Emerging Company Profile: The US biotech is developing a series of recombinant fusion proteins to tackle alopecia and other diseases without supressing the immune system.

Public Company Edition: The former Allergan CEO is taking a special purpose acquisition corporation public to generate $460m for deals in familiar biopharma niches. Also, IPOs are expected to keep up a robust pace in the fall and Albireo raises $160m on the success of its drug for pediatric liver diseases.

USITC’s initial decision in the Medytox and Daewoong botulinum dispute is favorable to Medytox and poised to take a toll on the Korean firm and partner Evolus as they face a 10-year ban on imports of their product to the US.

As South Korea’s drug ministry decides to rescind approval of Medytox’s botulinum toxin product following manipulation of manufacturing and quality control documents, competition among existing rivals and newcomers is expected to further intensify.

New Phase III results set stage for a potential US submission in high-need indication of congenital thrombotic thrombocytopenic purpura in the next few months if company sticks to initial development plans.

Editas is seen as a slow developer in the CRISPR-based therapeutics field compared with its rivals but its new CEO has unveiled a new strategy to speed progress.

The management team talked to Scrip at J.P. Morgan about plans for launching the first gene therapy for hemophilia A in Europe and the US, and its unique approach to reimbursement.

Jasper announced data on the first three patients in the trial of briquilimab in sickle cell disease and beta-thalassemia patients, not long after another player, Magenta, announced a setback in its program.

Emerging Company Profile: Patients with oral lichen planus suffer from painful lesions in the mouth that are hard to treat with topical steroids, leaving room for development of a new delivery method for the established clobetasol.

Coming up after Lilly’s Olumiant and Pfizer’s ritlecitinib in alopecia areata, deuterated ruxolitinib is said to offer a differentiated profile including patient-reported outcomes data.

The Danish group has cut 300 jobs to shift to an external innovation sourcing model that will make Leo more competitive in the dermatology space and help it break even this year, CEO Christophe Bourdon tells Scrip.

The French major is planning a Phase II trial of KT-474 in atopic dermatitis and hidradenitis suppurativa after the asset fared well in a small Phase I trial, although some analysts remain skeptical.

Watch out Sanofi. US- and China-based Connect BioPharma is looking to position its novel biologic for atopic dermatitis to compete head-on with best-selling Dupixent both inside and outside China in an increasingly crowded space, says co-founder and CEO Wei Zheng in an exclusive interview with Scrip.

The German biotech plans to prevent chemotherapy-induced hearing loss and treat chronic hearing loss by targeting a potassium channel in the ear’s sensory hair cells as it tackles a widespread but side-lined area.

With the planned $487m acquisition of sensorineural-focused Akouos, Lilly makes its second gene therapy M&A play in two years, on top of partnering/financing activity in the space.

Otividex did not significantly reduce vertigo three months after treatment, so Otonomy appears to be moving on from Meniere’s disease and focusing on earlier-stage tinnitus and hearing loss candidates.

Cisplatin is very effective but two thirds of children treated with the drug for cancer are left with some hearing loss. If approved this year, Fennec's Pedmark could go some way to preventing that distressing side effect.

After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.

With positive Phase III data for its Xhance (fluticasone propionate) nasal spray in chronic sinusitis, Optinose believes it is poised to expand the target market for the drug 10-fold.

Setback for company's near-term launch goals and US patients with rare esophageal inflammatory condition as regulator asks for additional clinical data. 

Further competition to Sanofi/Regeneron’s Dupixent in nasal polyps is on the horizon but the newcomers will have some catching up to do.

The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.

In this week's podcast edition of Five Must-Know Things: a market snapshot of inflammatory bowel disease; will biotech bounce back in 2023?; Phase III miss for Roche’s Alzheimer’s candidate; how Japan’s top firms did in the quarter; and China showcase hints at policies and strategies.

Japan-UK firm is looking to build on a combination of internal and external assets to pursue a more independent business development path in Japan and beyond, in parallel with ongoing discovery and development collaborations.

Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.

After failure to close of a potential $177m buyout by EW Pharma, TherapeuticsMD will resolve its debt by selling its three-product women’s health portfolio to Mayne.

The Swiss firm has divested yet another one of its key programs in a bid to stave off insolvency and remain a listed company, forcing it to focus solely on a pre-IVF drug candidate.

After fighting for years to bridge the gender health gap where many women receive poorer treatment than men from academia and non-profits, Kelle Moley has moved into pharma with Ferring to further her vision.

Sumitovant, a Sumitomo subsidiary, will pay $27 per share for the 48% of Myovant shares it does not already own, for a deal value of $1.7bn, up from a $22.75-per-share bid in early October.

The French firm is paying a 104% premium plus contingent value rights of an additional $10 per share to get hold of AstraZeneca spin-off Albireo and its lead asset Bylvay, which is approved for progressive familial intrahepatic cholestasis and is showing promise in two other more lucrative indications.

Two clinical trial announcements in the same NASH indication separated by almost nine years had very similar stock price reactions despite the known unknowns of NASH remaining unknown.

While plans to obtain accelerated approval of lanifibranor remain unchanged, Inventiva now plans to conduct the confirmatory Phase III in cirrhotic patients, meaning a shorter trial duration and possibly broader label.

Nearly two-and-a-half years after an FDA complete response letter stalled obeticholic acid’s path to the first approval in non-alcoholic steatohepatitis, Intercept refiled its NDA on 23 December.

The diabetic retinopathy candidate failed on its Phase II primary endpoint, but showed efficacy on a key secondary endpoint that the company hopes to use as the Phase III primary outcome measure.

The company will buy Oyster Point Pharma and Famy Life Sciences for $700m to $750m in total as management tries to move the business towards more innovation.

The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.

The company announced 24-week results from the Phase II BEHOLD trial in diabetic macular edema patients already treated with anti-VEGF therapy, showing gains in a tough population.

Emerging Company Profile: US firm Peptilogics is advancing through the clinic with its lead orthopedic anti-infective drug candidate based on an AI platform that utilizes algorithms to improve peptide design.

Faced with a scarily short cash runway and an ongoing expensive mid-stage study of an allogeneic cell therapy for the treatment of delayed-union bone fractures, Bone Therapeutics has found a saviour in France's Medsenic.

Major Korean firm Yuhan is seeing progress across multiple novel drug candidates licensed out to global partners, with two now entering pivotal trials. An innovative therapy for degenerative disc disease licensed to Spine BioPharma has received an FDA nod for a Phase III program and may change the standard of care for chronic low back pain patients.

The company said the study of JTA-004 failed to meet its primary and key secondary endpoints, though a post-hoc analysis indicated activity in a patient subset.

The sale of BTG Specialty Pharmaceuticals to two affiliates of European specialty firm SERB leaves Boston Scientific with BTG’s interventional oncology and vascular products.

Two major initiatives have been announced which hope to revolutionize the treatment of snakebites, which claims the lives of up to 138,000 people a year.

Addex Therapeutics says its licensing deal with Indivior to develop and commercialize its investigative addiction therapy ADX71441 'buys time' to find resources for progressing its own pipeline.

Much of the attention at the 2015 World Health Assembly (WHA) in Geneva, Switzerland later this month is expected to be focused on reforming the World Health Organization (WHO) and the failures by the international public health agency in responding to the ongoing Ebola epidemic in West Africa.

The French firm’s lead asset has impressed in a Phase IIa trial in sepsis patients at risk of kidney injury, triggering discussions with regulators for a path forward in the challenging and life-threatening condition.

The US biotech’s dual cytokine inhibitor has hit significance in a mid-stage trial with plans underway for a Phase III study, but concerns about its lacklustre efficacy when compared with a rival candidate from Chinook have taken the wind out of its sails.

The Swedish biotech has added another $40m to its coffers as it advances its potential ‘pipeline in a product’ for kidney disease.

The Swedish biotech’s successful launch in the US of Tarpeyo for immunoglobulin A nephropathy is progressing well and a Chinese approval is on the horizon as partner Everest’s application is accepted by regulators.

Centaur-CytoTools introduces novel topical treatment for diabetic foot ulcers in India, for which they see limited direct competition and hope to change the way the difficult-to-treat diabetes complication is managed. Phase III studies are ongoing in Europe.

Ghent, Belgium-based start-up, AgomAb Therapeutics NV secures funds and license to develop HGF-mimetic agonistic monoclonal antibodies for regeneration of damaged tissues.

Focused on autologous fibroblast cell therapies for rare diseases, the biotech appears cash-poor despite one candidate moving into Phase II and another ready to enter the clinic.

CEO Crowley points to the need to focus on a pair of Fabry candidates, including the pending NDA for migalastat, and notes that other companies have reached Phase III in EB.