared to an FDA-approved treatment marketed by Astellas Pharma. But late-stage clinical results released Tuesday raise questions whether Urovant can persuade doctors to prescribe it instead of a much cheaper generic competitor.

Irvine, CA-based Urovant (NASDAQ: UROV) said Tuesday that its drug vibegron hit the main goals of a Phase 3 study. Compared to a placebo, it reduced daily urges to urinate as well as episodes of urination. The difference was statistically significant.

However, the Urovant drug did not achieve statistical significance compared to a third group... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Douglas Pagán, chief financial officer of Paratek Pharmaceuticals (NASDAQ: PRTK) since 2017, is resigning to take a role at an undisclosed early-stage biopharmaceutical company. The Boston company said Monday that Pagán’s last day will be April 5. He has entered into a consulting agreement through Dec. 23 to help with the transition of his responsibilities and a search is underway for a successor. Last October, the FDA approved two Paratek drugs: omadacycline (Nuzyra) for community-acquired bacterial pneumonia and sarecycline (Seysara) for moderate-to-severe acne.

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Corcept Therapeutics (NASDAQ: CORT) has appointed Andreas Grauer to serve as chief medical officer. Grauer comes to Menlo Park, CA-based Corcept from Amgen (NASDAQ: AMGN), where he was vice president of global development. Corcept develops drugs that modulate a hormone called cortisol to treat metabolic and psychiatric disorders, as well as cancer.

Corcept has already commercialized mifepristone (Korylm), a drug approved in 2012 to treat hypercortisolism, a condition in which the body overproduces cortisol. The company’s pipeline includes relacorilant, which is in Phase 3 testing as s treatment for hypercortisolism and in Phase 2 testing for advanced ovarian... Read more »

Reprints | Share:          

The last 50 years have seen many great technical advances in medical treatments, ranging from drug delivery and imaging to skin grafts and prosthetics. These advances—both large and small—have drawn on many fields and have transformed patient care.

When examining the current state of clinical technology, the focus is naturally on the technology and its outcomes, rather than the process that led to that breakthrough. It is a popular notion that such advances are the result of “eureka moments” by individuals working in industry. More often, technical innovation is an iterative process with contributions from people in both academia and industry.... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

An experimental drug developed by Dermira to treat atopic dermatitis has hit the main goal of its mid-stage study, helping to build a case that the injectable treatment could measure up against a drug from Regeneron Pharmaceuticals and Sanofi.

Atopic dermatitis is the most common and severe form of eczema, an inflammatory condition that leads to rashes, redness, and chronic itching of the skin. It affects an estimated 16.5 million adults in the U.S. In clinical trial results released Monday, Dermira reported that each of three doses of its drug, lebrikizumab, demonstrated improvement in an assessment used to measure eczema severity.... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Houston—Tom Luby, the head of JLabs in Houston, has been named the new director of the Texas Medical Center’s Innovation Institute, the center announced Monday morning.

Luby takes over the innovation institute three months after former director Erik Halvorsen left the role.

Luby is already a known presence around the TMC innovation building thanks to the two years he has led JLabs @ TMC, the Houston outpost of Johnson & Johnson’s (NYSE: JNJ) network of innovation incubators. The pharmaceutical giant’s Houston incubator is embedded within TMC, but owned and managed by Johnson & Johnson. He came to... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

A global pharmaceutical company based in France has licensed software developed by San Diego digital health startup CureMatch that aims to help cancer doctors customize the combination of drugs they prescribe to patients based on mutations in cancer DNA.

CureMatch was founded in 2015 to commercialize technology developed at the UC San Diego Moores Cancer Center. The company, which CEO Bob Manning says has raised about $2.5 million in outside investment, says its software can help guide customized care by using a patient’s genetic information to score and rank treatment options. It calls the guides it produces PreciGENE reports.

Now it... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

Cancer genomics company Contextual Genomics has appointed Michael Ball to serve as its CEO. Ball comes to the Vancouver, BC-based company from Illumina (NASDAQ: ILMN), where he was global vice president commercial, informatics. Ball was previously CEO of GenoLogics Life Sciences Software, which was acquired by Illumina in 2015. Contextual Genomics develops molecular tests that help clinicians diagnose and treat cancer.

Reprints | Share:          
UNDERWRITERS AND PARTNERS

          

          

            

While all eyes in the biopharmaceutical world are currently trained on Bristol-Myers Squibb’s proposal to buy Celgene for $74 billion, it wasn’t that long ago that another company’s gaze was fixed on the Summit, NJ, drug maker.

In the early 2000s, before the FDA approved Celgene’s flagship multiple myeloma drug lenalidomide (Revlimid), Novartis (NYSE: NVS considered buying the company. It passed, unwilling to risk billions on an unapproved drug. Those details came from biopharma dealmaker George Golumbeski, who was profiled in Xconomy this week. Golumbeski rose through the ranks to top positions at both companies, eventually earning a reputation for... Read more »

Reprints | Share:          
UNDERWRITERS AND PARTNERS