Two privately held biotechs on Tuesday announced plans for reverse mergers, transactions that provide a faster route to go public than a conventional IPO and also give struggling public companies a chance to recoup some value for their shareholders. San Diego regenerative medicine company Histogen announced an agreement to gain a Nasdaq listing through a … Continue reading “Histogen, Timber Pharma Plan Reverse Mergers to Join Public Markets”
Category: New York
Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH
Sotatercept was one of the first compounds to emerge from the labs of Acceleron Pharma, but it became a forgotten piece of the company’s pipeline. Passed over as a candidate to treat a rare blood disorder and stalled in tests in chronic kidney disease, little was expected of the drug. The drug’s prospects have changed … Continue reading “Third Time’s the Charm as Acceleron Drug Shows Early Promise in PAH”
BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely
Subtle changes can presage a worsening of a chronic condition, but symptoms may not become apparent to a patient until it’s time to call an ambulance. BioIntelliSense, a Denver-based digital health startup, has developed a wearable sensor meant to monitor patients’ vital signs remotely and provide near real-time data that clinicians can use to identify … Continue reading “BioIntelliSense Debuts “Sticker” Sensor to Capture Patient Data Remotely”
Passage Bio Appoints Deerfield Management’s Bruce Goldsmith as CEO
Passage Bio on Tuesday announced it appointed Bruce Goldsmith, a venture partner at Deerfield Management, as its new CEO. At Deerfield, Goldsmith also served as interim chief executive officer of Civetta Therapeutics. His experience also includes positions at Lycera, Allos Therapeutics, GPC Biotech, and Johnson & Johnson (NYSE: [[ticker:JNJ]]). Goldsmith succeeds Passage co-founder Stephen Squinto, who … Continue reading “Passage Bio Appoints Deerfield Management’s Bruce Goldsmith as CEO”
Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report
Biopharmaceutical companies focused on advanced therapies are changing industry R&D, manufacturing, and supply chain models according to KPMG. The audit, tax, and advisory services firm shared details of the trend in its Healthcare & Life Sciences Outlook report, explaining that for companies developing cell, gene, and nucleic acid-based therapies, innovation is a necessity. “As pharmaceutical … Continue reading “Advanced Therapies Are Reshaping Biopharma R&D: KPMG Report”
Life Sciences IPOs Target Collective Raise of More Than $600M This Week
So far this year four privately held companies have made the transition to trading on the public markets. By month’s end, five more are anticipated to join the class of 2020 initial public offerings—and four of those are in life sciences, according to IPO research firm Renaissance Capital. Two are clinical-stage biotechs: Cambridge, MA-based Black … Continue reading “Life Sciences IPOs Target Collective Raise of More Than $600M This Week”
Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More
Company news slowed somewhat this week, perhaps as some took the federal Martin Luther King Jr. Day holiday away from the office and others recovered from back-to-back meetings and late nights at the JP Morgan Healthcare Conference. However, a new coronavirus believed to stem from Wuhan, China, captured the attention of the world healthcare community. … Continue reading “Bio Roundup: Coronavirus Concerns, Sarepta’s CRL, Eye Drug OK’d & More”
After AstraZeneca, Osbourn Reflects on Roles at CAT & MedImmune
MedImmune, AstraZeneca’s biologics division, is no more. The pharmaceutical giant announced last year that the name would be retired as part of a research and development restructuring. Before MedImmune became an AstraZeneca (NYSE: [[ticker:AZN]]) business unit, it was a standalone biologics company. In 2007, AstraZeneca paid $15.2 billion to acquire the biotech, which it integrated … Continue reading “After AstraZeneca, Osbourn Reflects on Roles at CAT & MedImmune”
Healthcare Investment Trends: Where Will the Money Flow in 2020?
From the event organizers: Registration is now open for NYCHBL’s 7th Annual Healthcare Investment Trends: Where Will the Money Flow in 2020? This year’s event will be the largest ever, held at the amazing event space at Convene with room for up to 300 attendees. The event will feature a panel of expert investors who … Continue reading “Healthcare Investment Trends: Where Will the Money Flow in 2020?”
Emendo Eyes the Clinic for CRISPR Therapy That Makes Single-Gene Edits
CRISPR gene editing offers the potential to selectively edit the genetic mutations causing inherited diseases, but Emendo Biotherapeutics CEO David Baram contends it’s not precise enough. A large number of genetic diseases can’t be addressed by current CRISPR approaches and the technology still raises safety concerns. Emendo is developing a way to make CRISPR gene … Continue reading “Emendo Eyes the Clinic for CRISPR Therapy That Makes Single-Gene Edits”
Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More
Perhaps the most talked-about news at the JP Morgan Healthcare Conference this week was a new startup that launched with $200 million and an ambitious claim that its first drug would be approved within five years, and 10 in total within as many years. Cambridge, MA-based EQRx contends it will be able achieve its goals … Continue reading “Bio Roundup: EQRx’s Ambitions, Nektar No Vote, New Frazier Fund & More”
Emendo Biotherapeutics Nabs $61M for “Next-Generation CRISPR” R&D
[Updated 1/22/20120, 7:17 a.m. See below.] Emendo Biotherapeutics, a company aiming to apply CRISPR gene editing to a wider range of genetic diseases, has raised $61 million in financing. The Series B round was led by AnGes, a Japan-based biopharmaceutical company. Want more cell and gene therapy content? Network and engage with industry leaders online … Continue reading “Emendo Biotherapeutics Nabs $61M for “Next-Generation CRISPR” R&D”
FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data
[Updated 1/15/2020, 8:51 a.m. See below.] As the nation grapples with the ongoing opioid crisis, an FDA advisory panel on Tuesday unanimously voted against recommending approval of a Nektar Therapeutics painkiller that would add a new compound to the drug class—even though it was designed to reduce the risk of abuse. Some members of the … Continue reading “FDA Panel Votes Down Nektar Opioid Painkiller, Asks for More Data”
Schrödinger Sets Course for IPO to Support Growing Internal Pipeline
Scan the landscape of experimental medicines in development today and you’ll spot Schrödinger’s handiwork. The company’s software has helped discover compounds that are now advancing in the pipelines of several drug developers. Schrödinger isn’t shying away from that work. But as it continues building its own drug pipeline, it’s now laying out plans to go … Continue reading “Schrödinger Sets Course for IPO to Support Growing Internal Pipeline”
Allogene, SpringWorks to Test Drug Combo in Multiple Myeloma Trial
Springworks Therapeutics and Allogene Therapeutics have agreed to collaborate on a clinical trial to test a combination of an investigational cancer drug from each biotech in patients with multiple myeloma. The experimental treatment from Springworks, nirogacestat, is one of the four drug compounds that the company took off the Pfizer (NYSE: [[ticker:PFE]]) shelf when it … Continue reading “Allogene, SpringWorks to Test Drug Combo in Multiple Myeloma Trial”
Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More
A letter signed by 215 people involved in the biopharma industry, including CEOs and investors, published Wednesday promised to put the “interests of patients first.” Six CEOs, including five who run public companies, co-authored the letter. Signatories agreed to what they dubbed a New Commitment to Patients, a list of “core principals and actions” promising … Continue reading “Biotech Roundup: Drug Pricing Promises, Bone Disease Data, IPO Plans & More”
Novome Lands $33M to Tweak a Gut Microbe Into a Metabolic Therapy
Food gurus tout the benefits of eating spinach and kale, but some people are better off leaving them on the plate. A molecule in these leafy greens contributes to hyperoxaluria, a condition characterized by kidney stones at first and serious organ damage later. Novome Biotechnologies is developing a gut microbiome treatment for hyperoxaluria. The company … Continue reading “Novome Lands $33M to Tweak a Gut Microbe Into a Metabolic Therapy”
Phathom Pharma Appoints Martin Gilligan as Chief Commercial Officer
Phathom Pharmaceuticals (NASDAQ: [[ticker:PHAT]]) on Monday named Martin Gilligan as its chief commercial officer. Gilligan was most recently a corporate vice president at Celgene, where he led marketing, market access, and business development for the Summit, NJ-based biopharma’s inflammation and immunology unit. Phathom, in Florham Park, NJ, is in late-stage development of vonoprazan—an acid blocker whose … Continue reading “Phathom Pharma Appoints Martin Gilligan as Chief Commercial Officer”
Merck Ramps Up KRAS Chase Through Licensing Deal With Taiho, Astex
The KRAS gene has become a hot target for cancer research for a growing number of drug developers. Merck, which is already testing a KRAS vaccine candidate, is now spreading its bets with a licensing deal for small molecule KRAS drugs being developed by two Otsuka Pharmaceutical subsidiaries. Merck (NYSE: [[ticker:MRK]]) is paying $25 million … Continue reading “Merck Ramps Up KRAS Chase Through Licensing Deal With Taiho, Astex”
Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More
In the week leading up to Christmas, six drugs won FDA approvals. The decisions covered insomnia, migraine, and several different forms of cancer. The FDA’s final tally for the year totaled 48 new drug approvals. If you’re keeping score, that compares with 59 approvals in 2018 and 46 in 2017. Most of the nods went to … Continue reading “Bio Roundup: FDA Approvals, Intrexon’s Shift, Melinta Bankruptcy & More”
No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health
Intrexon has spent two decades designing and building DNA sequences for applications in healthcare, food, energy, and the environment. Going forward, the synthetic biology company will focus exclusively on human health under the name of a subsidiary whose lead cell therapies are now in early-stage clinical testing in cancer. Germantown, MD-based Intrexon (NASDAQ: [[ticker:XON]]) announced … Continue reading “No More Fish or Fruit: Intrexon Turns SynBio Focus to Human Health”
Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines
The FDA on Monday approved a pill from Allergan to treat migraine in adults. The treatment, ubrogepant (Ubrelvy), is part of a new class of migraine medicines designed to block calcitonin gene-related peptide (CGRP), a protein thought to play a role in pain transmission. Ubrogepant is the first CGRP drug in tablet form to get … Continue reading “Allergan Wins FDA Nod for First Migraine Pill in New Class of Medicines”
Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More
As national politics dominates the news in the final days of the decade, we at Xconomy are wrapping up the year with some big moves by the FDA, including an approval of the first drug OK’d reduce heart risk in patients with high triglycerides who are already taking statins. Holidays don’t provide immunity to bad … Continue reading “Bio Roundup: Amarin’s Approval, FTC v. Illumina, a $120M Deal & More”
Takeda Pays Turnstone $120M to Start Alliance on Viral Cancer Therapies
[Updated 12/20/19, 2:51 p.m. See below.] Turnstone Biologics has yet to test its engineered viruses in cancer patients but Takeda Pharmaceutical sees enough promise in the technology to pay $120 million up front to start a partnership developing the biotech’s lead therapeutic candidate. The Takeda (NYSE: [[ticker:TAK]]) payment is a combination of cash, near-term milestones, … Continue reading “Takeda Pays Turnstone $120M to Start Alliance on Viral Cancer Therapies”
Zafgen’s Path Forward Is Reverse Merger With Chondrial Therapeutics
Zafgen stumbled in clinical trials testing its experimental therapies for metabolic diseases. Going forward, it will have a new name, new management, and a mitochondrial disorder drug from another company. Boston-based Zafgen (NASDAQ: [[ticker:ZFGN]]) has entered a merger agreement with Chondrial Therapeutics, a rare disease drug developer just entering the clinic. Chondrial shareholders will own … Continue reading “Zafgen’s Path Forward Is Reverse Merger With Chondrial Therapeutics”
Orbiting Organoids: Research in Space to Unveil New Neurodegeneration Insight
More than 250 miles above the Earth’s surface aboard the International Space Station, a first-in-kind study of neurodegenerative disease is expected to reveal never-before-seen cell interactions. The National Stem Cell Foundation (NSCF) is funding the study, which is the result of a bi-coastal collaboration between the New York Stem Cell Foundation (NYSCF) Research Institute and … Continue reading “Orbiting Organoids: Research in Space to Unveil New Neurodegeneration Insight”
Axsome’s Depression Drug Meets Phase 3 Goals, FDA Filing Planned
An experimental Axsome Therapeutics drug has succeeded in improving depression symptoms in a late-stage study, and the company is now preparing to seek regulatory approval next year. Axsome (NASDAQ: [[ticker:AXSM]]) is testing its drug, AXS-05, as a treatment for major depressive disorder (MDD). The Phase 3 study enrolled 327 patients with moderate-to-severe major depressive disorder. … Continue reading “Axsome’s Depression Drug Meets Phase 3 Goals, FDA Filing Planned”
Amarin’s Fish-Oil Pill Wins FDA Nod to Cut Heart Attack, Stroke Risk
A prescription pill derived from fish-oil received the regulatory nod Friday to expand its use as a supplementary treatment, alongside statins, to more patients at risk of heart attack or stroke. The FDA approved the Amarin Pharma drug, icosapent ethyl (Vascepa), for use as a secondary treatment for adults who are taking statins and have elevated … Continue reading “Amarin’s Fish-Oil Pill Wins FDA Nod to Cut Heart Attack, Stroke Risk”
Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More
If you’re keeping track, FDA drug approvals have been on a tear in the past month with several decisions coming well ahead of their targeted dates. And then there’s Sarepta Therapeutics. Late Thursday, the FDA announced approval of the Cambridge, MA, biotech’s drug for Duchenne muscular dystrophy in patients who have a specific mutation. The … Continue reading “Bio Roundup: Sarepta’s Approval, Merck M&A, Drug Price Bill & More”
Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink
Iterum Therapeutics’ bid to bring patients a new antibiotic that’s safer than currently available drugs has fallen short of the main efficacy goal of a late-stage clinical trial. But the company is pinning its hopes on another Phase 3 study that will report data early next year. Iterum (NASDAQ: [[ticker:ITRM]]) reported preliminary Phase 3 data … Continue reading “Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink”
KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test
A KalVista Pharmaceuticals eye drug at the center of a research collaboration with Merck has failed a mid-stage clinical trial. KalVista (NASDAQ: [[ticker:KALV]]) developed its drug, KVD001, to treat diabetic macular edema (DME), a complication of diabetes that can lead to blindness. On Monday, Cambridge, MA-based KalVista said patients treated with the drug, given as … Continue reading “KalVista Pharma Eye Drug Partnered With Merck Flunks Phase 2 Test”
Zentalis Steps Out With $147M Raised to Develop “Tried and True” Small Molecules
Zentalis Pharmaceuticals is banking on small molecules for cancer—leaving the “cool technologies” aside for a “tried and true” approach, says the CEO, who wants to let the science speak for itself. Since it was founded five years ago, the company has moved three compounds into the clinic. How? By operating under the radar. “If you … Continue reading “Zentalis Steps Out With $147M Raised to Develop “Tried and True” Small Molecules”
Perceptive Unveils New $210M Fund to Invest in Early-Stage Biotechs
Perceptive Advisors, an investment firm with a long track record of life science investing across all points of development, is now stepping up to pump money into companies at the earliest stages with a new $210 million venture capital fund. The Perceptive Xontogeny Venture Fund (PXV) is led by Chris Garabedian (pictured above, center), a … Continue reading “Perceptive Unveils New $210M Fund to Invest in Early-Stage Biotechs”
Merck Makes a Big Blood Cancer Bet With $2.7B Deal for ArQule
Merck is acquiring cancer drug developer ArQule for $2.7 billion, a cash deal that brings it a promising early-stage compound that could challenge a blockbuster leukemia drug from AbbVie. According to terms of the agreement announced Monday, a Merck (NYSE: [[ticker:MRK]]) subsidiary will pay $20 for each share of ArQule (NASDAQ: [[ticker:ARQL]]), a 107 percent … Continue reading “Merck Makes a Big Blood Cancer Bet With $2.7B Deal for ArQule”
Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More
It’s been a roller-coaster year for those hoping for new drugs to treat Alzheimer’s disease, a leading cause of death with rising treatment costs and no clear answer yet as to its cause. Clearing proteins, such as amyloid and tau, was once seen as the top contender for stopping or slowing neurodegeneration. Costly failures forced … Continue reading “Bio Roundup: Biogen at CTAD, Sage’s Stumble, Astellas’s $3B Offer & More”
FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder
[Corrected 12:27 p.m. See below.] The FDA has rejected an experimental regenerative therapy that Enzyvant developed to restore immune system function in babies born with a rare disorder. The agency cited manufacturing issues, according to the company. Enzyvant received the notification, formally known as a complete response letter, on Wednesday, CEO Rachelle Jacques tells Xconomy. … Continue reading “FDA Rejects Enzyvant’s Regenerative Therapy for Rare Immune Disorder”
6 Experimental Alzheimer’s Disease Diagnostics Projects Get Funding Boost
Scientists gathered this week in San Diego at the annual Clinical Trials on Alzheimer’s Disease Congress are focused on ways to treat the neurodegenerative disease, a task that continues to vex those working to develop potential medicines. Others are working on an intimately related problem: early detection of the disease and related dementias. On Wednesday … Continue reading “6 Experimental Alzheimer’s Disease Diagnostics Projects Get Funding Boost”
Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption
Editor’s note: This is Part 2 of a two-part post about innovation in digital health, co-authored by Rob Coppedge, CEO of Echo Health Ventures. Read Part 1 here. The Path Forward Between Echo Health Ventures and Blue Cross and Blue Shield of North Carolina, we work deeply on both sides of these partnerships and have perspective … Continue reading “Digital Health Survivors & Innovative Incumbents Must Team Up for True Disruption”
Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck
A Roche immunotherapy has won an additional FDA approval as a first-line treatment for non-small lung cancer, bolstering the product’s competitive stance versus one from Merck. The FDA approved atezolizumab (Tecentriq) for adults whose non-squamous non-small cell lung cancer (NSCLC) is metastatic, meaning it has spread, and does not have the EGFR or ALK genetic … Continue reading “Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck”
Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal
[Updated 12/4/19, 4:01 p.m. ET. See below.] Veracyte, a company whose tests help physicians make treatment decisions, is adding technology from NanoString to the fold to expand its diagnostic capabilities. South San Francisco-based Veracyte (NASDAQ: [[ticker:VCYT]]) announced Tuesday that it has reached a deal for global rights to develop and commercialize diagnostics based on the … Continue reading “Veracyte Aims to Expand Diagnostics Reach With $50M NanoString Deal”
Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down
Editor’s note: This is Part 1 of a two-part piece on innovation in digital health, co-authored by Bryony Winn, chief strategy and innovation officer at Blue Cross and Blue Shield of North Carolina. Read Part 2 here. More than 6,500 people descended on HLTH in Las Vegas in late October to “solve the most pressing … Continue reading “Partner or Die: How to Succeed Even After the Digital Health Hype Quiets Down”
IFM Lands $55.5M to Launch NewCo Quattro and Discovery Incubator
IFM Therapeutics has raised $55.5 million to launch its third drug subsidiary as well as an incubator, both of which are focused on developing new therapies for inflammatory diseases and cancers. Those endeavors will be led by a familiar face. Boston-based IFM has promoted its vice president of research and development, Martin Seidel, to become … Continue reading “IFM Lands $55.5M to Launch NewCo Quattro and Discovery Incubator”
Novartis to Acquire MedCo and FDA-Ready Cholesterol Drug for $9.7B
Novartis has agreed to acquire The Medicines Company for $9.7 billion, a cash deal that brings it a compound that is poised to become part of a new wave of cholesterol-lowering drugs. With the acquisition, Swiss pharma giant Novartis (NYSE: [[ticker:NVS]]) aims to compete with two other next-generation cholesterol drugs now being marketed by Amgen … Continue reading “Novartis to Acquire MedCo and FDA-Ready Cholesterol Drug for $9.7B”
Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More
Bristol-Myers Squibb this week completed its acquisition of Celgene, a $74 billion deal that creates a pharmaceutical juggernaut. And all it took was the largest asset sale ever required by federal antitrust regulators. As the Federal Trade Commission reviewed Bristol’s (NYSE: [[ticker:BMS]]) deal to acquire Celgene, anti-inflammatory drug apremilast (Otezla) emerged as a sticking point. … Continue reading “Bio Roundup: So Long Celgene, RNAi’s Arrival, Pharma in 2020 & More”
Azitra Names Jeanne Bertonis as Chief Operating Officer
Jeanne Bertonis has joined Azitra as chief operating officer. In this role, she will be responsible for building the clinical operations team as the company preps for multiple clinical trials in 2020, according to a statement from Azitra CEO Richard Andrews. Bertonis was previously CEO of Visgo Therapeutics – which she co-founded – and has … Continue reading “Azitra Names Jeanne Bertonis as Chief Operating Officer”
Ex-Novartis Cell & Gene Therapy Exec Chou Joins Aruvant as CEO
William Chou has been appointed CEO of Aruvant Sciences. Chou was most recently a vice president and global disease lead for the Novartis (NYSE: [[ticker:NVS]]) cell and gene therapy unit. Before Novartis, he worked at Boston Consulting Group. Aruvant, which splits its operations between New York and Basel, Switzerland, is developing therapies for severe blood … Continue reading “Ex-Novartis Cell & Gene Therapy Exec Chou Joins Aruvant as CEO”
Biopharma Execs Remain Optimistic Despite Political Headwinds
Drug pricing debates and uncertainty associated with Brexit are the issues most likely to keep biopharmaceutical executives awake at night. Nevertheless, senior figures remain optimistic about the industry’s prospects in 2020. These are among the major findings of a survey of 500 industry leaders and investors conducted by investment bank Jefferies. “Nearly half of respondents … Continue reading “Biopharma Execs Remain Optimistic Despite Political Headwinds”
With “Inflection Year” Ahead, Ovid Adds Novartis’s Tardio to C-Suite
About five years ago, former Teva Pharmaceutical CEO Jeremy Levin launched Ovid Therapeutics with a plan to develop treatments for rare brain diseases. Now, with the completion of a clinical trial on the horizon anticipated to provide enough data to file for FDA approval, the 55-person biotech has recruited a Novartis (NYSE: [[ticker:NVS]]) executive to … Continue reading “With “Inflection Year” Ahead, Ovid Adds Novartis’s Tardio to C-Suite”
Alkermes Eyes Brain Disorders and Beyond With $100M Deal for Rodin
[Updated 5:55 p.m. See below.] Rodin Therapeutics has limited data from human studies about its neurodegeneration drug, but the company’s new approach to treating brain disorders has proven attractive enough for Alkermes to plunk down $100 million to buy the startup. According to financial terms announced Monday, the cash sum is an upfront payment. Depending … Continue reading “Alkermes Eyes Brain Disorders and Beyond With $100M Deal for Rodin”
Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More
Lung injuries connected to the use of electronic cigarettes have topped 2,000 and killed 40 people, according to the Centers for Disease Control and Prevention. It’s still unclear whether the cases are tied to legally sold products or devices modified by e-cigarette users, but the CDC this week identified a “potential toxin of concern”—Vitamin E … Continue reading “Biotech Roundup: Gottlieb v. Juul, Solid Slumps, Avidity Gets $100M & More”