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Updated: 1 hour 49 min ago

Dyne’s Upsized IPO Brings In $233M for Muscle Disorders Drug R&D

Thu, 09/17/2020 - 09:56

Dyne Therapeutics, a company developing genetic medicines for rare muscular disorders, has raised $233 million in an IPO that topped the preclinical-stage biotech’s projections.

Late Wednesday, Dyne priced its offering of about 12.3 million shares at $19 each. The Waltham, MA-based biotech had previously planned to sell 10.3 million shares in the range of $16 to $18 per share. Those shares are expected to begin trading on the Nasdaq Thursday under the stock symbol “DYN.”

Dyne is developing drugs that employ a proprietary technology intended to overcome one of the hurdles to treating muscular disorders: getting enough medicine into muscle... Read more »

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BIO Chief: “Reckless” Executive Order on Drug Prices Threatens Innovation

Thu, 09/17/2020 - 07:31

The US is doing more in the COVID-19 space than anywhere in the world due to the strength of its innovative ecosystem, says Michelle McMurry-Heath, president & CEO of life sciences advocacy group Biotechnology Innovation Organization (BIO). But such innovation is under threat due to “reckless” orders coming out of the White House.

As part of an exclusive interview filmed for Xconomy’s Xcelerate’s Keynote Series at Biotech Week Boston next week, McMurry-Heath (pictured above) criticized an executive order issued by President Trump on Sunday intended on lowering drug pricing.

“The executive orders that were issued this week by President Trump are... Read more »

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Finch Therapeutics Fetches $90M to Advance Microbiome Drug Pipeline

Thu, 09/17/2020 - 04:00

When Seres Therapeutics reported positive late-stage data for its experimental microbiome treatment last month, scientists at Finch Therapeutics cheered the results from the rival company whose lead drug candidate addresses the same gut infection they aim to treat.

Positive data, no matter the source, helps the entire microbiome therapies field and paves the way for discussions with regulators, says Finch CEO Mark Smith. He adds that the data also help discussions with investors. Finch announced Thursday that it has raised $90 million to support its entire pipeline of microbiome therapies.

“It helps us in a lot of ways,” Smith says of... Read more »

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Arrowhead Pharma Shares Soar on Early Liver Data for RNAi Drug

Wed, 09/16/2020 - 10:39

An Arrowhead Pharmaceuticals drug for a rare liver disease now has early Phase 2 results and the data so far look good. Not only did the therapy reduce levels of a mutant protein associated with the disorder, but patients also showed improvements in several biological measures of liver injury.

The results are for just four patients from a small 16-patient study testing the drug, ARO-AAT, as a treatment for liver disease associated with alpha-1 antitrypsin deficiency. But the early results are an encouraging sign for Arrowhead (NASDASQ: ARWR) and its approach to treating inherited diseases by stopping genes from producing... Read more »

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Moderna CMO Talks COVID-19 Vaccine at Xcelerate Next Week

Wed, 09/16/2020 - 05:50

The Xcelerate Keynote Series has added Moderna CMO Tal Zaks to the expert lineup of speakers set to present next Monday, Sept. 21.

As you likely know, Moderna is one of the front-runners in the COVID-19 vaccine race, and we look forward to adding his insight to a packed agenda focused on innovative solutions during this time of uncertainty. The half-day online event also includes senior leaders from Amgen, BIO, Eli Lilly, Takeda, Alnylam, and UCB, featuring discussions on regulatory guidance, pipeline management, clinical trial recruitment, incorporating diversity, safety and efficacy, and more.

Presented by Xconomy, the online event on Monday,... Read more »

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Neogene Therapeutics Grabs $110M to Tackle Solid Tumors With Cell Therapy

Tue, 09/15/2020 - 16:02

Cell therapy offers another option for addressing the most difficult blood cancer cases, but such treatments, which are engineered from a patient’s own immune cells, don’t yet work on solid tumors. Neogene Therapeutics is developing technology with the potential to bring cell therapies to solid tumors and it now has $110 million to advance its research toward human testing.

The experimental therapies of Amsterdam-based Neogene target neoantigens, which are, as the term suggests, new antigens. These proteins arise from the mutations that drive cancer and they’re abundant on the surface of cancer cells but absent on healthy cells. That distinction makes... Read more »

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Unity Bio Restructuring Cuts 30% of Staff, Keeps Focus on Eye Drug

Tue, 09/15/2020 - 07:49

Unity Biotechnology is cutting nearly one third of its staff, a move that comes a month after the biotech’s lead drug candidate failed a mid-stage study in osteoarthritis.

South San Francisco-based Unity (NASDAQ: UBX) says that the corporate restructuring announced Tuesday should make the cash that it has left last through mid-2022, when data are expected for data the eye drug programs that are now the company’s focus. According to Unity’s second quarter financial report, the company had $39.6 million in cash and cash equivalents as of June 30.

Unity develops treatments for diseases of aging, which the company... Read more »

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Silence Therapeutics Taps Orchard’s Mark Rothera as President & CEO

Mon, 09/14/2020 - 14:28

Mark Rothera has been appointed president and CEO of Silence Therapeutics (NASDAQ: SLN). He comes to London-based Silence from Orchard Therapeutics (NASDAQ: ORTX), where he was chief executive. Rothera’s experience also includes positions at PTC Therapeutics (NASDAQ: PTCT), Aegerion Pharmaceuticals, and Shire.

Rothera is starting at Silence one week after the company debuted on the Nasdaq via a listing of American depositary shares. Silence is developing drugs intended to “silence” a gene, stopping it from producing a disease-causing protein. The company’s lead program, SLN124, is a potential treatment for the rare blood disorders beta thalassemia and myelodysplastic... Read more »

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Synlogic Names Metera’s David Hava as Chief Scientific Officer

Mon, 09/14/2020 - 14:16

David Hava has joined Synlogic (NASDAQ: SYBX) as chief scientific officer, the same position he held most recently at Metera Pharmaceuticals. He also previously served as chief scientific officer of Pulmatrix (NASDAQ: PULM). Cambridge, MA-based Synlogic is engineering bacteria to serve as “living medicines.” The biotech’s lead program, SYB1618, is in mid-stage development as a treatment for the rare metabolic disorder phenylketonuria.

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Seattle Genetics Lands $1.72B From Merck in Pair of Cancer Drug Deals

Mon, 09/14/2020 - 12:51

Seattle Genetics is in line to receive $1.72 billion from Merck via a pair of deals, one for a cancer drug that’s still in development and the other for partial rights to a therapy that won FDA approval earlier this year.

The larger of the two deals is for the drug still in clinical development, ladiratuzumab vedotin. According to terns announced Monday, the two companies have agreed to jointly develop that drug, both by itself and in combination with Merck (NYSE: MRK) blockbuster cancer drug pembrolizumab (Keytruda). The deal calls for Merck to pay Bothell, WA-based SeaGen (NASDAQ: SGE... Read more »

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Gilead Adds “Cornerstone” Cancer Drug in $21B Immunomedics Buyout

Sun, 09/13/2020 - 22:32

Gilead Sciences is acquiring Immunomedics in a $21 billion deal, the latest in a string of transactions the company has made to bolster its cancer drug portfolio.

The acquisition announced Sunday comes five months after Morris Plains, NJ-based Immunomedics won FDA approval for cancer drug sacitizumab govitecan (Trodelvy). The regulatory decision covers triple negative breast cancer but the drug, projected to become a blockbuster seller, is also being evaluated in other types of cancer.

According to deal terms announced Sunday, Foster City, CA-based Gilead (NASDAQ: GILD) has agreed to pay $88 cash per share of Immunomedics (NASDAQ: IMMU),... Read more »

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Bio Roundup: COVID-19 Pact, Gavreto Approval, Generative Biology & More

Fri, 09/11/2020 - 07:44

COVID-19 research efforts are often described as a race between companies, a description that reflects the urgency to develop a vaccine for the novel coronavirus. The description is not quite right. A race has one winner and public health officials have said we’ll need multiple vaccines to address the global need.

Vaccine developers have progressed to pivotal testing with unprecedented speed, compressing the years-long clinical testing process into months. Still, politicians have pressed companies to move even faster. This week, vaccine developers took a stand to insist that science and safety would not be sacrificed for speed. Nine companies signed a... Read more »

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Now Closer to Clinical Trials, Codiak BioSciences Refiles IPO Plans

Thu, 09/10/2020 - 14:00

Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, is lining up an IPO as it prepares for the first tests of its technology in humans later this year.

In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, MA-based biotech has applied for a Nasdaq listing under the stock symbol “CDAK.”

The research of Codiak focuses on exosomes, extracellular vesicles that carry proteins, genetic material, and other substances in and out of cells. Exosomes function as a messenger system between cells, transporting molecules that... Read more »

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Satsuma Pharma’s Migraine Drug Fails to Beat Placebo in Phase 3 Test

Thu, 09/10/2020 - 07:32

An experimental Satsuma Pharmaceuticals treatment for acute migraine has failed a late-stage clinical trial, dealing a setback to the company’s plans to offer another therapeutic option to the millions of people who suffer from the condition.

In Phase 3 results released Thursday, South San Francisco-based Satusuma (NASDAQ: STSA) reported that preliminary data showed both doses of its experimental treatment, STS101, led to improvement in measures of pain and other symptoms. But those differences, compared to a placebo, were not enough to be statistically significant.

Shares of Satsuma plummeted on the news, opening Thursday at $4.80 apiece, down nearly 80 percent... Read more »

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Generate Bio Aims to Reveal Nature’s Protein Secrets, Create New Drugs

Thu, 09/10/2020 - 03:00

When biotech startups emerge from stealth, executives typically talk about new molecules in the pipeline and novel approaches they take to treating a disease. The founders of Generate Biomedicines want to discuss none of those things, yet they contend their technology will upend the way protein drugs are discovered and developed.

Cambridge, MA-based Generate has been plugging away at its research within the labs of venture capital firm Flagship Pioneering for the past three years. On Thursday, the startup pulled back the curtain enough to give a glimpse of its technology, its potential applications, and the plans to use that platform... Read more »

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Grail Files to Go Public; 5 More Life Science Firms Join the IPO Queue

Wed, 09/09/2020 - 11:55

Grail, a company developing blood tests intended to detect cancer well before symptoms show, is taking its pitch to a broader swath of investors. The diagnostics company is looking ahead to potential commercialization of its technology as early as next year, and it has filed for an initial public offering to support its plans.

In paperwork filed with securities regulators Wednesday, the cancer diagnostics company set a preliminary $100 million target for its IPO. Menlo Park, CA-based Grail has applied for Nasdaq listing under the stock symbol “GRAL.”

Grail’s technology diagnoses cancer by detecting traces of genetic material that tumors shed... Read more »

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Agios Exec Andrew Hirsch Jumps to C4 Therapeutics for CEO Role

Tue, 09/08/2020 - 15:20

Andrews Hirsch has joined C4 Therapeutics as its new CEO. He comes to the Watertown, MA-based biopharmaceuticals company from Agios Pharmaceuticals (NASDAQ: AGIO), where he was chief financial officer and head of corporate development. Marc Cohen, the co-founder and interim CEO of C4, will remain executive chairman of the company. C4 is developing drugs that harness a cellular mechanism for disposing of unwanted proteins as a way of treating disease. Hirsch’s hire comes three months after C4 closed a $170 million Series B round of funding as it looks ahead to human testing.

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AlloVir Taps Merck’s Atillasoy as Chief Regulatory & Safety Officer

Tue, 09/08/2020 - 15:12

AlloVir (NASDAQ: ALVR) has appointed Ercem Atillasoy to serve as its chief regulatory and safety officer, a new position. He joins the Cambridge, MA-based cell therapy developer after a nearly 20-year career at Merck (NYSE: MRK). He most recently worked at Merck Research Laboratories, where he was vice president and therapeutic area head of vaccines and infectious disease.

AlloVir is developing allogeneic cell therapies to prevent and treat viral infections in patients undergoing transplant procedures. In July, the biotech’s IPO raised $276.3 million to fund Phase 3 tests of its lead therapeutic candidates.

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Grifols Moves Deeper Into Proteome R&D With $146M Deal for Alkahest

Tue, 09/08/2020 - 10:41

Alkahest, a company that analyzes blood proteins to develop therapies that address neurological disorders including Alzheimer’s disease, is set to be acquired by partner Grifols in a $146 million deal.

Grifols (NASDAQ: GRFS) announced Tuesday that it is acquiring the shares of privately held Alkahest that it does not already own. Barcelona-based Grifols says the deal will help it discover new therapies for age-related diseases.

Alkahest develops its therapeutic candidates by analyzing the proteome, the range of proteins produced by cells, tissues and organs. The San Carlos, CA-based biotech’s research on the proteome of plasma identified chronokines, proteins that the... Read more »

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Xconomy Awards On-Demand ‘Meet the Finalists’ Webcast Series Launches This Week

Tue, 09/08/2020 - 07:28

The 2020 National Xconomy Awards complimentary two-week, 11-part, on-demand Meet the Finalists daily webcast series starts this Tuesday, Sept. 8 at 11 a.m. ET. Registration is complimentary and includes access to a networking app with already more than 400 life science contacts.

The daily series leads up to the Thursday, Sept. 24 free online National Xconomy Awards ceremony – celebrating the best in biotech.

The 11-part Meet the Finalists webcast series provides an opportunity to get to know each of the 44 individuals and companies and better understand why they have earned the right to be named a finalist.

The event series’ custom... Read more »

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