→ Closing in on 3 years since Bristol-Myers $BMY struck an option deal to buy Promedior for up to $1.25 billion, the biotech says that it’s gained breakthrough therapy status for its star fibrosis drug PRM-151, now in a Phase III program for IPF. Promedior says that regulators based their decision on positive Phase II results, which set up the newly launched late-stage program. Researchers will be using forced vital capacity as a primary endpoint and six-minute walk distance as the key secondary endpoint.
→ Merck-partnered NASH hopeful NGM Biopharma on Monday broke out the terms of its IPO. The company, which plans to list on the Nasdaq under the symbol NGM, is offering about 6.7 million shares priced between $14 to $16, according to the filing. At the midpoint of the range, the company would command a market value of more than $1 billion. Net proceeds from the offering — excluding the $62 million Merck $MRK is forking over in a concurrent private placement — are expected to be roughly $89.5 million. Fellow NASH drug developer Genfit is also readying plans for its own IPO.
→ Looks like somebody got their wires crossed. In a strange turn of events, bluebird bio $BLUE issued a statement that the EMA’s CHMP has not issued its recommendation on the company’s gene-replacement therapy LentiGlobin, after two charities — Associazione Veneta Lotta alla Talassemia and the UK Thalassaemia Society — announced on Monday that the keenly anticipated treatment (expected to carry a seven-figure price tag) for beta thalassemia — a rare, inherited blood disorder — had secured conditional EU approval.
→ About a year following its US approval for Crysvita for patients with X-linked hypophosphatemia (XLH) — an inherited form of rickets — in adult and pediatric patients, Ultragenyx $RARE has secured the first Latin American nod for the pricey rare disease drug that has inspired analysts to predict blockbuster peak sales. On Tuesday, the drugmaker said it had won approval for the drug in Brazil. Crysvita is also approved for use in Europe and Canada.
→ Eiger BioPharma‘s $EIGR experimental GLP-1 antagonist, avexitide, has cleared a Phase II study by improving glucose levels and suppressed insulin levels relative to placebo in post-bariatric surgery patients, the company said on Monday. “With avexitide in PBH (post-bariatric hypoglycemia) representing only $0.36 of our $47 EIGR price target, we reiterate that this program represents essentially a free call option for investors,” Baird analysts wrote in a note.
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