Latest Pharmaceuticals News

CSL has secured an exclusive agreement to co-develop and co-promote Alentis Therapeutics’ investigational drug lixudebart, committing US$355 million upfront and funding a multi-trial development programme. The antibody remains unapproved, with its commercial potential dependent on results from ongoing and planned clinical studies.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

CONNEQT Health delivered sharp FY26 revenue growth and reduced its statutory loss as Pulse sales and clinical subscriptions expanded. But the ASX-listed medtech group ended the year with negative net assets, heavy cash burn and a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Compumedics Limited (ASX:CMP) returned to profit in FY26 as record revenue, stronger cash generation and a sharp rise in MEG and SaaS sales reshaped its earnings profile. The company enters FY27 with A$28.3 million of open orders, but lower gross margins and uneven US and European execution remain key tests.

Mayne Pharma has settled patent litigation with Sun Pharma over IMVEXXY, establishing 21 October 2032 as the agreed potential generic entry date, subject to court approval. The settlement involves no upfront payment, while one further Paragraph IV dispute remains unresolved.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

Neuren says its partner Acadia has received a US Notice of Allowance for a trofinetide patent that could protect weight-banded dosing through 28 March 2041. The patent has not yet formally issued, but the allowance could extend US protection by almost five years beyond the existing method-of-use patent.

The Hydration Pharmaceuticals Company (ASX:HPC) has sharply reduced its operating losses, with Hydralyte LLC recording its first monthly EBITDA profit in August. The group remains loss-making overall, but improved margins and a lower cost base are beginning to show in the numbers.

Argent BioPharma has secured exclusive commercialisation rights to selected Tollovir, Tollovid and NutraVir antiviral products in a worldwide deal excluding China. The agreement adds a new commercial pillar alongside CimetrA®, but does not itself grant pharmaceutical development rights or establish clinical efficacy.

Firebrick Pharma has approved a phased push into US retail pharmacies after Nasodine online sales grew by more than 200% in FY26. Up to six regional pharmacy groups representing about 700 stores have expressed strong interest in early orders, although no binding orders have been disclosed.