Two California biotechs have teamed up with LianBio, a new company launched earlier this week by hedge fund Perceptive Advisors, as part of deals that expand their reach into China as partners of the fledgling Shanghai-based firm. LianBio is getting the rights to develop and commercialize in Asia certain drugs from the pipelines of Brisbane, … Continue reading “Perceptive Advisors’ LianBio Inks Deals With BridgeBio, MyoKardia”
Category: San Francisco
FDA Green-Lights Roche Spinal Muscular Atrophy Drug, First Oral Therapy
The FDA on Friday approved a new spinal muscular atrophy drug that patients can take at home. Risdiplam (Evrysdi) is a liquid medicine intended for daily use that was developed by Roche subsidiary Genentech in partnership with the SMA Foundation and South Plainfield, NJ-based PTC Therapeutics (NASDAQ: [[ticker:PTCT]]). Regulators OK’d the drug, intended for daily … Continue reading “FDA Green-Lights Roche Spinal Muscular Atrophy Drug, First Oral Therapy”
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”
IgGenix Grabs $10M to Advance Antibody Treatments for Allergies
About six months after the FDA approved the first treatment for peanut allergy, a new biotech, IgGenix, has raised $10 million to discover antibodies that could address that and other common allergies. The six-person startup, which is based out of the Johnson & Johnson (NYSE: [[ticker:JNJ]]) JLABS incubator in South San Francisco, raised the Series … Continue reading “IgGenix Grabs $10M to Advance Antibody Treatments for Allergies”
As Patients Pivot to Telehealth, Teladoc & Livongo Plan $18.5B Tie-Up
Telemedicine giant Teladoc Health is buying health technology company Livongo Health in an $18.5 billion cash and stock deal that comes as the COVID-19 pandemic drives patients to seek ways to manage their health from home. Teladoc (NYSE: [[ticker:TDOC]]) provides “virtual healthcare services” that give patients the ability to visit with a doctor remotely. Most … Continue reading “As Patients Pivot to Telehealth, Teladoc & Livongo Plan $18.5B Tie-Up”
Still Stuck on Adhesion Issues, FDA Rejects DBV’s Peanut Allergy Patch
A skin patch developed by DBV Technologies to desensitize peanut allergy sufferers to the allergen over time has been rejected by the FDA, which says the French company needs to change its design and run another clinical trial testing the modified version if it wants the treatment reviewed again. DBV (NASDAQ: [[ticker:DBVT]]), which has its … Continue reading “Still Stuck on Adhesion Issues, FDA Rejects DBV’s Peanut Allergy Patch”
CymaBay PBC Drug Hits Phase 3 Goals With Signs of Side Effect Advantage
CymaBay Therapeutics’ investigational drug seladelpar succeeded in a late-stage trial in patients with primary biliary cholangitis (PBC), producing results that suggest it could have a key side effect advantage compared to a drug currently used to treat the rare liver disease. Patients with PBC, which damages the bile ducts of the liver, are initially treated … Continue reading “CymaBay PBC Drug Hits Phase 3 Goals With Signs of Side Effect Advantage”
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”
Novartis Pays $75M to Get Hands on Sangamo’s Zinc Fingers for Drug R&D
Another biopharma has signed up to use Sangamo Therapeutics’ gene editing technology to develop therapies that can address disease by heightening or depressing a gene’s activity level. Sangamo on Thursday announced that Novartis (NYSE: [[ticker:NVS]]) had agreed to shell out $75 million up front to leverage the biotech’s genome regulation technology to treat certain neurodevelopmental … Continue reading “Novartis Pays $75M to Get Hands on Sangamo’s Zinc Fingers for Drug R&D”
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”
Nura Bio Debuts With $73M and Plan to Develop “Neuroprotective” Drugs
Damage to axons, the slender tendrils through which nerve cells communicate, is an early indication of several neurological diseases. Nura Bio, which formed around new research into a mechanism underlying axonal degeneration, made its public debut Wednesday with a $73 million financing round and a chief executive who has experience shepherding multiple drug development programs … Continue reading “Nura Bio Debuts With $73M and Plan to Develop “Neuroprotective” Drugs”
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”
Gilead Gets Another CAR-T Approval, This Time for Mantle Cell Lymphoma
The FDA on Friday approved a Gilead Sciences drug developed for treating mantle cell lymphoma, paving the way for the company to commercialize its second cancer cell therapy. Approval for the drug, brexucabtagene autoleucel (Tecartus), covers patients whose cancer has relapsed or has not responded to earlier treatments. Gilead (NASDAQ: [[ticker:GILD]]) added the therapy to … Continue reading “Gilead Gets Another CAR-T Approval, This Time for Mantle Cell Lymphoma”
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”
Parker Institute Adds John Connolly as New Chief Scientific Officer
John Connolly joined the Parker Institute for Cancer Immunotherapy (PICI) as its new chief scientific officer. He was most recently CSO at Singaporean clinical-stage cell therapy company Tessa Therapeutics, which in 2017 struck up an alliance with PICI to develop next-generation cancer treatments. Connolly is an associate professor at National University of Singapore and an … Continue reading “Parker Institute Adds John Connolly as New Chief Scientific Officer”
Jazz Pharma Gets FDA Nod for New Drug to Treat Narcolepsy Symptoms
[Corrected 7/23/20, 10:13 am. See below.] Jazz Pharmaceuticals has received FDA approval for a narcolepsy drug that it has developed as a lower-sodium successor to its biggest moneymaker, a treatment that was first approved in 2002 to reduce attacks of muscle weakness associated with the disease. That drug, sodium oxybate (Xyrem), was first OK’d to reduce … Continue reading “Jazz Pharma Gets FDA Nod for New Drug to Treat Narcolepsy Symptoms”
Seer Raises $55M to Commercialize Tools to Analyze the Proteome
Illumina led the genomics revolution, developing tools that have changed how scientists discover drugs and how clinicians treat patients. Startup Seer is making the case that its technology for analyzing the proteome—the complement of proteins that cells, tissues, and organs produce—will take it to the head of the proteomics field. On Wednesday the Redwood City, … Continue reading “Seer Raises $55M to Commercialize Tools to Analyze the Proteome”
Olema Adds $54M to Start Human Tests of Breast Cancer Drug Candidate
Olema Oncology has raised $54 million to advance its lead drug candidate into human tests, having been working in stealth since 2007 to develop a daily pill to treat women with breast cancer whose disease is driven by the hormone estrogen. San Francisco-based Olema announced Wednesday that the Series B financing round will allow it to start … Continue reading “Olema Adds $54M to Start Human Tests of Breast Cancer Drug Candidate”
Gilead Sciences Splashes Out $300M for Tizona Stake & Option to Acquire
Gilead Sciences has made its second deal in as many months that puts the company first in line to acquire a biotech developing cancer immunotherapies. On Tuesday the Foster City, CA-based company said it would pay $300 million to South San Francisco-based Tizona Therapeutics for a 49.9 percent stake plus the option to later acquire … Continue reading “Gilead Sciences Splashes Out $300M for Tizona Stake & Option to Acquire”
Exalys Launches With $15M to Treat Postoperative Delirium & More
Venture capitalists like nothing more than pattern matching, and Domain Associates has identified one it especially prefers: licensing drug candidates from a Japanese biopharma and setting up a US company to move it through testing until Big Pharma starts nosing around. It’s a roadmap the VC firm, which has offices in San Diego and Princeton, … Continue reading “Exalys Launches With $15M to Treat Postoperative Delirium & More”
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”
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”
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”
Amgen Doubles Down on BeiGene Collaboration, Investing $421M More
At the year’s start Thousand Oaks, CA-based Amgen closed a strategic collaboration with BeiGene, investing $2.8 billion to gain a presence in what’s becoming an ever-more essential market for global drug development. The investment earned it an R&D pact and ownership of about one-fifth of the Chinese oncology drug company. Now the firm has snapped … Continue reading “Amgen Doubles Down on BeiGene Collaboration, Investing $421M More”
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”
VelosBio Tacks on $137M to Advance Its ROR1-Targeting Cancer Antibody Drugs
Dave Johnson has known UC San Diego physician and cancer reseacher Thomas Kipps for nearly 20 years. Now Johnson, CEO of San Diego-based cancer drug developer VelosBio, has secured $137 million to accelerate the company’s goal of developing targeted therapies based on an antibody program developed by Kipps that homes in on tumors with a … Continue reading “VelosBio Tacks on $137M to Advance Its ROR1-Targeting Cancer Antibody Drugs”
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”
On Heels of $100M Financing, Annexon Bio Aims to Tack On More Via IPO
The same week Annexon Biosciences announced it had raised $100 million in private financing to advance its research of antibody drugs to treat neurodegeneration, the company filed paperwork with regulators indicating its intention to tap the public markets, too. The South San Francisco-based company has two clinical-stage product candidates, both of which are designed to … Continue reading “On Heels of $100M Financing, Annexon Bio Aims to Tack On More Via IPO”
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”
Data Quantity, Complexity Drives Use of AI in Drug Discovery and Testing
The quantity of data about medicines, diseases, and biology is growing. So too, are the number of companies that employ artificial intelligence in drug discovery. Most of the low-hanging fruit in drug research has already been picked, and the industry is clamoring to make sense of the new data, according to Jeffrey Lu, CEO and … Continue reading “Data Quantity, Complexity Drives Use of AI in Drug Discovery and Testing”
Annexon Adds On $100M to Advance Antibodies to Treat Neurodegeneration
Annexon Biosciences, a biotech founded in late 2014 by former Elan Pharmaceuticals executives, has added $100 million to its coffers to move its two clinical-stage programs along and to continue advancing its preclinical pipeline. The South San Francisco-based company is developing drugs for patients with autoimmune and neurodegenerative disorders that are caused by an abnormal … Continue reading “Annexon Adds On $100M to Advance Antibodies to Treat Neurodegeneration”
Bolt Bio Adds $93.5M to Move Ahead Immune-Stimulating Cancer Drugs
Ten months ago Randy Schatzman was appointed CEO of cancer drug developer Bolt Biotherapeutics, and tasked with getting its first drug candidate into the clinic, building out its C-suite, and raising more money. On Wednesday Schatzman checked the last box on that priority list, closing a $93.5 million Series C financing round from a group … Continue reading “Bolt Bio Adds $93.5M to Move Ahead Immune-Stimulating Cancer Drugs”
Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder
Ultragenyx Pharmaceutical won FDA approval Tuesday for a therapy that treats a group of rare metabolic disorders that render the body unable to convert certain fats—such as those found in olive oil, fish, and nuts—into energy. People who have long-chain fatty acid oxidation disorders (LC-FAOD) typically manage the condition with dietary changes or by taking … Continue reading “Ultragenyx Pharma Wins FDA’s First Drug Nod for Rare Metabolic Disorder”
Code for Cures: Life Sciences Thrives on San Francisco’s Software Heritage
A growing population of people with software experience plus an interest in life sciences is boosting drug development in the San Francisco Bay Area, according to panelists at an Xcelerating event. Innovation in the San Francisco Bay Area may first bring to mind tech behemoths like Facebook and Google. But some drug development companies in … Continue reading “Code for Cures: Life Sciences Thrives on San Francisco’s Software Heritage”
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”
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”
La Jolla Pharma Steps In With Better Offer, Wins Tetraphase Bidding War
It’s common for antibiotics developers to run into financial trouble these days but what’s unusual is seeing a bidding war erupt for one of them. The competition for Tetraphase Pharmaceuticals now has a new winner: La Jolla Pharmaceutical. San Diego-based La Jolla (NASDAQ: [[ticker:LJPC]]) has pledged to pay Tetraphase shareholders $43 million in cash now … Continue reading “La Jolla Pharma Steps In With Better Offer, Wins Tetraphase Bidding War”
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”
Gilead Grabs Option to Acquire Pionyr & Its Clinic-Bound Immunotherapies
Effective checkpoint inhibitors facilitate immune cells’ ability to recognize and target tumors. But for some patients this approach to treating cancer doesn’t work. Pionyr Immunotherapeutics aims to help those people by developing antibody drugs that take a new approach toward boosting the body’s anti-tumor efforts. Now, as Pionyr prepares to ask the FDA to clear … Continue reading “Gilead Grabs Option to Acquire Pionyr & Its Clinic-Bound Immunotherapies”
Invitae Makes a Precision Oncology Push With $886M Deal for ArcherDx
Cancer treatment is increasingly moving toward targeted therapies based on the genetics of a patient’s tumor and Invitae is ensuring it gets its share of this growing market with a deal to acquire precision oncology startup ArcherDx. San Francisco-based Invitae announced Monday that it has agreed to pay $886 million for ArcherDx—$325 million in cash … Continue reading “Invitae Makes a Precision Oncology Push With $886M Deal for ArcherDx”