Among the casualties of the COVID-19 pandemic: the credibility of government agencies entrusted with protecting public health. The FDA this week granted emergency use authorization for convalescent plasma as a treatment for infection by the novel coronavirus. FDA Commissioner Stephen Hahn and Department of Health and Human Services Secretary Alez Azar both misrepresented the magnitude … Continue reading “Biotech Roundup: FDA Culpa, Tricida Trips, Freenome’s Funding & More”
Category: Boston
Freenome Tacks on $270M to Advance Blood Tests to Find Cancer Early
The ability to detect early signs of cancer in a patient’s blood could improve prognoses by helping doctors treat the disease before symptoms arise. Freenome, one of the companies racing to commercialize the first such screening test, on Wednesday announced it raised $270 million—money it plans to accelerate a clinical study of an experimental screening … Continue reading “Freenome Tacks on $270M to Advance Blood Tests to Find Cancer Early”
Dyne Eyes IPO for R&D of Genetic Medicines for Rare Muscle Diseases
Not long ago, having early data about how an experimental drug worked in humans was expected of biotechs considering IPOs. Dyne Therapeutics may not reach human testing until 2022, but, like many of its preclinical peers this year, the company is choosing to jump into public markets now while investor interest in the biotech sector … Continue reading “Dyne Eyes IPO for R&D of Genetic Medicines for Rare Muscle Diseases”
FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines
The FDA has authorized the use of plasma from people who have recovered from infection by the novel coronavirus as a treatment for hospitalized COVID-19 patients, a move widely perceived as influenced by political pressure given the lack of clear evidence of clinical benefit. Treating patients with plasma—the water, salts, and proteins that make up … Continue reading “FDA Adds Plasma as 2nd COVID-19 Treatment Under Emergency Guidelines”
Yumanity to Merge With Proteostasis to Advance Neuro Drug Pipeline
Yumanity is combining operations with Proteostasis Therapeutics, a deal that gives the biotech a public listing for its neurodegenerative disorder compounds including a Parkinson’s disease drug candidate in early-stage clinical development. According to terms of the merger agreement announced Monday, Proteostasis (NASDAQ: [[ticker:PTI]]) will acquire all outstanding shares of Yumanity in exchange for new shares … Continue reading “Yumanity to Merge With Proteostasis to Advance Neuro Drug Pipeline”
Astellas Reports Third Patient Death in Audentes Gene Therapy Study
A third patient who received an experimental Audentes gene therapy for a rare neuromuscular disorder has died, a disclosure that comes two months after the deaths of two patients led the FDA to place a clinical hold on the study. San Francisco-based Audentes, a subsidiary of Japanese pharmaceutical company Astellas Pharma, said Friday that early … Continue reading “Astellas Reports Third Patient Death in Audentes Gene Therapy Study”
Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More
While business is historically slow in August, this month seems to be bucking the trend, just like so many other unexpected developments in 2020. Perhaps life sciences executives have been less distracted by summer excursions this year in a world in which the COVID-19 pandemic has significantly curtailed travel. This week two pharmaceutical companies announced … Continue reading “Bio Roundup: J&J Buyout, BioMarin Rebuffed, Poseida on Hold & More”
Alzheon Lands $47M to Take Another Shot at a Pivotal Alzheimer’s Test
[Corrected 6:36 p.m. See below.] Alzheon, an Alzheimer’s disease drug developer that has twice filed and withdrawn its IPO plans, now has a $47 million commitment from the National Institutes of Health (NIH) to fund a pivotal study testing an experimental treatment in patients with the memory-robbing disorder. The cash, a five-year grant from the … Continue reading “Alzheon Lands $47M to Take Another Shot at a Pivotal Alzheimer’s Test”
J&J Boosts Autoimmune Disease Drug Pipeline With $6.5B Momenta Buyout
[Updated, 7:40 p.m. See below.] Johnson & Johnson is acquiring Momenta Pharmaceuticals in a $6.5 billion deal that brings the pharma giant a slate of experimental autoimmune disease therapies, including a potential blockbuster antibody drug in late-stage development for a rare type of anemia. Momenta (NASDAQ: [[ticker:MNTA]]) develops treatments for diseases driven by autoantibodies—antibodies produced … Continue reading “J&J Boosts Autoimmune Disease Drug Pipeline With $6.5B Momenta Buyout”
Genentech Gets FDA OK for Injectable Rare Neuroimmune Disease Drug
A drug that can be administered at home to treat a rare central nervous system disorder that damages the optic nerves and spinal cord now has FDA approval, marking the third nod the agency has given to a therapy for the condition. The drug, satralizumab (Enspryng), from Roche’s South San Francisco-based subsidiary Genentech, is for … Continue reading “Genentech Gets FDA OK for Injectable Rare Neuroimmune Disease Drug”
Tango Therapeutics Adds $175M, Deal Turns Partner Gilead Into Investor
Cancer drug developer Tango Therapeutics is adding $175 million more to its coffers in cash and equity, funds the company says will help it get its lead program into the clinic in 18 months. The money includes $50 million in equity financing, $20 million of that from Gilead Sciences (NASDAQ: [[ticker:GILD]]), plus another $125 million … Continue reading “Tango Therapeutics Adds $175M, Deal Turns Partner Gilead Into Investor”
Bristol Myers Squibb to Splash Out $475M on Dragonfly Immunotherapy
Bristol Myers Squibb is paying nearly half a billion dollars in up front and near-term payments to license an early-stage immunotherapy developed by Dragonfly Therapeutics, a firm that’s already a partner on potential treatments in oncology and other disease areas. New York-based Bristol (NYSE: [[ticker:BMY]]), which inherited a relationship with the biotech when it acquired … Continue reading “Bristol Myers Squibb to Splash Out $475M on Dragonfly Immunotherapy”
Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More
The road of drug development is rife with detours and disappointments but Seres Therapeutics showed this week that course corrections can work. Four years after its microbiome therapy failed in a mid-stage study, the company reported early positive data from a pivotal test of its treatment for a type of gut infection. The results are … Continue reading “Bio Roundup: Seres Soars, MesoBlast Vote, Duchenne Decision & More”
With FDA Nod, NS Pharma Duchenne Drug Becomes Sarepta Competitor
[Updated 8/13/2020, 3:19 p.m.] Duchenne muscular dystrophy (DMD) patients whose disease is characterized by a particular genetic mutation now have a new treatment option following the FDA’s Wednesday approval of a drug developed by NS Pharma. DMD is a genetic disorder that leaves patients unable to produce dystrophin, a protein key to muscle function. NS … Continue reading “With FDA Nod, NS Pharma Duchenne Drug Becomes Sarepta Competitor”
Seres Sets Sights on FDA After C. Diff Microbiome Therapy Scores in Phase 3
[Updated 12:37 p.m.] An experimental Seres Therapeutics capsule of live bacteria has met the goals of a pivotal study evaluating it as a treatment for a type of recurrent gut infection, preliminary results the company says put it on track for an FDA submission—potentially the first-ever application for a microbiome therapy. Seres (NASDAQ: [[ticker:MCRB]]) reported … Continue reading “Seres Sets Sights on FDA After C. Diff Microbiome Therapy Scores in Phase 3”
AbbVie Exits Editas Alliance, Pruning Another Genetic Medicines Pact
AbbVie has terminated a research partnership with Editas Medicines, returning to the biotech rights to an experimental gene-editing treatment. It’s the second genetic medicines alliance the pharmaceutical company exited this week. The Editas therapy, EDIT-101, is in Phase 1 testing as a treatment for a rare, inherited form of blindness called Leber congenital amaurosis type … Continue reading “AbbVie Exits Editas Alliance, Pruning Another Genetic Medicines Pact”
Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More
The novel coronavirus has driven the pharmaceutical industry to upend its research priorities. Big Pharma companies are focusing on vaccine development and a slew of biotechs are testing compounds, previously intended for a wide range of indications, as potential COVID-19 treatments. This week saw another major development brought on by industry efforts to adjust to … Continue reading “Bio Roundup: A Telehealth Combo, FDA’s BCMA OK, Biogen’s Bet & More”
Biogen to Pay Denali $1B to Partner on Parkinson’s Drug & Other Neuro Meds
Denali Therapeutics has selected a brain-penetrating Parkinson’s disease drug candidate to advance to late-stage testing, and Biogen is paying $1 billion to kick off a partnership on that compound and potentially others. According to terms of the deal announced Thursday, the companies will co-develop the small molecule, dubbed DNL151. Biogen (NASDAQ: [[ticker:BIIB]]) also gains options … Continue reading “Biogen to Pay Denali $1B to Partner on Parkinson’s Drug & Other Neuro Meds”
GentiBio Joins Cell Therapy Chase With $20M and New Treg Technology
One of the challenges facing cell therapy developers is collecting enough cells to produce a viable treatment. It’s a particularly pronounced problem for therapies employing regulatory T cells (Tregs), a type of immune cell that’s relatively scarce in the blood, says GentiBio CEO Adel Nada. Some biotech companies are developing Treg cell therapies from a … Continue reading “GentiBio Joins Cell Therapy Chase With $20M and New Treg Technology”
Black Diamond Makes Fang Ni’s Chief Business Officer Job Permanent
Black Diamond Therapeutics (NASDAQ: [[ticker:BDTX]]) has appointed Fang Ni to serve as its chief business officer. Ni has held the role on an interim basis since the company emerged from stealth in late 2018. Ni was most recently a principal and member of the investment team at Versant Ventures, which incubated Black Diamond before launching it … Continue reading “Black Diamond Makes Fang Ni’s Chief Business Officer Job Permanent”
AbbVie Walks From Voyager R&D Pact Spanning Alzheimer’s, Parkinson’s
A partnership between Voyager Therapeutics and AbbVie developing gene therapies for Alzheimer’s and Parkinson’s disease has ended without a drug for either disease reaching human testing. Voyager (NASDAQ: [[ticker:VYGR]]) announced the termination of the research pact after market close Monday. The Cambridge, MA-based biotech is keeping full rights to its technology for using engineered viruses … Continue reading “AbbVie Walks From Voyager R&D Pact Spanning Alzheimer’s, Parkinson’s”
Bluebird’s Susanna High Jumps to Dyne for Chief Operating Officer Role
Dyne Therapeutics has appointed Susanna High to serve as its chief operating officer, the same position she held most recently at Bluebird Bio (NASDAQ: [[ticker:BLUE]]). High’s experience also includes senior roles at Alynlam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]) and Millennium Pharmaceuticals. Last year, Cambridge, MA-based Dyne raised $50 million in Series A financing to support the development … Continue reading “Bluebird’s Susanna High Jumps to Dyne for Chief Operating Officer Role”
Kymera Therapeutics Unveils IPO Pitch for Protein Degradation
Kymera Therapeutics has a pipeline of preclinical drug candidates that use an experimental approach to get rid of disease-causing proteins and it’s now looking to tap the public markets to finance tests of the technology in humans. In paperwork submitted to the Securities and Exchange Commission on Friday, Kymera set a $100 million goal for … Continue reading “Kymera Therapeutics Unveils IPO Pitch for Protein Degradation”
Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More
The biotech IPO market is buzzing but Cerevel Therapeutics is showing that there’s more than one path to the public markets. This week the neuroscience drug developer reached a deal to merge with publicly traded Arya Sciences Acquisition Corp II. If you’ve never heard of Arya (NASDAQ: [[ticker:ARYBU]]), it’s a shell company that Perceptive Advisors … Continue reading “Bio Roundup: Cerevel’s Shell, Thrive’s Rise, Drug Price Drama & More”
AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients
AlloVir is the latest biotech company to go public, raising about $276.3 million to pull its cell therapies off the shelf and run multiple clinical trials testing them in stem cell and organ transplant patients. On Thursday, Cambridge, MA-based AlloVir (NASDAQ: [[ticker:ALVR]]) priced its offering of 16.25 million shares at $17 apiece, the midpoint of its … Continue reading “AlloVir’s IPO Raises $276M to Test Cell Therapies in Transplant Patients”
Roche Pays $120M for Rights to UCB’s Tau-Targeting Alzheimer’s Drug
As the Alzheimer’s disease world continues to closely follow the development of therapies that break up clumps of beta amyloid on patients’ brains, Roche is placing a bet on another approach via a deal that secures rights to a clinical-stage UCB compound that targets tau, another protein associated with the neurodegenerative disorder. According to terms … Continue reading “Roche Pays $120M for Rights to UCB’s Tau-Targeting Alzheimer’s Drug”
Omega Therapeutics Lands $85M to Tap Into “Control Room” of Biology
The promise of gene therapies and gene-editing drugs is a long-lasting treatment that’s potentially a cure. But making permanent genetic changes means any accompanying problems could be long-lasting as well, says Omega Therapeutics CEO Mahesh Karande. Omega is developing technology that takes a more nuanced approach to genomic medicine. Instead of fixing or replacing faulty … Continue reading “Omega Therapeutics Lands $85M to Tap Into “Control Room” of Biology”
Thrive Adds $257M, Plans Pivotal Trial of Early Cancer Detection Test
Thrive Earlier Detection, one of the companies vying to be the first to commercialize a blood test that can uncover cases of cancer before symptoms arise, has raised $257 million and announced plans to evaluate its CancerSEEK test in a registrational study. Many cancers grow silently, and once malignant cells are discovered a patient’s prognosis … Continue reading “Thrive Adds $257M, Plans Pivotal Trial of Early Cancer Detection Test”
Pfizer, BioNTech Choose Full Spike Protein for Pivotal Vaccine Test
Pfizer and BioNTech’s COVID-19 vaccine research started with multiple approaches—four shots on the messenger RNA goal. The partners have narrowed their choices to one for pivotal testing, and that candidate takes the same tack as other companies trying to address the novel coronavirus. BNT162b2, the vaccine candidate that Pfizer (NYSE: [[ticker:PFE]]) and BioNTech (NASDAQ: [[ticker:BNTX]]) … Continue reading “Pfizer, BioNTech Choose Full Spike Protein for Pivotal Vaccine Test”
AstraZeneca to Pay $1B to Team Up With Daiichi Sankyo Again in Cancer
AstraZeneca’s partnership with Daiichi Sankyo led to FDA approval of an antibody cancer drug late last year. Now the British pharmaceutical giant is paying $1 billion up front to join forces on another antibody drug addressing a different cancer target. The deal announced Monday calls for AstraZeneca (NYSE: [[ticker:AZN]]) to share in the development and, … Continue reading “AstraZeneca to Pay $1B to Team Up With Daiichi Sankyo Again in Cancer”
Bio Roundup: Jazz Drug OK’d, Gilead’s Bet, Moderna Patent Decision & More
EQRx launched in January during the JP Morgan Healthcare Conference with an audacious pledge to create 10 new drugs in as many years and then sell them at “dramatically” lower prices than existing medicines. But it offered few specifics about how it would achieve those goals. This week, drug licensing deals it made with two … Continue reading “Bio Roundup: Jazz Drug OK’d, Gilead’s Bet, Moderna Patent Decision & More”
Scholar Rock’s Alan Buckler Joins Triplet as Chief Scientific Officer
Triplet Therapeutics has appointed Alan Buckler to serve as chief scientific officer, the same role he held most recently at Scholar Rock (NASDAQ: [[ticker:SRRK]]). Buckler’s experience also includes positions at Biogen (NASDAQ: [[ticker:BIIB]]), the Novartis Institutes of Biomedical Research, and Axys Pharmaceuticals. Cambridge, MA-based Triplet launched last year with $49 million in financing to support … Continue reading “Scholar Rock’s Alan Buckler Joins Triplet as Chief Scientific Officer”
FDA Lifts CymaBay Drug Hold, Tests to Resume in Rare Liver Disease PBC
The FDA has lifted a hold on clinical trials for an experimental CymaBay Therapeutics drug in three liver diseases, clearing the way for tests to resume in all of them. But the company won’t be pressing forward in the biggest one, NASH, at least for now. The clinical hold on the drug, seladelpar, stemmed from … Continue reading “FDA Lifts CymaBay Drug Hold, Tests to Resume in Rare Liver Disease PBC”
Vesigen Nabs $28M to Wrap “ARMMS” Around Large Molecule Drug Delivery
It’s not enough for a cell or gene therapy to reach a cell, it must also get inside it to access most of the validated drug targets. Vesigen Therapeutics is developing technology that could best other approaches at penetrating the cellular membrane, and it launched on Wednesday with $28.5 million to advance its research. The … Continue reading “Vesigen Nabs $28M to Wrap “ARMMS” Around Large Molecule Drug Delivery”
Freeline Therapeutics and Checkmate Pharma Make Opening IPO Moves
The biotech IPO queue has added two more companies. Freeline Therapeutics and Checkmate Pharmaceuticals have each filed the regulatory paperwork to offer shares to the public. Freeline is raising cash to ensure that its lead program, a prospective hemophilia B gene therapy, keeps pace in the race to develop and commercialize a genetic treatment for … Continue reading “Freeline Therapeutics and Checkmate Pharma Make Opening IPO Moves”
Roche, Jnana Enter Drug R&D Alliance Targeting Metabolism’s Gatekeepers
Scientists know that proteins called solute carrier (SLC) transporters move substances important to metabolism across cellular membranes. But can drugs effectively hit these proteins to treat disease? Roche is paying startup Jnana Therapeutics $40 million to find out. The alliance announced Tuesday focuses on the discovery and preclinical development of drugs for immunological and neurological … Continue reading “Roche, Jnana Enter Drug R&D Alliance Targeting Metabolism’s Gatekeepers”
Forge Bio’s Combo Model for Gene Therapies Attracts $40M in Funding
Forge Biologics has something rare for most early-stage biotech startups: revenue from customers. Now it has $40 million to expand its model, which places contract manufacturing alongside the development of its own gene therapies, the most advanced of which is being readied for tests in humans. From operations in Columbus, OH, Forge makes gene therapies … Continue reading “Forge Bio’s Combo Model for Gene Therapies Attracts $40M in Funding”
Rhythm Pharma Taps Chairman David Meeker as President & CEO
Rhythm Pharmaceuticals (NASDAQ: [[ticker:RYTM]]) has appointed David Meeker, its chairman, to serve as CEO. He succeeds Hunter Smith, the company’s interim CEO and chief financial officer. Smith will continue serving as CFO. Meeker joined the Rhythm Pharma board in 2015 and has been its chairman since 2017. His experience also includes executive positions at the … Continue reading “Rhythm Pharma Taps Chairman David Meeker as President & CEO”
GSK Pays CureVac $328M in mRNA Vaccines Pact—Excluding COVID-19
GlaxoSmithKline is expanding its capabilities in messenger RNA (mRNA) research through a new alliance with CureVac spanning up to five programs targeting infectious disease pathogens. In addition to mRNA vaccines, those programs could also be antibody therapies. GSK (NYSE: [[ticker:GSK]]) is paying CureVac a total of £260 million (about $328 million) to kick off the … Continue reading “GSK Pays CureVac $328M in mRNA Vaccines Pact—Excluding COVID-19”
Two Days, Six IPOs, and $1B Raised for Biotech Research & More
Summer’s arrival hasn’t slowed the momentum of the biotech IPO market. Wall Street this week welcomed six new life science industry companies, which collectively raised more than $1 billion in their stock market debuts. Relay Therapeutics (NASDAQ: [[ticker:RLAY]]) notched the biggest biotech IPO of the week, raising $400 million. Investor interest in the Cambridge, MA-based … Continue reading “Two Days, Six IPOs, and $1B Raised for Biotech Research & More”
Bio Roundup: Moderna Publishes, Life Science Cash, AdComm Votes & More
If it seems like biotech investments have defied the financial headwinds of the pandemic, maybe it’s because they have. In the second quarter, 16 of the top 25 largest early-stage venture capital deals were investments in life science companies. The figures come from the National Venture Capital Association and financial research firm Pitchbook. This week … Continue reading “Bio Roundup: Moderna Publishes, Life Science Cash, AdComm Votes & More”
GSK Vaccine Vet Pfefer Tapped for Executive Roles at Flagship, Kintai
Flagship Pioneering has appointed Guillaume Pfefer to serve as CEO-partner of the venture capital firm. He will also become CEO of Kintai Therapeutics, one of the Cambridge, MA-based firm’s portfolio companies. Pfefer worked most recently at GlaxoSmithKline (NYSE: [[ticker:GSK]]), where he was senior vice president and global vaccine leader for Shingrix, the company’s shingles vaccine. … Continue reading “GSK Vaccine Vet Pfefer Tapped for Executive Roles at Flagship, Kintai”
Adimab Spinout Adagio Raises $50M for Coronavirus Antibody R&D
There’s a hard and fast rule at Adimab, a company that makes money by discovering and optimizing antibodies to pass off to drug development companies: Don’t compete with the customers. So, when its antibody science group produced a portfolio of anti-coronavirus antibodies, the Lebanon, NH-based company decided to spin off the assets into a new … Continue reading “Adimab Spinout Adagio Raises $50M for Coronavirus Antibody R&D”
Moderna Publishes Early COVID-19 Vaccine Data, Preps for Phase 3 Test
Moderna’s COVID-19 vaccine candidate stimulated production of antibodies to the novel coronavirus in all of the patients tested in an early-stage study, and the company says the data support the selection of which dose to test in a pivotal clinical trial slated to begin at the end of July. When the Cambridge, MA-based company initially … Continue reading “Moderna Publishes Early COVID-19 Vaccine Data, Preps for Phase 3 Test”
Last Chance for Xconomy Awards Nominations – Deadline is Friday, July 17
Have you had your say yet? The 2020 National Xconomy Awards represent the very best our life science industry has to offer. It is our privilege to recognize emerging companies and technologies, highlight groundbreaking business collaborations and strategies, celebrate corporate responsibility and diversity, and promote the innovation that delivers new therapeutics and better health to all. Finalists … Continue reading “Last Chance for Xconomy Awards Nominations – Deadline is Friday, July 17”
Dewpoint, Merck Team Up to Tackle HIV Using Condensate Know-How
Dewpoint Therapeutics has signed its second biopharma partnership, teaming up with Merck to explore the potential of using its discoveries around “droplets” of biomolecules that form inside cells to create a new HIV treatment. The companies’ aim is an ambitious one: develop a drug candidate that could prove curative, rather than suppress the infection as … Continue reading “Dewpoint, Merck Team Up to Tackle HIV Using Condensate Know-How”
Scholar Rock CEO Mahanthappa to Step Down, Kingsley Named Successor
Nagesh Manhanthappa, the founding employee of Scholar Rock (NASDAQ: [[ticker:SRRK]]) and its president and CEO for the past eight years, has decided to step down, the company announced Tuesday. No reason was given. The Cambridge, MA-based biotech said Mahanthappa is also leaving the board of directors on Aug. 1 but will continue to serve as … Continue reading “Scholar Rock CEO Mahanthappa to Step Down, Kingsley Named Successor”
Vor Biopharma Makes Slapak’s Chief Medical Officer Job Permanent
Vor Biopharma has appointed Christopher Slapak to serve as its chief medical officer. He had held that role on an interim basis for the past year. Slapak’s experience also includes positions at Eli Lilly (NYSE: [[ticker:LLY]]) and ImClone, which was acquired by the drug giant in 2008. Cambridge, MA-based Vor uses genetic engineering techniques to … Continue reading “Vor Biopharma Makes Slapak’s Chief Medical Officer Job Permanent”
Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact
A Blueprint Medicines cancer drug candidate currently under FDA review will have the marketing muscle of Roche behind it if it wins regulatory approval. The two companies are partnering on the drug, pralsetinib, a targeted cancer therapy developed for lung and thyroid cancers characterized by abnormalities in a gene called RET. According to deal terms … Continue reading “Roche, Blueprint Medicines Team Up Again in $775M RET Cancer Drug Pact”
New Xconomy Podcast & Special Report Feature Boston Biophama Leaders on Digital Health
Miss Xconomy’s Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health event or want to revisit the insightful content? Our new podcast and special report package the highlights for you. Listen to the podcast or download the report today. The podcast includes expert panels on: The convergence of data supporting emerging therapies Navigating approaches in a complex regulatory environment Managing the … Continue reading “New Xconomy Podcast & Special Report Feature Boston Biophama Leaders on Digital Health”