Ten years ago Mark Smith was at MIT doing basic research into the microbiome. Now, as CEO of Finch Therapeutics Group, Smith has hard data to back up his company’s thesis that using “good” bacteria as a therapeutic can best a placebo when it comes to at least one condition: a recurrent C. difficile infection. … Continue reading “In Microbiome Milestone, Finch Therapeutics C. diff Pill Bests Placebo”
Category: National
Alpine Immune Sciences Lands AbbVie as R&D Partner for Lupus Drug
Alpine Immune Sciences’ lupus drug candidate now has AbbVie lined up to continue the compound’s development. The drug, ALPN-101, is ready for Phase 2 testing, which will be conducted by Seattle-based Alpine. The deal announced Thursday grants AbbVie (NYSE: [[ticker:ABBV]]) an exclusive option to license the drug after that study. The North Chicago, IL-based pharmaceutical … Continue reading “Alpine Immune Sciences Lands AbbVie as R&D Partner for Lupus Drug”
Engrail Therapeutics Launches With $32M to Develop New Neuro Drugs
Typically a new biotech assembles a group of investors that collectively puts in the money a fledgling company requires to develop or acquire potential therapies. Engrail Therapeutics, which emerged from stealth Thursday with $32 million in outside financing, landed its entire Series A funding from a sole source: Nan Fung Life Sciences, a subsidiary of … Continue reading “Engrail Therapeutics Launches With $32M to Develop New Neuro Drugs”
Orca Bio Surfaces With $192M and Recipes for “Custom” Cell Therapies
The cancer cell therapies available today are made by tweaking a patient’s own immune cells to better recognize and fight the disease. Orca Bio is developing what it says is the next generation of cell therapy: custom preparations made without modifying cells or genes. Orca is already testing its technology in humans, though it has … Continue reading “Orca Bio Surfaces With $192M and Recipes for “Custom” Cell Therapies”
Frazier Launches Lassen to Advance Antibodies Against Fibrosis, Cancer
Lassen Therapeutics, a biotech that is developing antibodies as potential treatments for fibrosis, rare diseases, and cancer, debuted Wednesday with $31 million in Series A financing. The San Diego-based company says it will use the money to accelerate its antibody programs, including asking the FDA for the green light to move its lead drug candidate … Continue reading “Frazier Launches Lassen to Advance Antibodies Against Fibrosis, Cancer”
C4 Therapeutics Adds $170M to Test Protein Degraders in the Clinic
C4 Therapeutics, a biotech developing small molecules designed to take advantage of a cellular mechanism as a way to treat disease, has raised $170 million in venture equity and debt to start human testing. The Watertown, MA-based firm is among a number of companies competing in the popular protein degradation space, in which drug developers … Continue reading “C4 Therapeutics Adds $170M to Test Protein Degraders in the Clinic”
GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance
GlaxoSmithKline got its first taste of synthetically lethal cancer therapies via an acquisition. Now it’s trying for a bigger bite of this emerging drug class through a research alliance with Ideaya Biosciences that spans three of the biotech’s programs, all slated to reach clinical trials in the next three years. According to deal terms announced … Continue reading “GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance”
Exec Search Underway at PacBio After CEO, CFO Announce Plans to Retire
Gene sequencing company Pacific Biosciences of California is seeking two new leaders in the wake of retirement announcements by a pair of longtime top executives. PacBio (NASDAQ: [[ticker:PACB]]) president and CEO Michael Hunkapiller plans to retire by year’s end, and the company’s chief financial officer, Susan Barnes, is slated to do the same in August. … Continue reading “Exec Search Underway at PacBio After CEO, CFO Announce Plans to Retire”
Pharma Partnering: Perspectives from Xcelerating Life Sciences Panel
At some point, every biotech weighs whether to forge ahead alone or team up with a larger company that has the scientific know-how, clinical trial experience, or the cash to keep a program going. For early-stage developers of cell and gene therapies, these alliances are almost essential. Bruce Levine been on both sides of this … Continue reading “Pharma Partnering: Perspectives from Xcelerating Life Sciences Panel”
Jazz Pharma Gets Quick FDA OK for New Small Cell Lung Cancer Drug
The FDA on Monday approved a new drug for patients with advanced small cell lung cancer, permitting the treatment to be marketed based on less evidence than it traditionally requires in order to speed its path to market. Madrid-based PharmaMar, which developed lurbinectedin (Zepzelca), licensed its US commercialization rights to Jazz Pharmaceuticals (NASDAQ: [[ticker:JAZZ]]) last … Continue reading “Jazz Pharma Gets Quick FDA OK for New Small Cell Lung Cancer Drug”
Akili Interactive’s Video Game for ADHD Gets the FDA All Clear
The newest attention deficit hyperactivity disorder (ADHD) treatment comes with instructions unlike any other therapy: Press “PLAY.” Akili Interactive was awarded FDA clearance on Monday for EndeavorRx, a “digital therapeutic” developed to treat ADHD through a video game experience. The regulatory decision makes the Boston company’s product the first prescription therapy that comes in the … Continue reading “Akili Interactive’s Video Game for ADHD Gets the FDA All Clear”
FDA Reverses Authorization for Use of Antimalarials to Treat COVID-19
The FDA on Monday revoked its emergency authorization permitting use of the antimalarial drugs hydroxychloroquine and chloroquine to treat the novel coronavirus, citing a lack of evidence of their efficacy. In late March the agency authorized the drugs, which President Donald Trump touts often as a potential treatment, for patients who were hospitalized with COVID-19 … Continue reading “FDA Reverses Authorization for Use of Antimalarials to Treat COVID-19”
GlaxoSmithKline Keeps Oncology 2.0 Growth Plans on Track
[Corrected 6/17/20, 1:48 pm PT. See below.] GlaxoSmithKline’s years-long oncology resurgence is on track to have two new drugs approved in the US in mid-2020, after the company won a key first-line ovarian cancer indication for Zejula (niraparib) in April. The belantamab mafodotin and dostarlimab approvals also anticipated this year will give GSK its first … Continue reading “GlaxoSmithKline Keeps Oncology 2.0 Growth Plans on Track”
Viela Bio Gets FDA Green Light for Rare Autoimmune Disease Treatment
One year after the FDA approved the first-ever treatment for a rare autoimmune condition that primarily affects the optic nerves and spinal cord, the agency has approved the second. That second regulatory nod goes to Viela Bio (NASDAQ: [[ticker:VIE]]) drug inebilizumab (Uplizna) for adults with neuromyelitis optica spectrum disorder (NMOSD) who also have a particular … Continue reading “Viela Bio Gets FDA Green Light for Rare Autoimmune Disease Treatment”
Biotech Roundup: BIO on Racism, AbbVie Antibodies, IPO Surge & More
At the start of 2020 thousands of biotechies anticipated spending the second week of June in San Diego, hobnobbing at the annual conference hosted by the Biotechnology Innovation Organization. Instead, attendees from 64 countries spanning 28 times zones convened online this week for the first-ever virtual BIO International Convention. There, topics once as unanticipated as the … Continue reading “Biotech Roundup: BIO on Racism, AbbVie Antibodies, IPO Surge & More”
Novo Nordisk Strikes a $725M Deal for AstraZeneca Spinout Corvidia
Diabetes drug giant Novo Nordisk has reached a $725 million deal to acquire Corvidia Therapeutics, a clinical-stage biotech developing treatments for disorders affecting the heart and the kidneys. The upfront payment due to Corvidia shareholders is cash. According to the terms of the agreement, Denmark-based Novo Nordisk (NASDAQ: [[ticker:NVO]]) could be on the hook for … Continue reading “Novo Nordisk Strikes a $725M Deal for AstraZeneca Spinout Corvidia”
Reata Bags $350M as It Preps Rare Chronic Kidney Disease Drug for FDA
Reata Pharmaceuticals is readying its lead drug, a potential treatment for a rare, genetic form of chronic kidney disease called Alport syndrome, for an FDA filing this year. New York private equity giant Blackstone Group, via its newly flush life sciences investment arm, is betting $350 million that the treatment will be a big seller … Continue reading “Reata Bags $350M as It Preps Rare Chronic Kidney Disease Drug for FDA”
Moderna Finalizes Plan, Dose for Phase 3 Test of mRNA COVID Vaccine
Less than a month after reporting preliminary early-stage data for its experimental vaccine for the novel coronavirus, Moderna has finalized the plan for a Phase 3 test. The study, set to begin next month, is targeting enrollment of about 30,000 volunteers, Moderna (NASDAQ: [[ticker:MRNA]]) announced Thursday. Those patients will be randomly assigned to receive either … Continue reading “Moderna Finalizes Plan, Dose for Phase 3 Test of mRNA COVID Vaccine”
Verve Therapeutics Adds $63M to Edit Heart Attack Risk Out of Genes
Verve Therapeutics aims to use gene editing to address heart attacks by targeting the liver, not the heart. And it wants to make its edits inside the patient. The startup’s approach raises a lot of questions. Verve has some answers now, and it has raised $63 million to learn more. The new financing announced Thursday … Continue reading “Verve Therapeutics Adds $63M to Edit Heart Attack Risk Out of Genes”
AbbVie Commits $750M to Genmab Bispecific Antibody Cancer Drug Deal
In one of the largest oncology partnerships ever, AbbVie and Genmab are teaming up to accelerate development and commercialization of three of the Danish biotech’s investigational bispecific antibody drugs and potentially develop more. North Chicago, IL-based AbbVie (NYSE: [[ticker:ABBV]]) is spending $750 million up front to kick off the effort, which involves two clinical-stage drugs, … Continue reading “AbbVie Commits $750M to Genmab Bispecific Antibody Cancer Drug Deal”
Merck’s Keytruda Fails Pivotal Bladder Cancer Study, Sinks First-Line Hopes
Merck’s blockbuster cancer immunotherapy pembrolizumab (Keytruda) has failed a pivotal study testing it in an aggressive form of bladder cancer. The Merck (NYSE: [[ticker:MRK]]) drug was being evaluated in urothelial carcinoma, a form of cancer that starts in the cells that line the inside of the bladder. It’s the most common type of bladder cancer, … Continue reading “Merck’s Keytruda Fails Pivotal Bladder Cancer Study, Sinks First-Line Hopes”
Fauci Foresees “More Than 1 Winner” in Race for COVID-19 Vaccines, Drugs
To ameliorate a pandemic that infectious disease expert Anthony Fauci calls his “worst nightmare,” a winner-takes-all solution won’t be enough. Fauci, who directs the National Institute of Allergy and Infectious Diseases, this week told attendees at the Biotechnology Innovation Organization’s annual convention that developing multiple vaccines and therapeutics will be necessary to tamp down the … Continue reading “Fauci Foresees “More Than 1 Winner” in Race for COVID-19 Vaccines, Drugs”
Melinta Expands Antibiotics Lineup With $39M Tetraphase Acquisition
Melinta Therapeutics and Tetraphase Pharmaceuticals, two antibiotics companies that have struggled separately, will now see if they have better luck together. Morristown, NJ-based Melinta has reached a deal to acquire Tetraphase (NASDAQ: [[ticker:TTPH]]) for $39 million in cash up front. Tetraphase shareholders could earn up to $16 million more if the Watertown, MA-based biotech’s sole … Continue reading “Melinta Expands Antibiotics Lineup With $39M Tetraphase Acquisition”
CereVasc Lands $44M for New Medical Device to Drain “Water on the Brain”
When fluid builds up in the brain faster than the body can absorb it, pressure builds sparking what’s called hydrocephalus. Surgery can address this condition, but the decades-old approach to relieving the cranial pressure caused by the fluid is susceptible to failure, says Dan Levangie, CEO and president of CereVasc. Levangie’s medical device startup aims … Continue reading “CereVasc Lands $44M for New Medical Device to Drain “Water on the Brain””
Sarepta Eyes Key Test for Gene Therapy in Rare Muscular Dystrophy
The $165 million bet that Sarepta Therapeutics placed on the gene therapy programs of Myonexus Therapeutics is starting to pay off with more early but encouraging clinical data from the deal’s most advanced program—a potential treatment for a type of limb-girdle muscular dystrophy. Currently no available treatments exist for any of the many subtypes of … Continue reading “Sarepta Eyes Key Test for Gene Therapy in Rare Muscular Dystrophy”
Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic
Hearing loss can stem from a variety of reasons, but in rare cases it’s caused by genetic defects. Akouos is developing a gene therapy to address these problems and it’s planning an IPO to finance the first tests of its approach in humans. In paperwork filed with regulators late Friday, Boston-based Akouos set a preliminary … Continue reading “Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic”
Legend Biotech’s Upsized IPO Lands $424M for Multiple Myeloma Drug
The biggest life sciences IPO of the year so far belongs to Legend Biotech. The cancer drug developer was able to raise $423.8 million after pricing its shares well above the targeted price range. Legend, which has executive offices Somerset, NJ, had planned to sell 18 million shares in the range of $18 to $20 … Continue reading “Legend Biotech’s Upsized IPO Lands $424M for Multiple Myeloma Drug”
Bio Roundup: Race and Pharma, ASCO Recap, Warp Speed Ahead & More
Race is not a topic that often comes up in pharmaceutical discussions but perhaps it should. Disease doesn’t discriminate by race, but health and economic disparities put some groups at higher risk than others. And yet clinical trials fail to reflect the broad spectrum of patients that drug makers aim to treat. Racial disparities are … Continue reading “Bio Roundup: Race and Pharma, ASCO Recap, Warp Speed Ahead & More”
Atlas Venture Raises $400M Fund to Seed Another New Set of Biotechs
Another venture capital firm that backs biotechs has raised a multimillion-dollar fund—money the firm, Cambridge, MA-based Atlas Venture, says it will use to continue creating and funding companies that are creating new medicines. Atlas revealed Friday that it closed its 12th fund after raising $400 million, a total that pushes the amount the company has … Continue reading “Atlas Venture Raises $400M Fund to Seed Another New Set of Biotechs”
Cullinan Oncology Reels In $98M to Advance Cancer Drug Pipeline
Cullinan Oncology emerged nearly three years ago with an approach to cancer drugs its founders said would improve the odds of success. Now it has a pipeline of seven compounds and a fresh $98.5 million to advance all of them. The new cash announced Thursday is a Series B round of funding that added the … Continue reading “Cullinan Oncology Reels In $98M to Advance Cancer Drug Pipeline”
Accent, AstraZeneca Ink Cancer Drug Deal to Block RNA-Modifying Proteins
AstraZeneca is looking to bolster its cancer R&D portfolio with therapies that target RNA-modifying enzymes and other proteins involved in cancer. On Thursday the Cambridge, UK-based pharma giant announced it would pay Boston-area biotech Accent Therapeutics $55 million up front to gain access to its drug discovery know-how in RNA-modifying protein biology. The biology of … Continue reading “Accent, AstraZeneca Ink Cancer Drug Deal to Block RNA-Modifying Proteins”
Early Bird Sale Ends Friday, June 5 for Xconomy’s AI & Drug Discovery Online Forum and Networking Conference
The early bird sale for Xcelerating Life Sciences San Francisco: The AI, Big Data, and R&D Boom ends this Friday at 11:59 p.m. PT. Register today to lock in the low $99 rate and secure your spot at the online forum and networking event on June 25. This is your chance to explore how artificial … Continue reading “Early Bird Sale Ends Friday, June 5 for Xconomy’s AI & Drug Discovery Online Forum and Networking Conference”
NodThera Adds $55M to Advance Drugs to Better Regulate Inflammation
Our immune systems are designed to monitor for signs of foreign molecules, and among the first responses to such signals of potential danger are the formation of structures called inflammasomes. But the innate immune system’s natural inflammatory reaction, a protective mechanism meant to tackle any impending infection or injury, may also cause damaging inflammation in … Continue reading “NodThera Adds $55M to Advance Drugs to Better Regulate Inflammation”
Pliant Therapeutics Prices IPO, Lands $144M to Test Fibrosis Drugs
Pliant Therapeutics is now a public company, raising $144 million from its IPO, plus more from a separate transaction with partner Novartis. South San Francisco-based Pliant priced its offering of 9 million shares at $16 apiece, which was the high end of its revised price range. When the biotech initially set IPO terms last week, … Continue reading “Pliant Therapeutics Prices IPO, Lands $144M to Test Fibrosis Drugs”
Grail Plants a Seed in RTP, Pledges $100M Investment in New Site
Grail, a clinical-stage company developing cancer tests intended to detect early signs of the disease from a small blood sample, has agreed to invest $100 million in a new outpost planned for Research Triangle Park, NC. The new Grail site will have a laboratory and warehouse space, Gov. Roy Cooper announced Tuesday after an agreement … Continue reading “Grail Plants a Seed in RTP, Pledges $100M Investment in New Site”
Chinook, Aduro Merger Plan Sets Up New Kidney Disease-Focused Biotech
Chinook Therapeutics and Aduro Biotech, each pursuing different approaches to the same rare disease, are now converging on a path to combine their operations into a single company focused on developing new treatments for kidney disorders. The merger agreement announced Tuesday will result in a business whose ownership will be split evenly between the shareholders … Continue reading “Chinook, Aduro Merger Plan Sets Up New Kidney Disease-Focused Biotech”
Regeneron Pays Intellia $100M to Add Hemophilia to CRISPR R&D Pact
Four years after Regeneron Pharmaceuticals and Intellia Therapeutics began working together to research the use of CRISPR/Cas9 to treat liver diseases, the partners are expanding their pact to bleeding disorders. The deal announced Monday covers the development of potential treatments for hemophilia, which stems from genetic mutations that lead to insufficient levels of blood clotting … Continue reading “Regeneron Pays Intellia $100M to Add Hemophilia to CRISPR R&D Pact”
Forma Therapeutics Eyes IPO to Advance Sickle Cell, Prostate Cancer Drugs
Forma Therapeutics has developed a pipeline of small molecules aimed at rare blood disorders and cancers, but it aims to advance two—investigational treatments for sickle cell disease and for advanced prostate cancer—and find partners for the rest of them. Now the Watertown, MA-based company is considering tapping the public markets to add enough funds to … Continue reading “Forma Therapeutics Eyes IPO to Advance Sickle Cell, Prostate Cancer Drugs”
After Inking Bristol Myers Pact, Repare Therapeutics Sets Sights on IPO
It’s been a busy week for Repare Therapeutics. On Tuesday, the cancer drug developer struck up an alliance with Bristol Myers Squibb (NYSE: [[ticker:BMY]]) that pays $65 million now and as much as $3 billion later, depending on the progress made in coming years. On Friday, Repare filed for an IPO that could bring in … Continue reading “After Inking Bristol Myers Pact, Repare Therapeutics Sets Sights on IPO”
AbbVie Wins First FDA Approval of Drug to Treat Uterine Fibroid Bleeds
An AbbVie drug that treats pain in the uterus has notched an additional FDA approval for addressing heavy menstrual bleeding associated with uterine fibroids. The regulatory decision Friday covers that drug, elagolix, combined with estrogen and progestin in a capsule that North Chicago, IL-based AbbVie (NYSE: [[ticker:ABBV]]) plans to market as Oriahnn. Elagolix (Orilissa) was … Continue reading “AbbVie Wins First FDA Approval of Drug to Treat Uterine Fibroid Bleeds”
Bio Roundup: ASCO Opens, Merck Takes On COVID, Evofem’s Approval & More
A year ago about 40,000 people gathered in Chicago for the annual meeting of the American Society of Clinical Oncology. Today a virtual version of the ASCO conference, the cancer field’s largest, kicks off, with oncologists and others tuning in from throughout the country and around the world to check out the latest in cancer … Continue reading “Bio Roundup: ASCO Opens, Merck Takes On COVID, Evofem’s Approval & More”
Variant Emerges With $16M to Find “Outlier Humans” to Reveal New Drugs
Human DNA holds secrets that, once uncovered, have led scientists to develop a number of treatments for disease. A slew of biopharmas and biotechs—not to mention national health systems—have hoovered up genetic data from millions of people in hopes of leveraging the information contained within to drive their R&D. Variant Bio, which debuted Thursday with … Continue reading “Variant Emerges With $16M to Find “Outlier Humans” to Reveal New Drugs”
FDA Welcomes Variety of Phase 2/3 Trial Designs for COVID-19 Therapies
The US FDA’s formal guidance on development of COVID-19 treatments and preventative agents takes a broadly flexible approach to Phase 2 and 3 trial design, repeatedly indicating a willingness to consider varied options while urging sponsors to discuss their trials plans with the agency earlier rather than later. “FDA is committed to supporting all scientifically … Continue reading “FDA Welcomes Variety of Phase 2/3 Trial Designs for COVID-19 Therapies”
AbCellera Raises $105M to Advance Antibody Discovery Operations
Most of the best-selling drugs worldwide today are antibodies, and in the three decades-plus since the first such drug was approved, makers of such treatments have begun endeavoring to design drugs to tackle ever more difficult classes of therapeutic targets. Vancouver, BC-based AbCellera, which launched in 2012 based on work by CEO Carl Hansen (pictured), … Continue reading “AbCellera Raises $105M to Advance Antibody Discovery Operations”
New Webinars: In Vitro Hepatotoxicity Assessment Solutions & Enzyme Fragment Complementation Tech
Xconomy Insight is excited to offer two special webinars to our community this June. Sponsored by Eurofins, registration is free to all. Applying Cell-based In Vitro Assays to Improve In Vitro Hepatotoxicity Assessment Challenges Date: Wednesday, June 10, 2020 Time: 9:00am PDT / 12:00pm EDT Duration: 1 hour Register today In this webinar, we will … Continue reading “New Webinars: In Vitro Hepatotoxicity Assessment Solutions & Enzyme Fragment Complementation Tech”
Gilead Gains Foothold in Solid Tumors With $375M, 10-Year Arcus Bio Pact
With the year’s biggest oncology conference days away, Gilead Sciences is signaling now what its cancer immunotherapy pipeline could look like in the years to come. The drug maker is entering a partnership with Arcus Biosciences that spans the biotech’s four clinical-stage compounds, plus additional programs that may come out of the 10-year alliance. The … Continue reading “Gilead Gains Foothold in Solid Tumors With $375M, 10-Year Arcus Bio Pact”
Merck Outlines COVID-19 Ambitions With Buyout Deal, Collaborations
Merck exited the holiday weekend with some fireworks of its own, announcing three major programs on Tuesday all related to investments in finding ways to treat and prevent COVID-19. The Kenilworth, NJ-based pharma giant said it had inked an agreement to acquire Austrian vaccine developer Themis, which has a COVID-19 candidate in preclinical development; develop … Continue reading “Merck Outlines COVID-19 Ambitions With Buyout Deal, Collaborations”
Insitro Adds $143M to Fuel Machine Learning-Driven Drug Development
A stem cell biologist, a gene editing expert, and a data engineer walk into a room…and that’s just a few of the people Daphne Koller has recruited in the past two years to Insitro. The South San Francisco-based startup has grand plans to reevaluate and, potentially, reinvent the drug discovery and development process using the … Continue reading “Insitro Adds $143M to Fuel Machine Learning-Driven Drug Development”
Viacyte Adds $27M to Move Ahead Trio of Stem Cell Diabetes Treatments
Privately held biotech ViaCyte has banked $27 million, the majority an installment of cash from a tranched $80 million Series D financing round it closed in late 2018. The company says the money will go to further develop the three diabetes treatment programs it has underway, including enough prep work to enable it to bring … Continue reading “Viacyte Adds $27M to Move Ahead Trio of Stem Cell Diabetes Treatments”
COVID-19 Sparks New Opportunities for Digital Health Companies
Clinicians and regulators are rethinking how healthcare is provided amid precautions prompted by COVID-19. In-person physician visits don’t fit within the physical distancing guidelines that are now the new normal. New technology presents alternatives. As a digital therapeutics startup, Akili Interactive finds itself thrust in the midst of these changes. The Boston company has developed … Continue reading “COVID-19 Sparks New Opportunities for Digital Health Companies”