Clearing the way for a U.S. regulatory bid in the second half of this year are positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of Crinetics Pharmaceuticals Inc.’s oral, once-daily paltusotine for acromegaly.
The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder.
Camurus AB’s subcutaneous octreotide hydrochloride injection pen, CAM-2029, yielded statistically significant improvements in “multiple endpoints” in a 52-week phase III extension trial in patients with acromegaly, moving it closer to providing a more convenient treatment option for patients with the rare, chronic growth disorder than currently available therapies.
As investors await an MAA submission to the EMA for U.S.-approved Mycapssa (octreotide) in acromegaly, Chiasma Inc. disclosed its plan to merge with Amryt plc in an all-stock deal, thereby gaining a global commercial presence. Terms call for the exchange of each Chiasma share for 0.396 American depositary share of Amryt. The latter closed May 4 at $12.95, so the deal values Chiasma at $5.13 per share, an 81% premium over the previous day’s ending price, noted Piper Sandler analyst Edward Tenthoff. The stock (NASDAQ:CHMA) rose $1.14, or 40%, to finish at $3.98.
HONG KONG – Peptidream Inc. inked a research collaboration with Amolyt Pharma SAS to test and optimize Peptidream’s growth hormone receptor antagonist (GHRA) peptides, with the aim of selecting a candidate to develop as a potential treatment for acromegaly.
HONG KONG – Peptidream Inc. inked a research collaboration with Amolyt Pharma SAS to test and optimize Peptidream’s growth hormone receptor antagonist (GHRA) peptides, with the aim of selecting a candidate to develop as a potential treatment for acromegaly.
Prevailing after an initial complete response letter from the FDA, Chiasma Inc. on June 26 has finally secured U.S. approval for Mycapssa, the first oral formulation of the acromegaly medicine octreotide to get a regulatory green light. Octreotide has until now only been available by injection. The drug was approved for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide, both somatostatin analogues (SSAs).
Prevailing after an initial complete response letter from the FDA, Chiasma Inc. on Friday has finally secured U.S. approval for Mycapssa, the first oral formulation of the acromegaly medicine octreotide to get a regulatory green light.
Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.