Latest Pharmaceuticals News

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.

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.

Paradigm Biopharmaceuticals has entered voluntary administration after its pivotal Phase 3 trial produced an interim efficacy result below the threshold required for continuation. The company’s securities will remain suspended while administrators assess its viability, liabilities and possible restructuring options.

Firebrick Pharma has received a $293,000 R&D Tax Incentive payment linked to $673,000 of eligible development spending on new Nasodine products. The non-dilutive cash arrives as the company broadens its product range and pursues approvals in additional markets.

Avenira Limited (ASX: AEV) has pushed back the closing date of its $48.87 million renounceable rights issue by a week, responding to shareholder demand and expanding eligibility to overseas investors.

BLS Pharmaceuticals (ASX: BLS) reported a standout FY26 with revenue surging 161% to $74.2 million and net profit more than tripling to $15.4 million, driven by expanded manufacturing and major international contracts including a $50 million German supply deal.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

LTR Pharma is shifting gears from clinical trials to commercial rollout, securing US partnerships for ROXUS and reporting encouraging SPONTAN Phase II data that supports FDA approval ambitions.

Rua Bioscience's FY26 results highlight a 71% surge in customer revenue driven by international expansion, yet the company continues to face significant losses and going concern risks.

Clinuvel Pharmaceuticals marked its tenth consecutive profit with stable revenues and rising cash reserves, while accelerating U.S. expansion including a Nasdaq uplisting and potential ASX delisting.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.