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”
Category: New York
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”
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”
Elevation Oncology Debuts With $32.5M to Develop Targeted Cancer Drugs
Elevation Oncology formed last year with $32.5 million in a Series A financing round led by the initial investor in Loxo Oncology, a company that blazed a trail developing cancer therapies based on genetic signature rather than tumor origin. On Tuesday the New York-based biotech emerged from stealth aiming to follow in Loxo’s path. It … Continue reading “Elevation Oncology Debuts With $32.5M to Develop Targeted Cancer Drugs”
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”
MeiraGTx, J&J See Phase 3 Test Ahead for Vision Loss Gene Therapy
A gene therapy being jointly developed by MeiraGTx and Johnson & Johnson to treat an inherited disease of the retina that leads to blindness improved patients’ vision after six months, data that the companies say is enough to move the potentially long-lasting treatment into pivotal testing. The condition, called X-linked retinitis pigmentosa, is part of … Continue reading “MeiraGTx, J&J See Phase 3 Test Ahead for Vision Loss Gene Therapy”
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”
Mallinckrodt’s Kidney Failure Drug Narrowly Wins Backing of FDA Panel
An experimental Mallinckrodt Pharmaceuticals drug for a rare type of kidney failure has won the support of an FDA advisory panel by the thinnest of margins. The committee of mostly physicians concluded that the benefits of the drug, terlipressin, outweigh its safety risks as a treatment for hepatorenal syndrome type 1 (HRS-1), and panelists voted … Continue reading “Mallinckrodt’s Kidney Failure Drug Narrowly Wins Backing of FDA Panel”
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”
3 Biotech IPOs Together Rake In Over a Half Billion to Advance Treatments
Three biotech companies collectively raised $584 million in their initial public offerings last week, continuing a streak that has the healthcare sector playing a leading role in the robust level of market activity this summer. Of the three companies, the one with investigational therapies that haven’t yet begun tests in humans raised the most. South … Continue reading “3 Biotech IPOs Together Rake In Over a Half Billion to Advance Treatments”
Bio Roundup: Blackstone’s Billions, Biogen Finishes Filing, Novavax at “Warp Speed” & More
Cash flowed throughout the life sciences ecosystem this week as Blackstone (NYSE: [[ticker:BX]]) raised a record-setting life sciences fund, companies of all stages announced new financings, and money continued to find its way to those working on efforts to treat or prevent COVID-19. Financiers poured $100 million or more into at least three biotechs, a … Continue reading “Bio Roundup: Blackstone’s Billions, Biogen Finishes Filing, Novavax at “Warp Speed” & More”
Sanofi Pays Kymera $150M to Kick Off Protein Degrader Partnership
Kymera Therapeutics has signed a deal with French biopharma Sanofi to advance two potential treatments for immune-inflammatory diseases that leverage the Cambridge, MA-based company’s research into protein degradation, the natural mechanism cells use to get rid of unwanted proteins. Drug developers are eager to leverage that cellular recycling system to create new treatments because it … Continue reading “Sanofi Pays Kymera $150M to Kick Off Protein Degrader Partnership”
Novavax Gets $1.6B in Operation Warp Speed Funding for COVID-19 Vaccine
The federal government’s Operation Warp Speed has made its biggest financing award yet, promising $1.6 billion to a Maryland biotech to help advance its investigational COVID-19 vaccine and ready millions of doses in preparation for its possible success. Gaithersburg, MD-based Novavax, which has never before brought a product to market, announced the federal award Tuesday. … Continue reading “Novavax Gets $1.6B in Operation Warp Speed Funding for COVID-19 Vaccine”
PacBio CEO, CFO Plan Retirements and More People on the Move
Here’s a look back at some of the life science industry’s executive appointments, departures, and retirements from recent weeks: —Pacific Biosciences (NASDAQ: [[ticker:PACB]]) CEO Michael Hunkapiller and Chief Financial Officer Susan Barnes are retiring. —Moderna (NASDAQ: [[ticker:MRNA]]) appointed Ray Jordan as chief corporate affairs officer. —Aridis Pharmaceuticals (NASDAQ: [[ticker:ARDS]]) appointed Hasan Jafri its chief medical officer. … Continue reading “PacBio CEO, CFO Plan Retirements and More People on the Move”
Bristol Myers Pays Dragonfly $55M to Bring NK Cells to Neuro Diseases
Bristol Myers Squibb likes what it sees from the immune cell research of Dragonfly Therapeutics so far—enough to pay $55 million to add multiple sclerosis and neuroinflammation to their ongoing partnership. The alliance came to New York-based Bristol (NYSE: [[ticker:BMY]]) via its acquisition of Celgene last year. The original 2017 deal covered the development of … Continue reading “Bristol Myers Pays Dragonfly $55M to Bring NK Cells to Neuro Diseases”
Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients
Fast enrollment of the right patient populations will be critical to quickly conducting Phase III trials of COVID-19 vaccines and this will likely mean taking concerted steps to reach out to populations that can be harder to recruit for clinical trials, drug industry leaders said on a recent New York Academy of Sciences webinar. Moderna … Continue reading “Moderna: Speed of COVID 19 Vaccine Hinges On Enrolling Right Patients”
Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases
The blood-brain barrier protects the functioning of that essential organ, but it’s also a hurdle to delivering neurological drugs. Italy’s Chiesi Group has agreed to pay Guilford, CT-based Bioasis Technologies $3 million up front to use the preclinical firm’s technology to facilitate the delivery of enzymes across the blood-brain barrier to treat neurological symptoms associated … Continue reading “Chiesi Licenses Bioasis Tech to Tackle Brain Symptoms of Rare Diseases”
Roche Gets FDA OK for Injectable Version of Breast Cancer Drug
A new version of a combination drug marketed by Roche for early-stage and metastatic breast cancer with a specific genetic signature received FDA approval Monday for a formulation that can be delivered in minutes rather than an hour or more. The antibody combo, delivered alongside IV chemotherapy, is intended for women with breast cancer that … Continue reading “Roche Gets FDA OK for Injectable Version of Breast Cancer Drug”
FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data
The FDA has rejected an Intercept Pharmaceuticals drug developed to treat the fatty liver disorder nonalcoholic steatohepatitis, more commonly referred to as “NASH.” New York-based Intercept (NASDAQ: [[ticker:ICPT]]) said Monday that the agency’s complete response letter for obeticholic acid (OCA) stated that its review found that the investigational NASH drug’s benefit “remains uncertain” and does … Continue reading “FDA Says “No” to Intercept Pharma’s NASH Drug, Asks for More Data”
With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash
DBV Technologies still expects to receive an FDA decision in early August for its peanut allergy patch. But on Friday the company, which is headquartered in the southern outskirts of Paris, said it would start layoffs and scale down its drug development activities to save cash in case the radio silence it says it has … Continue reading “With Peanut Patch in FDA Purgatory, DBV Plans Layoffs to Stretch Cash”
Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection
The FDA has rejected an investigational AbbVie drug for the “wet” form of age-related macular degeneration, dealing a setback to the company’s bid to wrest market share from blockbuster drugs currently used to treat the condition. According to AbbVie (NYSE: [[ticker:ABBV]]), the FDA’s complete response letter states that the drug, abicipar pegol, caused a high … Continue reading “Eye Inflammation Dooms AbbVie Wet AMD Drug to an FDA Rejection”
Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More
Uncertainty related to the continued spread of the pandemic continued to consume most of the oxygen in the room this week, but life sciences news outside of that arena continued apace. Once considered all but shuttered, the IPO market again saw an active week between new public debuts and more companies joining the queue. Indeed, … Continue reading “Bio Roundup: Gilead’s Pionyr Grab, Relay to IPO, Unicorn Sana & More”
CSL Behring Bolsters Hemophilia Lineup With Deal for uniQure’s Gene Therapy
CSL Behring is joining the chase for a genetic treatment for hemophilia by acquiring a uniQure gene therapy that’s already in late-stage testing. King of Prussia, PA-based CSL Behring is paying $450 million up front to acquire the uniQure (NASDAQ: [[ticker:QURE]]) asset, etranacogene dezaparvovec (“EtranaDez” for short), the companies announced late Wednesday. Netherlands-based uniQure will … Continue reading “CSL Behring Bolsters Hemophilia Lineup With Deal for uniQure’s Gene Therapy”
AsclepiX Emerges With $35M and an Eye Drug Challenger to Eylea, Lucentis
The body’s natural process for healing wounds has led AsclepiX Therapeutics to a novel approach to treating diseases of the eye. The startup is now gearing up to test its technology in humans, and it has raised $35 million in Series A financing to support its research. Cuts and scrapes in the skin spark the … Continue reading “AsclepiX Emerges With $35M and an Eye Drug Challenger to Eylea, Lucentis”
Shattuck Labs Nabs $118M for Cancer Drugs Like Keytruda, But Better
Checkpoint inhibitors do one thing: release the molecular brake that keeps immune cells from recognizing and targeting tumors. This cancer immunotherapy approach has saved countless lives and turned drugs from Merck and Bristol Myers Squibb into blockbuster products. But what if a single drug could block checkpoint proteins while simultaneously sparking an anti-tumor response? That’s … Continue reading “Shattuck Labs Nabs $118M for Cancer Drugs Like Keytruda, But Better”
Timing Is an Essential Element of Cell & Gene Therapy Product Development
The science underpinning the latest investigational cell and gene therapies is complex enough. But the rapid advance of technologies that support development of these kinds of drugs presents logistical considerations, too. “Drug development is an interesting process because it takes five to 10 years to get a drug to market and invariably, somewhere along that … Continue reading “Timing Is an Essential Element of Cell & Gene Therapy Product Development”
Bio Roundup: A Royal IPO, Akili Arrives, Orca Bio Surfaces & More
The biggest life sciences deal this week involves a company that doesn’t discover or develop drugs, or even sell them. Yet its mark is found on pharmaceutical products spanning the entire sector. Royalty Pharma (NASDAQ: [[ticker:RPRX]]) acquires the royalty rights for drugs. Most of those royalties are for products that are already approved, but the … Continue reading “Bio Roundup: A Royal IPO, Akili Arrives, Orca Bio Surfaces & More”
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”
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”
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”
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”
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”
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””
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”
Cytovia Therapeutics Adds OliX’s Wei Li as Chief Scientific Officer
Cytovia Therapeutics appointed Wei Li as acting chief scientific officer. Li was most recently chief development officer at Korean biotech OliX Pharmaceuticals. Her prior experience includes more than a decade at cancer drug developer Boston Biomedical, where she led development of the company’s lead drug candidate. New York-based Cytovia is developing cancer immunotherapies based on … Continue reading “Cytovia Therapeutics Adds OliX’s Wei Li as Chief Scientific Officer”
Aruvant Taps Sarepta’s Palaniappan as Chief Technology Officer
Aruvant Sciences has appointed V. “Palani” Palaniappan to serve as chief technology officer. He comes to the clinical-stage gene therapy developer from Sarepta Therapeutics (NASDAQ: [[ticker:SRPT]]), where he was senior vice president and head of technical operations. His experience also includes positions at Takeda Pharmaceutical (NASDAQ: [[ticker:TAK]]), Millennium Pharmaceuticals, Biogen (NASDAQ: [[ticker:BIIB]]), and Nexstar Pharmaceuticals. … Continue reading “Aruvant Taps Sarepta’s Palaniappan as Chief Technology Officer”
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”
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”
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”
Immunomedics President & CEO Harout Semerjian Steps Down
Six weeks after starting as president and CEO of Immunomedics (NASDAQ: [[ticker:IMMU]]), Harout Semerjian has resigned. In a statement, the Morris Plains, NJ-based company said the decision was precipitated by the “significant logistical obstacles presented by the COVID-19 pandemic.” Semerjian was named the new CEO of Immunomedics in early April, joining from France-based Ipsen, where … Continue reading “Immunomedics President & CEO Harout Semerjian Steps Down”
Applied Therapeutics Taps Chuck Silberstein as Chief Financial Officer
Applied Therapeutics (NASDAQ: [[ticker:APLT]]) appointed Charles “Chuck” Silberstein as its chief financial officer and head of business development. He succeeds CFO Mark Vignola, who joined Applied as CFO in April 2019 and is now moving on “to pursue new business opportunities.” Silberstein was most recently senior vice president of corporate business development at Allergan, whose … Continue reading “Applied Therapeutics Taps Chuck Silberstein as Chief Financial Officer”