Ones To Watch News
Refine Search
Biotechnology
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022
Pharmaceutical
Shares of Clinical stage US biotech Minerva Neurosciences were up more than 5% at $4.35 pre-market, after it said it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. 23 August 2022
Pharmaceutical
Shares of US ophthalmic drugs specialist Aerie Pharmaceuticals shot up 34.55 to $15.00 pre-market, after it was announced it has entered into a definitive merger agreement through which Switzerland-headquartered eye-care company Alcon will acquire Aerie. 23 August 2022
Biotechnology
Following in the steps of US mRNA biotech Moderna, which last week gained a first regulator approval for its bivalent vaccine, now BioNTech and Pfizer say they have completed their submission to the US Food and Drug Administration (FDA) today requesting an Emergency Use Authorization of a 30µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years and older. 22 August 2022
Biotechnology
Singapore-based Tessa Therapeutics, a Temasek-backed clinical stage biotech company, today announced the appointment of Thomas Willemsen as its president and chief executive, effective October 1, 2022. 22 August 2022
Biotechnology
Roche majority-owned Japanese drugmaker Chugai Pharmaceutical has entered into a license agreement for Noile-Immune Biotech’s proprietary PRIME (proliferation-inducing and migration-enhancing) CAR-T technology. 22 August 2022
Pharmaceutical
US central nervous system specialist Axsome Therapeutics saw its shares close up more than 40% at $59.55 on Friday, after it revealed that the US Food and Drug Administration (FDA) has approved its Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. 22 August 2022
Pharmaceutical
The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has reviewed data on the monkeypox vaccine Imvanex used as an intradermal injection. 20 August 2022
Pharmaceutical
Italian drugmaker Alfasigma has signed an agreement to acquire the entire share capital of Sofar, a company with over half a century of operational history in the research, production and marketing of drugs, medical devices and food supplements. 18 August 2022
Biotechnology
US clinical-stage biotech firm Karuna Therapeutics recently announced positive top-line results from the Phase III EMERGENT-2 trial of KarXT (xanomeline + trospium chloride) in acutely psychotic hospitalized adult patients with schizophrenia. 18 August 2022
Biotechnology
Shares of China-based immuno-oncology-focussed biotech I-Mab plunged more than 13% to $6.90 yesterday, after the company revealed in a filing with the Securities and Exchange Commissions that AbbVie has discontinued a Phase I trial of I-Mab's anti-CD47 monoclonal antibody lemzoparlimab, which the US pharma major in-licensed for an upfront $180 million 2020. 18 August 2022
Biotechnology
Ideaya Biosciences has announced its financials for second-quarter 2022, saying it has a strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022, which is anticipated to fund planned operations into 2025. 17 August 2022
Biotechnology
US biotech Viridian Therapeutics has commenced an underwritten public offering of $175 million of shares of its common stock and series B preferred stock. 16 August 2022
Biotechnology
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
Biotechnology
Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022
Biotechnology
Switzerland-headquartered biotech Addex Therapeutics today announced that its collaboration agreement with UK-based Indivior for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023. 15 August 2022
Biotechnology
PsiOxus, a clinical-stage biotechnology company developing a novel platform technology for the targeted delivery of therapeutic transgenes to solid tumors, has announced the appointment of its new chief executive, Howard Davis. 12 August 2022
Biotechnology
Belgo-Dutch autoimmune diseases specialist argenx has announced that the European Commission (EC) has approved Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 11 August 2022
Biotechnology
Dutch rare diseases biotech firm ProQR Therapeutics today provided an update on its ophthalmology programs following feedback from the European Medicines Agency (EMA) related to sepofarsen and will now focus exclusively on its Axiomer RNA-editing technology platform. 11 August 2022
Biotechnology
Gemini Therapeutics and privately-held clinical-stage Disc Medicine today announced a merger agreement to create a NASDAQ-listed, clinical stage biopharma focused on advancing Disc’s pipeline of hematology programs. 10 August 2022
Biotechnology
Epitopea, a UK and Canada-based cancer immunotherapeutics company, has partnered with nucleic acid delivery specialist Genevant Sciences to develop new RNA-based therapies targeting proprietary tumor antigens. 20 December 2024
Pharmaceutical
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
Pharmaceutical
Privately-held Xcovery Holdings, an oncology-focused pharma company, has announced that the US Food and Drug Administration (FDA) has approved Ensacove (ensartinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 19 December 2024
Biotechnology
Privately-held biotech Ottimo Pharma today announces the completion of a Series A financing round of over $140 million. 19 December 2024
Biotechnology
Safi Biotherapeutics, a specialist in stem-cell derived red blood cell products, has received Rare Pediatric Disease designation and Orphan Drug designation from the US regulator. 19 December 2024
Biotechnology
BioAge Labs today announced a multi-year research collaboration with Swiss pharma giant Novartis, with the news pushing the US biotech’s shares up 6.1% to $4.35 by early afternoon. 18 December 2024
Pharmaceutical
Marking its second deal this month alone, Novo Nordisk has entered into a multi-year collaboration with Massachusetts, USA-based Photys Therapeutics to develop novel proximity-based therapeutics for a cardiometabolic disease target. 18 December 2024
Biotechnology
Cara Therapeutics and Tvardi Therapeutics have announced a definitive agreement to merge, creating a new entity under the Tvardi name. 18 December 2024
Pharmaceutical
SiteOne Therapeutics has announced the completion of a $100 million series C financing, led by Novo Holdings, with participation from OrbiMed, Wellington Management, Mission BioCapital, and others. 18 December 2024
Biotechnology
Flagship Pioneering-founded genome engineering biotech Tessera Therapeutics today announced an investment of up to $50 million from the Bill & Melinda Gates Foundation to develop curative, globally accessible in vivo genetic therapies for sickle cell disease. 18 December 2024
Biotechnology
San Francisco-based Indapta Therapeutics, a privately held start-up developing next-generation cell therapies, has raised $22.5 million in a new financing round. The firm raised over $50 million in series A funding in 2022. 18 December 2024
Biotechnology
French CNS specialist Theranexus saw its shares leap more than 34% to 0.65 euros as it revealed a license and supply agreement with Exeltis to commercialize TX01, its novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases. 18 December 2024
Biotechnology
Shares in US biopharma Viridian Therapeutics shot up by 21% on Monday. 17 December 2024
Biotechnology
US antivirals giant Gilead Sciences today revealed it has entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets with Californian biotech Terray Therapeutics. 17 December 2024
Pharmaceutical
Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Biotechnology
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Biotechnology
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
Biotechnology
In a filing with the US financial regulator, German mRNA specialist BioNTech has noted the lifting of a partial clinical hold on its PRESERVE-003 trial. 16 December 2024
Biotechnology
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
Biotechnology
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze