Hookipa Pharma Inc. is looking to raise about $50 million in a public offering to further advance its lead immunotherapy candidate, HB-200, into a pivotal phase III trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) for the first-line treatment of recurrent or metastatic head and neck cancer associated with human papillomavirus (HPV) 16.
With overuse of opioids – the standard of care for many chronic pain cases – becoming something of an epidemic in the U.S., the availability of an alternative, non-opioid analgesic is a big draw. Established in 2021, Adolore Biotherapeutics Inc. is one company that could provide the answer, with its locally and long-acting gene therapies potentially providing a breakthrough that “knocks everybody’s socks off.”
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
With overuse of opioids – the standard of care for many chronic pain cases – becoming something of an epidemic in the U.S., the availability of an alternative, non-opioid analgesic is a big draw. Established in 2021, Adolore Biotherapeutics Inc. is one company that could provide the answer, with its locally and long-acting gene therapies potentially providing a breakthrough that “knocks everybody’s socks off.”
Otsuka Pharmaceutical Co. Ltd. has gone back on efforts to get its medicine, Asimtufii (aripiprazole), a long-acting maintenance treatment for schizophrenia, approved in Europe, after the EMA gave a provisional negative opinion.
With its sights firmly set on being the first company to bring a topical diabetic macular edema (DME) treatment to market, Oculis Holding AG moved a step closer to this potentially game-changing reality as its dexamethasone formulation, OCS-01, turned up a statistically significant improvement in mean BCVA – a measure of visual acuity – at the three-month mark in the phase III DIAMOND trial.
Less than a year after submitting their NDA and several weeks before the June 28 PFUFA date, Bausch + Lomb Corp. and partner Novaliq GmbH have been awarded U.S. FDA approval for Miebo, their perfluorohexyloctane eye drop formulation designed to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction.
Heightening prospects for an oral neutropenia therapy, X4 Pharmaceuticals Inc.’s lead CXCR4 antagonist mavorixafor slashed yearly infection rates in patients with WHIM syndrome by 58% in a pivotal phase III trial, an effect that was statistically significant.
Scribe Therapeutics Inc. is selling exclusive rights to its CRISPR-based technology to Prevail Therapeutics Inc. for a figure that could top $1.6 billion as the firms team up to develop genetic therapies for serious neurological and neuromuscular diseases.
Fibrogen Inc. and its co-development partners for roxadustat, Astrazeneca plc and Astellas Pharma Inc., were dealt a major blow May 5 as the oral hypoxia-inducible factor prolyl hydroxylase inhibitor failed to meet its primary efficacy endpoint in a phase III trial in patients with anemia caused by transfusion-dependent lower-risk myelodysplastic syndromes (MDS).
