AbbVie & UroGen Overactive Bladder Treatment Misses in Phase 2 Trial

A formulation of AbbVie’s blockbuster wrinkle treatment, acquired through its buyout of Allergan, has failed a mid-stage trial as a potential fix for overactive bladder and urinary incontinence. The FDA in 2013 approved the use of onabotulinumtoxinA (Botox) via injection into the bladder as a treatment for overactive bladder in adults who can’t take or … Continue reading “AbbVie & UroGen Overactive Bladder Treatment Misses in Phase 2 Trial”

Kinnate Raises $98M for Human Tests of Targeted Cancer Therapies

Drugs designed to precisely target cancers with specific genetic signatures have changed the course of disease for many patients. But for the majority, such drugs either don’t work because of innate resistance or they eventually stop working once the cancer develops new mutations that hamper their effectiveness. Kinnate Biopharma, one of the biotechs working to … Continue reading “Kinnate Raises $98M for Human Tests of Targeted Cancer Therapies”

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”

Acadia Pharma Acquires CerSci, Potential Pain Meds in $52.5M Buyout

Acadia Pharmaceuticals has acquired Texas biotech CerSci Therapeutics, a privately held company with a clinical-stage molecule under evaluation as a potential therapy for post-surgical and nerve pain. The San Diego-based company splashed out $52.5 million on the buyout, a cash-and-stock deal—$47.2 million of it in Acadia shares, according to a regulatory filing—that closed Monday. Acadia … Continue reading “Acadia Pharma Acquires CerSci, Potential Pain Meds in $52.5M Buyout”

Kura Oncology Adds Kyowa Kirin’s Stephen Dale as Chief Medical Officer

Stephen Dale has joined Kura Oncology (NASDAQ: [[ticker:KURA]]) as its chief medical officer. He was most recently global head of medical science, with a primary focus in oncology, at Kyowa Kirin. Prior he held various roles at AstraZeneca (NYSE: [[ticker:AZN]]), including clinical head of oncology. The CMO role at Kura was previously held by company … Continue reading “Kura Oncology Adds Kyowa Kirin’s Stephen Dale as Chief Medical Officer”

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”

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”

Harmony Bio and Inhibrx Raise Combined $247M in Public Market Debuts

Two biotechs this week topped the $100 million mark in their respective initial public offerings, both of which were able to offer more shares than planned. One, a company with nearly nine month’s-worth of revenue from a newly commercialized drug and the other, an early-clinical stage oncology drug developer, illustrate the range of biotech companies … Continue reading “Harmony Bio and Inhibrx Raise Combined $247M in Public Market Debuts”

FDA Rejects BioMarin Hemophilia Gene Therapy, Asks for More Data

A gene therapy designed to treat the severest cases of the most common type of hemophilia has been rejected by the FDA, which wants more data on the durability of the investigational treatment developed by BioMarin Pharmaceutical. Letters issued by the FDA turning down experimental treatments aren’t made public, but BioMarin (NASDAQ: [[ticker:BMRN]]) says the … Continue reading “FDA Rejects BioMarin Hemophilia Gene Therapy, Asks for More Data”

Kronos Bio Names Yasir Al-Wakeel as Its First Chief Financial Officer

Kronos Bio has added Yasir Al-Wakeel to its senior management team as chief financial officer and head of corporate development, a newly created role. Al-Wakeel most recently served as chief financial and strategy officer at Neon Therapeutics, which was acquired this year by Mainz, Germany-based BioNTech (NASDAQ: [[ticker:BNTX]]). Previously he held the role of CFO … Continue reading “Kronos Bio Names Yasir Al-Wakeel as Its First Chief Financial Officer”

Fate Therapeutics Taps Celgene’s Dulac as Its Chief Financial Officer

Edward Dulac has joined Fate Therapeutics (NASDAQ: [[ticker:FATE]]) as its chief financial officer. Dulac was most recently vice president of business development and strategy at Celgene, which is now part of Bristol Myers Squibb. His prior experience includes serving as a biopharma equity research analyst at Barclays Capital and at Lehman Brothers and in corporate … Continue reading “Fate Therapeutics Taps Celgene’s Dulac as Its Chief Financial Officer”

Sorrento Therapeutics Cuts Ties With Chief Financial Officer Jiong Shao

Sorrento Therapeutics (NASDAQ: [[ticker:SRNE]]) has fired its chief financial officer, Jiong Shao, according to a regulatory filing. The San Diego-based company, which is among the biotechs developing potential COVID-19 treatments and tests, didn’t explain why. Sorrento appointed Najjam Asghar, its chief accounting officer, to handle CFO responsibilities as well until the firm finds a successor. … Continue reading “Sorrento Therapeutics Cuts Ties With Chief Financial Officer Jiong Shao”

Patient Death in Poseida Prostate Cancer Study Prompts Clinical Hold

A Phase 1 trial testing a Poseida Therapeutics cell therapy in men with prostate cancer is on hold after a patient enrolled in the study died of liver failure nearly three weeks after receiving the treatment. The San Diego company, which has touted its product candidates as safer than early-generation versions developed by other companies, … Continue reading “Patient Death in Poseida Prostate Cancer Study Prompts Clinical Hold”

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”

Advisory Body Backs MesoBlast Therapy for Transplant Complication

An FDA advisory committee Thursday voted 9-1 to recommend that the agency approve a stem cell therapy developed by MesoBlast as a treatment for acute graft-versus-host disease (aGVHD) in children. The panel weighed the need for a new way to address the potentially fatal condition against shortcomings of the clinical trial the Australian biotech conducted … Continue reading “Advisory Body Backs MesoBlast Therapy for Transplant Complication”

Perceptive Advisors’ LianBio Inks Deals With BridgeBio, MyoKardia

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”

Ligand to Spend $438M to Add Protein Maker Pfenex to Technology Lineup

Ligand Pharmaceuticals plans to acquire recombinant protein therapeutics maker Pfenex for $438 million, the companies announced Monday. The larger company agreed to pay $12 per share for Pfenex (NYSE American: [[ticker:PFNX]])—a 57 percent premium to its closing price Monday. San Diego-based Ligand (NASDAQ: [[ticker:LGND]]) generates revenue from licensing deals and royalties paid by pharmaceutical companies … Continue reading “Ligand to Spend $438M to Add Protein Maker Pfenex to Technology Lineup”

Roche Gut Disease Drug Produces Mixed Results in Late-Stage Trials

Results from four studies within a major Roche-run clinical trials program of an investigational gut disease drug have muddled the antibody’s path forward after its performance proved mixed. The company has been studying etrolizumab, an antibody designed to block two members of a family of proteins called integrins, as a potential treatment for the two … Continue reading “Roche Gut Disease Drug Produces Mixed Results in Late-Stage Trials”

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”

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”

GlaxoSmithKline Multiple Myeloma Drug Earns FDA’s First Anti-BCMA Nod

Patients with advanced multiple myeloma have a new treatment option with the FDA’s approval of a GlaxoSmithKline drug that targets B-cell maturation antigen, a protein found on the surface of cancerous plasma cells. The agency OK’d the London-based pharma giant’s cancer drug, belantamab mafodotin (Blenrep), based on the results of a study in which patients … Continue reading “GlaxoSmithKline Multiple Myeloma Drug Earns FDA’s First Anti-BCMA Nod”

G1 Vets Launch Arc Therapeutics to Take on New Cancer Target

Three early employees of G1 Therapeutics have launched a new oncology-focused company and raised $6 million to move a preclinical program licensed from their former employer into the clinic. The startup, Research Triangle Park, NC-based Arc Therapeutics, is headed by Patrick Roberts (pictured above), who most recently served as the head of translational medicine at … Continue reading “G1 Vets Launch Arc Therapeutics to Take on New Cancer Target”

MeiraGTx Names Immunovant’s Zeldin as Its Chief Medical Officer

Robert Zeldin has joined gene therapy developer MeiraGTx (NASDAQ: [[ticker:MGTX]]) as its chief medical officer. Most recently he held the same role at Immunovant (NASDAQ: [[ticker:IMVT]]). Prior Zeldin served as CMO at Acceleron Pharma (NASDAQ: [[ticker:XLRN]]) and at Ablynx. His experience also includes time at Stallergenes, Novartis (NYSE: [[ticker:NVS]]), and Merck, as well as a … Continue reading “MeiraGTx Names Immunovant’s Zeldin as Its Chief Medical Officer”

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”

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”

Aspen Neuroscience Chief Scientific Officer Loring to Step Down

Jeanne Loring, a co-founder of Aspen Neuroscience, is stepping down from her role as its chief scientific officer. The La Jolla, CA-based company said Loring—professor emeritus at the Scripps Research Institute, where her work on the genomics of induced pluripotent stem cells laid the foundation for the company’s launch—will become a special advisor to the … Continue reading “Aspen Neuroscience Chief Scientific Officer Loring to Step Down”

Prometheus Taps Conatus’s Marshall as Its Chief Financial Officer

Prometheus Biosciences has appointed Keith Marshall its chief financial officer. Marshall most recently served as chief operating officer and CFO at Conatus Pharmaceuticals, which earlier this year merged with Histogen (NASDAQ: [[ticker:HSTO]]). Before Conatus, Marshall was CFO and head of corporate development at Flagship Pioneering spinout Torque Therapeutics, since renamed Repertoire Immune Medicines. Marshall started … Continue reading “Prometheus Taps Conatus’s Marshall as Its Chief Financial Officer”

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”

AnaptysBio Appoints Paul Lizzul as Its Chief Medical Officer

Paul Lizzul has joined AnaptysBio (NASDAQ: [[ticker:ANAB]]) as the company’s chief medical officer. He succeeds Marco Londei, who held the roles of CMO and chief development officer at AnaptysBio until earlier this year, when he joined Dutch biotech Gadeta as CEO. Lizzul most recently served a short stint at Amgen (NASDAQ: [[ticker:AMGN]]) as global development … Continue reading “AnaptysBio Appoints Paul Lizzul as Its Chief Medical Officer”

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”

Arcutis Taps Verrica’s Burnett to Succeed Retiring Chief Medical Officer

Patrick Burnett is joining Arcutis Biotherapeutics (NASDAQ: [[ticker:ARQT]]) as its chief medical officer following the retirement of Howard Welgus, who has held the role since the company’s founding in 2016. Burnett was most recently CMO at dermatology therapeutics developer Verrica Pharmaceuticals (NASDAQ: [[ticker:VRCA]]), whose investigational topical therapy for molluscum contagiosum was rejected by the FDA earlier this month. … Continue reading “Arcutis Taps Verrica’s Burnett to Succeed Retiring Chief Medical Officer”

Amid Boom Days for Biotech, Inhibrx Lines Up Another IPO Effort

Public investors are betting big on biotechs, and Inhibrx is looking to capitalize on the industry’s recent resurgence of initial public offerings. The La Jolla, CA-based company, which is developing drugs for cancer and a rare respiratory disease, has again applied for a listing on the Nasdaq, a filing that comes more than a year … Continue reading “Amid Boom Days for Biotech, Inhibrx Lines Up Another IPO Effort”

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”

Telehealth Firm AristaMD Adds $24M to Link Primary Docs With Specialists

Telemedicine isn’t just another way to connect patients with doctors. AristaMD has carved out a niche in connecting doctors with, well, other doctors. The San Diego-based telehealth company’s software links primary care physicians and medical specialists through virtual consultations, communication that is intended to reduce healthcare costs by slimming down the number of referrals made … Continue reading “Telehealth Firm AristaMD Adds $24M to Link Primary Docs With Specialists”

Avidity Biosciences Appoints Alnylam’s Jae Kim as Chief Medical Officer

Avidity Biosciences (NASDAQ: [[ticker:RNA]]) has added Jae Kim to its C-suite as chief medical officer. Kim most recently served as vice president of clinical development at Alnylam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]). His prior experience includes roles at MyoKardia (NASDAQ: [[ticker:MYOK]]) and Amgen (NASDAQ: [[ticker:AMGN]]). San Diego-based Avidity, which raised a $100 million Series C financing round … Continue reading “Avidity Biosciences Appoints Alnylam’s Jae Kim as Chief Medical Officer”

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”

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”

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”

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”

Acadia Halts Work on Depression Drug After Late-Stage Trial Failure

Acadia Pharmaceuticals received the FDA’s OK for pimavanserin (Nuplazid), the first drug approved to treat hallucinations and delusions associated with Parkinson’s disease, in 2016. Since then, the San Diego company has looked to expand its use into other indications, with mixed results. That trend continued Monday when Acadia (NASDAQ: [[ticker:ACAD]]) reported it would end its … Continue reading “Acadia Halts Work on Depression Drug After Late-Stage Trial Failure”

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”

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”

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”