Company Product Description Indication Status
Acceleron Pharma Inc., of Cambridge, Mass. Sotatercept  Ligand trap for members of the TGF-beta superfamily Pulmonary arterial hypertension FDA granted breakthrough therapy designation
Aeglea Biotherapeutics Inc., of Austin, Texas ACN-00177  Recombinant enzyme that degrades homocysteine and homocystine dimers Homocystinuria U.K.’s Medicines and Healthcare Products Regulatory Agency approved the CTA
Aeterna Zentaris Inc., of Charleston, S.C. Macimorelin  Ghrelin agonist Growth hormone deficiency EMA agreed to adjust the company's pediatric investigation plan, so study P02 can be used to meet requirements for FDA and EMA.
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) N-methyl-D-aspartate receptor glutamate receptor antagonist COVID-19 Company received positive feedback from Health Canada's office of clinical trials and plans to submit a CTA for a phase II study within the next week
Bellerophon Therapeutics Inc., of Warren, N.J. Inopulse  Inhaled nitric oxide system COVID-19 Submitted IND to the FDA
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) and Yervoy (ipilimumab) Monoclonal antibodies targeting PD-1 and CTLA4 First-line metastatic or recurrent non-small-cell lung cancer with no EGFR or ALK genomic tumor aberrations FDA accepted the supplemental BLA for the drugs in combination with a limited course of chemotherapy and granted a priority review with a PDUFA date of Aug. 6, 2020; EMA validated the type II variation for the same indication
Nicox SA, of Sophia Antipolis, France NCX-4251 Ophthalmic suspension of fluticasone propionate that targets the glucocorticoid receptor Blepharitis and dry eye disease Reached agreement with FDA on phase IIb trial designs for both acute exacerbations of blepharitis and the reduction of signs and symptoms of dry eye disease 
Polaryx Therapeutics Inc., of Paramus, N.J. PLX-200 Binds to the retinoid X receptor-alpha Juvenile neuronal ceroid lipofuscinosis FDA approved the IND application
Roche Holding AG, of Basel Switzerland Risdiplam  Survival motor neuron-2 splicing modifier Spinal muscular atrophy FDA extended PDUFA date to Aug. 24, 2020, to allow time to review data from part 2 of the Sunfish study, which was submitted in February 2020

Notes

For more information about individual companies and/or products, see Cortellis.

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