COVID-19 has ravaged the economy, and it was expected to quash the IPO market, too. But the biotech sector is defying the pandemic with crossover financings and freshly minted public companies. On Friday, three firms added their names to the list of life science companies preparing to join the public markets. Gene therapy company Generation … Continue reading “Generation Bio Leads a Trio of Biotech Companies Aiming for the Nasdaq”
Category: National
FDA Approves Evofem’s “On-Demand” Non-Hormonal Birth Control Gel
While treatments for many health conditions have undergone reinvention in the past two decades, birth control options haven’t changed much. On Friday, San Diego-based Evofem Biosciences said it received FDA approval for a new kind of contraceptive: a non-hormonal vaginal gel intended for use directly before intercourse. The drug, a combination of lactic acid, citric … Continue reading “FDA Approves Evofem’s “On-Demand” Non-Hormonal Birth Control Gel”
Bio Roundup: mRNA Vaccine Data, Rise of Rallybio, Roche’s Protein Play & More
As the nation started to reopen this week following two months of closed businesses and stay-at-home orders, public health officials and economists cautioned that society won’t truly return to anything resembling a pre-pandemic normal without a COVID-19 vaccine. Moderna (NASDAQ: [[ticker:MRNA]]) moved one step closer to filling that need with the release of preliminary Phase … Continue reading “Bio Roundup: mRNA Vaccine Data, Rise of Rallybio, Roche’s Protein Play & More”
AMAG Pharma Sells Off Women’s Health Product in Planned Divestment
AMAG Pharmaceuticals wants out of the women’s health business—and now it’s halfway there. On Thursday the Waltham, MA-based biotech said it had found a buyer for prasterone (Intrarosa), a steroid designed to treat pain during intercourse associated with menopause, one of two commercialized drugs it has been shopping around. The buyer of the AMAG Pharma … Continue reading “AMAG Pharma Sells Off Women’s Health Product in Planned Divestment”
Sunovion Drug Gets FDA Nod for Treating Parkinson’s “Off” Episodes
The FDA on Thursday approved a Sunovion Pharmaceuticals treatment for Parkinson’s disease, giving patients a new way to take an old drug. The Sunovion product, Kynmobi, is a formulation of apomorphine hydrochloride, a drug that treats “off” episodes experienced by Parkinson’s patients. These are times when the standard of care drug, levodopa, wears off and … Continue reading “Sunovion Drug Gets FDA Nod for Treating Parkinson’s “Off” Episodes”
HotSpot Therapeutics Adds $65M to Steer Allosteric Medicines to the Clinic
HotSpot Therapeutics set out two years ago to find new ways to address elusive disease targets. It now has molecules on the path to becoming potential medicines backed by a fresh $65 million. The Series B round of funding announced Thursday was led by SR One, the venture investment arm of GlaxoSmithKline (NYSE: [[ticker:GSK]]). The … Continue reading “HotSpot Therapeutics Adds $65M to Steer Allosteric Medicines to the Clinic”
Vividion Gets $135M in Collaboration With Roche on Protein Degradation
Biotechs are increasingly looking to leverage a mechanism cells use to get rid of unwanted proteins to drug targets previously considered out of reach. Roche ponied up $135 million upfront this week to work with Vividion Therapeutics in search of small molecules that use that “protein degradation” process to do just that. The drug discovery … Continue reading “Vividion Gets $135M in Collaboration With Roche on Protein Degradation”
Applied Molecular Plots IPO to Back Transport of Biologic Drugs to Gut
The human gut hosts a hub of activity spanning the immune system, the nervous system, and more. But drugging this nexus comes with challenges. Applied Molecular Transport is developing biologic drugs that use a cell’s own mechanisms to get a therapy to a target and the biotech is now planning to tap the public markets … Continue reading “Applied Molecular Plots IPO to Back Transport of Biologic Drugs to Gut”
Explore San Diego’s Precision Medicine and Genomics Sector in Xconomy’s New Podcast and Special Report
Learn what’s fueling San Diego’s biotech investment and partnership opportunities by downloading Xconomy’s new special report and podcast that package the highlights from the recent Xcelerating Life Sciences San Diego: Biomedical Breakthroughs in Precision Medicine & Genomics event. The special report includes: San Diego Biotech Entrepreneurs, Innovation Leads to “Maturing” Ecosystem What It Takes for … Continue reading “Explore San Diego’s Precision Medicine and Genomics Sector in Xconomy’s New Podcast and Special Report”
With $30M, Octant Launches Synthetic Bio Search for Multi-Target Drugs
Octant, a new drug discovery company, launched Wednesday with millions in backing from tech investors to push ahead plans to leverage advances in science and in tech—including genomics, synthetic biology, and big data computation—to map out the relationships between chemicals, drug receptors, and diseases. On Wednesday the Emeryville, CA-based startup announced it raised $30 million … Continue reading “With $30M, Octant Launches Synthetic Bio Search for Multi-Target Drugs”
Amplyx Adds Cash from Pfizer, Adage as Funding Round Tops $90M
Amplyx Pharmaceuticals has completed enrollment in one mid-stage trial of its lead drug candidate, a new kind of antifungal treatment, and has finished treating the first patients in two more such studies. Now the San Diego-based company has added $53 million to a round of funding it first closed in 2017, money that it plans … Continue reading “Amplyx Adds Cash from Pfizer, Adage as Funding Round Tops $90M”
Rallybio Lands $145M to Alter Course of FNAIT and More Rare Diseases
One of the risks to a newborn’s life comes from the mother’s immune system. It attacks the platelets of the fetus, depleting these blood-clotting cells and risking uncontrollable bleeding in the baby. Rallybio aims to develop the first FDA-approved treatment for this rare condition and the startup has raised $145 million to bring that drug, … Continue reading “Rallybio Lands $145M to Alter Course of FNAIT and More Rare Diseases”
Early COVID-19 Vaccine Data Sets Up Moderna for Next Stages of Testing
Moderna’s experimental COVID-19 vaccine is showing signs it can elicit antibodies at levels comparable to those found in the blood of dozens of patients who have recovered from the infectious disease, according to early results released Monday. The company is now preparing to quickly bring its vaccine candidate into the next stages of human testing. … Continue reading “Early COVID-19 Vaccine Data Sets Up Moderna for Next Stages of Testing”
Antibiotic Development: HHS Not Yet Sold on “Pull” Incentives
The US Health and Human Services agency isn’t ready to go all in on “pull” incentives to encourage the development of new antibiotics, the agency indicated in response to a new Government Accountability Office report. “It is still unclear whether post-market financial incentives should necessarily be part of HHS’s forthcoming strategic framework to further incentivize … Continue reading “Antibiotic Development: HHS Not Yet Sold on “Pull” Incentives”
Deciphera Pharmaceuticals Wins Early FDA Nod for GI Cancer Treatment
Some patients with a deadly type of tumor that forms in the gastrointestinal tract don’t respond to existing targeted therapies. On Friday the FDA approved Deciphera Pharmaceuticals drug ripretinib (Qinlock), a new treatment intended for patients with a gastrointestinal stromal tumor (GIST) who have failed at least three previous treatments. Deciphera (NASDAQ: [[ticker:DCPH]]) said the … Continue reading “Deciphera Pharmaceuticals Wins Early FDA Nod for GI Cancer Treatment”
ADC’s $233M IPO Brings It to NYSE With Cancer Drug Launch on Horizon
ADC Therapeutics is making its public markets debut, raising about $233 million six months after the cancer drug developer withdrew its initial IPO plans. Not only did Épalinges, Switzerland-based ADC go through with the stock offering this time around, it was also able to boost the deal’s size—not once, but three times. On Monday, the … Continue reading “ADC’s $233M IPO Brings It to NYSE With Cancer Drug Launch on Horizon”
Bio Roundup: FDA Dings BMS, Genfit’s Fall, Alexion’s Activist & More
This was a disappointing week for at least two major drug makers. French firm Genfit reported a trial failure in an intensely competitive indication, and New York-based Bristol Myers Squibb encountered a delay when the FDA declined to review its experimental multiple myeloma treatment. Genfit (NASDAQ: [[ticker:GNFT]]) was developing a treatment for nonalcoholic steatohepatitis, or … Continue reading “Bio Roundup: FDA Dings BMS, Genfit’s Fall, Alexion’s Activist & More”
From Overseas, Legend Biotech and Calliditas Therapeutics Eye the Nasdaq
Legend Biotech, a cancer cell therapy developer with roots in China, is preparing for a US stock exchange listing as its lead candidate keeps pace in the race for a multiple myeloma drug that addresses a new molecular target. The drug, known as JNJ-4528, is being developed in partnership with Johnson & Johnson (NYSE: [[ticker:JNJ]]) … Continue reading “From Overseas, Legend Biotech and Calliditas Therapeutics Eye the Nasdaq”
Biotech “Mapmaker” Immunai Launches With $20M to Chart the Immune System
It may seem like an unlikely link but the body’s response to arthritis may hold answers for better cancer drugs, says Luis Voloch, chief technology officer of startup Immunai. Immune cells respond to both conditions, but in different ways. Insights into the response for one disease could inform the treatment of the other, he says. … Continue reading “Biotech “Mapmaker” Immunai Launches With $20M to Chart the Immune System”
Boehringer Ingelheim Acquires Northern Biologics’ Preclinical Pipeline
Two preclinical programs developed by Canadian biotech Northern Biologics have been acquired by privately held German company Boehringer Ingelheim, which is looking to bolster its cancer immunology portfolio. The assets acquired from Northern Biologics in the deal, announced Thursday, are designed to target two aspects of what’s known as the tumor microenvironment: stroma, or connective … Continue reading “Boehringer Ingelheim Acquires Northern Biologics’ Preclinical Pipeline”
BCMA Delay: FDA Refuses Review of Bristol Drug, Asks for More Info
Bristol Myers Squibb’s bid to win FDA approval for its multiple myeloma cell therapy has hit a detour. The FDA declined to review the experimental treatment and has instead asked the company to provide more information. Bristol (NYSE: [[ticker:BMY]]) announced Wednesday that it received a “refusal to file” letter for the experimental therapy, idecabtagene vicleucel … Continue reading “BCMA Delay: FDA Refuses Review of Bristol Drug, Asks for More Info”
QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing
Few drugs exist that treat amyotrophic lateral sclerosis, a progressive disease that kills the nerve cells that allow patients to initiate and control muscle movement. QurAlis, a Cambridge, MA-based startup, has an ambitious plan to develop a number of “precision” therapies for the disease based on forms of the condition identified by genetic mutation or … Continue reading “QurAlis Hauls In $42M to Move New ALS Therapies Into Human Testing”
Oncology Biotech CEO Activates “Latent Viral Side” Against COVID-19
In every National Football League game, athletes must accomplish two difficult things that rest at opposite ends of the spectrum: rigor and speed. If their movements are off by even half a second, they risk being tackled by their opponent. Game over. In this COVID-19 day and age, believe it or not, the NFL serves … Continue reading “Oncology Biotech CEO Activates “Latent Viral Side” Against COVID-19″
Pliant Pushes Forward With IPO Plans to Back Fibrosis Drug Studies
Pliant Therapeutics has a pipeline of experimental fibrosis treatments and a research alliance with Novartis. Now the biotech is preparing an IPO to raise cash to advance its clinical-stage programs. In paperwork filed with securities regulators, Pliant set an $86 million IPO target. That amount is a placeholder figure as the South San Francisco-based biotech … Continue reading “Pliant Pushes Forward With IPO Plans to Back Fibrosis Drug Studies”
Join us this Wednesday for Xcelerating Life Sciences: Biopharma’s Future in Digital Health
Learn how digital tech is accelerating medical breakthroughs by registering your team to attend Xcelerating Life Sciences Boston: Biopharma’s Future in Digital Health. While some content focuses on the Boston ecosystem, we’re confident the forum – and virtual networking – will be valuable to a national audience. The May 13, 2020 event will explore the … Continue reading “Join us this Wednesday for Xcelerating Life Sciences: Biopharma’s Future in Digital Health”
Genfit Contender in Heated NASH Drug Race Fails in Phase 3 Study
Genfit, once considered among the frontrunners in the biotech race to commercialize a treatment for nonalcoholic steatohepatitis (NASH), has come up short. The French company said Monday that its investigational treatment, elafibranor, did not meet the main goal of a late-stage trial evaluating its ability to resolve the fatty liver disease without worsening related scarring. … Continue reading “Genfit Contender in Heated NASH Drug Race Fails in Phase 3 Study”
AMAG Pharma Cuts 140 Jobs Amid Restructuring, COVID-19 Disruptions
Disruption caused by the pandemic has intensified a round of planned layoffs at AMAG Pharmaceuticals, new CEO Scott Myers said Monday morning on his first earnings call with the company. The Waltham, MA-based firm said it would cut 140 positions, or about 30 percent of its workforce, as part of a restructuring plan announced in … Continue reading “AMAG Pharma Cuts 140 Jobs Amid Restructuring, COVID-19 Disruptions”
MyoKardia’s Heart Drug Shines in Phase 3, FDA Filing Planned for 2021
An experimental MyoKardia drug developed to treat an inherited cardiovascular condition that restricts blood flow is showing it can improve on the symptoms of this condition as well as the heart’s ability to function. MyoKardia (NASDAQ: [[ticker:MYOK]]) is testing its drug, mavacamten, in patients who have obstructive hypertrophic cardiomyopathy (HCM), a hardening and thickening of … Continue reading “MyoKardia’s Heart Drug Shines in Phase 3, FDA Filing Planned for 2021”
Dyno Debuts With Plan, Partnerships for Better Gene Therapy Vectors
Gene therapies deliver healthy genetic material to patients’ cells to replace a mutated, disease-causing variant. Dyno Therapeutics aims to create better delivery vehicles for those genes by using machine-learning tools to engineer new types of harmless viruses that are more effective and simpler to manufacture. The Cambridge, MA-based biotech emerged from stealth Monday having signed … Continue reading “Dyno Debuts With Plan, Partnerships for Better Gene Therapy Vectors”
Eli Lilly Gets Edge in the “RET” Race With FDA Nod for Cancer Drug
[Updated, 5/11/2020, 10:03 a.m. See below.] Eli Lilly received accelerated FDA approval Friday for a drug that treats advanced cancers carrying a certain genetic signature. It’s the latest targeted cancer therapy to pass the regulatory bar and the first that addresses tumors characterized by aberrations in one particular gene. The gene in question, RET, produces … Continue reading “Eli Lilly Gets Edge in the “RET” Race With FDA Nod for Cancer Drug”
Bio Roundup: Acquisitive Alexion, CRISPR on COVID, C. diff Success & More
Alexion Pharmaceuticals CEO Ludwig Hantson has made no secret that he wants to diversify his company’s drug portfolio and he has shown willingness to open the corporate checkbook to accomplish that goal. Last October, Alexion (NASDAQ: [[ticker:ALXN]]) struck a $930 million deal to acquire Achillion Pharmaceuticals, a biotech whose lead drug complements the Boston company’s … Continue reading “Bio Roundup: Acquisitive Alexion, CRISPR on COVID, C. diff Success & More”
Ayala’s IPO Raises $55M to Test Two Former Bristol Myers Cancer Drugs
Ayala Pharmaceuticals has two clinical-stage cancer drugs licensed from Bristol Myers Squibb. Now it has $55 million to take those drugs further than the pharmaceutical giant did. On Thursday evening, Ayala priced its IPO, which consisted of 3.7 million shares sold for $15 each. That price was the midpoint of the targeted $14 to $16 … Continue reading “Ayala’s IPO Raises $55M to Test Two Former Bristol Myers Cancer Drugs”
Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO
Trovagene (NASDAQ: [[ticker:TROV]]), which started out as a diagnostics company, has renamed itself Cardiff Oncology to better reflect its focus on the cancer drug it is advancing in three clinical trials. In 2017 the San Diego area-based biotech made the first step in its transformation into a drug development-focused organization, licensing rights to an investigational … Continue reading “Trovagene Rebrands as Cardiff Oncology, Promotes Longtime Exec to CEO”
PTC Therapeutics to Acquire Censa Pharma for Mid-Stage Rare Disease Drug
PTC Therapeutics has reached an agreement to acquire Censa Pharmaceuticals and its lead asset, an experimental metabolic disorder therapy that is now being prepared for a pivotal study. The deal, announced after the market close Wednesday, will bring South Plainfield, NJ-based PTC (NASDAQ: [[ticker:PTCT]]) another compound for its pipeline of rare disease drugs. Want more … Continue reading “PTC Therapeutics to Acquire Censa Pharma for Mid-Stage Rare Disease Drug”
Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation
As cancer research reveals the genetic basis of the disease, pharmaceutical companies are pursuing targeted therapies that address certain groups of patients. One such drug from Novartis won FDA approval Wednesday, making it the first therapy cleared by the agency to treat patients whose non-small cell lung cancer (NSCLC) carries a certain genetic mutation. The … Continue reading “Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation”
AstraZeneca Diabetes Drug Gets FDA OK for Reducing Heart Health Risks
An AstraZeneca diabetes drug that brought in more than $1.5 billion in sales last year has won an FDA nod expanding its use to adults with systolic heart failure, a condition in which the heart struggles to pump with enough force to push enough blood into circulation. The drug, the once-daily pill dapagliflozin (Farxiga), was … Continue reading “AstraZeneca Diabetes Drug Gets FDA OK for Reducing Heart Health Risks”
Ventus Launches With $60M to Shine Light on Innate Immune System Drugs
The innate immune system has become a hot area for drug development, and for good reason. As the body’s first line of defense, its function (or dysfunction) plays a role in many diseases. The problem, says Ventus Therapeutics CEO Marcelo Bigal, is that drug developers have been working in the dark. Scientists don’t know the … Continue reading “Ventus Launches With $60M to Shine Light on Innate Immune System Drugs”
Encouraging Signals for New Cancer Cell Therapy Strategies
Chimeric antigen receptor T-cell therapies have shown remarkable efficacy in leukemia and lymphoma patients who relapsed or were refractory to several prior treatments, but many challenges remain in the cancer cell therapy field. Strategies that may improve upon first-generation therapies were presented during the American Association for Cancer Research virtual meeting with encouraging early activity, … Continue reading “Encouraging Signals for New Cancer Cell Therapy Strategies”
Kura Narrows Pipeline After Strategic Review Prompted by COVID-19
Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: [[ticker:KURA]]) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug … Continue reading “Kura Narrows Pipeline After Strategic Review Prompted by COVID-19”
Alexion Pharma Boosts Blood Drug Lineup With $1.4B Deal for Portola
Alexion Pharmaceuticals has agreed to buy Portola Pharmaceuticals in a $1.4 billion deal that brings it a first-in-class therapy for treating life-threatening bleeding. According to financial terms announced Tuesday, Boston-based Alexion (NASDAQ: [[ticker:ALXN]]) will pay $18 for each outstanding share of Portola (NASDAQ: [[ticker:PTLA]]). That price is a a nearly 132 percent premium to Monday’s … Continue reading “Alexion Pharma Boosts Blood Drug Lineup With $1.4B Deal for Portola”
COVID-19 and Fungal Superinfections: The Deadly, Perfect Storm
Virtually unknown just a few months ago, the COVID-19 pandemic has already resulted in over 239,000 deaths worldwide—including over 67,000 in the United States alone. Now, emerging reports suggest that as many as one third of patients with severe COVID-19 infection requiring intensive care may also be battling another life-threatening infection: invasive aspergillosis, a deadly … Continue reading “COVID-19 and Fungal Superinfections: The Deadly, Perfect Storm”
Arrowhead Pharma’s Chief Operating Officer Bruce Given Retires
Bruce Given, chief operating officer and head of R&D for Arrowhead Pharmaceuticals (NASDAQ: [[ticker:ARWR]]), has retired. Given’s responsibilities are being divided among the company’s chief medical officer, chief scientific officer, and chief commercial officer. Given, who joined Arrowhead in 2011, will serve as an advisor to the Pasadena, CA, company for at least one year. … Continue reading “Arrowhead Pharma’s Chief Operating Officer Bruce Given Retires”
Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M
Stemline Therapeutics, whose drug for a rare, aggressive type of acute leukemia was approved by the FDA about 18 months ago, has signed an acquisition deal with Italian biopharma Menarini Group. Stemline (NASDAQ: [[ticker:STML]]), a New York-based company, developed the first FDA-approved drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN. The drug, tagraxofusp (Elzonris) … Continue reading “Stemline Slated for Acquisition by Menarini in Deal Worth Up to $677M”
Backed by $100M, Praxis Aims to Turn Epilepsy Research Into New Neuro Drugs
The genetic mutations that cause epilepsy don’t stop there. Praxis Precision Medicines CEO Marcio Souza says research also links these genes to other neurological conditions. The biotech startup is turning that research into new neuro drugs and it’s coming out of stealth to share details about its science and its pipeline, which already has two … Continue reading “Backed by $100M, Praxis Aims to Turn Epilepsy Research Into New Neuro Drugs”
Pfizer Pays Valneva $130M for a Bite at a Lyme Disease Vaccine
If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant … Continue reading “Pfizer Pays Valneva $130M for a Bite at a Lyme Disease Vaccine”
FDA Authorizes “Emergency” Use of Gilead’s Remdesivir for Severe COVID-19
Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was … Continue reading “FDA Authorizes “Emergency” Use of Gilead’s Remdesivir for Severe COVID-19″
Lyra Therapeutics IPO Raises $56M for Tests of Tech for Runny Noses
Lyra Therapeutics, a biotech company developing a new way to treat your persistently runny nose, has raised $56 million in its public markets debut. Late Thursday, Lyra offered 3.5 million shares priced at $16 apiece, which was the high end of its projected $14 to $16 price range. Those shares are expected to begin trading … Continue reading “Lyra Therapeutics IPO Raises $56M for Tests of Tech for Runny Noses”
Bio Roundup: Remdesivir Data, Erasca’s $200M, a New FDA Nod & More
Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 … Continue reading “Bio Roundup: Remdesivir Data, Erasca’s $200M, a New FDA Nod & More”
Podcast: How San Diego is Building a Biotech Ecosystem – Genomics & Precision Medicine Experts Weigh in
Miss the event or want to revisit the insightful content? Our new podcast packages the highlights from the recent Xcelerating Life Sciences San Diego: Biomedical Breakthroughs in Precision Medicine & Genomics forum. Listen today. Featuring expert panels on: Successful R&D models What it takes for commercialization Building a biotech ecosystem in San Diego Dozens of … Continue reading “Podcast: How San Diego is Building a Biotech Ecosystem – Genomics & Precision Medicine Experts Weigh in”
BridgeBio’s Pipeline Expansion Continues as Portfolio’s Milestones Approach
BridgeBio Pharma Inc. is poised to achieve its goal of rapidly bringing treatments for genetic diseases and genetically defined cancers to the market with two different products expected to be submitted to the US Food and Drug Administration before the end of 2021—just four years after the company’s first big funding round. Palo Alto, CA-based … Continue reading “BridgeBio’s Pipeline Expansion Continues as Portfolio’s Milestones Approach”